Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence

NCT00064662 | Completed Phase 2 Results

• 1 other identifier: UITN-RCT (completed)
• Study Type: interventional
• Target: 655
• Locations: 1 country
• Sites: 9

Brief Summary

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 directly to each other in a large, rigorously conducted randomized trial. The secondary aims of the trial are to compare other outcomes for the two surgical procedures, including quality of life, sexual function, satisfaction with treatment outcomes, complications, and need for other treatment(s)after surgery. Follow-up will be a minimum of two years and up to four years.

Conditions

Urinary Incontinence

Keywords

Stress urinary incontinence; Surgery

Outcome Measures

Primary Outcomes (2)

• 24 Month Cumulative Success Rate Computed From Kaplan Meier Time-to-event Analysis (Reported as Percent Success).

  Success defined as composite measure including: no self-reported incontinence symptoms reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire, \<15g in pad weight during 24 hr pad test, no incontinence episodes on 3-day voiding diary, negative results (no leakage) on provocative stress test at standardized bladder volume, no retreatment for urinary incontinence. Additional treatment for stress urinary incontinence (SUI) includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.

  Two years

• 24 Month Cumulative Stress Specific Success Rates Computed From Kaplan Meier Time-to-event Analysis (Reported as % Success)

  Stress-specific success defined by composite measure including: no self-reported symptoms of stress incontinence reported on the Medical, Epidemiologic, and Social Aspects of Aging Project (MESA) questionnaire , negative results (no leakage) on a provocative stress test at standardized bladder volume and no retreatment for stress incontinence Additional treatment for SUI includes anti-incontinence surgery, tightening of sling, collagen injections, medication, behavioral treatment, or devices specifically for the treatment of SUI.

  Two years

Study Arms (2)

Burch

OTHER

The Burch colposuspension

Procedure: Burch Modified Tanagho

Sling

OTHER

Pubovaginal sling, using autologous rectus fascia

Procedure: Autologous Fascia Sling

Interventions

Burch Modified Tanagho PROCEDURE

The Burch colposuspension is a well-established procedure for surgically treating women with stress urinary incontinence. The Burch modified colposuspension suspends the anterior vaginal wall (at the level of the bladder neck) with permanent sutures tied to the iliopectineal ligament.

Burch

Autologous Fascia Sling PROCEDURE

The fascial sling is also a well-established procedure for surgically treating women with stress urinary incontinence. The autologous sling procedure places a harvested strip of rectus fascia transvaginally at the level of the proximal urethra. The fascial strip is secured superiorly to the rectus fascia with permanent sutures

Sling

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* Predominant stress urinary incontinence by self-report,examination and test; * Urethral hypermobility; * Eligible for both surgical procedures; * Ambulatory; * Not pregnant; * \>12 months post-partum; * No systemic disease known to affect bladder function; * No current chemotherapy or radiation therapy; * No urethral diverticulum, augmentation cytoplasty, or artificial sphincter; * No recent pelvic surgery; * Available for follow-up and able to complete study assessments; * Signed informed consent.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Carelon Research: lead
• University of Alabama at Birmingham: collaborator
• University of California, San Diego: collaborator
• University of Maryland: collaborator
• University of Pittsburgh: collaborator
• University of Texas: collaborator
• The University of Texas at San Antonio: collaborator
• University of Utah: collaborator
• Beaumont Hospital: collaborator
• Loyola University: collaborator

Study Sites (9)

University of Alabama

Birmingham, Alabama, 35249-7333, United States

Location

University of California

San Diego, California, 92037, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas, Southwestern

Dallas, Texas, 75390-9110, United States

Location

University of Texas Health Sciences Center

San Antonio, Texas, 78229-3900, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (39)

• Albo M, Wruck L, Baker J, Brubaker L, Chai T, Dandreo KJ, Diokno A, Goode P, Kraus S, Kusek JW, Lemack G, Lowder J, Steers W; Urinary Incontinence Treatment Network. The relationships among measures of incontinence severity in women undergoing surgery for stress urinary incontinence. J Urol. 2007 May;177(5):1810-4. doi: 10.1016/j.juro.2007.01.032.

