DRKS00011657
Completed
Not Applicable
Prospective multicenter post- marketing surveillance study for surgical pelvic floor reconstruction in the anterior compartment with the polypropylen mesh InGYNious - InGYNious - AWB
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- N81.1
- Sponsor
- A.M.I. GmbH (Agency for Medical Innovations)
- Enrollment
- 254
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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