The trial of mid-urethral slings (TOMUS): Design and methodology

Journal of Applied Research

Volumn 8, Issue 1, 2008, Pages 1-13

  Albo, Michael E ^a   Steers, William ^b   Diokno, Ananias ^c,d   Khandwala, Salil ^c,d   Brubaker, Linda ^e   FitzGerald, Mary Pat ^e   Richter, Holly E ^f   Lloyd, L Keith ^f   Albo, Michael ^a   Nager, Charles ^a   Chai, Toby ^g   Johnson, Harry W ^g   Zyczynski, Halina M ^h   Leng, Wendy ^h   Zimmern, Philippe ⁱ   Lemack, Gary ⁱ   Kraus, Stephen ^j   Rozanski, Thomas ^j   Norton, Peggy ^k   Kerr, Lindsey ^k   Tennstedt, Sharon ^l   Stoddard, Anne ^l   Chang, Debuene ^m   Kusek, John W ^m   Nyberg, Leroy M ^m   Weber, Anne M ⁿ   more..

^a UNIVERSITY OF CALIFORNIA   (United States)

^b UNIVERSITY OF VIRGINIA   (United States)

^c WILLIAM BEAUMONT HOSPITAL   (United States)

^d OAKWOOD HOSPITAL AND MEDICAL CENTER   (United States)

^e LOYOLA UNIVERSITY MEDICAL CENTER   (United States)

^f UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^g UNIVERSITY OF MARYLAND   (United States)

^h UNIVERSITY OF PITTSBURGH   (United States)

ⁱ UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^j UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^k UNIVERSITY OF UTAH   (United States)

^l NEW ENGLAND RESEARCH INSTITUTES   (United States)

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

ⁿ EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT   (United States)

more..

Author keywords

Mid urethral sling; Randomized surgical trial; Tension free vaginal sling; Transobturator sling; Urinary incontinence; Urodynamics

Indexed keywords

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FEMALE; GYNECOLOGIC SURGERY; HEALTH CARE COST; HUMAN; MICTURITION; MID URETHRAL SLING; MORBIDITY; MULTICENTER STUDY; OUTCOME ASSESSMENT; PATIENT SAFETY; PATIENT SATISFACTION; POSTOPERATIVE COMPLICATION; PREOPERATIVE EVALUATION; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; STRESS; STRESS INCONTINENCE; SURGICAL TECHNIQUE; SYMPTOM; URODYNAMICS;

EID: 42649107481     PISSN: 1537064X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (56)

