## Protocol Section
### Identification Module
**NCT ID:** NCT03053479

**Acronym:** SAME

**Brief Title:** Comparison of the Efficacy of Sacrocolpopexy, the Amreich-Richter Procedure and Transvaginal Mesh

**Official Title:** Comparison of the Efficacy of Three Surgical Methods in the Treatment of POP: Sacrocolpopexy,the Amreich-Richter Procedure and Transvaginal Mesh

#### Organization Study ID Info
**ID:** SAME
#### Organization
**Class:** OTHER
**Full Name:** Charles University, Czech Republic
### Status Module
#### Completion Date
**Date:** 2028-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-02-15

**Type:** ACTUAL

**Last Update Submit Date:** 2023-02-12

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-09-01

**Type:** ACTUAL

**Status Verified Date:** 2023-02

#### Study First Post Date
**Date:** 2017-02-15
**Type:** ACTUAL
**Study First Submit Date:** 2017-02-08
**Study First Submit QC Date:** 2017-02-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Charles University, Czech Republic

#### Responsible Party

**Investigator Affiliation:** Charles University, Czech Republic

**Investigator Full Name:** Kamil Svabik

**Investigator Title:** MD PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. Very little is known about the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) have been associated with an increased risk of reoperation in some studies. According to some studies patients had poorer anatomical outcome after traditional repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic sacrocolpopexy. The purpose of this study is to assess and compare the efficacy of these three procedures in a randomized controlled trial.

**Detailed Description:** Pelvic organ prolapse, POP, is a common health problem affecting up to 40% of women. The lifetime likelihood of undergoing at least one incident of pelvic organ prolapse surgery has been estimated at approximately 13%. The prevalence of reoperation after primary pelvic reconstructive surgery is high at around 30%, while some studies report the figure as up to 58%. In the early 1990s the perception of pelvic floor defects and urinary incontinence in women started to change significantly. The diagnostics and management of these defects became an independent uro-gynecological sub-specialization within gynaecology and obstetrics, and it has been included among 4 basic sub-specializations recognized by the European Board and College of Obstetrics and Gynecology. Surgical treatment is indicated in women with symptomatic POP when conservative management has failed or has been declined. There is no indication for repair of asymptomatic POP as an isolated procedure where surgical correction is of uncertain benefit and adds peri- and post-operative risks. The objective of our treatment should always aim to restore quality of life and comfort. Very little is known about the factors associated with surgical failure. Studies have identified a variety of risk factors: younger age, high body mass index and advanced preoperative prolapse (grade III-IV) have been associated with an increased risk of reoperation in some studies, while other studies did not prove these hypotheses. One factor which significantly influences the result of the pelvic organ surgery is the presence of pelvic floor injury. Injury of the musculus levator ani mainly affects the results of traditional vaginal wall repair, with 60% risk of recurrence. In the last few years, in an attempt to reduce recurrence and improve the outcome of reconstructive surgery in the treatment of pelvic organ prolapse, surgeons have started to use transvaginally introduced prosthetic material (mesh). This type of surgery significantly increases the efficacy of the procedure (anatomic cure rate over 90%), but its use is associated with a risk of some complications (vaginal erosions and potential consecutive infections, granulomas, dyspareunia, vesico-vaginal fistulas, chronic pain) thereby potentially reducing patient quality of life and leading to additional surgery. If the mesh is introduced during sacrocolpopexy and the vaginal wall is not open, there is a significant decrease of mesh-related complications. Laparoscopic sacrocolpopexy is considered the gold standard for the management of apical prolapse with high long-term efficacy. According to some studies patients had poorer anatomical outcome after traditional repairs but were able to enjoy the same quality of life as after transvaginal mesh surgery or laparoscopic sacrocolpopexy. Therefore the investigators plan to assess the efficacy in a randomized trial of three different surgical methods (the Amreich-Richter procedure, transvaginal mesh and laparoscopic sacrocolpopexy) in patients with high risk of recurrence; i.e. patients with advanced pelvic organ prolapse (at least stage III) and proved injury of pelvic floor muscles.