  PMID: 17437826 BACKGROUND

• Albo ME, Richter HE, Brubaker L, Norton P, Kraus SR, Zimmern PE, Chai TC, Zyczynski H, Diokno AC, Tennstedt S, Nager C, Lloyd LK, FitzGerald M, Lemack GE, Johnson HW, Leng W, Mallett V, Stoddard AM, Menefee S, Varner RE, Kenton K, Moalli P, Sirls L, Dandreo KJ, Kusek JW, Nyberg LM, Steers W; Urinary Incontinence Treatment Network. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. N Engl J Med. 2007 May 24;356(21):2143-55. doi: 10.1056/NEJMoa070416. Epub 2007 May 21.

  PMID: 17517855 BACKGROUND

• Brubaker L, Chiang S, Zyczynski H, Norton P, Kalinoski DL, Stoddard A, Kusek JW, Steers W; Urinary Incontinence Treatment Network. The impact of stress incontinence surgery on female sexual function. Am J Obstet Gynecol. 2009 May;200(5):562.e1-7. doi: 10.1016/j.ajog.2008.11.017. Epub 2009 Mar 16.

  PMID: 19286143 BACKGROUND

• Brubaker L, Stoddard A, Richter H, Zimmern P, Moalli P, Kraus SR, Norton P, Lukacz E, Sirls L, Johnson H; Urinary Incontinence Treatment Network. Mixed incontinence: comparing definitions in women having stress incontinence surgery. Neurourol Urodyn. 2009;28(4):268-73. doi: 10.1002/nau.20698.

  PMID: 19274758 BACKGROUND

• Burgio KL, Brubaker L, Richter HE, Wai CY, Litman HJ, France DB, Menefee SA, Sirls LT, Kraus SR, Johnson HW, Tennstedt SL. Patient satisfaction with stress incontinence surgery. Neurourol Urodyn. 2010 Nov;29(8):1403-9. doi: 10.1002/nau.20877.

  PMID: 20976815 BACKGROUND

• Chai TC, Albo ME, Richter HE, Norton PA, Dandreo KJ, Kenton K, Lowder JL, Stoddard AM; Urinary Incontinence Treatment Network. Complications in women undergoing Burch colposuspension versus autologous rectus fascial sling for stress urinary incontinence. J Urol. 2009 May;181(5):2192-7. doi: 10.1016/j.juro.2009.01.019. Epub 2009 Mar 17.

  PMID: 19296969 BACKGROUND

• FitzGerald MP, Burgio KL, Borello-France DF, Menefee SA, Schaffer J, Kraus S, Mallett VT, Xu Y; Urinary Incontinence Treatment Network. Pelvic-floor strength in women with incontinence as assessed by the brink scale. Phys Ther. 2007 Oct;87(10):1316-24. doi: 10.2522/ptj.20060073. Epub 2007 Aug 7.

  PMID: 17684087 BACKGROUND

• Kenton K, Richter H, Litman H, Lukacz E, Leng W, Lemack G, Chai T, Arisco A, Tennstedt S, Steers W; Urinary Incontinence Treatment Network. Risk factors associated with urge incontinence after continence surgery. J Urol. 2009 Dec;182(6):2805-9. doi: 10.1016/j.juro.2009.08.032. Epub 2009 Oct 17.

  PMID: 19837421 BACKGROUND

• Kirby AC, Nager CW, Litman HJ, FitzGerald MP, Kraus S, Norton P, Sirls L, Rickey L, Wilson T, Dandreo KJ, Shepherd JP, Zimmern P; Urinary Incontinence Treatment Network. Preoperative voiding detrusor pressures do not predict stress incontinence surgery outcomes. Int Urogynecol J. 2011 Jun;22(6):657-63. doi: 10.1007/s00192-010-1336-5. Epub 2010 Dec 10.

  PMID: 21153471 BACKGROUND

• Kraus SR, Markland A, Chai TC, Stoddard A, FitzGerald MP, Leng W, Mallett V, Tennstedt SL; Urinary Incontinence Treatment Network. Race and ethnicity do not contribute to differences in preoperative urinary incontinence severity or symptom bother in women who undergo stress incontinence surgery. Am J Obstet Gynecol. 2007 Jul;197(1):92.e1-6. doi: 10.1016/j.ajog.2007.03.072.

  PMID: 17618773 BACKGROUND

• Lemack GE, Krauss S, Litman H, FitzGerald MP, Chai T, Nager C, Sirls L, Zyczynski H, Baker J, Lloyd K, Steers WD; Urinary Incontinence Treatment Network. Normal preoperative urodynamic testing does not predict voiding dysfunction after Burch colposuspension versus pubovaginal sling. J Urol. 2008 Nov;180(5):2076-80. doi: 10.1016/j.juro.2008.07.027. Epub 2008 Sep 18.

