A Danish national survey of women operated with mid-urethral slings in 2001

Abstract

Objective. To perform a national survey on self-reported cure, satisfaction and complications four years after mid-urethral sling (MUS) for urinary stress incontinence in Danish women operated in 2001. Design. A postal questionnaire survey. Population. All Danish women who received an MUS operation in 2001 extracted from the Danish National Patient Register. Methods. The women received a validated postal questionnaire in 2005. The questionnaire included questions about subjective cure, satisfaction, complications and a Danish version of International Consultation on Incontinence Questionnaire-Short Form. The study was carried out in cooperation with the Danish National Board of Health. Results. A total of 335 (92%) women responded to the questionnaire, among whom 105 (32%) felt completely cured, 119 (36%) were much improved, 55 (17%) were improved and 48 (15%) unchanged or worse. Cure rate varied between departments from 0% to 67%. Low-volume departments (<10 operations/year) had a significantly (p = 0.05) lower cure rate compared to the department with a higher volume. Altogether, 238 (73%) women were very satisfied with their operation. Self-reported bladder emptying difficulties were reported by 103 (32%) and the need for clean intermittent catherization (CIC) at any stage was reported by 21 (7%). No woman was still performing CIC. Of the women, 126 (42%) had made contact with the healthcare system because of their operation after discharge from hospital. Conclusions. Long-term outcome of MUS operations in Denmark in terms of cure, satisfaction and complication rates seems comparable to international results; however, the decentralized organization with many low-volume departments seems inappropriate.

Key words::

• Mid-urethral slings
• tension-free vaginal tape
• questionnaire
• national survey

Declaration of interest: This study was funded by the Department of Gynecology and Obstetrics, Glostrup Hospital, Denmark, the Danish Centre for Health Technology Assessment, Johnson & Johnson/Gynecare (3 grants), an Organon research grant, the Danish Doctors Insurance Association of 1891, the Danish Doctors Research Fund, a Paula and Axel Nissen grant.

Gunnar Lose has acted for Contura (consultant, trial participation), Pfizer (trial participation), Coloplast (consultant), Ethicon (workshop honorarium) and Novartis (advisory board).

