Retropubic vs. transobturator tension-free vaginal tape for female stress urinary incontinence: 3-month results of a randomized controlled trial

Int Urogynecol J. 2014 Aug;25(8):1023-30. doi: 10.1007/s00192-014-2384-z. Epub 2014 May 13.


Background: We conducted a prospective randomized controlled noninferiority trial to compare objective and subjective outcomes of retropubic tension-free vaginal tape (TVT) with those of transobturator tape (TVT-O) as primary treatment for stress urinary incontinence (SUI) in women.

Study design: The study was conducted at 25 gynecology units in Austria and Germany; regional and academic hospitals participated. A total of 569 patients were randomly assigned to undergo TVT or TVT-O.

Results: A total of 480 patients (85%) were examined at 3 months. A negative cough stress test with stable cystometry to 300 ml was seen in 87% of patients after TVT and in 84% after TVT-O; 64% and 59% of patients, respectively, reported no pad use, and 88% of patients in both groups considered themselves much or very much better on the Patient Global Impression of Improvement (PGI-I) scale. Quality of life (QoL) as assessed with the SF-12 Health Survey, Kings' Health Questionnaire, (KHQ), and EuroQol-5D (EQ-5D) was significantly improved in both arms, with no differences between arms. There were no significant differences in postoperative pain or complications.

Conclusions: Results of this trial demonstrate noninferiority between TVT and TVT-O with regard to postoperative continence and QoL and suggest little difference in perioperative problems ( NCT 00441454).

Trial registration: NCT00441454.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Absorbent Pads
  • Aged
  • Female
  • Follow-Up Studies
  • Humans
  • Middle Aged
  • Prospective Studies
  • Quality of Life
  • Suburethral Slings* / adverse effects
  • Surveys and Questionnaires
  • Treatment Outcome
  • Urinary Incontinence, Stress / surgery*

Associated data