  PMID: 18804239 BACKGROUND

• Lemack GE, Xu Y, Brubaker L, Nager C, Chai T, Moalli P, Kraus SR, Kerr L, Sirls L, Stoddard A; Urinary Incontinence Treatment Network. Clinical and demographic factors associated with valsalva leak point pressure among women undergoing burch bladder neck suspension or autologous rectus fascial sling procedures. Neurourol Urodyn. 2007;26(3):392-6. doi: 10.1002/nau.20325.

  PMID: 17304525 BACKGROUND

• Mallett VT, Brubaker L, Stoddard AM, Borello-France D, Tennstedt S, Hall L, Hammontree L; Urinary Incontinence Treatment Network. The expectations of patients who undergo surgery for stress incontinence. Am J Obstet Gynecol. 2008 Mar;198(3):308.e1-6. doi: 10.1016/j.ajog.2007.09.003.

  PMID: 18313452 BACKGROUND

• Markland AD, Kraus SR, Richter HE, Nager CW, Kenton K, Kerr L, Xu Y; Urinary Incontinence Treatment Network. Prevalence and risk factors of fecal incontinence in women undergoing stress incontinence surgery. Am J Obstet Gynecol. 2007 Dec;197(6):662.e1-7. doi: 10.1016/j.ajog.2007.08.062.

  PMID: 18060972 BACKGROUND

• Nager CW, Albo ME, Fitzgerald MP, McDermott S, Wruck L, Kraus S, Howden N, Norton P, Sirls L, Varner E, Zimmern P; Urinary Incontinence Treatment Network. Reference urodynamic values for stress incontinent women. Neurourol Urodyn. 2007;26(3):333-40. doi: 10.1002/nau.20348.

  PMID: 17315221 BACKGROUND

• Nager CW, Albo ME, Fitzgerald MP, McDermott SM, Kraus S, Richter HE, Zimmern P; Urinary Incontinence Treatment Network. Process for development of multicenter urodynamic studies. Urology. 2007 Jan;69(1):63-7; discussion 67-8. doi: 10.1016/j.urology.2006.08.1118.

  PMID: 17270617 BACKGROUND

• Nager CW, FitzGerald M, Kraus SR, Chai TC, Zyczynski H, Sirls L, Lemack GE, Lloyd LK, Litman HJ, Stoddard AM, Baker J, Steers W; Urinary Incontinence Treatment Network. Urodynamic measures do not predict stress continence outcomes after surgery for stress urinary incontinence in selected women. J Urol. 2008 Apr;179(4):1470-4. doi: 10.1016/j.juro.2007.11.077. Epub 2008 Mar 4.

  PMID: 18295276 BACKGROUND

• Richter HE, Burgio KL, Brubaker L, Moalli PA, Markland AD, Mallet V, Menefee SA, Johnson HW, Boreham MK, Dandreo KJ, Stoddard AM; Urinary Incontinence Treatment Network. Factors associated with incontinence frequency in a surgical cohort of stress incontinent women. Am J Obstet Gynecol. 2005 Dec;193(6):2088-93. doi: 10.1016/j.ajog.2005.07.068.

  PMID: 16325621 BACKGROUND

• Richter HE, Diokno A, Kenton K, Norton P, Albo M, Kraus S, Moalli P, Chai TC, Zimmern P, Litman H, Tennstedt S; Urinary Incontinence Treatment Network. Predictors of treatment failure 24 months after surgery for stress urinary incontinence. J Urol. 2008 Mar;179(3):1024-30. doi: 10.1016/j.juro.2007.10.074. Epub 2008 Jan 18.

  PMID: 18206917 BACKGROUND

• Richter HE, Goode PS, Brubaker L, Zyczynski H, Stoddard AM, Dandreo KJ, Norton PA. Two-year outcomes after surgery for stress urinary incontinence in older compared with younger women. Obstet Gynecol. 2008 Sep;112(3):621-9. doi: 10.1097/AOG.0b013e31818187c2.

  PMID: 18757661 BACKGROUND

• Sanses TV, Brubaker L, Xu Y, Kraus SR, Lowder JL, Lemack GE, Norton P, Litman HJ, Tennstedt SL, Chai TC. Preoperative hesitating urinary stream is associated with postoperative voiding dysfunction and surgical failure following Burch colposuspension or pubovaginal rectus fascial sling surgery. Int Urogynecol J. 2011 Jun;22(6):713-9. doi: 10.1007/s00192-010-1328-5. Epub 2010 Dec 3.

