title: Randomized controlled trial of cough test versus no cough test in the tension-free vaginal tape procedure: effect upon voiding dysfunction and 12-month efficacy.
abstract: OBJECTIVE
  This is a prospective randomized controlled trial of cough versus no cough test in the tension-free vaginal tape (TVT) procedure to determine its effect upon voiding dysfunction and 12-month efficacy.
  
  
  METHODS
  The trial was conducted in a single tertiary urogynecology unit. Women ≥21 years old with primary urodynamic stress incontinence without voiding dysfunction were considered eligible. Participants were randomized to undergo the TVT procedure using either an intraoperative cough test or using no intraoperative cough test. Our hypothesis was that postoperative voiding dysfunction would be more common in the "no cough test" arm. The primary outcome was proportion of patients successfully completing a trial of void (TOV) within 24 h of catheter removal. Efficacy at 12 months comprised the secondary outcome. Participants were randomized using a computer-generated randomization sequence by an independent party who was not the operating surgeon. Due to the nature of the intervention to be tested, neither the patients nor the operating surgeons were blinded to the randomization process during the procedure.
  
  
  RESULTS
  This trial is reported according to the recommendations of the 2010 CONSORT statement. In total, 94 women were recruited over a 4-year study period. Of these, 92 women were randomized (47 in the "cough" group and 45 in the "no cough" group). In one case, the TVT procedure was abandoned intraoperatively, leaving 91 women who underwent analysis. There was no significant difference in the proportion of women with a successful TOV within 24 h between the two arms (79% in the "cough" group versus 71% in the "no cough" group; p = 0.47). Efficacy data at 12 months were not significantly different between groups.
  
  
  CONCLUSIONS
  Our data suggest that the performance of the intraoperative cough test during the TVT procedure does not reduce the incidence of postoperative voiding dysfunction (as determined by successful TOV within 24 h) nor affect efficacy. The removal of the cough test from the standard TVT technique may be appropriate.
authors.affiliation: Department of Urogynaecology, St George Hospital, University of New South Wales, Sydney, Australia. k.moore@unsw.edu.au
authors.forename: Kate H
authors.initials: KH
authors.lastname: Moore
authors.forename: Rihan B
authors.initials: RB
authors.lastname: Shahab
authors.forename: Colin A
authors.initials: CA
authors.lastname: Walsh
authors.forename: William M A
authors.initials: WM
authors.lastname: Kuteesa
authors.forename: Susmita
authors.initials: S
authors.lastname: Sarma
authors.forename: Monique
authors.initials: M
authors.lastname: Cebola
authors.forename: Wendy
authors.initials: W
authors.lastname: Allen
authors.forename: Yueping A
authors.initials: YA
authors.lastname: Wang
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Karantanis
mesh_terms: D000328:Adult; D003371:Cough; D005080:Exercise Test / Q000379:methods*; D005260:Female; D013509:Gynecologic Surgical Procedures / Q000379:methods*; D006801:Humans; D015994:Incidence; D007432:Intraoperative Period; D008137:Longitudinal Studies; D008875:Middle Aged; D011446:Prospective Studies; D053825:Suburethral Slings; D013997:Time Factors; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000601:surgery*; D014555:Urination Disorders / Q000453:epidemiology*
references.citation: Br J Obstet Gynaecol. 1999 Apr;106(4):345-50
references.pmid: 10426241
references.citation: BJOG. 2004 Aug;111(8):859-62
references.pmid: 15270937
references.citation: Br J Obstet Gynaecol. 1996 Feb;103(2):162-7
references.pmid: 8616134
references.citation: Eur Urol. 2002 Jul;42(1):29-33
references.pmid: 12121726
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2007 Oct;18(10):1197-200
references.pmid: 17268766
references.citation: Obstet Gynecol. 2003 Apr;101(4):666-70
references.pmid: 12681868
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2008 Feb;19(2):257-60
references.pmid: 17549428
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2004 Sep-Oct;15(5):328-30
references.pmid: 15580418
references.citation: Neurourol Urodyn. 1995;14(2):131-9
references.pmid: 7780440
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 2007 Dec;18(12):1445-7
references.pmid: 17396207
references.citation: Int Urogynecol J. 2010 Jan;21(1):5-26
references.pmid: 19937315
references.citation: Int Urogynecol J Pelvic Floor Dysfunct. 1996;7(2):81-5; discussion 85-6
references.pmid: 8798092