Urinary Incontinence, Stress Clinical Trial
— CAREOfficial title:
CARE: A Randomized Trial of Colpopexy and Urinary Reduction Efforts
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
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 |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
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
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 |
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