Comparison of an adjustable anchored single-incision mini-sling, Ajust (R), with a standard mid-urethral sling, TVT-OTM

a health economic evaluation

Dwayne Boyers*, Mary Kilonzo, Alyaa Mostafa, Mohamed Abdel-Fattah

*Corresponding author for this work

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

Objectives To assess the cost, quality of life (QoL) and cost-effectiveness of a single-incision mini-sling (SIMS; Ajust((R)), C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid-urethral sling (SMUS; TVT-O, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incontinence.

Patients and Methods A total of 137 women, in a secondary care setting, were randomized between October 2009 and October 2011 to undergo SIMS placement (n = 69) under local anaesthesia as an opt-out policy or SMUS placement (n = 68) under general anaesthesia. Clinical outcome measures included the patient-reported success rate (Patient Global Impression of Improvement [PGI-I]) and the impact on the patients' QoL (King's Health Questionnaire [KHQ]). Health economic data (cost and quality-adjusted life year [QALY] data) were compared using linear regression models to generate an incremental cost per QALY estimate, in order to determine a measure of cost-effectiveness. Deterministic sensitivity analyses investigated uncertainty in the results, and non-parametric bootstrapping techniques were used to estimate a probability of cost-effectiveness.

Results There were no significant differences between the groups in terms of the KHQ total score (P = 0.27) or the patient-reported success rate (P = 1.00, odds ratio: 0.895; 95% confidence interval [CI]: 0.344 to 2.330). There was no significant difference in QALYs for the SIMS group compared with the SMUS group (mean difference: -0.003; 95% CI: -0.008 to +0.002). The SIMS was on average less costly, -142.41 95% CI: (-316.99 to 32.17) and generated cost savings of 48419 per QALY loss with 94% probability of cost savings to the health services. Taking a wider perspective on the costing analysis by including the wider community benefit associated with the significantly earlier return to work observed in the SIMS group (P = 0.006, 95% CI: 11.756 to 17.217), there was an increase in cost savings to -477, (95% CI: -823.65 to -129.63), with a probability of 100% of cost savings to the wider economy.

Conclusions The adjustable anchored SIMS (Ajust), performed under local anaesthesia as an opt-out policy, delivers cost savings to the health service provider when compared with the SMUS (TVT-O), and is likely to be cost-effective up to 1 year after placement. Further research should be undertaken to confirm the results of our study over longer follow-up and should explore patient preferences alongside an adequately powered non-inferiority randomized controlled trial.

Original languageEnglish
Pages (from-to)1169-1177
Number of pages9
JournalBJU International
Volume112
Issue number8
Early online date4 Nov 2013
DOIs
Publication statusPublished - Dec 2013

Keywords

  • stress urinary incontinence
  • mini-slings
  • mid-urethral slings
  • surgery
  • cost-effectiveness
  • cost analysis
  • stress urinary-incontinence
  • cost-effectiveness analysis
  • management
  • outcomes
  • women
  • questionnaires
  • reliability
  • multicenter
  • trial
  • tape

