Phase 4 Completed N=76 Randomized Double-blind Treatment

Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Cystocele · uterine prolapse · Urinary Incontinence

Source: ClinicalTrials.gov NCT00535301 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcomePrimary: Recurrent Stage II or Greater Anterior Vaginal Prolapse — 24; 11 participants — p=0.005

Summary

The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.

Outcome Measures

Outcome	Result	p-value
PRIMARY Recurrent Stage II or Greater Anterior Vaginal Prolapse	24; 11	0.005 sig
SECONDARY Operative Time	120; 135	0.5
SECONDARY Vaginal Mesh Exposure	0; 4	<0.05 sig

Eligibility Criteria

Inclusion Criteria

stage II or greater anterior vaginal prolapse requiring surgical correction
age 21 years and older

Exclusion Criteria

less than Stage II anterior vaginal prolapse
decline participation
pregnant or contemplating future pregnancy
prior anterior vaginal prolapse repair with biologic or synthetic graft
active or latent systemic infection
compromised immune system
previous pelvic irradiation or cancer
known hypersensitivity to polypropylene
uncontrolled diabetes mellitus
unable or unwilling to give valid informed consent
unable or unwilling to comply with the protocol
scheduled to undergo concomitant Burch colposuspension or pubovaginal sling

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00535301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.