Physiotherapy as an adjunct to prolapse surgery: an assessor-blinded randomized controlled trial. Return to continence after radical retropubic prostatectomy: a randomized trial of verbal and written instructions versus therapist-directed pelvic floor muscle therapy. The recovery of urinary continence after radical retropubic prostatectomy: a randomized trial comparing the effect of physiotherapist-guided pelvic floor muscle exercises with guidance by an instruction folder only. Benefits of supervised group exercise programme for women being treated for early stage breast cancer: pragmatic randomised controlled trial. Effectiveness of early pelvic floor rehabilitation treatment for post-prostatectomy incontinence.
This assessor-blinded randomized controlled trial investigated the effect of a pre- and post-operative physiotherapy-supervised pelvic floor muscle (PFM) training program in women undergoing surgery for prolapse or hysterectomy.
                Participants were assessed pre-operatively, and at 3, 6, and 12 months post-operatively by a blinded physiotherapy assessor. Following randomization, participants were allocated to a control group (CG) which included "usual care" (as provided by the surgeon and the hospital staff), or a treatment group (TG) which included one pre-operative and seven post-operative treatment sessions over 12 months. Primary outcomes were bladder and prolapse symptoms, measured by the Urogenital Distress Inventory (UDI) and the Incontinence Impact Questionnaire (IIQ).
                Fifty-one participants were randomized. The 12-month post-operative findings showed there was no difference in the prevalence of the primary outcomes (ORs 1.2, 1.3). There were no significant differences between groups on the change scores of the UDI (mean: 44.1 [5.1]; 54.0 [5.4], P = 0.20) nor the IIQ (median: 0.0 [9,14]; 10.0 [5,19], P = 0.09). The repeated measures analyses also demonstrated no significant changes.
                The program tested did not improve bladder or prolapse symptoms in this trial. Reasons may include the effectiveness of surgery alone, wide variance in data, small sample size, insufficient training by the TG, and PFM training by the usual care group.
                (c) 2010 Wiley-Liss, Inc. To test the effectiveness of weekly postoperative pelvic floor muscle training (PFMT) versus supportive telephone contact by a urology nurse for men at 4 weeks after radical prostatectomy.
                This was a randomized controlled trial in three Canadian centers. At 4 weeks after surgery, standardized verbal and written instruction about PFMT was provided to all subjects. Randomization occurred after initial instruction. Continence was defined as 8 g or less of urine loss on a 24-hour pad test. Primary outcome was grams of urine loss on pad test; secondary outcomes were International Prostate Symptom Score (IPSS), Incontinence Impact Questionnaire (IIQ-7) score, cost, and perception of urine loss as a problem. Data were obtained at baseline (preoperatively) and at weeks 4, 8, 12, 16, and 28 and 1 year after surgery.
                A total of 216 men were enrolled; 11 were dry or withdrew at 4 weeks. Ninety-nine were randomized to the control group and 106 to the treatment group. There were no group differences at baseline for prostate-specific antigen level (mean [standard deviation] 8.4 [10.4] ng/mL; 7.6 [4.6] ng/mL), Gleason score (6.3 [0.86]), IPSS, IIQ-7 score, pad test, or voiding diary. At 8 weeks 23% of the control group and 20% of the treatment group were continent; at 12 weeks, 28% and 32%; 16 weeks, 40% and 44%; 28 weeks, 50% and 47%; and at 52 weeks, 64% and 60%, respectively. There were no significant differences between groups at any time point for the outcome variables.
                Verbal instruction and written information with telephone support seemed to be as effective as intensive PFMT. Less-intense therapy may be more cost-effective. To compare the effect on the recovery of incontinence after retropubic radical prostatectomy (RRP) of intensive physiotherapist-guided pelvic floor muscle exercises (PG-PFME) in addition to an information folder, with PFME explained to patients by an information folder only (F-PFME), and to determine independent predictors of failure to regain continence after RRP.
                We postulated that a 10% increase in the proportion of men who regained continence at 6 months with PG-PFME compared with men treated with F-PFME only would constitute a clinically relevant effect. To show statistical significance of this difference with a power of 80%, 96 men should be randomized to each of the two arms. One day before operation, all patients received verbal instruction and an information folder on PFME. Patients randomized to the F-PFME arm received no further physiotherapist guidance, whereas those in the PG-PFME arm received a maximum of nine sessions with the physiotherapist. The men underwent a 1-h pad-test at 1, 12 and 26 weeks, and a 24-h pad-test at 1, 4, 8, 12 and 26 weeks after catheter removal. We defined 'continence' as urine loss of <1 g at the 1-h and <4 g at the 24-h pad-test.