Aims of the study: To evaluate on the basis of a prospective randomized trial the clinical efficacy of three different surgical procedures (the Amreich-Richter procedure, transvaginal mesh and laparoscopic sacrocolpopexy) in women with advanced pelvic organ prolapse and proved pelvic floor muscle injury

All patients will undergo complete urogynecological investigation before the procedure (history, clinical examination, assessment of pelvic organ prolapse using the POPQ system, examination of the levator resting tone and contraction (Oxford scale),where appropriate urodynamics according to ICS recommendation and ultrasound examination), and they will fill in standardized international questionnaires (ICIQ-UI SF, PISQ 12, UDI_POPDI-CRADI, POP-SF). Ultrasound examinations will be performed as a combined examination using a convex probe, from abdominal and perineal approaches, and sectoral vaginal probe from the introital approach. Investigation will be preserved mainly in digital form and partly on videotapes. Acquired data from 4D imagery will be preserved in the form of data set and processed with appropriate software. Ultrasound examination will assess standards parameters describing position of the urethrovesical junction, bladder descent, uterus descent, posterior vaginal wall descent (rectocele, enterocele). Using 3D/4D ultrasound examination the status of the pelvic floor will be evaluated (presence of avulsion of puborectalis muscle, abnormal genital hiatus distension). Women will be randomized into three groups: 1. Group - Laparoscopic sacrocolpopexy 2. Group - Transvaginal mesh procedure 3. Group - Amreich-Richter procedure (traditional vaginal wall repair with apical fixation to sacrospinous ligament.

All surgical procedures will be performed under general, spinal or epidural anesthesia where indicated, and antibiotic prophylaxis will be used. Surgery will be provided in standardized steps, see arm descriptions.

In an early postoperative check-up 2-3 weeks after surgery evaluation of post-operative pain will be performed and late post-operative complication such as de novo constipation, urinary retention, infections analyzed. The next post-operative complete examination is planned for 3 months after surgery (the same examination as before the procedure including clinical exam, ultrasound the QoL (ICIQ- SF, POP-SF, PISQ 12, UDI_POPDI-CRADI, TS-VAS). The next visits will be provided one year and two years after surgery, and the procedure will be the same as at the 3-month check-up. In addition to pre-operative ultrasound examination the position of the mesh will be monitored. All patients in this study will have a minimum one year follow-up and, whenever possible, a two year follow-up. Postoperative follow-up will be terminated if the result of surgery is evaluated as a failure, and in these cases reoperation will be offered. Further post-operative follow-up up to five years is also planned.

### Conditions Module

**Conditions:**

- Pelvic Organ Prolapse

**Keywords:**

- surgery

- native tissue prolapse repair

- laparoscopic sacrocolpopexy

- vaginal mesh

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 462

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Laparoscopic sacrocolpopexy will be performed in the following way: Identification of the promontory, dissection of the peritoneum above the promontory and preparation of the ligamentum longitudinale anterior, peritoneum dissection, dissection of the vesicovaginal septum up to the bladder neck, dissection of the rectovaginal septum towards the perineum, application of Y mesh, fixation to the vaginal apex using non-absorbable sutures, and for anterior and posterior vaginal wall absorbable sutures. Fixation of the upper mesh arm to the ligamentum longitudinale anterior using non-absorbable suture, following with complete peritoneum closure above the mesh. The procedure could include salpingo-oophorectomy, supracervical hysterectomy or total hysterectomy (concomitant procedures are not exclusion criteria).

**Intervention Names:**

- Procedure: Laparoscopic sacrocolpopexy

**Label:** Laparoscopic sacrocolpopexy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Hydrodissection of the anterior vaginal wall, midline anterior colporrhaphy, preparation beyond the endopelvic fascia, mesh kit with bilateral fixation to sacrospinous ligaments should be used. The procedure could include salpingo-oophorectomy, total hysterectomy and posterior vaginal wall repair (concomitant procedures are not exclusion criteria).

**Intervention Names:**

- Procedure: Transvaginal mesh procedure

**Label:** Transvaginal mesh procedure

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** At least unilateral fixation with non-absorbable suture to sacrospinous ligament (fixation could be performed from the anterior approach). At the time of anterior vaginal wall repair or traditional posterior approach, it is possible to use a device for stich fixation (for example Capio, I- stitch etc). The procedure could include salpingo-oophorectomy, total hysterectomy and posterior vaginal wall repair (concomitant procedures are not exclusion criteria).

