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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.
Eur J Obstet Gynecol Reprod Biol. 2012 Nov; 165(1):115-21.EJ

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.

Authors+Show Affiliations

University of Aberdeen, Aberdeen, United Kingdom.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

22917936

Citation

Mostafa, Alyaa, et al. "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." European Journal of Obstetrics, Gynecology, and Reproductive Biology, vol. 165, no. 1, 2012, pp. 115-21.
Mostafa A, Agur W, Abdel-All M, et al. 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. Eur J Obstet Gynecol Reprod Biol. 2012;165(1):115-21.
Mostafa, A., Agur, W., Abdel-All, M., Guerrero, K., Lim, C., Allam, M., Yousef, M., N'Dow, J., & Abdel-fattah, M. (2012). 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. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 165(1), 115-21. https://doi.org/10.1016/j.ejogrb.2012.06.022
Mostafa A, et al. 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. Eur J Obstet Gynecol Reprod Biol. 2012;165(1):115-21. PubMed PMID: 22917936.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Mostafa,Alyaa, AU - Agur,Wael, AU - Abdel-All,Mohamed, AU - Guerrero,Karen, AU - Lim,Chi, AU - Allam,Mohamed, AU - Yousef,Mohamed, AU - N'Dow,James, AU - Abdel-fattah,Mohamed, Y1 - 2012/08/20/ PY - 2011/11/24/received PY - 2012/05/25/revised PY - 2012/06/12/accepted PY - 2012/8/25/entrez PY - 2012/8/25/pubmed PY - 2013/4/23/medline SP - 115 EP - 21 JF - European journal of obstetrics, gynecology, and reproductive biology JO - Eur J Obstet Gynecol Reprod Biol VL - 165 IS - 1 N2 - 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. SN - 1872-7654 UR - https://www.unboundmedicine.com/medline/citation/22917936/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0301-2115(12)00289-8 DB - PRIME DP - Unbound Medicine ER -