Colpopexy and Urinary Reduction Efforts (CARE) Protocol

Study Overview
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Brief Summary
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Pelvic organ prolapse occurs when the muscles holding pelvic organs (e.g., the uterus or bladder) weaken and the organs fall or slide down into the vagina. Pelvic organ prolapse can be corrected with surgery. However, women who have this surgery may develop urinary incontinence. This study will determine how doctors can predict this problem and whether an additional surgical procedure at the time of prolapse surgery can prevent the development of urinary incontinence.

Detailed Description
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Many women have surgery for pelvic organ prolapse (cystocele, uterine prolapse, rectocele). Women with advanced pelvic organ prolapse may experience stress urinary incontinence following surgery to repair the prolapse. Development of incontinence is unpredictable. This study will determine which, if any, clinical tests are useful for predicting post-operative urinary incontinence. The study will also determine if a Burch urethropexy should be performed routinely or selectively at the time of sacrocolpopexy in continent women. Women with pelvic organ prolapse who are scheduled for prolapse repair will be randomized to a Burch urethropexy group or to a control group. Women in the Burch group will undergo urethropexy at the time of prolapse repair. Assessments will include a quality of life telephone interview, urodynamic testing, and physical examination. Follow-up evaluations occur at 6 weeks, 3 months, and 1 and 2 years following surgery. Post-operative phone interviews will occur at 3 months, 6 months, and 1 and 2 years.

Official Title
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CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

Conditions
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Urinary Incontinence, Stress, Uterine Prolapse, Vaginal Prolapse

Intervention / Treatment
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* Procedure: Burch urethropexy at time of sacrocolpopexy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Eligibility for primary procedure (sacrocolpopexy) Eligibility for secondary procedure (Burch colposuspension) Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm. Negative stress incontinence screen Negative stress incontinence screen (MESA questionnaire) Exclusion Criteria Contraindication for sacrocolpopexy or Burch colposuspension. Anatomic contraindication for Burch colposuspension (i.e., Point Aa fixed at -2 or -3 cm). Surgeon judgment that a contraindication to Burch colposuspension exists. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening). Inability to provide informed consent or to complete testing or data collection. Currently pregnant.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Abdominal Sacral Colpopexy with no Burch colposuspension<br>Abdominal sacral colpopexy is performed through a laparotomy approach. | |
| Experimental: Abdominal Sacral Colpopexy with Burch Colposuspension<br>The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone). | Procedure: Burch urethropexy at time of sacrocolpopexy<br>* The Burch colposuspension procedure entails the retropubic placement of at least two stitches in the vaginal tissue lateral to each side of the urethra, and suspension of these stitches from Cooper's ligament (the iliopectineal line at the superior aspect of the posterior pubic bone).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress urinary continence | Patients will be categorized as stress continent or stress incontinent on the basis of symptom assessment and stress testing. The symptoms will be assessed by the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications at surgery | Complications at surgery | 2 years | 
| Occurrence of other lower urinary tract symptoms | measured by the urgency and obstructed voiding subscales of the PFDI | 3 mo, 2 years | 
| Other pelvic symptoms and health-related quality of life | includes bowel function and sexual function | 3 mo, 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary incontinence, Pelvic organ prolapse, Stress incontinence, Sacrocolpopexy, Burch urethropexy, Surgical Trials