Colporrhaphy compared with mesh or graft-reinforced vaginal paravaginal repair for anterior vaginal wall prolapse: a randomized controlled trial. Outcome after anterior vaginal prolapse repair: a randomized controlled trial. Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse. Anterior colporrhaphy versus repair with mesh for anterior vaginal wall prolapse: a comparative clinical study. Primary surgical repair of anterior vaginal prolapse: a randomised trial comparing anatomical and functional outcome between anterior colporrhaphy and trocar-guided transobturator anterior mesh. Vaginal repair with mesh versus colporrhaphy for prolapse: a randomised controlled trial. Vaginal mesh for prolapse: a randomized controlled trial. Trocar-guided mesh compared with conventional vaginal repair in recurrent prolapse: a randomized controlled trial. Anterior repair with or without collagen matrix reinforcement: a randomized controlled trial. Laparoscopic sacral colpopexy versus total vaginal mesh for vaginal vault prolapse: a randomized trial. Randomized prospective comparison of needle colposuspension versus endopelvic fascia plication for potential stress incontinence prophylaxis in women undergoing vaginal reconstruction for stage III or IV pelvic organ prolapse. The Continence Program for Women Research Group. Anterior vaginal wall prolapse: a randomized controlled trial of SIS graft versus traditional colporrhaphy. A randomized controlled trial comparing fascia lata and synthetic mesh for sacral colpopexy. Symptom resolution and sexual function after anterior vaginal wall repair with or without polypropylene mesh. Comparison of polyglycolic acid and polypropylene mesh for rectopexy in the treatment of rectal prolapse. Porcine skin collagen implants to prevent anterior vaginal wall prolapse recurrence: a multicenter, randomized study. Abdominal sacral colpopexy or vaginal sacrospinous colpopexy for vaginal vault prolapse: a prospective randomized study. Rectocele repair: a randomized trial of three surgical techniques including graft augmentation. Anterior colporrhaphy: a randomized trial of three surgical techniques. Transanal or vaginal approach to rectocele repair: a prospective, randomized pilot study. A prospective randomized trial using solvent dehydrated fascia lata for the prevention of recurrent anterior vaginal wall prolapse. Randomised comparison of Burch colposuspension versus anterior colporrhaphy in women with stress urinary incontinence and anterior vaginal wall prolapse. A randomised controlled trial evaluating the use of polyglactin mesh, polydioxanone and polyglactin sutures for pelvic organ prolapse surgery. Infracoccygeal sacropexy or sacrospinous suspension for uterine or vaginal vault prolapse. Porcine skin collagen implants for anterior vaginal wall prolapse: a randomised prospective controlled study. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. A randomised controlled trial comparing abdominal and vaginal prolapse surgery: effects on urogenital function. Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence. A randomized comparison of polypropylene mesh surgery with site-specific surgery in the treatment of cystocoele. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomized study with long-term outcome evaluation. Tension-free vaginal tape and laparoscopic mesh colposuspension for stress urinary incontinence. Randomized controlled trial between perineal and anal repairs of rectocele in obstructed defecation. Randomized clinical trial of laparoscopic versus open abdominal rectopexy for rectal prolapse. Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial. Surgery for genitourinary prolapse and stress incontinence: a randomized trial of posterior pubourethral ligament plication and Pereyra suspension. Clinical and functional results of abdominal rectopexy with absorbable mesh-graft for treatment of complete rectal prolapse. Comparison of J-pouch and coloplasty pouch for low rectal cancers: a randomized, controlled trial investigating functional results and comparative anastomotic leak rates. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Prevention of postoperative urinary stress incontinence after surgery for genitourinary prolapse. Laparoscopic Burch colposuspension: a randomized controlled trial comparing two transperitoneal surgical techniques. A randomised trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence. Must colposuspension be associated with sacropexy to prevent postoperative urinary incontinence? Autologous fascial sling vs polypropylene tape at short-term followup: a prospective randomized study. Role of prostaglandin in the management of prelabour rupture of the membranes at term.
To report 2-year outcomes of a randomized controlled trial comparing standard anterior colporrhaphy with reinforced vaginal paravaginal repair using xenograft or synthetic mesh in women with symptomatic anterior vaginal wall prolapse.
                Women with stage II or greater anterior prolapse were randomly assigned to three groups: anterior colporrhaphy, paravaginal repair with porcine dermis, or polypropylene mesh. Outcomes of prolapse stage, quality of life, degree of bother, and sexual symptoms were assessed by blinded examiners and validated measures at 2 years. Anatomic failure was defined as anterior prolapse at stage II or greater. Composite failure was defined as symptoms of "bulge" and anterior prolapse at stage II or greater. Power calculations determined 33 participants per arm would detect a 40% difference in anatomic success between standard and grafted repair. χ, Mann-Whitney U, and Student's t tests were used for comparisons.
                Of the 99 participants enrolled, 78 (79%) completed a minimum of 2-year follow-up. Those with mesh had a significantly lower anatomic failure rate (18%) than both the porcine (46%, P=.015) and colporrhaphy groups (58%, P=.002). All groups had statistically similar reductions in their prolapse and urinary symptom subscale scores. Composite failure was not statistically different between groups: 13% colporrhaphy, 12% porcine, and 4% mesh. Two reoperations for anterior prolapse occurred in the porcine group. Mesh erosion rates were 14% for the mesh group.
                Vaginal paravaginal repair with polypropylene mesh has the lowest anatomic failure rate when compared with that with xenograft and anterior colporrhaphy without differences in composite failures.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT0139171.
                I. To report 1-year outcomes of a randomized controlled trial comparing polypropylene mesh-reinforced anterior vaginal prolapse repair with anterior colporrhaphy.
                Seventy-six patients with stage II or greater anterior vaginal prolapse were randomly assigned to either colporrhaphy or polypropylene mesh repair. The primary outcome was recurrent stage II anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, blood loss, length of hospitalization, and adverse events.
                Thirty-eight women had anterior colporrhaphy, and 37 had polypropylene mesh repair. One patient allocated to mesh repair withdrew from the study before surgery. Clinical and demographic data did not differ significantly between the two treatment groups. One year after surgery, optimal and satisfactory anterior vaginal support were obtained in 21 of 38 (55%) of the colporrhaphy group and 33 of 38 (87%) of the mesh group (P=.005). Patients in both groups reported less bother after surgery in both prolapse and urinary symptoms. The rates of de novo dyspareunia were 4 of 26 (16%) and 2 of 23 (9%) in the colporrhaphy and mesh groups, respectively. Two of 37 (5%) patients had vaginal mesh extrusion. Nine anterior colporrhaphy patients would have to have recurrent anterior vaginal prolapse to prevent one vaginal mesh extrusion. Neither serious adverse events nor deaths occurred in either group.
                Anterior vaginal prolapse repair with polypropylene mesh reinforcement offers lower anatomic recurrence than anterior colporrhaphy at one year. However, quality of life and sexual symptoms scores improved in both groups. The use of standardized mesh kits for repair of pelvic-organ prolapse has spread rapidly in recent years, but it is unclear whether this approach results in better outcomes than traditional colporrhaphy.
                In this multicenter, parallel-group, randomized, controlled trial, we compared the use of a trocar-guided, transvaginal polypropylene-mesh repair kit with traditional colporrhaphy in women with prolapse of the anterior vaginal wall (cystocele). The primary outcome was a composite of the objective anatomical designation of stage 0 (no prolapse) or 1 (position of the anterior vaginal wall more than 1 cm above the hymen), according to the Pelvic Organ Prolapse Quantification system, and the subjective absence of symptoms of vaginal bulging 12 months after the surgery.
                Of 389 women who were randomly assigned to a study treatment, 200 underwent prolapse repair with the transvaginal mesh kit and 189 underwent traditional colporrhaphy. At 1 year, the primary outcome was significantly more common in the women treated with transvaginal mesh repair (60.8%) than in those who underwent colporrhaphy (34.5%) (absolute difference, 26.3 percentage points; 95% confidence interval, 15.6 to 37.0). The surgery lasted longer and the rates of intraoperative hemorrhage were higher in the mesh-repair group than in the colporrhaphy group (P<0.001 for both comparisons). Rates of bladder perforation were 3.5% in the mesh-repair group and 0.5% in the colporrhaphy group (P=0.07), and the respective rates of new stress urinary incontinence after surgery were 12.3% and 6.3% (P=0.05). Surgical reintervention to correct mesh exposure during follow-up occurred in 3.2% of 186 patients in the mesh-repair group.
