Avaulta versus anterior colporraphy

Recruiting

• Conditions: anterior prolapse surgery; cystoceleIn het Nederlands:vaginale prolaps chirurgie; cystocele

• Registration Number: NL-OMON21781
• Lead Sponsor: niversity Medical Center Utrecht (UMCU)

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 115

Inclusion Criteria

1. Women aged 40-80 years

2. Cystocele stage ¡Ý 2 according to POP Q classification

Exclusion Criteria

1. Women with childbearing potential who do not use adequate contraceptive measures (hormonal contraceptives, barrier methods (condoms), intra uterine device, male vasectomy, sterilisation).

2. History of major gynaecological or urological surgery, with the exception of a hysterectomy for reasons other than a genital prolapse.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of women who will have a recurrence, defined as a stage ¡Ý 2 anterior vaginal prolapse at 2 years follow-up.

Secondary Outcome Measures

Name	Time	Method
- The effect of surgery on urogenital symptoms and quality of life <br /><br>- Complications of surgery (direct and medium term)<br /><br>- Cost-effectiveness analysis.