Prospectively randomised multicenter trial on the influence on mesh exposure rates of partially absorbable transobturatoric mesh after surgery for pelvic organ prolapse in the anterior compartment

Not Applicable

• Conditions: N81.1; N81.2; Cystocele; Incomplete uterovaginal prolapse

• Registration Number: DRKS00004566
• Lead Sponsor: Diakoniekrankenhaus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-12-01
• Study Start: 2012-11-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Patients were eligible for participation in the trial when they had a symptomatic cystocele > stage 2 or stage 2 in combination with a considerable lateral defect and risk factors for recurrent POP: chronic obstructive pulmonary disease, chronic obstipation, overweight.

Exclusion Criteria

age <18 yrs, imcompleted family planning, allergy to polypropylene, previous malignancy of lower urinary tract, genital organs or rectosigmoid, previous mesh implantation, missing informed consent, life expectancy <3 yrs or patients that could not ensure follow up visits over 3 years.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
What: Vaginal mesh exposure rate<br>Wann: 12 months postoperatively<br>Wie: vaginale examination: visible parts of the mesh

Secondary Outcome Measures

Name	Time	Method
Which other factors have an influence on mesh exposure rates? The following factors will be investigates: <br>preoperatively: patients´charakteristics, proliferation of vaginal epithelium, bacterial colonisation of the vagina, molecularbiologic factors of the vaginal wall (e.g. collagen composition and adherence, extracellular matrix proteines)<br>intraoperative: surgical technique (thickness of vaginal wall. lenght of colpotomy, simultaneous hysterectomy).<br>3, 12 and 36 months postoperatively: proliferation of vaginal epithelium, bacterial colonisation of the vagina <br>Furthermore, the influence of the mesh used on pelvic floor related quality of life will be evaluated, using the German pelvic floor questionnaire (Deutscher Beckenbodenfragebogen, Baessler et al. 2004) and on prolapse recurrence rates (vaginal examination). Both items will be tested after 3,12 and 36 months.