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Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse

Sponsor
Turku University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02092623
Collaborator
Oulu University Hospital (Other), Helsinki University Central Hospital (Other), Tampere University Hospital (Other)
111
Enrollment
1
Location
1
Arm
51
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transvaginal posterior mesh
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
111 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Single Incision Transvaginal Mesh (Elevate® Posterior) in Treatment of Posterior Vaginal Wall Prolapse Without Concurrent Surgery - National Prospective Multicenter Study
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Other: Transvaginal posterior mesh surgery

All study patients undergo transvaginal mesh operation.

Device: Transvaginal posterior mesh
A trocar-free fixation system with low-weight mesh
Other Names:
  • Elevate®Posterior

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with adverse events as a measure of safety and tolerability [up to 1 year]

    Secondary Outcome Measures

    1. POP-Q measurement [preoperatively, 3 months and 1 year]

      Objective results of the operation (vaginal anatomy)

    2. Pelvic floor distress inventory (PFDI-20) [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) [preoperatively, 3 months and 1 year]

      Subjective outcome of the operation on sexual functioning

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 90 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turku University Central Hospital Turku Varsinais-Suomi Finland 20520

    Sponsors and Collaborators

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

    Investigators

    • Study Director: Mervi Haarala, MD, Turku University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seija Ala-Nissilä, MD, Turku University Hospital
    ClinicalTrials.gov Identifier:
    NCT02092623
    Other Study ID Numbers:
    • 50/180/2010
    • 21011
    First Posted:
    Mar 20, 2014
    Last Update Posted:
    May 27, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Seija Ala-Nissilä, MD, Turku University Hospital
    Female
    Prolapse surgery with transvaginal mesh
    Subjective outcome
    Additional relevant MeSH terms:
    Prolapse

    Study Results

    No Results Posted as of May 27, 2015