                As compared with anterior colporrhaphy, use of a standardized, trocar-guided mesh kit for cystocele repair resulted in higher short-term rates of successful treatment but also in higher rates of surgical complications and postoperative adverse events. (Funded by the Karolinska Institutet and Ethicon; ClinicalTrials.gov number, NCT00566917.). To compare the clinical effectiveness of anterior colporrhaphy versus mesh repair as surgical management of anterior vaginal prolapse.
                Of 50 patients with ≥stage II anterior vaginal prolapse on Pelvic Organ Prolapse Quantification (POPQ) system who were initially approached, 44 consented and underwent surgery. They were randomly recruited into two groups. Group I (23 patients) received anterior colporrhaphy, while group II (21 patients) received soft polypropylene mesh (GYNEMESH*PS, Gynecare, Ethicon, France). Clinical assessment took place preoperatively and postoperatively at definite intervals. Functional and anatomical comparisons were based on comparison between preoperative and 24 months postoperative assessments of symptoms and POPQ stages, respectively. Four patients in total did not complete the follow-up assessments and were excluded.
                Both groups showed clinical improvement in their symptoms and POPQ staging at the end of the postoperative follow-up period. Improvement, however, was more significant in the repair with mesh group, as patients in this group reported better improvement of their prolapse symptoms, mainly vaginal bulge/pressure sensation (P < 0.05), and showed better improvement in the anatomical staging, individual POP-Q points Aa and Ba (P < 0.01), than the anterior colporrhaphy group. Group II also showed more satisfactory outcome with the general POP-Q staging (P < 0.05) than group I, reflecting a better quality of life of the patients in the repair with mesh group.
                Our data shows that repair with mesh is superior to anterior colporrhaphy with more satisfactory outcome to the patients. Due to the small size of our study and uncertainty of the long-term safety and resilience of the mesh, we recommend larger studies to confirm our preliminary results. To compare anterior colporrhaphy with a trocar-guided transobturator mesh procedure (Avaulta(®) anterior).
                Randomised, controlled trial.
                Three teaching hospitals.
                Women with a symptomatic cystocele at least stage II requiring primary surgical correction.
                A total of 125 women were assessed at baseline and 1-year follow up. A sacrospinous hysteropexy or posterior colporrhaphy was performed when indicated.
                The primary outcome was the difference in anatomical cure (defined as Pelvic Organ Prolapse-Quantification <stage II cystocele). Secondary outcomes were complications, self-reported urogenital symptom severity, and quality of life, as measured with validated questionnaires.
                In all, 64 women were allocated to the anterior colporrhaphy group and 61 to the mesh group; 58/64 women versus 56/61 completed 12 months of follow-up analysis. Compared with the anterior colporrhaphy group, the mesh reduced the risk of anatomical failure at 12 months follow up from 59 to 9% (risk reduction 50.3%, 95% CI 35.5-65.1). Only three (5%) re-operations for anatomical failure in the anterior colporrhaphy group were performed versus 0% in the mesh group. Functional outcome improved significantly at 12 months on almost all domains, with similar results between groups. Mesh exposure occurred in two (4%) women. Baseline dyspareunia disappeared significantly more often after an anterior colporrhaphy (80%) than in the mesh group (20%). There was a trend towards more de novo dyspareunia in the mesh group (15% versus 9%).
                Primary cystocele repair with trocar-guided transobturator mesh resulted in a statistically significant better anatomical outcome compared with the anterior colporrhaphy. However, functional outcome was similar between groups.
                © 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG. To compare vaginal repair augmented by mesh with traditional colporrhaphy for the treatment of pelvic organ prolapse.
                Prospective randomised controlled trial.
                Tertiary teaching hospital.
                One hundred and thirty-nine women with stage >or=2 prolapse according to the pelvic organ prolapse quantification (POP-Q) system requiring both anterior and posterior compartment repair.
                Subjects were randomised to anterior and posterior vaginal repair with mesh augmentation (mesh group, n = 69) or traditional anterior and posterior colporrhaphy (no mesh group, n = 70).
                The primary outcome was the absence of POP-Q stage >or=2 prolapse at 12 months. Secondary outcomes were symptoms, quality-of-life outcomes and satisfaction with surgery. Complications were also reported.
                For subjects attending the 12-month review, success in the mesh group was 81.0% (51 of 63 subjects) compared with 65.6% (40/61) in the no mesh group and was not significantly different (P-value = 0.07). A high level of satisfaction with surgery and improvements in symptoms and quality-of-life data were observed at 12 months compared to baseline in both groups, but there was no significant difference in these outcomes between the two groups. Vaginal mesh exposure occurred in four women in the mesh group (5.6%). De novo dyspareunia was reported by five of 30 (16.7%) sexually active women in the mesh group and five of 33 (15.2%) in the no mesh group at 12 months.
                In this study, vaginal surgery augmented by mesh did not result in significantly less recurrent prolapse than traditional colporrhaphy 12 months following surgery. To present 3-month outcomes of a double-blind, multicenter randomized controlled trial comparing traditional vaginal prolapse surgery without mesh with vaginal surgery with mesh.
                Women with pelvic organ prolapse quantification prolapse stages 2-4 were randomized to vaginal colpopexy repair with mesh or traditional vaginal colpopexy without mesh. The primary outcome measure was objective treatment success (pelvic organ prolapse quantification stage 1 or lower) at 3 months. Secondary outcome measures included quality-of-life variables and complication rates.
                Sixty-five women were recruited from January 2007 to August 2009, when the study was halted due to predetermined stopping criteria for vaginal mesh erosion at a median follow-up of 9.7 months (range, 2.4-26.7 months). Thirty-two women underwent mesh colpopexy (24 anterior mesh, eight total mesh), and 33 women had vaginal colpopexies without mesh (primarily uterosacral ligament suspension) and concurrent colporrhaphy. There were no statistically significant baseline differences between the mesh and no-mesh groups with respect to demographics, menopausal status, and race. Analysis of the mesh and no-mesh women found no difference with respect to overall recurrence (mesh: 19 [59.4%] compared with no mesh: 24 [70.4%], P=.28). There were five (15.6%) vaginal mesh erosions. Two cystotomies and one blood transfusion occurred in the mesh group only. Subjective cure of bulge symptoms was noted in 93.3% of mesh patients and 100% of no-mesh patients. Furthermore, subjective quality-of-life measurements did not differ between the two groups at baseline or 3 months postoperatively.
                At 3 months, there is a high vaginal mesh erosion rate (15.6%) with no difference in overall objective and subjective cure rates. This study questions the value of additive synthetic polypropylene mesh for vaginal prolapse repairs.
                Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540.
                I. To compare efficacy and safety of trocar-guided tension-free vaginal mesh insertion with conventional vaginal prolapse repair in patients with recurrent pelvic organ prolapse.
                Patients with recurrent pelvic organ prolapse stage II or higher were randomly assigned to either conventional vaginal prolapse surgery or polypropylene mesh insertion. Primary outcome was anatomic failure (pelvic organ prolapse stage II or higher) in the treated vaginal compartments. Secondary outcomes were subjective improvement, effects on bother, quality of life, and adverse events. Questionnaires such as the Incontinence Impact Questionnaire and Urogenital Distress Inventory were administered at baseline, 6 months, and 12 months. Anatomic outcomes were assessed by an unblinded surgeon. Power calculation with α=0.05 and β=0.80 indicated that 194 patients were needed.
                Ninety-seven women underwent conventional repair and 93 mesh repair. The follow-up rate after 12 months was 186 of 190 patients (98%). Twelve months postsurgery, anatomic failure in the treated compartment was observed in 38 of 84 patients (45.2%) in the conventional group and in eight of 83 patients (9.6%) in the mesh group (P<.001; odds ratio, 7.7; 95% confidence interval, 3.3-18). Patients in either group reported less bulge and overactive bladder symptoms. Subjective improvement was reported by 64 of 80 patients (80%) in the conventional group compared with 63 of 78 patients (81%) in the mesh group. Mesh exposure was detected in 14 of 83 patients (16.9%).
                At 12 months, the number of anatomic failures observed after tension-free vaginal mesh insertion was less than after conventional vaginal prolapse repair. Symptom decrease and improvement of quality of life were equal in both groups.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00372190.
