Challenges in designing a pragmatic clinical trial: The mixed incontinence - Medical or surgical approach (MIMOSA) trial experience

Clinical Trials

Volumn 6, Issue 4, 2009, Pages 355-364

  Brubaker, Linda ^a   Moalli, Pamela ^b   Richter, Holly E ^c   Albo, Michael ^d   Sirls, Larry ^e   Chai, Toby ^f   Kraus, Stephen R ^g   Norton, Peggy ^h   Chang, Debuene ⁱ   Tennstedt, Sharon L ^j  

^a LOYOLA UNIVERSITY CHICAGO   (United States)

^b UNIVERSITY OF PITTSBURGH SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^d UNIVERSITY OF CALIFORNIA   (United States)

^e WILLIAM BEAUMONT HOSPITAL   (United States)

^f UNIVERSITY OF MARYLAND   (United States)

^g Mays Cancer Center at UT Health San Antonio   (United States)

^h UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

ⁱ NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES   (United States)

^j NEW ENGLAND RESEARCH INSTITUTES   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CHOLINERGIC RECEPTOR BLOCKING AGENT;

ADULT; ARTICLE; BEHAVIOR THERAPY; CLINICAL ARTICLE; CLINICAL EFFECTIVENESS; CLINICAL RESEARCH; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEASIBILITY STUDY; FEMALE; HUMAN; INTERMETHOD COMPARISON; METHODOLOGY; MIXED INCONTINENCE; PILOT STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STRESS INCONTINENCE; TREATMENT OUTCOME; URGE INCONTINENCE; UROLOGIC SURGERY; CLINICAL TRIAL (TOPIC); HEALTH STATUS INDICATOR; QUESTIONNAIRE; URINARY INCONTINENCE, STRESS; URINARY INCONTINENCE, URGE;

CLINICAL TRIALS AS TOPIC; FEASIBILITY STUDIES; FEMALE; HEALTH STATUS INDICATORS; HUMANS; QUESTIONNAIRES; RESEARCH DESIGN; TREATMENT OUTCOME; URINARY INCONTINENCE, STRESS; URINARY INCONTINENCE, URGE;

EID: 70449720797     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774509339239     Document Type: Article

References (31)

