Clinical trial NCT02092623: Single Incision Transvaginal Mesh in Treatment of Posterior Vaginal Wall Prolapse
Official title: Single Incision Transvaginal Mesh (Elevate® Posterior) in Treatment of Posterior Vaginal Wall Prolapse Without Concurrent Surgery - National Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Female Genital Prolapse
Keywords: Female
Prolapse surgery with transvaginal mesh
Subjective outcome
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Oulu University Hospital
name: Helsinki University Central Hospital
name: Tampere University Hospital
First posted: 2014-03-20
Enrollment: 111
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: up to 1 year
Secondary outcomes:
measure: POP-Q measurement
timeFrame: preoperatively, 3 months and 1 year
measure: Pelvic floor distress inventory (PFDI-20)
timeFrame: preoperatively, 3 months and 1 year
measure: Pelvic organ prolapse/urinary incontinence sexual questionnaire (PISQ-12)
timeFrame: preoperatively, 3 months and 1 year
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Central Hospital
state: Varsinais-Suomi
Study officials:
affiliation: Turku University Hospital
name: Mervi Haarala, MD
role: STUDY_DIRECTOR
References: