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)

Research output: Contribution to journalArticle

44 Citations (Scopus)

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

Fingerprint

Suburethral Slings
Stress Urinary Incontinence
Prospective Studies
Pain
Postoperative Pain
Random Allocation
Return to Work
Local Anesthesia
Visual Analog Scale
Exercise Test
Cough
Telephone
Sample Size
General Anesthesia
Length of Stay
Software
Quality of Life

Keywords

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

Cite this

@article{50e93942cea346cbac5cab597f887d27,
title = "A multicentre prospective randomised study of single-incision mini-sling (Ajust {\circledR}) versus tension-free vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes",
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 {\circledR}, 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 {\circledR} 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 {\circledR} 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 {\circledR} group (21.7{\%} versus 8.8{\%}) but this did not reach statistical significance (p = 0.063). Women in the SIMS Ajust {\circledR} 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 {\circledR}) 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.",
keywords = "mid-urethral slings, mini-slings, single-incision tapes, stress urinary incontinence, tension-free vaginal tape",
author = "Alyaa Mostafa and Wael Agur and Mohamed Abdel-All and Karen Guerrero and Chi Lim and Mohammed Allam and Mohamed Yousef and James N'Dow and Mohamed Abdel-Fattah",
note = "The authors thank Dr. Mohamed Riad (clinical research fellow, Crosshouse Hospital Kilmarnock); Sarah Griffin and Rhona Dow (Urogynaecobgy sisters, NHS Grampian); Audrey Connolly and Carol Archibald (Urogynaecobgy sisters, Greater Glasgow and Clyde health Board) for their role in patients follow-up.",
year = "2012",
month = "11",
doi = "10.1016/j.ejogrb.2012.06.022",
language = "English",
volume = "165",
pages = "115--121",
journal = "European Journal of Obstetrics & Gynecology and Reproductive Biology",
issn = "0301-2115",
publisher = "Elsevier Ireland Ltd",
number = "1",

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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

T2 - pain profile and short-term outcomes

AU - Mostafa, Alyaa

AU - Agur, Wael

AU - Abdel-All, Mohamed

AU - Guerrero, Karen

AU - Lim, Chi

AU - Allam, Mohammed

AU - Yousef, Mohamed

AU - N'Dow, James

AU - Abdel-Fattah, Mohamed

N1 - The authors thank Dr. Mohamed Riad (clinical research fellow, Crosshouse Hospital Kilmarnock); Sarah Griffin and Rhona Dow (Urogynaecobgy sisters, NHS Grampian); Audrey Connolly and Carol Archibald (Urogynaecobgy sisters, Greater Glasgow and Clyde health Board) for their role in patients follow-up.

PY - 2012/11

Y1 - 2012/11

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.

AB - 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.

KW - mid-urethral slings

KW - mini-slings

KW - single-incision tapes

KW - stress urinary incontinence

KW - tension-free vaginal tape

U2 - 10.1016/j.ejogrb.2012.06.022

DO - 10.1016/j.ejogrb.2012.06.022

M3 - Article

VL - 165

SP - 115

EP - 121

JO - European Journal of Obstetrics & Gynecology and Reproductive Biology

JF - European Journal of Obstetrics & Gynecology and Reproductive Biology

SN - 0301-2115

IS - 1

ER -