A randomized controlled trial of anterior colporraphy and PerigeeTM as surgical correction of symptomatic cystocele.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24040

Enrollment

Registered

2007-11-18

Start date

2006-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic cystocele (NLD: Symptomatische cystocele).

Interventions

Women are either allocated to classic anterior colporraphy repair or to cystocele using PerigeeTM.

Eligibility

Inclusion criteria

Inclusion criteria: Women undergoing primary or secondary surgical repair of cystocele stage 2 or higher, according to the POP-Q classification.

Exclusion criteria

Exclusion criteria: 1. Patients with an indication for posterior vaginal wall repair; 2. Patients with an indication for hysterectomy; 3. Patients in whom the anterior vaginal wall is not the most descending part of the prolapse.

Design outcomes

Primary

Measure	Time frame
Quality of life related to pelvic floor function.	—

Secondary

Measure	Time frame
1. Morbidity; 2. POP-Q classification of the prolapse; 3. General quality of life.	—

Contacts

Public ContactJan-Paul W.R. Roovers

PO Box 22660

j.p.roovers@amc.uva.nl+31 (0)20 5666429

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)