N/A
N=50
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
Pelvic Organ Prolapse · Urinary Incontinence,Stress · Urinary Incontinence, Urge · Bowel Dysfunction · Sexual Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT03841513 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Participants With Stress Urinary Incontinence — 10; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laparoscopic Burch Colposuspension (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Northwestern University
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Stress Urinary Incontinence |
10; 13 | — |
| SECONDARY Number of Participants With Urinary Urgency Incontinence |
1; 2 | — |
| SECONDARY Number of Participate With Urinary Frequency |
2; 4 | — |
| SECONDARY Number of Participants With Urinary Retention |
1; 3 | — |
| SECONDARY Number of Participants With Urinary Tract Infection |
2; 1 | — |
| SECONDARY Pelvic Organ Prolapse Symptoms |
8.3; 2.1 | — |
| SECONDARY Bowel Symptoms |
6.3; 6.7 | — |
| SECONDARY Sexual Function |
10.5; 12.0 | — |
| SECONDARY Number of Participants With Surgical Complication |
3; 5 | — |
Summary
This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence. Half of the participants will undergo Burch colposuspension procedure at the time of sacrocolpopexy, and half of the participants will undergo sacrocolpopexy alone.
Eligibility Criteria
Inclusion Criteria
- English or Spanish speaking and reading
- Symptomatic pelvic organ prolapse with any compartment at or beyond the hymen
- Stress-continent, as defined as response of "no" to question 17 of PFDI-20: "Do you usually experience urine leakage related to coughing, sneezing, or laughing?", as well as a negative empty supine stress test.
- Planning laparoscopic or robotic sacrocolpopexy, with or without hysterectomy
- Have completed childbearing
Exclusion Criteria
- Adults unable to consent
- Pregnant women or patients desiring future pregnancy
- Patients undergoing uterine sparing surgery
- Individuals under age 18
- Prior procedure for stress urinary incontinence
- Prior retropubic surgery
Data sourced from ClinicalTrials.gov (NCT03841513). 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.