NCT02092623

Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: 30 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Female Genital Prolapse

Interventions

Type	Name	Description
DEVICE	Transvaginal posterior mesh	A trocar-free fixation system with low-weight mesh

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-11-01
• Completion: 2014-12-01
• First posted: 2014-03-20
• Last updated: 2015-05-27

Locations

1 site across 1 country: Finland