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Phase 4 N=76 Randomized Double-blind Treatment

Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

Cystocele · Uterine Prolapse · Urinary Incontinence

Bottom Line

View on ClinicalTrials.gov: NCT00535301 ↗
Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Recurrent Stage II or Greater Anterior Vaginal Prolapse — 24; 11 participants — p=0.005

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
grafted anterior prolapse repair (Device); sutured anterior vaginal prolapse repair (Procedure)
Age
Adult, Older Adult · 21+ yrs
Sex
Female
Sponsor
Kaiser Permanente
Primary completion
Apr 2008

Outcome Measures

OutcomeResultp-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

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.

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.

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