  PMID: 21128068 BACKGROUND

• Steers W, Richter H, Nyberg L, Kusek J, Kraus S, Dandreo K, Chai T, Brubaker L. Challenges of conducting multi-center, multi-disciplinary urinary incontinence clinical trials: experience of the urinary incontinence treatment network. Neurourol Urodyn. 2009;28(3):170-6. doi: 10.1002/nau.20653.

  PMID: 19030190 BACKGROUND

• Subak LL, Brubaker L, Chai TC, Creasman JM, Diokno AC, Goode PS, Kraus SR, Kusek JW, Leng WW, Lukacz ES, Norton P, Tennstedt S; Urinary Incontinence Treatment Network. High costs of urinary incontinence among women electing surgery to treat stress incontinence. Obstet Gynecol. 2008 Apr;111(4):899-907. doi: 10.1097/AOG.0b013e31816a1e12.

  PMID: 18378749 BACKGROUND

• Tennstedt S; Urinary Incontinence Treatment Network. Design of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Urology. 2005 Dec;66(6):1213-7. doi: 10.1016/j.urology.2005.06.089.

  PMID: 16360445 BACKGROUND

• Tennstedt SL, Fitzgerald MP, Nager CW, Xu Y, Zimmern P, Kraus S, Goode PS, Kusek JW, Borello-France D, Mallett V; Urinary Incontinence Treatment Network. Quality of life in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007 May;18(5):543-9. doi: 10.1007/s00192-006-0188-5. Epub 2006 Oct 12.

  PMID: 17036169 BACKGROUND

• Tennstedt SL, Litman HJ, Zimmern P, Ghetti C, Kusek JW, Nager CW, Mueller ER, Kraus SR, Varner E; Urinary Incontinence Treatment Network. Quality of life after surgery for stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Dec;19(12):1631-8. doi: 10.1007/s00192-008-0700-1. Epub 2008 Aug 6.

  PMID: 18682875 BACKGROUND

• Walsh LP, Zimmern PE, Pope N, Shariat SF; Urinary Incontinence Treatment Network. Comparison of the Q-tip test and voiding cystourethrogram to assess urethral hypermobility among women enrolled in a randomized clinical trial of surgery for stress urinary incontinence. J Urol. 2006 Aug;176(2):646-9; discussion 650. doi: 10.1016/j.juro.2006.03.091.

  PMID: 16813912 BACKGROUND

• Zimmern P, Nager CW, Albo M, Fitzgerald MP, McDermott S; Urinary Incontinence Treatment Network. Interrater reliability of filling cystometrogram interpretation in a multicenter study. J Urol. 2006 Jun;175(6):2174-7. doi: 10.1016/S0022-5347(06)00343-0.

  PMID: 16697832 BACKGROUND

• Zyczynski HM, Lloyd LK, Kenton K, Menefee S, Boreham M, Stoddard AM; Urinary Incontinence Treatment Network (UITN). Correlation of Q-tip values and point Aa in stress-incontinent women. Obstet Gynecol. 2007 Jul;110(1):39-43. doi: 10.1097/01.AOG.0000267190.09976.81.

  PMID: 17601894 BACKGROUND

• Kraus SR, Lemack GE, Sirls LT, Chai TC, Brubaker L, Albo M, Leng WW, Lloyd LK, Norton P, Litman HJ; Urinary Incontinence Treatment Network. Urodynamic changes associated with successful stress urinary incontinence surgery: is a little tension a good thing? Urology. 2011 Dec;78(6):1257-62. doi: 10.1016/j.urology.2011.07.1413. Epub 2011 Oct 11.

  PMID: 21996108 BACKGROUND

• Kraus SR, Lemack GE, Richter HE, Brubaker L, Chai TC, Albo ME, Sirls LT, Leng WW, Kusek JW, Norton P, Litman HJ; Urinary Incontinence Treatment Network. Changes in urodynamic measures two years after Burch colposuspension or autologous sling surgery. Urology. 2011 Dec;78(6):1263-8. doi: 10.1016/j.urology.2011.07.1411. Epub 2011 Oct 11.

