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

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.

Study Overview

• Status: Completed
• Conditions: Female Genital Prolapse
• Intervention / Treatment: Device: Transvaginal posterior mesh

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 Type: Interventional
• Enrollment (Actual): 111
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Varsinais-Suomi
    • Turku, Varsinais-Suomi, Finland, 20520
      • Turku University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events as a measure of safety and tolerability	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POP-Q measurement	Objective results of the operation (vaginal anatomy)	preoperatively, 3 months and 1 year
Pelvic floor distress inventory (PFDI-20)	Subjective outcome of the operation on pelvic floor symptoms	preoperatively, 3 months and 1 year
Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12)	Subjective outcome of the operation on sexual functioning	preoperatively, 3 months and 1 year

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Helsinki University Central Hospital; Oulu University Hospital; Tampere University Hospital
• Investigators: Study Director: Mervi Haarala, MD, Turku University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: March 18, 2014
• First Posted (Estimate): March 20, 2014

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Female; Prolapse surgery with transvaginal mesh; Subjective outcome
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse
• Other Study ID Numbers: 50/180/2010; 21011 (Other Identifier: TurkuUH)