N/A
N=70
Surgical Study Comparing 2 Procedures for the Treatment of a Dropped Bladder
Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT00271102 ↗Enrolled (actual)
70
Serious AEs
—
Results posted
Sep 2019
Primary outcome: Primary: Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- anterior vaginal repair (colporrhaphy) (Procedure); abdominal paravaginal defect repair (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Geisinger Clinic
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Stage of Prolapse of the Anterior Vaginal Wall Before and One Year After Surgery |
— | — |
| SECONDARY The Difference in Intra-operative and Post-operative Complications. Patient Satisfaction Before and One Year After Surgery Based on Quality of Life and Sexual Function Questionnaires Specifically Designed for Patients With Pelvic Organ Prolapse. |
— | — |
Summary
The purpose of this study is to determine whether vaginal repair or abdominal repair is the procedure of choice for the surgical management of a prolapsed bladder.
Eligibility Criteria
Inclusion Criteria
- Women over the age of 18 seen at the urogynecology clinic at Geisinger with primary or recurrent pelvic organ prolapse including an anterior vaginal wall relaxation with or without urinary incontinence who are scheduled to have pelvic reconstructive surgery will be eligible to participate in the trial.
Exclusion Criteria
- Patients with at least 2 previous prolapse surgeries
- Patients who are pregnant or planning to have a pregnancy
Data sourced from ClinicalTrials.gov (NCT00271102). 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.