                I. To compare outcomes of anterior colporrhaphy alone to that reinforced with bovine pericardium graft.
                Women with anterior vaginal wall prolapse were enrolled in a randomized fashion in this grafted compared with nongrafted repair study. Outcome measures included pelvic organ prolapse quantification data, quality-of-life assessment, healing abnormalities, and complications.
                Ninety-four patients were enrolled. Seventy-two (77%) provided 1-year data, and 59 (63%) supplied 2-year data. Demographics and stage of prolapse were similar between groups at baseline. Postoperative complications consisted basically of low urinary tract infection and were low in both groups (10 in bovine pericardium graft and 16 in anterior colporrhaphy alone). One year after surgery, successful anterior vaginal wall support was obtained in 85.7% of the bovine pericardium graft group and 78.4% of anterior colporrhaphy-alone group (P=.544). For the cohort that comprised 2-year analyses, the success rate was 76.5% for the bovine pericardium graft group and 63% for anterior colporrhaphy-alone group (P=.509). Postoperative Urogenital Distress Inventory-6 and Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire-12 scores were uniformly improved over baseline in both groups.
                The use of bovine pericardium graft for anterior vaginal prolapse does not have higher complication rates or healing difficulties. At 1- and 2-year follow-up, anterior colporrhaphy with bovine pericardium reinforcement did not show a statistically significant improvement over colporrhaphy alone.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00860912
                I. To compare the laparoscopic sacral colpopexy and total vaginal mesh for vaginal vault prolapse.
                Women with symptomatic stage ≥2 vault prolapse were randomly allocated the laparoscopic sacral colpopexy (53) or total vaginal mesh (55). Primary outcome measures were objective success rates at pelvic organ prolapse quantification sites individually and collectively. Secondary outcome measures included perioperative outcomes, patient satisfaction, quality of life outcomes, complications, and reoperations.
                The laparoscopic sacral colpopexy group had a longer operating time, reduced inpatient days, and quicker return to activities of daily living as compared with the total vaginal mesh group. At the 2-year review, the total objective success rate at all vaginal sites was 41 of 53 (77%) for laparoscopic sacral colpopexy as compared with 23 of 55 (43%) in total vaginal mesh (P < .001). Reoperation rate was significantly higher after the vaginal mesh surgery 12 of 55 (22%) as compared with laparoscopic sacral colpopexy 3 of 53 (5%) (P = .006).
                At 2 years, the laparoscopic sacral colpopexy had a higher satisfaction rate and objective success rate than the total vaginal mesh with lower perioperative morbidity and reoperation rate.
                Crown Copyright © 2011. Published by Mosby, Inc. All rights reserved. Severe prolapse may mask potential genuine stress urinary incontinence in women. Some have suggested that a suspending urethropexy be performed in women who have potential genuine stress incontinence demonstrated by barrier reduction of the prolapse preoperatively. Our aim was to compare outcomes after prolapse surgery that included a formal bladder neck suspension with those operations that did not.
                This prospective randomized clinical trial assigned 32 women with bladder neck hypermobility and stage III or IV pelvic organ prolapse to receive either a needle colposuspension or bladder neck endopelvic fascia plication as part of the vaginal reconstructive surgery. Twenty-nine subjects underwent detailed clinical, anatomic, urodynamic, and quality-of-life evaluations before and 6 weeks and 6 months after surgery; 23 completed urinary diary and quality-of-life evaluations after a mean of 2.9 years.
                Needle colposuspension increased short-term complications without providing additional protection from de novo stress incontinence. Barrier testing before surgery predicted urethral sphincteric resistance after surgery; however, such testing neither predicted a patient's function after surgery nor indicated the need for a suspending urethropexy. The combination of a needle colposuspension with a sacrospinous ligament suspension predisposed to the early development of support defects of the upper anterior vaginal segment and to failure of bladder neck support.
                Preoperative barrier testing in women with severe prolapse is not useful in identifying individuals who require a suspending urethropexy. Needle colposuspension increases short-term complications, lacks durability, and may predispose to early and severe recurrent anterior prolapse when performed with a sacrospinous ligament vault suspension. This study seeks to compare the small intestine submucosa (SIS) graft with traditional colporrhaphy (TC) for surgical treatment of anterior vaginal prolapse.
                Subjects were randomly assigned to SIS (n = 29) or to TC (n = 27) preoperatively and outcomes analyzed at 12 months postoperatively. The primary outcome was the absence of POP-Q stage >or= II prolapse, and secondary outcome was improvement in quality of life. Data were compared with independent samples or paired Student's t test.
                SIS group had 86.2% anatomic cure compared to 59.3% in TC (p = 0.03). SIS improved point Ba measurement significantly (-1.93 cm versus -1.37 cm, p = 0.02). Both operations significantly improved quality of life, although there were no differences between the groups. We observed a greater number of complications in the SIS group, with no infections or erosion.
                SIS repair improved point Ba significantly. However, there were no differences observed in quality of life between the techniques. To compare the objective anatomic outcomes after sacral colpopexy performed with cadaveric fascia lata and polypropylene mesh.
                Patients undergoing a sacral colpopexy were randomized to receive either fascia lata or polypropylene mesh in a double-blinded fashion. Data were collected at 6 weeks, 3 months, 6 months, and 1 year postoperatively. The main outcome measures were pelvic organ prolapse quantification (POP-Q) system stage and individual POP-Q points over time. Objective anatomic failure was defined as POP-Q stage 2 or more at any point during the follow-up period. Proportions of patients with objective anatomic failure at 1 year in each group were compared using the chi(2) test. Mean POP-Q points and stage at 1 year were compared by using the independent samples t test.
                One hundred patients were randomized to receive either fascia (n = 46) or mesh (n = 54). Of the 89 patients returning for 1-year follow-up, 91% (41/45) of the mesh group and 68% (30/44) of the fascia group were classified as objectively cured (P = .007). We found significant differences between the mesh and fascia groups with respect to the 1-year postoperative comparisons of points Aa, C, and POP-Q stage. There were no differences between the 2 groups with respect to points TVL (total vaginal length), GH (genital hiatus), PB (perineal body), Ap or Bp (2 points along the posterior vaginal wall).
                Polypropylene mesh was superior to fascia lata in terms of POP-Q points, POP-Q stage, and objective anatomic failure rates.
                I. To evaluate whether symptom resolution and sexual function is better after reinforcement with polypropylene mesh than with traditional anterior repair. Ninety-seven patients were randomized to anterior colporrhaphy and 105 to an operation with mesh. Participants were evaluated up to 24 months by physical examination, standard questions, and questionnaire. The overall symptom rate did not differ between the groups, but a sensation of vaginal bulge was reported less frequently in the mesh group, the figures being 17 versus 5 (p = 0.003). The recurrence rate for the no-mesh group was 41% and for the mesh group 11% (p < 0.001). The dyspareunia score was statistically significantly lower in the mesh group (p = 0.015). The mesh exposure rate was 8%. Sensation of vaginal bulge was relieved more efficiently by the mesh technique without causing dyspareunia. To compare the efficacy of absorbable and non-absorbable mesh for rectal fixation in abdominal rectopexy.
                Prospective open study.
                University hospital, Israel.
                37 consecutive patients with complete rectal prolapse.
                Posterior abdominal rectopexy with non-absorbable mesh (Polypropylene, Prolene, Ethicon Ltd) in 17 patients and with absorbable mesh (Polyglycolic acid, Dexon, Davis & Geck) in 20.
                There was no operative mortality, and there were no significant differences between the groups in the incidence of postoperative complications. Mean (SD) follow up was 3.6(0.5) years and 3.8(0.7) years in the Dexon and Prolene groups, respectively. Preoperative and postoperative performance indices based on the Gastrointestinal Quality of Life Index were similar in both groups.
                Dexon mesh may be as effective as Prolene mesh in the treatment of complete rectal prolapse. A performance index seems to be a useful tool for evaluating the outcome of patients after repair of complete rectal prolapse. We evaluated the efficacy of the Pelvicol porcine collagen implant for preventing recurrent anterior vaginal wall prolapse in women undergoing primary surgery for pelvic organ prolapse.
                This was a prospective, randomized, multicenter trial in 206 women with stage II or greater anterior vaginal wall prolapse (point Ba -1 or greater) according to the pelvic organ prolapse quantification system. The patients were randomly assigned to undergo anterior vaginal repair or the same procedure with Pelvicol implant reinforcement. SPSS software was used for data analysis.
