Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse
- Conditions
- Female Genital Prolapse
- Interventions
- Device: Transvaginal posterior mesh
- Registration Number
- NCT02092623
- Lead Sponsor
- Turku University Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 111
- patients with symptomatic posterior vaginal wall with or without apical prolapse with stage II or more
- concomitant surgery, immunosuppressive treatment of any kind, previous or forthcoming bowel operation with low anastomosis creation and previous vaginal radiation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transvaginal posterior mesh surgery Transvaginal posterior mesh All study patients undergo transvaginal mesh operation.
- Primary Outcome Measures
Name Time Method Number of participants with adverse events as a measure of safety and tolerability up to 1 year
- Secondary Outcome Measures
Name Time Method POP-Q measurement preoperatively, 3 months and 1 year Objective results of the operation (vaginal anatomy)
Pelvic floor distress inventory (PFDI-20) preoperatively, 3 months and 1 year Subjective outcome of the operation on pelvic floor symptoms
Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12) preoperatively, 3 months and 1 year Subjective outcome of the operation on sexual functioning
Trial Locations
- Locations (1)
Turku University Central Hospital
🇫🇮Turku, Varsinais-Suomi, Finland