Cite this

@article{a629766581134d1fa09281a06a483d31,
title = "Comparison of an adjustable anchored single-incision mini-sling, Ajust (R), with a standard mid-urethral sling, TVT-OTM: a health economic evaluation",
abstract = "Objectives To assess the cost, quality of life (QoL) and cost-effectiveness of a single-incision mini-sling (SIMS; Ajust((R)), C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid-urethral sling (SMUS; TVT-O, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incontinence.Patients and Methods A total of 137 women, in a secondary care setting, were randomized between October 2009 and October 2011 to undergo SIMS placement (n = 69) under local anaesthesia as an opt-out policy or SMUS placement (n = 68) under general anaesthesia. Clinical outcome measures included the patient-reported success rate (Patient Global Impression of Improvement [PGI-I]) and the impact on the patients' QoL (King's Health Questionnaire [KHQ]). Health economic data (cost and quality-adjusted life year [QALY] data) were compared using linear regression models to generate an incremental cost per QALY estimate, in order to determine a measure of cost-effectiveness. Deterministic sensitivity analyses investigated uncertainty in the results, and non-parametric bootstrapping techniques were used to estimate a probability of cost-effectiveness.Results There were no significant differences between the groups in terms of the KHQ total score (P = 0.27) or the patient-reported success rate (P = 1.00, odds ratio: 0.895; 95{\%} confidence interval [CI]: 0.344 to 2.330). There was no significant difference in QALYs for the SIMS group compared with the SMUS group (mean difference: -0.003; 95{\%} CI: -0.008 to +0.002). The SIMS was on average less costly, -142.41 95{\%} CI: (-316.99 to 32.17) and generated cost savings of 48419 per QALY loss with 94{\%} probability of cost savings to the health services. Taking a wider perspective on the costing analysis by including the wider community benefit associated with the significantly earlier return to work observed in the SIMS group (P = 0.006, 95{\%} CI: 11.756 to 17.217), there was an increase in cost savings to -477, (95{\%} CI: -823.65 to -129.63), with a probability of 100{\%} of cost savings to the wider economy.Conclusions The adjustable anchored SIMS (Ajust), performed under local anaesthesia as an opt-out policy, delivers cost savings to the health service provider when compared with the SMUS (TVT-O), and is likely to be cost-effective up to 1 year after placement. Further research should be undertaken to confirm the results of our study over longer follow-up and should explore patient preferences alongside an adequately powered non-inferiority randomized controlled trial.",
keywords = "stress urinary incontinence, mini-slings, mid-urethral slings, surgery, cost-effectiveness, cost analysis, stress urinary-incontinence, cost-effectiveness analysis, management, outcomes, women, questionnaires, reliability, multicenter, trial, tape",
author = "Dwayne Boyers and Mary Kilonzo and Alyaa Mostafa and Mohamed Abdel-Fattah",
note = "The authors would like to thank Prof John Brazier, University of Sheffield, for kindly providing the algorithm to develop QALY weights from the KHQ. Appreciation is also noted for the comments received at the ICS 2012 conference on analysis of an earlier version of this dataset. A.M. and M. A.-F. are both members of the Scottish Pelvic Floor Network. This study was funded by Henry Smith Charity.",
year = "2013",
month = "12",
doi = "10.1111/bju.12388",
language = "English",
volume = "112",
pages = "1169--1177",
journal = "BJU International",
issn = "1464-4096",
publisher = "Wiley-Blackwell",
number = "8",

}

TY - JOUR

T1 - Comparison of an adjustable anchored single-incision mini-sling, Ajust (R), with a standard mid-urethral sling, TVT-OTM

T2 - a health economic evaluation

AU - Boyers, Dwayne

AU - Kilonzo, Mary

AU - Mostafa, Alyaa

AU - Abdel-Fattah, Mohamed

N1 - The authors would like to thank Prof John Brazier, University of Sheffield, for kindly providing the algorithm to develop QALY weights from the KHQ. Appreciation is also noted for the comments received at the ICS 2012 conference on analysis of an earlier version of this dataset. A.M. and M. A.-F. are both members of the Scottish Pelvic Floor Network. This study was funded by Henry Smith Charity.