                A total of 201 women were available for surgical outcome analysis, including 98 and 103 in the implant and no implant groups, respectively. All completed the 1-year followup visit. Most women were satisfied with the postoperative condition with a significant decrease in the visual analog scale score in each group (p <0.001). Anatomical anterior recurrence (point Ba greater than -1) was observed in 7 women (7%) in the implant group and in 20 (19%) in the other groups (OR 3.13, 95% CI 1.26-7.78, p = 0.019). Additionally, there were 11 women (3 and 8, respectively, or 5%) with posterior recurrence and 6 (3 per group or 3%) with unsatisfactory results at the upper vaginal segment. One patient who received a porcine implant had vaginal extrusion of the mesh 1 month after surgery.
                Our data show that the Pelvicol implant can be easily and readily used to augment and reinforce anterior colporrhaphy. The prolapse recurrence rate was considerably lower in the implant group compared with outcomes in patients treated with simple anterior repair. The purpose of this study was to compare the abdominal sacral colpopexy and vaginal sacrospinous colpopexy in the treatment of vaginal vault prolapse.
                Ninety-five women with vaginal vault prolapse were allocated randomly to sacral colpopexy (47 women) or sacrospinous colpopexy (48 women). Primary outcome measurements include subjective, objective, and patient-determined success rates. Secondary outcomes include the impact on bowel, bladder, and sexual function, cost, and quality of life.
                Two years after the operation (range, 6-60 months), the subjective success rate was 94% in the abdominal and 91% in the vaginal group (P=.19). The objective success rate was 76% in the abdominal group and 69% in the vaginal group (P=.48). The abdominal approach was associated with a longer operating time, a slower return to activities of daily living, and a greater cost than the sacrospinous colpopexy (P<.01). Both surgeries significantly improved the patient's quality of life (P<.05).
                Abdominal sacral colpopexy and vaginal sacrospinous colpopexy are both highly effective in the treatment of vaginal vault prolapse. This study was undertaken to compare outcomes of 3 different rectocele repair techniques.
                One hundred six women with stage II or greater posterior vaginal wall prolapse were randomly assigned to either posterior colporrhaphy (n = 37), site-specific rectocele repair (n = 37), or site-specific rectocele repair augmented with a porcine small intestinal submucosa graft (Fortagen, Organogenesis, Inc, Canton, MA; n = 32). Subjects underwent a physical examination and completed 3 validated pelvic floor instruments at baseline and 6 months, 1 year, and 2 years after surgery. Anatomic failure was defined as pelvic organ prolapse quantitation system (POPQ) point Bp > or = -2 at 1 year.
                Of 106 subjects who enrolled, 105 underwent surgery and of those 105, 98 subjects returned (93%) with a mean follow-up of 17.5 +/- 7 months. After 1 year, those subjects who received graft augmentation had a significantly greater anatomic failure rate (12/26; 46%) than those who received site-specific repair alone (6/27; 22%) or posterior colporraphy (4/28; 14%), P = .02. There was a significant improvement in prolapse and colorectal scales and overall summary scores of the Pelvic Floor Distress Inventory short form 20 (PFDI-20), the Pelvic Floor Impact Questionnaire short form 7 (PFIQ-7) after surgery in all groups (P < .001 for each) with no differences between groups. The proportion of subjects with functional failures was 15% overall, and not significantly different between groups. There was no significant change in the rate of dyspareunia 1 year after surgery and there were no differences between groups. Overall sexual function as measured by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form (PISQ-12) improved significantly in all groups postoperatively (P < . 001), with no differences between groups.
                Posterior colporraphy and site-specific rectocele repair result in similar anatomic and functional outcomes. The addition of a porcine-derived graft does not improve anatomic outcomes. All 3 methods of rectocele repair result in significant improvements in symptoms, quality of life, and sexual function. The purpose of this study was to compare outcomes after anterior colporrhaphy with the use of 3 different surgical techniques.
                One hundred fourteen women with anterior vaginal prolapse were randomly assigned to undergo anterior repair by one of 3 techniques: standard, standard plus polyglactin 910 mesh, or ultralateral anterior colporrhaphy. Before and after operation, patients underwent physical examination staging of prolapse; the International Continence Society system was used. Symptoms were assessed by questionnaire and visual analog scales. We defined "cure" as satisfactory (stage I) or optimal (stage 0) outcome at points Aa and Ba.
                Of 114 patients who were originally enrolled, 109 patients underwent operation, and 83 patients (76%) returned for follow-up. Mean age (+/- SD) was 64.7 +/- 11.1 years. At entry, 7 patients (7%) had stage I anterior vaginal prolapse; 35 patients (37%) had stage II anterior vaginal prolapse; 51 patients (54%) had stage III anterior vaginal prolapse; and 2 patients (2%) had stage IV anterior vaginal prolapse. At a median length of follow-up of 23.3 months, 10 of 33 patients (30%) who were randomly assigned to the standard anterior colporrhaphy group experienced satisfactory or optimal anatomic results, compared with 11 of 26 patients (42%) with standard plus mesh and with 11 of 24 patients (46%) with ultralateral anterior colporrhaphy. The severity of symptoms that were related to prolapse improved markedly (preoperative score, 6.9 +/- 2.7; postoperative score, 1.1 +/- 0.8). Twenty-three of 24 patients (96%) no longer required manual pressure to void after operation.
                These 3 techniques of anterior colporrhaphy provided similar anatomic cure rates and symptom resolution for anterior vaginal prolapse repair. The addition of polyglactin 910 mesh did not improve the cure rate compared with standard anterior colporrhaphy. This study was designed to compare outcomes of transanal and vaginal techniques for rectocele repair.
                Thirty females with symptomatic rectocele were enrolled in a prospective, randomized study. Fifteen underwent transanal rectoceleplasty, the other 15 underwent vaginal posterior colporrhaphy. Patients were assessed by clinical interview and examination, defecography, colon transit study, and anorectal manometry before randomization and 12 months postoperatively. Patients with compromised anal sphincter function or other symptomatic prolapse were excluded.
                The study groups were comparable in terms of demographic factors and rectocelerelated symptoms and signs. Eleven (73 percent) patients in the vaginal group and 10 (66 percent) in the transanal group digitally assisted rectal emptying preoperatively. The mean depth of the rectocele was 6.0 +/- 1.6 cm vs. 5.6 +/- 1.8 cm (P = 0.53) in the respective groups. At follow-up, 14 (93 percent) patients in the vaginal group and 11 (73 percent) in the transanal group reported improvement in symptoms (P = 0.08). Need to digitally assist rectal emptying decreased significantly in both groups, to one (7 percent) for the vaginal group and four (27 percent) for the transanal group (P = 0.17 between groups). The respective recurrence rates of rectocele were one (7 percent) vs. six (40 percent) (P = 0.04), and enterocele rates were zero vs. four (P = 0.05). In the vaginal group defecography showed a significant decrease in rectocele depth whereas in the transanal group the difference did not reach statistical significance. None of the patients reported de novo dyspareunia, but 27 percent reported improvement.
                Patients' symptoms were significantly alleviated by both operative techniques. The transanal technique was associated with more clinically diagnosed recurrences of rectocele and/or enterocele. Adverse effects on sexual life were avoided by use of both techniques. This study was undertaken to compare outcomes after anterior colporrhaphy with and without a solvent dehydrated cadaveric fascia lata graft.
                A total of 162 women were enrolled in a prospective, randomized trial that evaluated the impact of a solvent dehydrated cadaveric fascia lata patch on recurrent anterior vaginal prolapse. Subjects were randomly assigned to standard colporrhaphy with or without a patch. Before and after surgery, subjects were evaluated by both the Baden-Walker and pelvic organ prolapse quantification systems. "Failure" was defined as stage II anterior wall prolapse or worse.
                Of 154 women randomly assigned (76 patch: 78 no patch), all underwent surgery and 153 (99%) returned for follow-up. Sixteen women (21%) in the patch group and 23 (29%) in the control group experienced recurrent anterior vaginal wall prolapse (P = .229). Only 26% of all recurrences were symptomatic. Concomitant transvaginal Cooper's ligament sling procedures were associated with a dramatic decrease in recurrent prolapse (odds ratio [OR] 0.105 , P < .0001).
                Solvent dehydrated fascia lata as a barrier does not decrease recurrent prolapse after anterior colporrhaphy. Transvaginal bladder neck slings were associated with a significant reduction in the risk of recurrent anterior wall prolapse. To compare the Burch colposuspension and the anterior colporrhaphy in women with both stress urinary incontinence and advanced anterior vaginal wall prolapse (cystocele).
