A multicentre prospective randomised study of single-incision mini-sling (Ajust ®) versus tension-free vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes

Alyaa Mostafa, Wael Agur, Mohamed Abdel-All, Karen Guerrero, Chi Lim, Mohammed Allam, Mohamed Yousef, James N'Dow, Mohamed Abdel-Fattah (Corresponding Author)

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Abstract

Objectives: To compare the postoperative pain profile, peri-operative details, and short-term patient-reported and objective success rates of single-incision mini-slings (SIMS) versus standard mid-urethral slings (SMUS). Study design: In a multicentre prospective randomised trial in six UK centres in the period between October 2009 and October 2010, 137 women were randomised to either adjustable SIMS (Ajust ®, C. R. Bard Inc., NJ, USA), performed under local anaesthesia as an opt-out policy (n = 69), or SMUS (TVT-O™, Ethicon Inc., Somerville, USA) performed under general anaesthesia (n = 68). Randomisation was done through number-allocation software and using telephone randomisation. Postoperative pain profile (primary outcome) was assessed on a ten-point visual analogue scale at fixed time-points. Pre- and post operatively (4-6 months) women completed symptom severity, urgency perception scale (UPS), quality of life and sexual function questionnaires. In addition, women completed a Patient Global Impression of Improvement Questionnaire and underwent a cough stress test at 4-6 months follow up. Sample size calculation was performed and data were analysed using SPSS 18. Descriptive analyses are given and between-group comparisons were performed using chi-square, Fischer exact test and Mann-Whitney test as appropriate. Significance level was set at 5%. Results: Women in the SIMS Ajust ® group had a significantly lower postoperative pain profile up to 4 weeks (p = <0.001, 95% CI 1.151, 2.480). There was no significant difference in peri-operative complications between groups. All 137 women completed the 4-6 months follow-up. Patient-reported and objective cure rates were not significantly different: 85.5% versus 91.2% (p = 0.443) and 90% versus 97% (p = 0.165) between the SIMS Ajust ® and TVT-O™ groups respectively. There was a trend towards higher rates of de novo urgency or worsening of pre-existing urgency in the SIMS Ajust ® group (21.7% versus 8.8%) but this did not reach statistical significance (p = 0.063). Women in the SIMS Ajust ® group had shorter hospital stay (median (IQR) 3.65 (2.49, 4.96)) compared to (4.42 (3.16, 5.56)) the TVT-O™ group 95% CI (-0.026, 1.326), with significantly earlier return to normal activities (p = 0.025) and to work (p = 0.006). Conclusion: The adjustable single-incision mini-sling (Ajust ®) is associated with a significantly improved postoperative pain profile and earlier return to work when compared to standard mid-urethral slings (TVT-O™), with encouraging results in patient-reported and objective success rates at short-term follow-up.
Original languageEnglish
Pages (from-to)115-121
Number of pages7
JournalEuropean Journal of Obstetrics & Gynecology and Reproductive Biology
Volume165
Issue number1
Early online date20 Aug 2012
DOIs
Publication statusPublished - Nov 2012

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Keywords

  • mid-urethral slings
  • mini-slings
  • single-incision tapes
  • stress urinary incontinence
  • tension-free vaginal tape

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