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Treatment of refractory overactive bladder with OnabotulinumtoxinA vs PTNS: TROOP trial

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Abstract

Introduction and hypothesis

We hypothesized that patients with refractory overactive bladder (rOAB) have similar improvement with percutaneous tibial nerve stimulation (PTNS) and OnabotulinumtoxinA (BTX).

Methods

This multicenter cohort study compared BTX and PTNS in women with rOAB. Baseline information included Overactive Bladder Questionnaire (OABq) short form, Urinary Distress Inventory-6 (UDI-6), and voiding diary. Primary outcome was cure, defined as “very much better” or “much better” on the Patient Global Impression of Improvement (PGII) AND a reduction in OABq symptom severity scale (SSS) ≥10 at 3 months after treatment. Assuming 80% power to detect a ten-point difference in OABq-SSS, 80 participants were required per group.

Results

A total of 150 patients were enrolled; 97 completed 3 months of therapy and were included. At baseline, BTX patients had more detrusor overactivity (70% vs 40%, p = 0.025), urgency incontinence (UUI; OABq-SSS#6 4 vs 3, p = 0.02, SSS 65 vs 56, p = 0.04), but similar health-related quality of life (HRQL 49 vs 54, p = 0.28), voids (7 vs 8, p = 0.13), and UUI episodes (2 vs 2, p = 1.0). At 3 months, cure rates were similar: BTX 50% vs PTNS 44.2% (p = 0.56). Both groups had improved SSS (−37 vs −29, p = 0.08) and HRQL (31 vs 24, p = 0.14). Patients receiving BTX had a greater improvement in urgency (ΔOABq-SSS#2–3 vs −2; p = 0.02) and UUI (ΔOABq-SSS#6–2 vs -1; p = 0.02). No characteristics were predictive of cure.

Conclusions

BTX resulted in significantly greater improvement in urgency and UUI than PTNS, but no difference in success based on PGII and OABq-SSS, which may be due to a lack of power.

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Funding

IUGA Uroplasty 2015 Research Grant: Drs. Cheryl Iglesia and Katelyn Smithling Kopcsay.

MedStar Washington Hospital Center Graduate Medical Education Research grant (#2014–277).

Author information

Authors and Affiliations

  1. Obstetrics & Gynecology, Division of Urogynecology, Baystate Health, 759 Chestnut St, S1681, Springfield, MA, 01199, USA

    Katelyn Smithling Kopcsay

  2. Obstetrics & Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Mount Auburn Hospital/Beth Israel Deaconess Medical Center, Boston, MA, USA

    Tara Doyle Marczak

  3. Obstetrics & Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, University of New Mexico, Albuquerque, NM, USA

    Peter C. Jeppson

  4. Urology, Division of Neurourology and Pelvic Reconstruction, University of Michigan, Ann Arbor, MI, USA

    Anne P. Cameron

  5. Urology, Houston Methodist Hospital, Houston, TX, USA

    Rose Khavari

  6. Department of Biostatistics and Epidemiology, MedStar Health Research Institute, Hyattsville, MD, USA

    Eshetu Tefera

  7. Obstetrics & Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Georgetown University/MedStar Washington Hospital Center, Washington, DC, USA

    Robert E. Gutman

Authors
  1. Katelyn Smithling Kopcsay
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  2. Tara Doyle Marczak
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  3. Peter C. Jeppson
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  4. Anne P. Cameron
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  5. Rose Khavari
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  6. Eshetu Tefera
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  7. Robert E. Gutman
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Contributions

K.S. Kopcsay: project development, data collection, manuscript writing; A.P. Cameron: project development, data collection, manuscript editing; R. Khavari: project development, data collection, manuscript editing; R.E. Gutman: project development, data collection, manuscript editing; T.D. Marczak: data collection, manuscript editing; P.C. Jeppson: data collection, manuscript editing; E. Tefera: data analysis.

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Correspondence to Katelyn Smithling Kopcsay.

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AUGS/IUGA Joint Scientific Meeting 2019, Nashville, TN 9/25/19, USA

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Kopcsay, K.S., Marczak, T.D., Jeppson, P.C. et al. Treatment of refractory overactive bladder with OnabotulinumtoxinA vs PTNS: TROOP trial. Int Urogynecol J 33, 851–860 (2022). https://doi.org/10.1007/s00192-021-05030-3

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  • DOI: https://doi.org/10.1007/s00192-021-05030-3

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