**Intervention Names:**

- Procedure: Amreich-Richter procedure

**Label:** Amreich-Richter procedure:

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Laparoscopic sacrocolpopexy

**Description:** see arm/group descriptions

**Name:** Laparoscopic sacrocolpopexy

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Transvaginal mesh procedure

**Description:** see arm/group descriptions

**Name:** Transvaginal mesh procedure

**Type:** PROCEDURE

#### Intervention 3

**Arm Group Labels:**

- Amreich-Richter procedure:

**Description:** see arm/group descriptions

**Name:** Amreich-Richter procedure

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** absence of pelvic organ prolapse (using the POPQ system - maximal I. stage prolapse)

**Measure:** Objective cure rate

**Time Frame:** 2 years

**Description:** failure is defined as pelvic organ prolapse stage II or higher using the POPQ system during the clinical examination, or as a descent 1 cm below the lower edge of pubic bone based on ultrasound examination.

**Measure:** Number of failures in each group

**Time Frame:** 2 years

**Description:** new occurence of painful sexual intercourse after the surgery.

**Measure:** de novo dyspareunia

**Time Frame:** 2 years

**Description:** extrusion rate, pain

**Measure:** mesh related complications

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** Measured at Valsalva from rendered 4D volume

**Measure:** Change of the genital hiatus size

**Time Frame:** 2 years

**Description:** Measured from sagittal plane, transperineal ultrasound

**Measure:** Distance of mesh from the bladder neck

**Time Frame:** 2 years

**Description:** Measured from sagittal plane, transperineal ultrasound at Valsalva. Distance in relation to a horizontal line at the level of symphysis.

**Measure:** Lowest position of the mesh

**Time Frame:** 2 years

**Description:** International Consultation on Incontinence questionnaire, urinary incontinence, short form

**Measure:** ICIQ-UI SF

**Time Frame:** 2 years

**Description:** Pelvic organ prolapse symptom scale

**Measure:** POP-SS

**Time Frame:** 2 years

**Description:** Prolapse/incontinence sexual questionnaire

**Measure:** PISQ-12

**Time Frame:** 2 years

**Description:** Pelvic floor distress inventory

**Measure:** PFDI

**Time Frame:** 2 years

**Description:** Treatment satisfaction - visual analog scale

**Measure:** TS-VAS

**Time Frame:** 2 years

**Description:** any occurence

**Measure:** de novo stress urinary incontinence

**Time Frame:** 2 years

**Description:** any occurence

**Measure:** de novo symptoms of overactive bladder

**Time Frame:** 2 years

**Description:** rate

**Measure:** reoperation for pelvic organ prolapse recurrence

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* age over18
* signed informed consent
* symptomatic pelvic organ prolapse stage III or higher (according to the International Continence Society Pelvic Organ Prolapse quantification system - POPQ) in anterior and apical (central) compartments, one at least stage II and the second at least stage III
* presence of at least a unilateral avulsion injury of the puborectalis muscle
* agreement with postoperative follow-up.

Exclusion Criteria:

* previous pelvic reconstructive surgery with mesh
* isolated posterior compartment prolapse
* previous radiotherapy in true pelvis
* contraindication for one of the planned surgical methods.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Frýdek-Místek

**Country:** Czechia

**Facility:** Frýdek-Místek regional hospital

**Zip:** 73801

**Location 2:**

**City:** Olomouc

**Country:** Czechia

**Facility:** Faculty of Medicine in Olomouc, Palackeho University

**Location 3:**

**City:** Plzen

**Country:** Czechia

**Facility:** Faculty of Medicine in Pilsen, Charles University

**Zip:** 30460

**Location 4:**

**City:** Prague

**Country:** Czechia

**Facility:** General University Hospital, 1st Faculty of Medicine, Charles University

**Zip:** 12800

**Location 5:**

**City:** Prague

**Country:** Czechia

**Facility:** Hospital Na Bulovce, 1st Faculty of Medicine, Charles University

**Zip:** 18000

**Location 6:**

**City:** Zlin

**Country:** Czechia

**Facility:** Tomas Bata Regional Hospital in Zlin

**Zip:** 762 75

**Location 7:**

**City:** Košice

**Country:** Slovakia

**Facility:** Louis Pasteur University Hospital Kosice

**Zip:** 04011

### IPD Sharing Statement Module

**Description:** IPD sharing not planned

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M14261

- Name: Prolapse

- Relevance: HIGH

- As Found: Prolapse

- ID: M28618

- Name: Pelvic Organ Prolapse

- Relevance: HIGH

- As Found: Pelvic Organ Prolapse

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011391

- Term: Prolapse

- ID: D000056887

- Term: Pelvic Organ Prolapse

### Misc Info Module

#### Removed Countries

- Country: Czech Republic

- Version Holder: 2024-05-24
