Prospective multicenter post- marketing surveillance study for surgical pelvic floor reconstruction in the anterior compartment with the polypropylen mesh InGYNious
- Conditions
- N81.1N81.2CystoceleIncomplete uterovaginal prolapse
- Registration Number
- DRKS00011657
- Lead Sponsor
- A.M.I. GmbH (Agency for Medical Innovations)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 254
Inclusion Criteria
symptomatic cystocele according to ICS (international continence society) grade >= POPQ 2 (primary cystocele and recurrence)
Compliance according to evaluation of data, therapy and follow- up
Written consent form of patient
Exclusion Criteria
Asymptomatic prolapse of uterus
age< 18 years
missing written consent form
lacling compliance according to evaluation of data, therapy and follow- up
known incompatibility in regard to mesh products
expectation of life less than period of review, ASA 4
progredient malignancy
state after radiotherapy of the true pelvis
chronic cortisone medication
fibromyalgia, chronic pain syndrome, connective tissue disease, immunodeficiency
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Evaluation of quality of life and sexuality pre- vs. post- operatively after surgical repair of cystocele with implantation of InGYNious mesh.<br> The German Version of the P- QOL(Prolapse Quality of Life) questionnaire is used. The patients complete the questionnaire pre- operatively, after 6 and 12 months.<br><br>2) Determination of cystocele recurrence rate after implantation of InGYNious mesh. The quantiication of prolapse is ensued with the POP- Q (Pelvic Organ Prolapse Quantification)- system, published by Bump et al., 1996
- Secondary Outcome Measures
Name Time Method Evaluation of intra- and post- operative side effects after repair of cystocele with InGYNious mesh