Prospective observational study to evaluate the efficacy and safety of laparoscopic bilateral uterosacropexy with DynaMesh®-CESA and VASA mesh implants in women with pelvic organ prolapse

Recruiting

• Conditions: N81.2; Incomplete uterovaginal prolapse

• Registration Number: DRKS00032443
• Lead Sponsor: Frauenklinik der Universität zu Köln

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 163

Inclusion Criteria

• Impaired by pelvic organ prolaps symptoms >4 (according to the Numerical Rating Scale (NRS) score from 0-10, where 0 = not affected to 10 = severely affected)
• Signed declaration of consent including authorization for data processing
• Women of childbearing potential with adequate contraceptive protection. Safe contraceptive measures are considered (Pearl Index < 1%):

Exclusion Criteria

• Serious, life-threatening and/or active malignancy
• Congenital uterine anomalies
• Conspicuous PAP smears or evidence of CIN II/III or unexplained postmenopausal bleeding
• Surgical pre-treatment for descensus uteri
• Existing or planned pregnancy: In patients of childbearing age, pregnancy must be ruled out by means of a pregnancy test or other suitable methods.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of anatomical recurrences (repeated apical descensus, measured as POPQ > 1) with/without reoperation.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints are used to assess the safety of the product. Measured by the incidence of potential (mesh-related) postoperative complications.<br>As part of the integrated, contrast medium-free MRI study, the position, fixation points (posterior wall of the cervix and os sacrum) and the course of the ligament, including anatomical changes.