                Prospective randomised study.
                Secondary referral centre, Urogynaecology Unit, San Gerardo Hospital, Monza, Italy.
                Seventy-one women undergoing surgery for primary genuine stress incontinence and concurrent grade 2 or 3 cystocele (descending at or outside the vaginal introitus).
                Full urodynamic investigation performed pre-operatively and repeated six months after surgery. Clinical follow up continued for 8 to 17 years.
                Subjective (patient history) and objective (negative stress test result) cure of stress incontinence. Assessment of cystocele recurrence.
                Thirty (86%) of the 35 evaluable women who had the Burch colposuspension and 17 (52%) of the 33 evaluable women who had the anterior colporrhaphy were subjectively cured (OR 5.6, 95% CI 1.6 to 21.6; P = 0.005). Objective cure rates were 74% (26 of 35) and 42% (14 of 33), respectively (OR 3.9, 95% CI 1.3 to 12.5; P = 0.02). A recurrent cystocele of grade 2 or 3 with or without prolapse at other vaginal sites was recorded in 34% (12 of 35) and 3% (1 of 33) of women, respectively (OR 16.7, 95% CI 2.0 to 368.1; P = 0.003).
                The Burch colposuspension was better in controlling stress incontinence but it lead to an unacceptable high rate of prolapse recurrence. The anterior colporrhaphy was more effective in restoring vaginal anatomy but it was accompanied by an unacceptable low cure rate of stress incontinence. Neither of the two operations is recommended for women who are suffering from a combination of stress incontinence and advanced cystocele. To compare the effectiveness of polyglactin mesh, and polydioxanone or polyglactin sutures in women having pelvic organ prolapse surgery. Randomised controlled trial with a factorial 2(2 design of polyglactin mesh or not, and polydioxanone or polyglactin suture. Outcomes were assessed using questionnaires at baseline and on the third day and at 6 months after surgery. Women were also examined clinically 3 months after surgery. The primary outcome was the subjective improvement in prolapse symptoms and quality of life scores from baseline to 6 months. There was a subjective improvement in the prolapse symptom score from baseline to 6 months after surgery (mean difference of 9.2 (95% CI for difference 7.2-11.2, p < 0.001) and an improvement in the mean quality of life score over the same period with a reduction of 3.4 (95% CI for difference 2.4-4.3, p < 0.001). However, there were no significant differences in the mean difference in prolapse symptoms and quality of life (QoL) scores according to the randomised groups. The majority (86%) of women were satisfied with their surgery. Our study demonstrated that at short-term follow-up, there was no significant difference in the mean differences in prolapse symptoms and QoL scores after surgery using polyglactin mesh or not, polyglactin or polyglactin sutures, but the numbers were too small for a definitive conclusion. Longer-term follow-up and/or a larger trial are required. To compare infracoccygeal sacropexy (IS) and sacrospinous suspension (SS) for the treatment of uterine or vault prolapse.
                A randomized trial of 49 women assigned to either the IS group using IVS tape (n=24) or SS group (n=25). Concomitant hysterectomy and repairs were performed as appropriate. Evaluations included prolapse staging using the POP-Q system and validated questionnaires for symptoms (PFDI), quality of life (PFIQ), and sexuality (PISQ-12). The primary outcome measure was postoperative pain.
                Patients' characteristics were similar in both groups. IS was quicker, easier, and less painful than SS (P<0.01). Hemorrhage or hematoma rates were similar. Neither rectal injury nor vaginal erosion occurred. Mean follow-up was 16.8 months. Prolapse cure rates, symptom scores, and quality of life were similar. Postoperative cystocele occurred in 4.8% of women after IS and 25% after SS (P>0.05).
                Infracoccygeal sacropexy is equivalent to sacrospinous suspension, with a decreased rate of postoperative pain and cystocele recurrence. The effect of a Pelvicol graft compared with a conventional anterior vaginal repair was evaluated in this randomised controlled study.
                Only patients with a stage II or higher (Ba >or= -1) defect were included.
                Thirty-one patients were allocated to a conventional anterior repair; 30 to Pelvicol graft. At 12 months follow-up, four patients among controls (15%) and two in the graft group (7%) had objective recurrence. Among controls, the difference at 3 months follow-up in Ba was 6.0 cm when compared with the position of Ba prior to surgery. In the graft group, the difference was 7.0 cm (P < 0.05). This difference was still present at 12 months follow-up (6.0 vs. 7.0 cm; P < 0.05).
                The implantation of a Pelvicol graft does not improve the POP-Q stage. Our aim was to evaluate the efficacy of polyglactin 910 mesh in preventing recurrent cystoceles and rectoceles.
                In a prospective, randomized, controlled trial, patients undergoing vaginal reconstructive surgery with cystoceles to the hymenal ring and beyond were randomly selected to undergo anterior and posterior colporrhaphy with or without polyglactin 910 mesh reinforcement. Results were evaluated preoperatively and at 2, 6, 12, and 52 weeks postoperatively.
                A total of 161 women were randomly selected for this study. One woman was excluded at the time of surgery, and 17 women were lost to follow-up. Eighty women received mesh, and 80 did not. Both groups were found to be equivalent with respect to age, parity, concomitant surgery, and menopausal and hormone replacement status. Preoperatively 49 women had a central cystocele to the hymenal ring and 111 women had cystoceles beyond the introitus; 91 women had a rectocele to the mid-vaginal plane, 31 to the hymenal ring, and 22 beyond the introitus. After 1 year, 30 (43%) of 70 subjects without mesh and 18 (25%) of 73 subjects with mesh had recurrent cystoceles beyond the mid-vaginal plane (P =.02). Eight women without mesh and 2 women with mesh had recurrent cystoceles to the hymenal ring (P =.04). No recurrent cystoceles beyond the hymenal ring occurred in either group. Multivariate logistic regression analysis showed concurrent slings to be associated with significantly fewer recurrent cystoceles (odds ratio, 0.32; P =.005), whereas the presence of mesh remained significantly predictive of fewer cystocele recurrences in this analysis. Thirteen recurrent rectoceles were noted 1 year postoperatively, with no differences between groups.
                Polyglactin 910 mesh was found to be useful in the prevention of recurrent cystoceles. To compare the effects of vaginal hysterectomy (combined with anterior and/or posterior colporraphy) and abdominal sacro-colpopexy (with preservation of the uterus) on urogenital function.
                Randomised trial.
                Three teaching hospitals in The Netherlands.
                Eighty-two patients undergoing surgical correction of uterine prolapse stages II-IV.
                Participating patients completed the urogenital distress inventory (UDI), before and at six weeks, six months and one year after surgery, to measure discomfort of prolapse and micturition symptoms. Domain scores of the UDI (ranging from 0 to 100, higher scores indicating more discomfort) were compared between groups at all time points. Findings at pelvic examination, number of doctor visits within the first year after surgery because of pelvic floor symptoms and performed or planned surgery of recurrent genital prolapse were also compared.
                Domain scores of the UDI at one year after surgery.
                At one year after surgery, scores on the discomfort/pain domain (mean difference 7.1, 95% confidence interval [CI] 1.1-13.2), overactive bladder domain (mean difference 8.7, 95% CI 0.5-16.9) and obstructive micturition domain (mean difference 10.3, 95% CI 0.6-20.1) of the UDI were significantly higher in the abdominal group than in the vaginal group. Findings at pelvic examination were similar in both groups. Doctor visits because of pelvic floor symptoms were more frequent in the abdominal group than in the vaginal group. Re-operation was performed or planned in 9 of the 41 patients who underwent abdominal surgery and in 1 of the 41 patients who underwent vaginal surgery (odds ratio [OR] = 11.2, 95% CI 1.4-90.0).
                Our findings suggest that vaginal hysterectomy with anterior and/or posterior colporraphy is preferable to abdominal sacro-colpopexy with preservation of the uterus as surgical correction in patients with uterine prolapse stages II-IV. To report anatomic and functional outcomes 2 years after sacrocolpopexy in stress-continent women with or without prophylactic Burch colposuspension.
                In the Colpopexy and Urinary Reduction Efforts (CARE) trial, stress-continent women undergoing sacrocolpopexy were randomized to receive or not receive a Burch colposuspension. Outcomes included urinary symptoms, other pelvic symptoms, and pelvic support. Standardized pelvic organ prolapse quantification examinations and validated outcome measures including the Pelvic Floor Distress Inventory and the Pelvic Floor Impact Questionnaire were completed before surgery and at several postoperative intervals, including at 2 years.
