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Colpopexy and Urinary Reduction Efforts (CARE) Protocol

2014-07-23 21:52:19 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Conditions

Urinary Incontinence, Stress

Intervention

Burch urethropexy at time of sacrocolpopexy

Location

The University of Alabama at Birmingham
Birmingham
Alabama
United States
35233-7333

Status

Active, not recruiting

Source

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:52:19-0400

Clinical Trials [1493 Associated Clinical Trials listed on BioPortfolio]

Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse

Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anteri...

Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence

Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also i...

Solace Stress Urinary inContinence Control Efficacy and Safety Study

The SUCCESS Trial is designed to determine whether the Solace Bladder Control System is safe and effective for the treatment of Stress Urinary Incontinence (SUI) in adult females.

Outcomes Following Vaginal Prolapse Repair and Mid Urethral Sling Trial

Pelvic organ prolapse is common among women with a prevalence that has been estimated to be as high as 30%. Prolapse may be corrected by surgery using either a vaginal or abdominal incisi...

Randomized Clinical Trial of Burch vs Sling Procedures for Women With Stress Urinary Incontinence

The primary aim of this clinical trial is to compare the treatment success for two surgical procedures that are frequently used and have similar cure rates, yet have not been compared dire...

PubMed Articles [15383 Associated PubMed Articles listed on BioPortfolio]

Laparoscopic sacrocolpopexy with or without midurethral sling insertion: Is a two- step approach justified? A prospective study.

Most data support the fact that women with symptomatic pelvic organ prolapse (POP) with concomitant symptomatic or occult stress urinary incontinence (SUI) benefit from concurrent POP and anti-inconti...

Robotic-Assisted Sacrocolpopexy: Early Postoperative Outcomes after Surgical Reduction of Enlarged Genital Hiatus.

Currently, the decision to perform a concurrent posterior repair/perineoplasty at the time of robotic-assisted sacrocolpopexy is not standardized.

A Case of Mesh Erosion to the Sigmoid After Laparoscopic Sacrocolpopexy and a Literature Review of Mesh Related Complications.

Sacrocolpopexy has long been the preferred surgical procedure for the management of apical vaginal prolapse. The published literature regarding rectal mesh erosion after sacrocolpopexy includes only 6...

A national contemporary analysis of perioperative outcomes for open versus minimally-invasive sacrocolpopexy.

To evaluate the perioperative morbidity of open abdominal sacrocolpopexy (ASC) and minimally invasive sacrocolpopexy (MISC) using data from a contemporary nationwide cohort.

Long-term follow-up of bulking agents for stress urinary incontinence in older patients.

Implantation of bulking agents represents a noninvasive procedure for the treatment of stress urinary incontinence (SUI) in all patients where a more invasive procedure may increase perioperative risk...

Medical and Biotech [MESH] Definitions

Involuntary loss of URINE, such as leaking of urine. It is a symptom of various underlying pathological processes. Major types of incontinence include URINARY URGE INCONTINENCE and URINARY STRESS INCONTINENCE.

Abnormal descent of a pelvic organ resulting in the protrusion of the organ beyond its normal anatomical confines. Symptoms often include vaginal discomfort, DYSPAREUNIA; URINARY STRESS INCONTINENCE; and FECAL INCONTINENCE.

An ANTIMUSCARINIC AGENT selective for the MUSCARINIC RECEPTORS of the BLADDER that is used in the treatment of URINARY INCONTINENCE and URINARY URGE INCONTINENCE.

Support structures, made from natural or synthetic materials, that are implanted below the URETHRA to treat URINARY STRESS INCONTINENCE.

Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.

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