1. Lose G, Ostergard DR. Medical technology assessment and surgery for stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1999;10:351-352.
2. Nilsson CG. Introduction of a new surgical procedure for treatment of female urinary incontinence. Acta Obstet Gynecol Scand. 2004;83:877-880.
3. Ulmsten U, Henriksson L, Johnson P, Varhos G. An ambulatory surgical procedure under local anesthesia for treatment of female urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 1996;7:81-85; discussion 5-6.
4. Delorme E. Transobturator urethral suspension: mini-invasive procedure in the treat ment of stress urinary incontinence in women [in French]. Prog Urol. 2001;11:1306-1313.
5. David-Montefiore E, Frobert JL, Grisard-Anaf M, et al. Peri-operative complications and pain after the suburethral sling procedure for urinary stress incontinence: a French prospective randomised multicentre study comparing the retropubic and transobturator routes. Eur Urol. 2006;49:133-138.
6. Neuman M. TVT and TVT-Obturator: comparison of two operative procedures. Eur J Obstet Gynecol Reprod Biol. 2007;131:89-92.
7. Delorme E, Droupy S, de Tayrac R, Delmas V. Transobturator tape (Uratape): a new minimally-invasive procedure to treat female urinary incontinence. Eur Urol. 2004;45:203-207.
8. Morey AF, Medendorp AR, Noller MW, et al. Transobturator versus transabdominal mid urethral slings: a multi-institutional comparison of obstructive voiding complications. J Urol. 2006;175:1014-1017.
9. Laurikainen E, Valpas A, Kivela A, et al. Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2007;109:4-11.
10. Leach GE, Dmochowski RR, Appell RA, et al. Female Stress Urinary Incontinence Clinical Guidelines Panel summary report on surgical management of female stress urinary incontinence. The American Urological Association. J Urol. 1997;158:875-880.
11. Nygaard IE, Heit M. Stress urinary incontinence. Obstet Gynecol. 2004;104:607-620.
12. Herzog AR, Diokno AC, Brown MB, Normolle DP, Brock BM. Two-year incidence, remission, and change patterns of urinary incontinence in noninstitutionalized older adults. J Gerontol. 1990;45:M67-M74.
13. Locher JL, Goode PS, Roth DL, Worrell RL, Burgio KL. Reliability assessment of the bladder diary for urinary incontinence in older women. J Gerontol A Biol Sci Med Sci. 2001;56:M32-M35.
14. Nygaard I, Holcomb R. Reproducibility of the seven-day voiding diary in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2000;11:15-17.
15. Wyman JF, Choi SC, Harkins SW, Wilson MS, Fantl JA. The urinary diary in evaluation of incontinent women: a test-retest analysis. Obstet Gynecol. 1988;71:812-817.
16. Jorgensen L, Lose G. Diagnosis of mild stress incontinence in females: 24-hour home pad weighing test versus the 1-hour ward test. Neurourol Urodyn. 1987;6:165-166.
17. Lose G, Jorgensen L, Thunedborg P. 24-hour home pad weighing test versus 1-hour ward test in the assessment of mild stress incontinence. Acta Obstet Gynecol Scand. 1989;68:211-215.
18. Shull BL, Halasaka M, Hurt G, et al. Physical examination. In: Abrams P, Saad K, Wein A, eds. Incontinence: Proceedings of the 1st International Consultation on Incontinence: June 28-July 1, 1998. England: Health Publications Ltd.; 1998.
19. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23:322-330.
20. Shumaker SA, Wyman JF, Uebersax JS, McClish D, Fantl JA. Health-related quality of life measures for women with urinary incontinence: the Incontinence Impact Questionnaire and the Urogenital Distress Inventory. Continence Program in Women (CPW) Research Group. Qual Life Res. 1994;3:291-306.
21. Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003;14:164-168; discussion 8.
22. Rogers RG, Kammerer-Doak D, Villarreal A, Coates K, Qualls C. A new instrument to measure sexual function in women with urinary incontinence or pelvic organ prolapse. Am J Obstet Gynecol. 2001;184:552-558.
23. Tennstedt S. Design of the Stress Incontinence Surgical Treatment Efficacy Trial (SISTEr). Urology. 2005;66:1213-1217.
24. Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003;189:98-101.
25. McCarthy M, Jr., Jonasson O, Chang CH, et al. Assessment of patient functional status after surgery. J Am Coll Surg. 2005;201:171-178.
26. Dowell CJ, Bryant CM, Moore KH, Simons AM. Calculating the direct costs of urinary incontinence: a new test instrument. BJU Int. 1999;83:596-606.
27. Cardinale V. Drug Topics: Red Book. Montvale, NJ: Medical Economics Co, Inc.; 1997.
28. Feeny D, Furlong W, Boyle M, Torrance GW. Multi-attribute health status classification systems. Health Utilities Index. Pharmacoeconomics. 1995;7:490-502.