                This analysis is based on 302 of 322 randomized participants. Most were Caucasian (94%), with a mean age of 62+/-10 years (mean+/-standard deviation). Two years after surgery, 32.0% and 45.2% of women in the Burch and control groups, respectively, met the stress incontinence endpoint (presence of symptoms or positive cough stress test or interval treatment for stress incontinence, P=.026). The apex was well supported (point C within 2 cm of total vaginal length) in 95% of women, and this was not affected by concomitant Burch (P=.18). There was a trend toward fewer urgency symptoms in the Burch group (32.0% versus 44.5% no Burch, P=.085). Twenty participants experienced mesh or suture erosions.
                The early advantage of prophylactic Burch colposuspension for stress incontinence that was seen at 3 months remains at 2 years. Apical anatomic success rates are high and not affected by concomitant Burch.
                (www.clinicaltrials.gov), ClinicalTrials.gov, NCT00065845.
                I. The aim of this study was to compare the efficiency of polypropylene mesh surgery with the site-specific repair surgeries in the treatment of cystocoeles. We randomized 90 patients into two groups according to a computer-based program. After a 12-month (mean) follow up, we noticed that the polypropylene mesh surgery yielded good anatomical results. Acceptable anatomical cure rates were 91 and 72% in the mesh surgery group and site-specific surgery group, respectively. There were three cases (6.9%) of mesh erosion. One case of urinary retention and two cases of de novo dyspareunia were seen in the mesh surgery group. De novo stress urinary incontinence developed in three patients in the site-specific surgery group. We concluded that surgery with light polypropylene mesh (Sofradim, Parietene) is superior to the site-specific surgery in the treatment of cystocoeles. Our purpose was to determine whether a vaginal or abdominal approach is more effective in correcting uterovaginal prolapse.
                Eighty-eight women with cervical prolapse to or beyond the hymen or with vaginal vault inversion > 50% of its length and anterior vaginal wall descent to or beyond the hymen were randomized to a vaginal versus abdominal surgical approach. Forty-eight women underwent a vaginal approach with bilateral sacrospinous vault suspension and paravaginal repair, and 40 women underwent an abdominal approach with colposacral suspension and paravaginal repair. Ancillary procedures were performed as indicated. Detailed pelvic examination was performed postoperatively by the nonsurgeon coauthor yearly up to 5 years. The women were examined while standing during maximum strain. Surgery was classified as optimally effective if the woman remained asymptomatic, the vaginal apex was supported above the levator plate, and no protrusion of any vaginal tissue beyond the hymen occurred. Surgical effectiveness was considered unsatisfactory if the woman was symptomatic, the apex descended > 50% of its length, or the vaginal wall protruded beyond the hymen.
                Eighty women (vaginal 42, abdominal 38) were available for evaluation at 1 to 5.5 years (mean 2.5 years). The groups were similar in age, weight, parity, and estrogen status, and 56% had undergone prior pelvic surgery. There was no significant difference between the groups in morbidity, complications, hemoglobin change, dyspareunia, pain, or hospital stay. The vaginal group had longer catheter use, more urinary tract infections, more incontinence, decreased operative time, and lower hospital charge. Surgical effectiveness was optimal in 29% of the vaginal group and 58% of the abdominal group and was unsatisfactory leading to reoperation in 33% of the vaginal group and 16% of the abdominal group. The reoperations included procedures for recurrent incontinence in 12% of the vaginal and 2% of the abdominal groups. The relative risk of optimal effectiveness by the abdominal route is 2.03 (95% confidence interval 1.22 to 9.83), and the relative risk of unsatisfactory outcome using the vaginal route is 2.11 (95% confidence interval 0.90 to 4.94).
                Reconstructive pelvic surgery for correction of significant pelvic support defects was more effective with an abdominal approach. To compare objective and subjective outcomes after the tension-free vaginal tape procedure (TVT) with laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence. Objective outcome measures were stress test and 48-hour pad test.
                In 6 departments of gynecology in Finland, including 4 university teaching hospitals and 2 central hospitals, 128 women with urodynamic stress incontinence were randomly allocated to 2 treatment groups. Seventy were treated with TVT and 51 by means of laparoscopic mesh colposuspension. There were 7 dropouts. Inclusion criteria were history of stress incontinence, positive stress test, and urodynamic conformation of stress incontinence. Exclusion criteria were age older than 70 years, previous incontinence surgery, more than 3 episodes of urinary tract infection within the last 2 years, coincident other gynecological surgery, body mass index more than 32 kg/m(2), urethral closure pressure less than 20 cm H(2)O, and residual volume more than 100 mL in preoperative urodynamic evaluation. Assessment took place before treatment and at 12 months postoperatively with the cough stress test, Urge Score, 48-hour pad test, King's College Health Questionnaire, Visual Analog Scale, and Urinary Incontinence Severity Score.
                When negative stress test was used as criteria for cure, 85.7% of women in the TVT group and 56.9% in the laparoscopic mesh colposuspension group were objectively cured. Subject satisfaction was significantly better after the TVT procedure than after laparoscopic mesh colposuspension.
                Treatment with TVT results in higher objective and subjective cure rates at 1 year than treatment by means of laparoscopic mesh colposuspension. The present study was designed to evaluate functional outcome of perineal repair with and without levatorplasty versus transanal repair of rectocele in obstructed defecation.
                A total of 48 multiparous women with obstructed defecation caused by a rectocele were randomly allocated to three groups: transperineal repair with levatorplasty (TPR-LP; n = 16); transperineal repair without levatorplasty (TPR; n = 16); and transanal repair (TAR; n = 16). The study included defecographic assessment, anal manometry, symptom improvement, sexual function, and score on a function questionnaire. Assessments were done preoperatively and 6 months postoperatively.
                Defecography showed significant reduction in size of rectocele in all groups. Constipation improved significantly in both groups with transperineal repair but not in the group with transanal repair. Significant reductions in mean anal resting pressure, maximum reflex volume, and urge-to-defecate volume were observed only with the transperineal approach (with and without levatorplasty). Functional score improved significantly in the transperineal groups (with levatorplasty, P < 0.001; without levatorplasty, P < 0.01), but not in the transanal group (P = 0.142). Levatorplasty added to transperineal repair significantly improved the overall functional score compared with transperineal repair alone (P < 0.01) and transanal repair TAR (P < 0.001).
                Rectocele repair appears to improve anorectal function by improving rectal urge sensitivity. Transperineal repair of rectocele is superior to transanal repair in both structural and functional outcome. Levatorplasty improves functional outcome, but potential effects on dyspareunia should be discussed with the patient. The objectives of this study were to compare both subjective clinical outcomes and the objective stress response of laparoscopic and open abdominal rectopexy in patients with full-thickness rectal prolapse. Abdominal rectopexy for patients with rectal prolapse is well suited for a laparoscopic approach as no resection or anastomosis is necessary.
                Forty patients with a full-thickness rectal prolapse were randomized before operation to a laparoscopic group and an open group. They agreed to conform to a clinical pathway (CP) of liquid diet (CP1) and full mobility (CP2) on day 1, solid diet (CP3) on day 2 and discharge (CP4) before day 5. Their compliance was monitored by an assessor blinded to the operative group, who also rated pain and mobility. Patient-controlled morphine use was documented. Neuroendocrine and immune stress response and respiratory function were measured.
                Some 75 per cent of all clinical pathway objectives of early recovery were achieved in the laparoscopic group compared with 37 per cent in the open group (P < 0.01). Significant differences in favour of laparoscopy were noted with regard to narcotic requirements, and pain and mobility scores. Differences in objective measures of stress response favouring laparoscopy were found for urinary catecholamines, interleukin 6, serum cortisol and C-reactive protein. No differences were noted in respiratory function but significant respiratory morbidity was greater in the open group (P < 0.05). None of the measured outcomes, subjective or objective, favoured the open group apart from operating time, which was significantly shorter (153 versus 102 min; P < 0.01).
                This study has demonstrated significant subjective and objective differences in favour of a laparoscopic technique for abdominal rectopexy. The advantages were all short term but no evidence of any adverse effect on longer-term outcomes was observed. To estimate the effect of porcine subintestinal submucosal graft augmentation on improving anatomic and subjective rectocele repair outcomes compared with native tissue repair.
