title: Protocol for the CUPIDO trials; multicenter randomized controlled trials to assess the value of combining prolapse surgery and incontinence surgery in patients with genital prolapse and evident stress incontinence (CUPIDO I) and in patients with genital prolapse and occult stress incontinence (CUPIDO II).
abstract: BACKGROUND
  About 40% of all patients with genital prolapse report stress-incontinence. In about half of the 60% patients that do not report stress-incontinence, occult urinary stress-incontinence can be detected. In these patients stress-incontinence is masked due to kinking or compression of the urethra by the prolapse.In case surgical correction is indicated there are two strategies to manage patients with combined prolapse and (occult) stress incontinence. This strategy is either (i) a combination of prolapse surgery and stress-incontinence surgery or (ii) to correct the prolapse first and evaluate afterwards whether additional stress-incontinence surgery is indicated. The advantage of combining prolapse and stress-incontinence surgery is that only few patients report stress-incontinence following such combination. However, this combination has been associated with an increased risk on complications, of which the development of obstructive micturition symptoms, overactive bladder symptoms and bladder retention are the most important ones. Furthermore, combining two procedures may be unnecessary as performing only prolapse surgery may cure stress-incontinence. In the randomized CUPIDO trials both strategies are compared in patients with prolapse and evident stress incontinence (CUPIDO I trial) and in patients with prolapse and occult stress incontinence (CUPIDO II trial).
  
  
  METHODS
  The CUPIDO trials are two multicenter randomized controlled trials in which women with stress urinary incontinence (SUI) or occult stress urinary incontinence (OSUI) are randomized to prolapse surgery combined with anti incontinence surgery (concomitant surgery) or to prolapse surgery only. Patients with at least stage 2 POP are eligible, women with evident SUI are randomized in CUPIDO I. Patients without SUI are eligible for CUPIDO II and will have urodynamic evaluation or a standardized redression test. Women with OSUI are randomized, women without OSUI are followed up but not randomized. The primary outcome measure is absence of SUI twelve months after surgery. Furthermore, economic evaluations are conducted, and the effectiveness of urodynamic investigation is evaluated against a non-invasive way to determine SUI in women with POP. A total of 450 women will be included in the study.
  
  
  BACKGROUND
  Trial registration http://www.trialregister.nl NTRR 1197 en 1070.
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Centre Groningen, PO Box 30.001, 9700 RB, Groningen, the Netherlands. a.vdsteen@yahoo.com
authors.forename: Annemarie
authors.initials: A
authors.lastname: van der Steen
authors.forename: Marinus
authors.initials: M
authors.lastname: van der Ploeg
authors.forename: Marcel G W
authors.initials: MG
authors.lastname: Dijkgraaf
authors.forename: Huub
authors.initials: H
authors.lastname: van der Vaart
authors.forename: Jan-Paul W R
authors.initials: JP
authors.lastname: Roovers
mesh_terms: D000328:Adult; D003362:Cost-Benefit Analysis; D005260:Female; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D018570:Risk Assessment; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D014596:Uterine Prolapse / Q000601:surgery*
references.citation: Am J Obstet Gynecol. 2005 May;192(5):1537-43
references.pmid: 15902154
references.citation: Br J Obstet Gynaecol. 1982 Jun;89(6):459-63
references.pmid: 7082603
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jan;17(1):27-9
references.pmid: 16094506
references.citation: BJU Int. 2002 Jun;89(9):863-7
references.pmid: 12010229
references.citation: Cochrane Database Syst Rev. 2002;(3):CD003195
references.pmid: 12137680
references.citation: N Engl J Med. 2006 Apr 13;354(15):1557-66
references.pmid: 16611949
references.citation: Qual Life Res. 1994 Oct;3(5):291-306
references.pmid: 7841963
references.citation: Acta Obstet Gynecol Scand. 2003 Nov;82(11):1049-53
references.pmid: 14616280
references.citation: Acta Obstet Gynecol Scand. 1989;68(6):545-9
references.pmid: 2520812
references.citation: Clin Obstet Gynecol. 1998 Sep;41(3):777-85
references.pmid: 9742373
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2007 Apr;18(4):437-42
references.pmid: 16909194
references.citation: Int J Gynaecol Obstet. 2007 Apr;97(1):31-4
references.pmid: 17291508
references.citation: Med Care. 1997 Nov;35(11):1095-108
references.pmid: 9366889
references.citation: Int Urogynecol J. 2010 Feb;21(2):179-86
references.pmid: 19940978
references.citation: Neurourol Urodyn. 2003;22(2):97-104
references.pmid: 12579625
references.citation: Am J Obstet Gynecol. 2002 Jun;186(6):1292-5; discussion 1295-8
references.pmid: 12066111
references.citation: Am J Obstet Gynecol. 2000 Jun;182(6):1378-81
references.pmid: 10871452
references.citation: Eur Urol. 2004 Mar;45(3):356-61
references.pmid: 15036683
references.citation: Acta Obstet Gynecol Scand. 2004 Oct;83(10):950-4
references.pmid: 15453892
references.citation: Eur J Obstet Gynecol Reprod Biol. 2002 Jul 10;103(2):163-7
references.pmid: 12069741
references.citation: Ned Tijdschr Geneeskd. 2005 Jul 9;149(28):1574-8
references.pmid: 16038162
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2007 Apr;18(4):455-60
references.pmid: 17120169
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2006 Jan;17(1):60-5
references.pmid: 15965574
references.citation: Int J Technol Assess Health Care. 1996 Summer;12(3):405-15
references.pmid: 8840661