29. Furlong W, Feeny D, Torrance GW, et al. Multiplicative Multi-Attribute Utility Function for the Health Utilities Index Mark 3 (HUI3) System: A Technical Report. McMaster University Centre for Health Economics and Policy Analysis Working Paper No. 98-11: McMaster University Centre for Health Economics and Policy Analysis; 1998.
30. Kobelt G. Economic considerations and outcome measurement in urge incontinence. Urology. 1997;50:100-107; discussion 8-10.
31. Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205-213.
32. McCarthy M Jr, Chang CH, Pickard AS, et al. Visual analog scales for assessing surgical pain. J Am Coll Surg. 2005;201:245-252.
33. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology in lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Urology. 2003;61:37-49.
34. Schafer W, Abrams P, Liao L, et al. Good urodynamic practices: uroflowmetry, filling cystometry, and pressure-flow studies. Neurourol Urodyn. 2002;21:261-274.
35. Nager CW, Albo ME, Fitzgerald MP, et al. Process for development of multicenter urodynamic studies. Urology. 2007;69:63-67; discussion 7-8.
36. Jennison C, Turnbull BW. Group Sequential Methods with Applications to Clinical Trials. Boca Raton, FL: Chapman & Hall/CRC; 2000.
37. Lan KKG, DeMets DL. Discrete sequential boundaries for clinical trials. Biometrika. 1983;70:659-663.
38. Nilsson CG, Falconer C, Rezapour M. Seven-year follow-up of the tension-free vaginal tape procedure for treatment of urinary incontinence. Obstet Gynecol. 2004;104:1259-1262.
39. Alcalay M, Monga A, Stanton SL. Burch colposuspension: a 10-20 year follow up. Br J Obstet Gynaecol. 1995;102:740-745.
40. Morgan TO Jr, Westney OL, McGuire EJ. Pubovaginal sling: 4-YEAR outcome analysis and quality of life assessment. J Urol. 2000;163:1845-1848.
41. Wadie BS, Edwan A, Nabeeh AM. Autologous fascial sling vs polypropylene tape at short-term follow-up: a prospective randomized study. J Urol. 2005;174:990-993.
42. Paraiso MF. Laparoscopic Burch colposuspension and the tension-free vaginal tape procedure. Curr Opin Obstet Gynecol. 2006;18:385-390.
43. Valpas A, Kivela A, Penttinen J, Kujansuu E, Haarala M, Nilsson CG. Tension-free vaginal tape and laparoscopic mesh colposuspension for stress urinary incontinence. Obstet Gynecol. 2004;104:42-49.
44. Hilton P. Trials of surgery for stress incontinence: thoughts on the 'Humpty Dumpty principle'. BJOG. 2002;109:1081-1088.
45. Liapis A, Bakas P, Creatsas G. Burch colposuspension and tension-free vaginal tape in the management of stress urinary incontinence in women. Eur Urol. 2002;41:469-473.
46. Darai E, Jeffry L, Deval B, Birsan A, Kadoch O, Soriano D. Results of tension-free vaginal tape in patients with or without vaginal hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2002;103:163-167.
47. Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tensionfree vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002;81:72-77.
48. Dietz HP, Foote AJ, Mak HL, Wilson PD. TVT and Sparc suburethral slings: a case-control series. Int Urogynecol J Pelvic Floor Dysfunct. 2004;15:129-131; discussion 31.
49. Tseng LH, Wang AC, Lin YH, Li SJ, Ko YJ. Randomized comparison of the suprapubic arc sling procedure vs tension-free vaginal taping for stress incontinent women. Int Urogynecol J Pelvic Floor Dysfunct. 2005;16:230-235.
50. de Leval J. Novel surgical technique for the treatment of female stress urinary incontinence: transobturator vaginal tape inside-out. Eur Urol. 2003;44:724-730.
51. Costa P, Delmas V. Trans-obturator-tape procedure - " inside out or outside in": current concepts and evidence base. Curr Opin Urol. 2004;14:313-315.
52. Dietz HP, Barry C, Lim Y, Rane A. TVT vs Monarc: a comparative study. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17:566-569.
53. Deprest J, Zheng F, Konstantinovic M, et al. The biology behind fascial defects and the use of implants in pelvic organ prolapse repair. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17(suppl 1):S16-S25.
54. Papas NP, Abramowitch SD, Menefee SA, Albo M, Moalli PA. Tensile properties of commercially available urinary incontinence slings. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17:S370-S371.
55. Dietz HP, Vancaillie P, Svehla M, Walsh W, Steensma AB, Vancaillie TG. Mechanical properties of urogynecologic implant materials. Int Urogynecol J Pelvic Floor Dysfunct. 2003;14:239-243; discussion 43.
56. Lemack GE. Urodynamic assessment of patients with stress incontinence: how effective are urethral pressure profilometry and abdominal leak point pressures at case selection and predicting outcome? Curr Opin Urol. 2004;14:307-311.