                We conducted a randomized controlled trial at two sites, including women with at least stage 2 symptomatic rectocele. Anatomic and subjective outcomes (vaginal bulge and defecatory) were collected 12 months postoperatively, including blinded Pelvic Organ Prolapse Quantification (POP-Q) examinations. Anatomic failure was defined as points Ap or Bp -1 or greater on POP-Q. Subjective failure was defined as no improvement or worsening of symptoms. We estimated number needed to treat and adjusted odds ratios (ORs). Assuming graft use is associated with 93% anatomic success, 63 women per group would be needed to detect a 20% difference at α=.05 and β=.20.
                One hundred sixty women were randomized; 137 had 12-month anatomic data (67 graft; 70 control). There was no difference in anatomic failure (12% compared with 9%, P=.5), vaginal bulge symptom failure (3% compared with 7%, P=.4, number needed to treat=26) or defecatory symptom failure (44% compared with 45%, P=.9, number needed to treat=91) for graft compared with control, respectively. Both groups reported improvement in vaginal bulge and defecatory symptoms (P<.05 for all). On multiple logistic regression, graft use was not associated with a decreased odds of anatomic failure (adjusted OR 1.36, 95% confidence interval [CI] 0.44-4.25), vaginal bulge symptoms (adjusted OR 0.46, 95% CI 0.08-2.68), or defecatory symptoms (adjusted OR 0.98, 95% CI 0.48-2.03).
                Although rectocele repair by either approach is associated with improved symptoms, subintestinal submucosal graft augmentation was not superior to native tissue for anatomic or subjective outcomes at 12 months.
                ClinicalTrials.gov, www.clinicaltrials.gov, NCT00321867. Our purpose was to compare two antiincontinence procedures in patients with severe genitourinary prolapse and coexisting clinical or potential stress incontinence.
                In addition to cystopexy, 109 patients with a urethrocystocele of grade 2 or more and a positive stress test result with prolapse reduction received posterior pubourethral ligament plication or Pereyra suspension.
                Of 55 patients undergoing posterior pubourethral ligament plication, 15 were clinically and 40 potentially incontinent; the same figures were 21 and 33, respectively, among 54 patients undergoing the Pereyra procedure. Follow-up was for 3 to 9 years. Subjective (60% vs 71%, p = 0.72) and objective (27% vs 57%, p = 0.14) cure rates were not statistically different among patients who were clinically incontinent (posterior pubourethral ligament plication vs Pereyra suspension). Among potentially incontinent patients, subjective (85% vs 100%, p = 0.03) and objective (50% vs 76%, p = 0.04) continence rates were higher after the Pereyra procedure. Overall, the cotton swab test had negative results (maximum straining angle < or = 30 degrees) after successful surgery in 79% and 96%, respectively, of patients (p = 0.03). Four subjects (7%) underwent removal of one Pereyra suture because of urinary retention or suprapubic wound infection.
                Cystopexy with Pereyra suspension is recommended, particularly for patients with prolapse and potential stress incontinence. To report the long term results of abdominal rectopexy in patients with complete rectal prolapse.
                Ongoing prospective randomised study.
                Department of Surgery, Westfälische Wilhelms-University, Münster.
                47 patients with complete rectal prolapse operated on between 1982 and 1989.
                Abdominal rectopexy with absorbable mesh made of either polyglycolic acid (n = 17) or polyglactine 910 (n = 30).
                Postoperative complications and late results at a mean of 50.5 (range 2-102) months after operation.
                Thirteen patients (28%) developed postoperative complications, most of them minor; there was one enterocutaneous fistula. Thirty five patients (74%) were available for late follow up. There were no case of recurrent prolapse and 5 (14%) had developed mucosal prolapse. Of the 22 patients who had been incontinent before operation, 8 had become totally continent and 6 partially continent Overall continence improved in 18 (51%) of the 35 patients. Three patients who were continent before operation had become incontinent.
                Absorbable mesh is a suitable material for abdominal rectopexy. To assess the efficacy of a novel coloplasty colonic pouch design in optimizing bowel function after ultralow anterior resection.
                A colonic J-pouch may reduce excessive stool frequency and incontinence after anterior resection, but at the risk of evacuation problems. Experimental surgery on pigs has suggested that a coloplasty pouch (CP) may be a useful alternative. Although CP has recently been shown to be feasible in patients, there is no randomized controlled trial comparing bowel function with the J-pouch.
                After anterior resection for cancer, patients were allocated to either J-pouch or CP-anal anastomoses. Continence scoring, anorectal manometry, and endoanal ultrasound assessments were made before surgery. All complications were recorded, and these preoperative assessments were repeated at 4 months. The assessments were repeated again at 1 year, and a quality of life questionnaire was added.
                Eighty-eight patients were recruited from October 1998 to April 2000. Both groups were well matched for age, gender, staging, adjuvant therapy, and mean follow-up. There were no differences in the intraoperative time and hospital stay. CP resulted in more anastomotic leaks. At 4 months, J-pouch patients had 10.3% less stool fragmentation but poorer stool deferment and more nocturnal leakage. However, there were no differences in the bowel function, continence score, and quality of life at 1 year. There were no differences in the anorectal manometry and endoanal ultrasound findings.
                Coloplasty pouches resulted in more anastomotic leaks and minimal differences in bowel function. At present, the J-pouch remains the benchmark for routine clinical practice, and due care (including defunctioning stoma) should be exercised in situations requiring CP. To compare conventional laparoscopic and robotic-assisted laparoscopic sacrocolpopexy for vaginal apex prolapse.
                This single-center, blinded randomized trial included participants with stage 2-4 posthysterectomy vaginal prolapse. Participants were randomized to laparoscopic or robotic sacrocolpopexy. The primary outcome was total operative time from incision to closure. Secondary outcomes were postoperative pain, functional activity, bowel and bladder symptoms, quality of life, anatomic vaginal support, and cost from a health care system perspective.
                A total of 78 patients enrolled and were randomized (laparoscopic n=38; robotic n=40). Total operative time was significantly longer in the robotic group compared with the laparoscopic group (+67-minute difference; 95% confidence interval [CI] 43-89; P<.001). Anesthesia time, total time in the operating room, total sacrocolpopexy time, and total suturing time were all significantly longer in the robotic group. Participants in the robotic group also had significantly higher pain at rest and with activity during weeks 3 through 5 after surgery and required longer use of nonsteroidal anti-inflammatory drugs (median, 20 compared with 11 days, P<.005). The robotic group incurred greater cost than the laparoscopic group (mean difference +$1,936; 95% CI $417-$3,454; P=.008). Both groups demonstrated significant improvement in vaginal support and functional outcomes 1 year after surgery with no differences between groups.
                Robotic-assisted sacrocolpopexy results in longer operating time and increased pain and cost compared with the conventional laparoscopic approach. To compare cystopexy alone versus cystopexy with posterior pubourethral ligaments plication for the occurrence of postoperative stress incontinence after prolapse surgery, and to compare the two surgical series in terms of complications and urodynamic effects.
                One hundred two continent patients randomly underwent cystopexy alone (N = 52) or cystopexy with posterior pubourethral ligaments plication (N = 50). All had a urethrocystocele grade 2 or greater and a negative stress test with the prolapse repositioned. A full urodynamic investigation was repeated 6 months after surgery.
                Twelve (23%) and 14 (28%) patients (P = .73) required intermittent self-catheterization for 11.1 +/- 5.1 and 16.5 +/- 11.1 days, respectively (cystopexy alone versus cystopexy with posterior pubourethral ligaments plication, P = .002). Long-lasting difficulties in voiding were present in zero and five (10%) patients (P = .02). One subject receiving posterior pubourethral ligaments plication underwent urethral dilation for complete urinary retention. At 1 year follow-up, four patients (8%) in each series developed postoperative stress incontinence (P = .62). Symptomatic detrusor instability complicated the postoperative course in one patient (2%) of each group.
                Cystopexy alone implied lower morbidity in terms of resumption of spontaneous voiding and long-lasting difficulties in voiding. The procedure could be recommended as an effective and safe treatment for continent patients with severe urethrocystocele. Additional plication of the posterior pubourethral ligaments did not seem superior to cystopexy alone in preventing the postoperative occurrence of stress incontinence. To compare the effectiveness of two transperitoneal laparoscopic Burch procedures.