  PMID: 21996105 BACKGROUND

• Zimmern PE, Dandreo KJ, Sirls L, Howell A, Hall L, Gruss J, Jesse K, Dickinson T, Prather C. Lessons from a patient experience survey in a randomized surgical trial of treatment of stress urinary incontinence in women. Int Urogynecol J. 2011 Oct;22(10):1273-8. doi: 10.1007/s00192-011-1507-z. Epub 2011 Jul 26.

  PMID: 21789658 BACKGROUND

• Kirby AC, Nager CW, Litman HJ, Fitzgerald MP, Kraus S, Norton P, Sirls L, Rickey L, Wilson T, Dandreo KJ, Shepherd J, Zimmern P; Urinary Incontinence Treatment Network. Perineal surface electromyography does not typically demonstrate expected relaxation during normal voiding. Neurourol Urodyn. 2011 Nov;30(8):1591-6. doi: 10.1002/nau.21080. Epub 2011 May 10.

  PMID: 21560157 BACKGROUND

• Brubaker L, Litman HJ, Kim HY, Zimmern P, Dyer K, Kusek JW, Richter HE, Stoddard A; Urinary Incontinence Treatment Network. Missing data frequency and correlates in two randomized surgical trials for urinary incontinence in women. Int Urogynecol J. 2015 Aug;26(8):1155-9. doi: 10.1007/s00192-015-2661-5. Epub 2015 Mar 24.

  PMID: 25800900 DERIVED

• Richter HE, Brubaker L, Stoddard AM, Xu Y, Zyczynski HM, Norton P, Sirls LT, Kraus SR, Chai TC, Zimmern P, Gormley EA, Kusek JW, Albo ME; Urinary Incontinence Treatment Network. Patient related factors associated with long-term urinary continence after Burch colposuspension and pubovaginal fascial sling surgeries. J Urol. 2012 Aug;188(2):485-9. doi: 10.1016/j.juro.2012.04.010. Epub 2012 Jun 15.

  PMID: 22704099 DERIVED

• Brubaker L, Richter HE, Norton PA, Albo M, Zyczynski HM, Chai TC, Zimmern P, Kraus S, Sirls L, Kusek JW, Stoddard A, Tennstedt S, Gormley EA; Urinary Incontinence Treatment Network. 5-year continence rates, satisfaction and adverse events of burch urethropexy and fascial sling surgery for urinary incontinence. J Urol. 2012 Apr;187(4):1324-30. doi: 10.1016/j.juro.2011.11.087. Epub 2012 Feb 15.

  PMID: 22341290 DERIVED

• Brubaker L, Rickey L, Xu Y, Markland A, Lemack G, Ghetti C, Kahn MA, Nagaraju P, Norton P, Chang TD, Stoddard A; Urinary Incontinence Treatment Network. Symptoms of combined prolapse and urinary incontinence in large surgical cohorts. Obstet Gynecol. 2010 Feb;115(2 Pt 1):310-316. doi: 10.1097/AOG.0b013e3181cb86b2.

  PMID: 20093904 DERIVED

• Brubaker L, Moalli P, Richter HE, Albo M, Sirls L, Chai T, Kraus SR, Norton P, Chang D, Tennstedt SL. Challenges in designing a pragmatic clinical trial: the mixed incontinence -- medical or surgical approach (MIMOSA) trial experience. Clin Trials. 2009 Aug;6(4):355-64. doi: 10.1177/1740774509339239. Epub 2009 Jul 22.

  PMID: 19625327 DERIVED

• Richter HE, Burgio KL, Chai TC, Kraus SR, Xu Y, Nyberg L, Brubaker L. Predictors of outcomes in the treatment of urge urinary incontinence in women. Int Urogynecol J Pelvic Floor Dysfunct. 2009 May;20(5):489-97. doi: 10.1007/s00192-009-0805-1. Epub 2009 Jan 30.

  PMID: 19183825 DERIVED

Related Links

• www.uitn.net

MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Patients received care at tertiary care centers which could limit the generalizability of the findings. Patients and providers were aware of treatment assignment which could lead to assessment bias.

Results Point of Contact

• Title: Anne M. Stoddard, ScD
• Organization: New England Research Institutes

astoddard@neriscience.com

617-972-3331

Study Officials

• William D. Steers, M.D.

  University of Virginia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2003
• First Posted: July 11, 2003
• Study Start: February 1, 2002
• Primary Completion: June 1, 2006
• Study Completion: March 1, 2010
• Last Updated: May 10, 2013
• Results First Posted: September 28, 2012

Record last verified: 2013-05

Locations

US (9)