Comparison of Surgical Procedures to Reduce Urinary Stress Incontinence

Urinary Incontinence Clinical Trial

— SISTEr  

Official title:

Randomized Clinical Trial of the Burch Modified Tanagho and Autologous Fascia Sling Procedures for Women With Predominantly Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064662
• Other study ID #: UITN-RCT (completed)
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 10, 2003
• Last updated: May 8, 2013
• Start date: February 2002
• Est. completion date: March 2010

Study information

• Verified date: May 2013
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. completion date: March 2010
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Procedure:
• Burch Modified Tanagho
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.
• Autologous Fascia Sling
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

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of Texas, Southwestern	Dallas	Texas
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Beaumont Hospital	Royal Oak	Michigan
United States	University of Utah	Salt Lake City	Utah
United States	University of Texas Health Sciences Center	San Antonio	Texas
United States	University of California	San Diego	California

Sponsors (10)

Lead Sponsor	Collaborator
New England Research Institutes	Beaumont Hospital, Loyola University, The University of Texas at San Antonio, University of Alabama at Birmingham, University of California, San Diego, University of Maryland, University of Pittsburgh, University of Texas, University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (33)

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. — View Citation

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. Epub 2007 May 21. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2007 Aug 7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Tennstedt S; Urinary Incontinence Treatment Network. Design of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Urology. 2005 Dec;66(6):1213-7. — View Citation

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. Epub 2006 Oct 12. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No