Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse

Female Genital Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092623
• Other study ID #: 50/180/2010
• Secondary ID: 21011
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: May 26, 2015
• Start date: September 2010
• Est. completion date: December 2014

Study information

• Verified date: May 2015
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: December 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Genital Prolapse
• Prolapse
• Uterine Prolapse

Intervention

Device:
• Transvaginal posterior mesh
A trocar-free fixation system with low-weight mesh

Locations

Country	Name	City	State
Finland	Turku University Central Hospital	Turku	Varsinais-Suomi

Sponsors (4)

Lead Sponsor	Collaborator
Turku University Hospital	Helsinki University Central Hospital, Oulu University Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		up to 1 year	Yes
Secondary	POP-Q measurement	Objective results of the operation (vaginal anatomy)	preoperatively, 3 months and 1 year	No
Secondary	Pelvic floor distress inventory (PFDI-20)	Subjective outcome of the operation on pelvic floor symptoms	preoperatively, 3 months and 1 year	No
Secondary	Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12)	Subjective outcome of the operation on sexual functioning	preoperatively, 3 months and 1 year	No