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Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent

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Abstract

Introduction and hypothesis

Patient-reported outcome measures (PROMs) are important for understanding the success of surgery for stress urinary incontinence, as patient perception of success does not always correlate with physician perception of success. We report PROMS after single-incision slings (SIS) and transobturator mid-urethral slings (TMUS).

Methods

This was a planned outcome analysis of secondary endpoints in a study in which the primary aim was to compare efficiency and safety using a non-inferiority design (results reported previously). In this analysis of quality of life (QOL), validated PROMs were collected at baseline, 6, 12, 18, 24, and 36 months to quantify incontinence severity (Incontinence Severity Index), symptom bother (Urogenital Distress Inventory), disease-specific QOL impact (Urinary Impact Questionnaire), and generic QOL impact (PGI-I; not applicable at baseline). PROMs were analyzed within treatment groups as well as between groups. Propensity score methods were used to adjust for baseline differences between groups.

Results

A total of 281 subjects underwent the study procedure (141 SIS, 140 TMUS). Baseline characteristics were balanced after propensity score stratification. Participants had significant improvement in incontinence severity, disease-specific symptom bother, and QOL impact. Improvements persisted through the study and PROMs were similar between treatment groups in all assessment at 36 months

Conclusions

Following SIS and TMUS, patients with stress urinary incontinence had significant improvement in PROMs including Urogenital Distress Inventory, Incontinence Severity Index, and Urinary Impact Questionnaire at 36 months, indicating disease-specific QOL improvement. Patients have a more positive impression of change in stress urinary incontinence symptoms at each follow-up visit, indicating generic QOL improvement.

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Acknowledgements

We acknowledge Guang Yang and Dongfeng Qi at Boston Scientific for their contributions to the statistical analysis and Kristen Griffin at Boston Scientific for editing support. We also thank the participating study sites and investigators: Scott R. Serels, Norwalk Urology Associates, Norwalk, CT, USA; Sam Siddighi, Loma Linda University, Loma Linda, CA, USA; Pill Raja, Permian Research Foundation, Odessa, TX, USA; Thomas Hutchens, Mid Dakota Clinic, Bismarck, ND, USA; Barry Jarnagin, Center for Pelvic Health, Franklin, TN, USA; Amanda White, University of Texas at Austin Dell Medical School, Austin, TX, USA; Michael Litrel, Cherokee Women’s Health Specialists, Canton, GA, USA; Ricardo Gonzalez, Houston Methodist, Houston, TX, USA; Bradley Jacobs, Lyndhurst Clinical Research, Winston Salem, NC, USA; Kaiser Robertson III, Chesapeake Urology Research Associates, Hanover, MD, USA; Karyn Eilber, Cedars-Sinai Medical Center, Beverly Hills, CA, USA; Michael England, Baylor University Medical Center, Fort Worth, TX, USA; Bruce Kahn, Scripps Clinic, San Diego, CA, USA; William Porter, Novant Health Presbyterian Medical Center, Charlotte, NC, USA; Joseph Gauta, The Florida Bladder Institute, Naples, FL, USA; Kyle P. McMorries/Mitchell Silver, Nacogdoches, TX, USA; Howard Goldstein, Christiana Care, Newark, DE, USA; James Rice, Multicare Women’s Center, Covington, WA, USA; John Zavaleta, Las Colinas ObGyn, Irving, TX, USA; Jeff Livingston, MacArthur Ob/Gyn Management, Irving, TX, USA; and Anna Rosamilia, Monash Medical Centre and Cabrini Hospital, Melbourne, Australia.

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Authors and Affiliations

  1. Urology and Female Pelvic Medicine and Reconstructive Surgery, Houston Methodist Hospital, Houston, TX, 77030, USA

    Ricardo R. Gonzalez

  2. Department of Obstetrics and Gynaecology, Monash Medical Centre and Cabrini Hospital, Melbourne, Australia

    Anna Rosamilia

  3. Division of Urology, Cedars-Sinai Health System, Los Angeles, CA, USA

    Karyn Eilber

  4. Department of Obstetrics and Gynecology, Scripps Clinic, San Diego, CA, USA

    Bruce S. Kahn

  5. Department of Women’s Health, Dell Medical School, University of Texas at Austin, TX, USA, Austin, USA

    Amanda B. White

  6. Department of Urology, University of California San Diego Health, San Diego, CA, USA

    Jennifer T. Anger

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Contributions

R.R.G.: manuscript writing/editing, project development; A.R.: recruitment/manuscript writing and editing; K.E.: manuscript writing/editing; B.S.K.: manuscript writing/editing, data analysis; A.B.W.: manuscript writing/editing; J.T.A.: manuscript writing/editing.

Corresponding author

Correspondence to Ricardo R. Gonzalez.

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Financial disclaimers/conflicts of interest

R.R.G.: Boston Scientific (consultant, investigator); A.R.: Boston Scientific (investigator), Glycolyx Inc (consultant), International Continence Society (ICS) (co-scientific Chair, 2021); K.E.: Coloplast (consultant), Boston Scientific (investigator); B.S.K.: Boston Scientific (investigator), Solaire (investigator), Ark Surgical (consultant); A.B.W.: Boston Scientific (consultant).

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Gonzalez, R.R., Rosamilia, A., Eilber, K. et al. Three-year patient-reported outcomes of single-incision versus transobturator slings for female stress urinary incontinence are equivalent. Int Urogynecol J 34, 2265–2274 (2023). https://doi.org/10.1007/s00192-023-05538-w

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