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
Mostafa A.,University of Aberdeen |
Agur W.,Ayrshire and Arran NHS |
Abdel-All M.,Borders and General Hospital |
Lim C.,NHS Fife |
And 3 more authors.
European Journal of Obstetrics Gynecology and Reproductive Biology | Year: 2012
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. © 2012 Elsevier Ireland Ltd. All rights reserved.
Abdel-Fattah M.,University of Aberdeen |
Agur W.,Ayrshire and Arran NHS |
Abdel-All M.,Borders General Hospital |
Guerrero K.,Greater Glasgow Health Board |
And 4 more authors.
BJU International | Year: 2012
OBJECTIVES To determine whether an adjustable single-incision mini-sling (SIMS, Ajust®) is safe and effective in the management of female stress urinary incontinence (SUI) at 12 months follow-up. To determine whether it is feasible to be performed under local anesthesia (LA). MATERIALS AND METHODS The present study is a multicentre prospective cohort study in which 90 female patients underwent SIMS-Ajust® using a standardized insertion technique. The last 45 women were offered the procedure under LA. All patients completed their 12-month follow-up. RESULTS The patient-reported success rate, using Patient Global Impression of Improvement (PGI-I), was 80% at 12 months follow-up and a further 6% (n= 5) reported themselves to be 'improved'. In all, 32/45 (71%) patients agreed to undergo the procedure under LA while one patient required conversion to general anaesthetic. There was no organ damage or requirement for blood transfusion. Significantly lower rates of blood loss (P= 0.025) and postoperative voiding difficulties (P= 0.026) were seen in the LA group. The re-operation rate for SUI was 6% at 12 months. CONCLUSIONS SIMS (Ajust) appears to be a safe procedure, which is feasible under LA. SIMS (Ajust) have an 80% patient-reported success rate at 12 months follow-up. © 2011 BJU INTERNATIONAL.