                The sample size required was 30 subjects per group to detect a statistically significant estimated difference of 15% between two surgical procedures with an alpha = 0.05 and a power of 0.7. Sixty women affected by genuine stress incontinence (GSI) were enrolled and randomly assigned to two groups of 30 women each. All women were treated with the transperitoneal laparoscopic Burch procedure using nonabsorbable sutures (group A) or Prolene mesh (Ethicon, Somerville, NJ) fixed with tacks or staples (group B). The failure rate was defined subjectively and objectively. The subjective evaluation was performed by asking the women to rate their urine loss on a visual analog scale. The objective evaluation was a clinical evaluation using multichannel urodynamic studies.
                The subjective failure rate was not significantly different between the two groups at 3 months (0% for both groups), 6 months (3.7% versus 3.8% for groups A and B, respectively), and 12 months (7.4% versus 15.4% for groups A and B, respectively) after surgery. At 3 months (3.7% versus 3.8% for groups A and B, respectively) and 6 months (7.4% versus 15.4% for groups A and B, respectively) follow-up, the objective failure rate was not significantly different between the two groups. However, at 12 months after the surgical procedure, the objective failure rate was significantly lower in group A than in group B (11.1% versus 26.9%, respectively; P <.05).
                Transperitoneal laparoscopic Burch colposuspension performed using sutures was more effective than the mesh technique. To compare open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence.
                Multicentre, prospective randomised trial.
                Departments of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Göteborg, Borås County Hospital and Orebro University Hospital, Sweden.
                Women with genuine stress urinary incontinence or mixed incontinence with a predominantly stress component were included, and were randomised to either open colposuspension (n= 120) or laparoscopic colposuspension (n= 120).
                Women were randomised to open colposuspension with sutures or laparoscopic colposuspension with polypropylene mesh and staples. Anaesthesia/operation time, blood loss, complications and other related surgical parameters were compared.
                Objective and subjective cure rates from 48-hour frequency-volume chart, a 48-hour pad test and a subjective assessment of the woman's incontinence and quality of life performed one year after surgery.
                Objective and subjective cure rates were higher after open compared with laparoscopic colposuspension (P < 0.001). Quality of life was improved following surgery in both groups (P < 0.0001) and the improvement was significantly greater in the open colposuspension group (P < 0.05) with regard to physical activity. Performing an open colposuspension was less time consuming (P < 0.0001), resulted in more blood loss (P < 0.0001), longer catheterisation time (P < 0.01), greater risk of urinary retention (P < 0.01) and a longer hospital stay (P < 0.0001) compared with performing a laparoscopic colposuspension. The rate of serious complications was low in both groups.
                Open colposuspension had a higher objective and subjective cure rate one year after surgery but with a greater blood loss, greater risk of urinary retention and a longer hospital stay than laparoscopic colposuspension. This prospective, randomised study investigated whether a prophylactic procedure, performed during colposacropexy for prolapse repair, prevents ex novo postoperative incontinence. Sixty-six consecutive continent patients with advanced prolapse were randomised into two groups: group A underwent sacropexy combined with a Burch colposuspension; no anti-incontinence procedure was performed in group B patients.
                Work-up included clinical assessment (Halfway System and International Continence Society [ICS] classification for prolapse and Ingelman Sunderberg scale for incontinence), the Urogenital Distress Inventory and Impact Incontinence Quality of Life questionnaires, urogynaecologic ultrasound scans, and complete urodynamic testing that included the urethral pressure profile and Valsalva leak point pressure with reduced prolapse. Check-ups were done at 3, 6, 12 mo postoperatively and then yearly. Mean follow-up time was 39.5 mo.
                The mean age (+/- standard deviation) was 62+/-9 yr. All patients presented with grade (G) 3-4 prolapse. Postoperative incontinence was present in 12 of the 34 patients in group A: 7 G1; 4 G2, and 1 G3. Postoperative incontinence was present in 3 of the 32 patients in group B: 2 G1, 1 G3. The frequency of postoperative incontinence was significantly greater in patients who had undergone colposuspension (p<0.05).
                These preliminary data cast doubt on whether colposuspension should be performed during sacropexy for severe urogenital prolapse as prophylaxis for postoperative incontinence because it seems to emerge as overtreatment. Incontinence developed ex novo in 35% of continent patients treated with colposuspension combined with sacropexy. The incidence of urinary incontinence in women of childbearing age is about 30%. Around half have stress incontinence. Many treatment modalities have been elucidated to treat stress incontinence, and among the most popular are rectus fascia sling and tension-free vaginal tape (TVT). The introduction of TVT to the urological armamentarium put a multiplicity of synthetic materials into use in the correction of stress urinary incontinence. A comparison of the impact of these 2 commonly used techniques is needed.
                A total of 53 female patients older than 21 years (mean age 45.09) were randomized, using closed envelopes, to undergo TVT or rectus fascia sling. Randomization was performed after patients received spinal anesthesia. One surgeon performed the 2 types of treatment. Associated grade 2 cystocele was simultaneously corrected. Patients with bladder or urethral pathology, as well as those with cystocele greater than grade 2, were excluded from analysis.
                All 53 patients completed 6 months of followup and all had stress urinary incontinence. There were 15 patients who underwent sling surgery and 17 who underwent TVT who had concomitant grade 1 or 2 cystocele. No statistically significant difference was found between the 2 groups at baseline. Cure was accomplished in 23 of 25 (92%) with sling and in 26 of 28 (92.9%) with TVT at first followup visit (1 week). There were 7 patients who needed at least 1 extra week of catheterization in the sling group and 3 in the TVT group. No significant difference was detected in terms of post-void residual urine, symptom score, and filling and voiding parameters. At 6 months 1 patient had de novo detrusor overactivity and 7 had wound pain. Compared to those with TVT, 2 cases of sling were considered treatment failures, none had de novo overactivity and 2 had wound pain. None of the patients had symptoms suggestive of urethral erosion.
                Rectus fascia sling and TVT seem to be equally effective regarding primary outcome measure (ie cure of stress incontinence). Symptom score related to incontinence surgery as well as simultaneous correction of cystocele are comparable in the 2 groups. Fascial sling is a longer treatment process yet it is more economical. Longer followup is vital before rigorous conclusions can be drawn. To compare conservative versus prostaglandin management of prelabour rupture of the membranes (PROM) in healthy primigravid women at term.
                A prospective randomized study.
                Labour Ward, Aberdeen Maternity Hospital.
                230 primigravidae at terms with PROM, 115 allocated to be treated conservatively and 115 to be managed with prostaglandin treatment.
                In the conservatively managed group the women were observed for up to 24 h after hospital admission with PROM. The actively managed group had PGE2 gel (2 mg) instilled into the posterior fornix and if contractions had not commenced, a further dose of PGE2 gel (1 mg) was instilled 6 h later. In both groups, if labour had not established 24 h after admission, intravenous oxytocin was given in escalating doses.
                PROM to delivery interval, oxytocin augmentation, mode of delivery, maternal and neonatal infective morbidity.
                There was a significant reduction in the PROM to delivery interval in the women managed actively with PGE2 gel and fewer women in the PGE2 group required oxytocin augmentation (31% vs 51%). The two managements groups were comparable for intrapartum analgesia, antibiotic treatment, babies requiring admission to the special care nursery unit and delivery by caesarean section.
                The early use of prostaglandin is associated with a significant reduction in PROM to delivery interval without a significant increase in infective morbidity or caesarean section rate. However, the advantages of the conservative approach should not be overlooked. More work is still needed in the management of those women where uterine activity fails to establish within 24 h after PROM.
Sacral colpopexy has superior outcomes to a variety of vaginal procedures including sacrospinous colpopexy, uterosacral colpopexy and transvaginal mesh. These benefits must be balanced against a longer operating time, longer time to return to activities of daily living, and increased cost of the abdominal approach.
The use of mesh or graft inlays at the time of anterior vaginal wall repair reduces the risk of recurrent anterior wall prolapse on examination. Anterior vaginal polypropylene mesh also reduces awareness of prolapse, however these benefits must be weighted against increased operating time, blood loss, rate of apical or posterior compartment prolapse, de novo stress urinary incontinence, and reoperation rate for mesh exposures associated with the use of polypropylene mesh.
Posterior vaginal wall repair may be better than transanal repair in the management of rectocele in terms of recurrence of prolapse. The evidence is not supportive of any grafts at the time of posterior vaginal repair. Adequately powered randomised, controlled clinical trials with blinding of assessors are urgently needed on a wide variety of issues, and they particularly need to include women's perceptions of prolapse symptoms. Following the withdrawal of some commercial transvaginal mesh kits from the market, the generalisability of the findings, especially relating to anterior compartment transvaginal mesh, should be interpreted with caution.