Skip to main content
OpenTrials
Completed

NCT Number: NCT02092623

Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Female Genital Prolapse

Age range

30 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Turku University Central Hospital

Turku, Southwest Finland, 20520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transvaginal posterior mesh

Device

A trocar-free fixation system with low-weight mesh

Other names: Elevate®Posterior

Primary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability

    Time frame: up to 1 year

Secondary outcomes

  1. POP-Q measurement

    Time frame: preoperatively, 3 months and 1 year

    Objective results of the operation (vaginal anatomy)

  2. Pelvic floor distress inventory (PFDI-20)

    Time frame: preoperatively, 3 months and 1 year

    Subjective outcome of the operation on pelvic floor symptoms

  3. Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12)

    Time frame: preoperatively, 3 months and 1 year

    Subjective outcome of the operation on sexual functioning

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Helsinki University Central Hospital
  • Oulu University Hospital
  • Tampere University Hospital

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Mar 20, 2014
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.