1. Nygaard I., Barber MD, Burgio KL et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA 2008; 300: 1311-16.
2. Diokno AC, Brock BM, Brown MB et al. Prevalence of urinary incontinence and other urological symptoms in the noninstitutionalized elderly. J Urol 1986; 136: 1022-25.
3. Hampel C., Wienhold D., Benken N. et al. Definition of overactive bladder and epidemiology of urinary incontinence. Urology 1997; 50: 4-14.
4. Hannestad YS, Rortveit G., Sandvik H. et al. A community-based epidemiological survey of female urinary incontinence: The Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol 2000; 53: 1150-57.
5. Sandvik H., Hunskaar S., Vanvik A. et al. Diagnostic classification of female urinary incontinence: An epidemiological survey corrected for validity. J Clin Epidemiol 1995; 48: 339-43.
6. Lukacz ES, Lawrence JM, Buckwalter JG et al. Epidemiology of prolapse and incontinence questionnaire: Validation of a new epidemiologic survey. Int Urogynecol J 2005; 16: 272-84.
7. Jeffry L., Deval B., Birsan A. et al. Objective and subjective cure rates after tension-free vaginal tape for treatment of urinary incontinence. Urology 2001; 58 (5): 702-06.
8. Meschia M., Pifarotti P., Spennacchio M. et al. A randomized comparison of tension-free vaginal tape and endopelvic fascia plication in women with genital prolapse and occult stress urinary incontinence. Am J Obstet Gynecol 2004; 190 (3): 609-13.
9. Albo ME, Richter H., Brubaker L. et al. Burch colposuspension versus fascial sling to reduce urinary stress incontinence. [see comment]. N Engl J Med 2007; 356 (21): 2143-55.
10. Osman T. Stress incontinence surgery for patients presenting with mixed incontinence and a normal cystometrogram. BJU Int 2003; 92 (9): 964-68.
11. Barber MD, Walters MD, Bump RC Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol 2005; 193 (1): 103-13.
12. Carr LK, Webster GD Voiding dysfunction following incontinence surgery: diagnosis and treatment with retropubic or vaginal urethrolysis. J Urol 1997; 157 (3): 821-23.
13. Hay-Smith J., Herbison P., Ellis G. et al. Which anticholinergic drug for overactive bladder symptoms in adults. Cochrane Database of Systematic Reviews 2005; (issue 3) Art. No: 005429.
14. Dumoulin C., HaySmith J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women. Cochrane Database of Systematic Reviews 2009; (issue 1) Art. No: 005654.
15. Burgio KL, Kraus SR, Menefee S. et al. Behavioral therapy to enable women with urge incontinence to discontinue drug treatment: A randomized trial. Ann Intern Med 2008; 149 (3): 161-69.
16. Williams KS, Assassa RP, Gillies CL et al. A randomized controlled trial of the effectiveness of pelvic floor therapies for urodynamic stress and mixed incontinence. BJU Int 2006; 98 (5): 1043-50.
17. Mahajan S., Fitzgerald MP, Kenton K. et al. The second continence procedure: Do results depend on what was done first? J Pelvic Med Surg 2005; 12 (2): 111.
18. Mahajan ST, Elkadry EA, Kenton KS et al. Patient-centered surgical outcomes: The impact of goal achievement and urge incontinence on patient satisfaction one year after surgery. Am J Obstet Gynecol 2006; 194 (3): 722-28.
19. Elkadry EA, Kenton KS, FitzGerald MP et al. Patient-selected goals: A new perspective on surgical outcome. Am J Obstet Gynecol 2003; 189 (6): 1551-57; discussion 1557-58.
20. MacPherson H. Pragmatic clinical trials. Complement Ther Med 2004; 12 (2 - 3): 136-40.
21. Schwartz D., Lellouch J. Explanatory and pragmatic attitudes in therapeutic trials. J Chronic Dis 1967; 20: 637-48.
22. Tunis SR, Stryer DB, Clancy CM Practical clinical trials: Increasing the value of clinical research for decision making in clinical and health policy. JAMA 2003; 290 (12): 1624-32.
23. Yalcin I., Bump RC Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 2003; 189 (1): 98-101.
24. Shumaker SA, Wyman JF, Uebersax JS et al. Health-related quality of life measures for women with urinary incontinence: The incontinence impact questionnaire and the urogenital distress inventory. Qual Life Res 1994; 3: 291-306.
25. Uebersax JS, Wyman JF, Shumaker SA et al. Short forms to assess life quality and symptom distress for urinary incontinence in women: The Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program for Women Research Group. Neurourol Urodyn 1995; 14 (2): 131-39.
26. Ware JE, Kosinski M., Keller SD A 12-item Short-form Health Survey. Construction of scales and preliminary tests of reliability and validity. Med Care 1996; 34: 220-33.
27. Rogers RG, Kammerer-Doak D., Villarreal A. et al. A new instrument to measure sexual function in women with urinary incontinence or pelvic organ prolapse. Am J Obstet Gynecol 2001; 184 (4):552-58.
28. Dindo D., Demartines N., Claiven PA Classification of surgical complications. A new proposal with evlaution in a cohort of 6336 patients and results of a survey. Ann Surg 2004; 240 (2):205-13.
29. Rolnick SJ, Flores SK, Fowler SE et al. Conducting randomized, controlled trials. Experience with the dysfunctional uterine bleeding intervention trial. J Reprod Med 2001; 46 (1):1-5.
30. Wilt TJ BM The Prostate Cancer Intervention Versus Observation Trial (PIVOT). Oncology (Williston Park) 1997; 11 (8): 1133-39; discussion 1139 - 40.
31. Kirkley A., Birmingham TB, Litchfield RB et al. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. [see comment]. N Engl J Med 2008; 359 (11): 1097-107.