                During the 2-year recruitment period, the number of patients randomized fell short of the target determined by the sample size calculation, because of limitations of resources and unexpected changes in treatment preferences. Despite this, we analysed the data. Of the 82 randomized patients, 70 completed the study. Of these, 34 and 36 men had been assigned to the PG-PFME and the F-PFME group, respectively. At 6 months after RRP, 10 (30%) and nine (27%) men were completely dry on both the 1-h and 24-h pad-test in the PG-PFME and the F-PFME group, respectively (difference not significant). In a multivariate analysis the amount of urine loss at 1 week after catheter removal seemed to be an independent prognostic factor for failure to regain continence.
                PG-PFME seems to have no beneficial effect on the recovery of continence within the first 6 months after RRP, over an instruction folder-guided approach. However, due to under-powering there is a high risk of type II error. Nevertheless, these findings add to the knowledge base for availability in meta-analyses and can serve as a starting point for the design of new randomized studies. To determine functional and psychological benefits of a 12 week supervised group exercise programme during treatment for early stage breast cancer, with six month follow-up.
                Pragmatic randomised controlled prospective open trial.
                Three National Health Service oncology clinics in Scotland and community exercise facilities.
                203 women entered the study; 177 completed the six month follow-up.
                Supervised 12 week group exercise programme in addition to usual care, compared with usual care.
                Functional assessment of cancer therapy (FACT) questionnaire, Beck depression inventory, positive and negative affect scale, body mass index, seven day recall of physical activity, 12 minute walk test, and assessment of shoulder mobility.
                Mixed effects models with adjustment for baseline values, study site, treatment at baseline, and age gave intervention effect estimates (intervention minus control) at 12 weeks of 129 (95% confidence interval 83 to 176) for metres walked in 12 minutes, 182 (75 to 289) for minutes of moderate intensity activity reported in a week, 2.6 (1.6 to 3.7) for shoulder mobility, 2.5 (1.0 to 3.9) for breast cancer specific subscale of quality of life, and 4.0 (1.8 to 6.3) for positive mood. No significant effect was seen for general quality of life (FACT-G), which was the primary outcome. At the six month follow-up, most of these effects were maintained and an intervention effect for breast cancer specific quality of life emerged. No adverse effects were noted.
                Supervised group exercise provided functional and psychological benefit after a 12 week intervention and six months later. Clinicians should encourage activity for their patients. Policy makers should consider the inclusion of exercise opportunities in cancer rehabilitation services. Trial registration Current controlled trials ISRCTN12587864 [controlled-trials.com]. Urinary incontinence after radical prostatectomy is a significant clinical problem. In this prospective study we investigate the effectiveness of early pelvic floor muscle training (PFMT) on a large population, that had undergone radical retropubic prostatectomy (RRP) at our department.
                300 consecutive patients who had undergone RRP for clinically confined prostate cancer were randomized in two groups after catheter removal. One group of 150 patients took part in a structured PFMT program. This began before discharge and consisted of Kegel exercises. The remaining 150 patients constituted the control group, they were not formally instructed in PFMT. Incontinence was assessed objectively using the 1 hour and 24 hour pad test, as well as with the ICS-Male questionnaire. All patients who were incontinent after 6 months underwent urodynamic evaluation.
                In the treated group, 19% (29 patients) achieved continence after 1 month, and 94.6% (146 patients) after 6 months. In the control group 8% (12 patients) achieved continence after 1 month, and 65% (97 patients) after 6 months (p<0.001). Patient age did not correlate with continence in the control group (p>0.05), although a significant correlation was revealed within the treated group (p<0.01). Overall, 93.3% of the total population achieved continence after one year.
                After RRP an early supportive rehabilitation program like PFMT significantly reduces continence recovery time.
There is now some evidence available indicating a positive effect of PFMT for prolapse symptoms and severity. The largest most rigorous trial to date suggests that six months of supervised PFMT has benefits in terms of anatomical and symptom improvement (if symptomatic) immediately post-intervention. Further evidence relating to effectiveness and cost-effectiveness of PFMT, of different intensities, for symptomatic prolapse in the medium and long term is needed. A large trial of PFMT supplementing surgery is needed to give clear evidence about the usefulness of combining these treatments. Other comparisons which have not been addressed in trials to date and warrant consideration include those involving lifestyle change interventions, and trials aimed at prolapse prevention.