Colpopexy and Urinary Reduction Efforts (CARE) Protocol

Urinary Incontinence, Stress Clinical Trial

— CARE  

Official title:

CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065845
• Other study ID #: U01HD041249
• Secondary ID: U10HD041268U10HD
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2003
• Last updated: January 9, 2011
• Start date: April 2002
• Est. completion date: April 2007

Study information

• Verified date: October 2010
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 322
• Est. completion date: April 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria

1. Eligibility for primary procedure (sacrocolpopexy)

2. Eligibility for secondary procedure (Burch colposuspension)

3. Stage II-IV anterior vaginal prolapse, defined as POP-Q Point Aa at -1, 0, +1, +2, or +3 cm.

4. Negative stress incontinence screen

5. Negative stress incontinence screen (MESA questionnaire)

Exclusion Criteria

1. 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.

2. Anticipated geographic relocation within the first three months after surgery (e.g., within approximately 6 months of screening).

3. Inability to provide informed consent or to complete testing or data collection.

4. Currently pregnant.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prolapse
• Urinary Incontinence
• Urinary Incontinence, Stress
• Uterine Prolapse
• Vaginal Prolapse

Intervention

Procedure:
• Burch urethropexy at time of sacrocolpopexy
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).

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	The University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa College of Medicine	Iowa City	Iowa
United States	Loyola University Medical Center	Maywood	Illinois
United States	Magee-Womens Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

References & Publications (11)

Barber MD, Brubaker L, Nygaard I, Wheeler TL 2nd, Schaffer J, Chen Z, Spino C; Pelvic Floor Disorders Network. Defining success after surgery for pelvic organ prolapse. Obstet Gynecol. 2009 Sep;114(3):600-9. doi: 10.1097/AOG.0b013e3181b2b1ae. — View Citation

Bradley CS, Kenton KS, Richter HE, Gao X, Zyczynski HM, Weber AM, Nygaard IE; Pelvic Floor Disorders Network. Obesity and outcomes after sacrocolpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):690.e1-8. doi: 10.1016/j.ajog.2008.07.030. Epub 2008 Oct 9. — View Citation

Bradley CS, Nygaard IE, Brown MB, Gutman RE, Kenton KS, Whitehead WE, Goode PS, Wren PA, Ghetti C, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women 1 year after sacrocolpopexy. Am J Obstet Gynecol. 2007 Dec;197(6):642.e1-8. — View Citation

Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15): — View Citation

Brubaker L, Nygaard I, Richter HE, Visco A, Weber AM, Cundiff GW, Fine P, Ghetti C, Brown MB. Two-year outcomes after sacrocolpopexy with and without burch to prevent stress urinary incontinence. Obstet Gynecol. 2008 Jul;112(1):49-55. doi: 10.1097/AOG.0b0 — View Citation

Burgio KL, Nygaard IE, Richter HE, Brubaker L, Gutman RE, Leng W, Wei J, Weber AM; Pelvic Floor Disorders Network. Bladder symptoms 1 year after abdominal sacrocolpopexy with and without Burch colposuspension in women without preoperative stress incontine — View Citation

Cundiff GW, Varner E, Visco AG, Zyczynski HM, Nager CW, Norton PA, Schaffer J, Brown MB, Brubaker L; Pelvic Floor Disorders Network. Risk factors for mesh/suture erosion following sacral colpopexy. Am J Obstet Gynecol. 2008 Dec;199(6):688.e1-5. doi: 10.10 — View Citation

Goode PS, Fitzgerald MP, Richter HE, Whitehead WE, Nygaard I, Wren PA, Zyczynski HM, Cundiff G, Menefee S, Senka JM, Gao X, Weber AM; Pelvic Floor Disorders Network. Enhancing participation of older women in surgical trials. J Am Coll Surg. 2008 Sep;207(3 — View Citation

Nygaard I, Handa VL, Brubaker L, Borello-France D, Wei J, Wells E, Goode P; Pelvic Floor Disorders Network. Changes in physical activity after abdominal sacrocolpopexy for advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):570.e1-5. doi: — View Citation

Visco AG, Brubaker L, Nygaard I, Richter HE, Cundiff G, Fine P, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. The role of preoperative urodynamic testing in stress-continent women undergoing sacrocolpopexy: the Colpopexy and Urinary Red — View Citation

Wren PA, Janz NK, FitzGerald MP, Barber MD, Burgio KL, Cundiff GW, Nygaard IE, Zyczynski HM, Gao X; Pelvic Floor Disorders Network. Optimism in women undergoing abdominal sacrocolpopexy for pelvic organ prolapse. J Am Coll Surg. 2008 Aug;207(2):240-5. doi — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Complications at surgery	Complications at surgery	2 years	Yes
Secondary	Occurrence of other lower urinary tract symptoms	measured by the urgency and obstructed voiding subscales of the PFDI	3 mo, 2 years	No
Secondary	Other pelvic symptoms and health-related quality of life	includes bowel function and sexual function	3 mo, 2 years	No

External Links

•   Pelvic Floor Disorders Network website