PY - 2013/12

Y1 - 2013/12

N2 - Objectives To assess the cost, quality of life (QoL) and cost-effectiveness of a single-incision mini-sling (SIMS; Ajust((R)), C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid-urethral sling (SMUS; TVT-O, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incontinence.Patients and Methods A total of 137 women, in a secondary care setting, were randomized between October 2009 and October 2011 to undergo SIMS placement (n = 69) under local anaesthesia as an opt-out policy or SMUS placement (n = 68) under general anaesthesia. Clinical outcome measures included the patient-reported success rate (Patient Global Impression of Improvement [PGI-I]) and the impact on the patients' QoL (King's Health Questionnaire [KHQ]). Health economic data (cost and quality-adjusted life year [QALY] data) were compared using linear regression models to generate an incremental cost per QALY estimate, in order to determine a measure of cost-effectiveness. Deterministic sensitivity analyses investigated uncertainty in the results, and non-parametric bootstrapping techniques were used to estimate a probability of cost-effectiveness.Results There were no significant differences between the groups in terms of the KHQ total score (P = 0.27) or the patient-reported success rate (P = 1.00, odds ratio: 0.895; 95% confidence interval [CI]: 0.344 to 2.330). There was no significant difference in QALYs for the SIMS group compared with the SMUS group (mean difference: -0.003; 95% CI: -0.008 to +0.002). The SIMS was on average less costly, -142.41 95% CI: (-316.99 to 32.17) and generated cost savings of 48419 per QALY loss with 94% probability of cost savings to the health services. Taking a wider perspective on the costing analysis by including the wider community benefit associated with the significantly earlier return to work observed in the SIMS group (P = 0.006, 95% CI: 11.756 to 17.217), there was an increase in cost savings to -477, (95% CI: -823.65 to -129.63), with a probability of 100% of cost savings to the wider economy.Conclusions The adjustable anchored SIMS (Ajust), performed under local anaesthesia as an opt-out policy, delivers cost savings to the health service provider when compared with the SMUS (TVT-O), and is likely to be cost-effective up to 1 year after placement. Further research should be undertaken to confirm the results of our study over longer follow-up and should explore patient preferences alongside an adequately powered non-inferiority randomized controlled trial.

AB - Objectives To assess the cost, quality of life (QoL) and cost-effectiveness of a single-incision mini-sling (SIMS; Ajust((R)), C. R. Bard Inc., New Providence, NJ, USA) compared with a standard mid-urethral sling (SMUS; TVT-O, Ethicon Inc., Somerville, NJ, USA) in the surgical management of female stress urinary incontinence.Patients and Methods A total of 137 women, in a secondary care setting, were randomized between October 2009 and October 2011 to undergo SIMS placement (n = 69) under local anaesthesia as an opt-out policy or SMUS placement (n = 68) under general anaesthesia. Clinical outcome measures included the patient-reported success rate (Patient Global Impression of Improvement [PGI-I]) and the impact on the patients' QoL (King's Health Questionnaire [KHQ]). Health economic data (cost and quality-adjusted life year [QALY] data) were compared using linear regression models to generate an incremental cost per QALY estimate, in order to determine a measure of cost-effectiveness. Deterministic sensitivity analyses investigated uncertainty in the results, and non-parametric bootstrapping techniques were used to estimate a probability of cost-effectiveness.Results There were no significant differences between the groups in terms of the KHQ total score (P = 0.27) or the patient-reported success rate (P = 1.00, odds ratio: 0.895; 95% confidence interval [CI]: 0.344 to 2.330). There was no significant difference in QALYs for the SIMS group compared with the SMUS group (mean difference: -0.003; 95% CI: -0.008 to +0.002). The SIMS was on average less costly, -142.41 95% CI: (-316.99 to 32.17) and generated cost savings of 48419 per QALY loss with 94% probability of cost savings to the health services. Taking a wider perspective on the costing analysis by including the wider community benefit associated with the significantly earlier return to work observed in the SIMS group (P = 0.006, 95% CI: 11.756 to 17.217), there was an increase in cost savings to -477, (95% CI: -823.65 to -129.63), with a probability of 100% of cost savings to the wider economy.Conclusions The adjustable anchored SIMS (Ajust), performed under local anaesthesia as an opt-out policy, delivers cost savings to the health service provider when compared with the SMUS (TVT-O), and is likely to be cost-effective up to 1 year after placement. Further research should be undertaken to confirm the results of our study over longer follow-up and should explore patient preferences alongside an adequately powered non-inferiority randomized controlled trial.

KW - stress urinary incontinence

KW - mini-slings

KW - mid-urethral slings

KW - surgery

KW - cost-effectiveness

KW - cost analysis

KW - stress urinary-incontinence

KW - cost-effectiveness analysis

KW - management

KW - outcomes

KW - women

KW - questionnaires

KW - reliability

KW - multicenter

KW - trial

KW - tape

U2 - 10.1111/bju.12388

DO - 10.1111/bju.12388

M3 - Article

VL - 112

SP - 1169

EP - 1177

JO - BJU International

JF - BJU International

SN - 1464-4096

IS - 8

ER -