References

• 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;7:81–5.
   PubMedGoogle Scholar
• Ammendrup AC, Bendixen A, Sander P, Ottesen BS, Lose G. Urininkontinenskirurgi i Danmark 2001–2003. [Urinary incontinence surgery in Denmark 2001–2003]. Ugeskr Laeger. 2009;171:399–404.
   PubMedGoogle Scholar
• Kulseng-Hanssen S. The development of a national database of the results of surgery for urinary incontinence in women. BJOG. 2003;110:975–82.
   PubMed Web of Science ®Google Scholar
• Kuuva N, Nilsson CG. A nationwide analysis of complications associated with the tension-free vaginal tape (TVT) procedure. Acta Obstet Gynecol Scand. 2002;81:72–7.
   PubMed Web of Science ®Google Scholar
• Tamussino KF, Hanzal E, Kolle D, Ralph G, Riss PA. Tension-free vaginal tape operation: results of the Austrian registry. Obstet Gynecol. 2001;98(5 Pt 1):732–6.
   PubMed Web of Science ®Google Scholar
• Ward KL, Hilton P. A prospective multicenter randomized trial of tension-free vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up. Am J Obstet Gynecol. 2004;190:324–31.
   PubMed Web of Science ®Google Scholar
• 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;104:1259–62.
   PubMed Web of Science ®Google Scholar
• Ward KL, Hilton P. Tension-free vaginal tape versus colposuspension for primary urodynamic stress incontinence: 5-year follow up. BJOG. 2008;115:226–33.
   PubMed Web of Science ®Google Scholar
• Tamussino KF, Zivkovic F, Pieber D, Moser F, Haas J, Ralph G. Five-year results after anti-incontinence operations. Am J Obstet Gynecol. 1999;181:1347–52.
   PubMed Web of Science ®Google Scholar
• Utzon J, Olsen PS, Bay-Nielsen M, Andersen KB, Christensen B, Endahl LA, Vurdering af kirurgiske ydelser i Danmark. [Evaluation of surgical interventions in Denmark]. Ugeskr Laeger. 2001;163:5662–4.
   PubMedGoogle Scholar
• Donovan J, Bosch R. Symptoms and quality of life assessment. In: Abrams P ,Cardozo L ,Khoury S ,Wein A. (eds). Plymbridge, PA: Health Publication Ltd., Incon tinence. 3rd International Consultation on Urinary Incontinence. 2005 edn. 2005 . pp.519–84.
   Google Scholar
• 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;23:322–30.
   PubMed Web of Science ®Google Scholar
• Ward K, Hilton P. Prospective multicentre randomised trial of tension-free vaginal tape and colposuspension as primary treatment for stress incontinence. BMJ. 2002;13;325–67.
   Google Scholar
• Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003;189:98–101.
   PubMed Web of Science ®Google Scholar
• Cohen J. A coefficient of agreement for nominal scales. Educ Psychol Meas. 1960;20:37–46.
   Web of Science ®Google Scholar
• Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977;33:159–74.
   PubMed Web of Science ®Google Scholar
• Kulseng-Hanssen S, Husby H, Schiotz HA. Follow-up of TVT operations in 1,113 women with mixed urinary incontinence at 7 and 38 months. Int Urogynecol J Pelvic Floor Dysfunct. 2008;19:391–6.
   PubMed Web of Science ®Google Scholar
• Hilton P. Trials of surgery for stress incontinence – thoughts on the ‘Humpty Dumpty principle’. BJOG. 2002;109:1081–8.
   PubMed Web of Science ®Google Scholar
• Kuuva N, Nilsson CG. Long-term results of the tension-free vaginal tape operation in an unselected group of 129 stress incontinent women. Acta Obstet Gynecol Scand. 2006;85:482–7.
   PubMed Web of Science ®Google Scholar
• Ankardal M, Heiwall B, Lausten-Thomsen N, Carnelid J, Milsom I. Short- and long-term results of the tension-free vaginal tape procedure in the treatment of female urinary incontinence. Acta Obstet Gynecol Scand. 2006;85:986–92.
   PubMed Web of Science ®Google Scholar
• Kuo HC. Long-term surgical results of pubovaginal sling procedure using polypropylene mesh in the treatment of stress urinary incontinence. Urol Int. 2005;74:147–52.
   PubMed Web of Science ®Google Scholar
• Koops SE, Bisseling TM, van Brummen HJ, Heintz AP, Vervest HA. What determines a successful tension-free vaginal tape? A prospective multicenter cohort study: results from The Netherlands TVT database. Am J Obstet Gynecol. 2006;194:65–74.
   PubMed Web of Science ®Google Scholar
• Lee KS, Choo MS, Doo CK, Han DH, Lee YS, Kim JY, The long term (5-years) objective TVT success rate does not depend on predictive factors at multivariate analysis: a multicentre retrospective study. Eur Urol. 2008;53:176–83.
   PubMed Web of Science ®Google Scholar
• Oh SJ, Ku JH, Hong SK, Kim SW, Paick JS, Son H. Factors influencing self-perceived disease severity in women with stress urinary incontinence combined with or without urge incontinence. Neurourol Urodyn. 2005;24:341–7.
   PubMed Web of Science ®Google Scholar
• Sander P, Sorensen F, Lose G. Does the tension-free vaginal tape procedure (TVT) affect the voiding function over time? Pressure-flow studies 1 year and 3(1/2) years after TVT. Neurourol Urodyn. 2007;26:995–7.
   PubMed Web of Science ®Google Scholar
• Vervest HA, Bisseling TM, Heintz AP, Schraffordt Koops SE. The prevalence of voiding difficulty after TVT, its impact on quality of life, and related risk factors. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18:173–82.
   PubMed Web of Science ®Google Scholar
• Cody J, Wyness L, Wallace S, Glazener C, Kilonzo M, Stearns S, Systematic review of the clinical effectiveness and cost-effectiveness of tension-free vaginal tape for treatment of urinary stress incontinence. Health Technol Assess. 2003;iii, 1–189.
   PubMedGoogle Scholar