Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse

Study Overview
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Brief Summary
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Definition: To find out complications, objective and subjective outcomes of patients with symptomatic posterior vaginal wall prolapse undergoing posterior mesh operation in nine Finnish hospitals during September 2010 and August 2013. The study hypothesis is that complications are acceptable and both objective and subjective outcomes are satisfying.

Detailed Description
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The aim of this study is to investigate the safety and efficacy of Elevate®Posterior transvaginal mesh kit. Secondly the investigators want to evaluate the effect of this surgical method on non-affected anterior vaginal compartment as well as patients' outcome. This prospective multicenter national study include patients (n=111) with symptomatic posterior vaginal wall with or without apical prolapse with stage II or more. Patients were recruited at four university hospitals and five central hospitals in Finland between September 2010 and August 2013. The study protocol was approved by the Ethics Committees in participating hospitals and all attending patients gave written consent after oral and written counseling. Baseline evaluation include standardized gynecological examination in supine position using the POP-Q system. Detailed information on patients' characteristics and medical history is gathered, focusing on especially gynecological issues. Patients fill in Pelvic Floor Distress Inventory (PFDI-20) and Pelvic organ prolapse/urinary Incontinence Sexual Questionnaire (PISQ-12). The operations are performed by qualified surgeons (n=9) familiar with transvaginal mesh surgery. Intraoperative data is collected and immediate postoperative problems are registered. The first follow-up visit take place at three months postoperatively. Gynecological examination with POP-Q measurements are performed and complications documented. As preoperatively, PFDI-20 and PISQ-12 questionnaires are filled in by the patients. The second visit take place at one year postoperatively. Gynecological examination with POP-Q measurements are performed and possible late complications documented. PFDI-20 and PISQ-12 questionnaires are filled in again by the patients.

Official Title
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Single Incision Transvaginal Mesh (Elevate® Posterior) in Treatment of Posterior Vaginal Wall Prolapse Without Concurrent Surgery - National Prospective Multicenter Study

Conditions
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Female Genital Prolapse

Intervention / Treatment
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* Device: Transvaginal posterior mesh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with symptomatic posterior vaginal wall with or without apical prolapse with stage II or more Exclusion Criteria: concomitant surgery, immunosuppressive treatment of any kind, previous or forthcoming bowel operation with low anastomosis creation and previous vaginal radiation therapy

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Transvaginal posterior mesh surgery<br>All study patients undergo transvaginal mesh operation. | Device: Transvaginal posterior mesh<br>* A trocar-free fixation system with low-weight mesh<br>* Other names: Elevate®Posterior;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POP-Q measurement | Objective results of the operation (vaginal anatomy) | preoperatively, 3 months and 1 year | 
| Pelvic floor distress inventory (PFDI-20) | Subjective outcome of the operation on pelvic floor symptoms | preoperatively, 3 months and 1 year | 
| Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12) | Subjective outcome of the operation on sexual functioning | preoperatively, 3 months and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female, Prolapse surgery with transvaginal mesh, Subjective outcome