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Bieri U, Slieker J, Hefermehl LJ, et al. Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study protocol. BMJ Open. 2021;11(12):e048911doi: 10.1136/bmjopen-2021-048911.
Bieri, U., Slieker, J., Hefermehl, L. J., Soppe, S., Teufelberger, G., Tedaldi, R., Graf, N., Bieri, M., & Nocito, A. (2021). Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study protocol. BMJ open, 11(12), e048911. https://doi.org/10.1136/bmjopen-2021-048911
Bieri, Uwe, et al. "Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study protocol." BMJ open vol. 11,12 (2021): e048911. doi: https://doi.org/10.1136/bmjopen-2021-048911
Bieri U, Slieker J, Hefermehl LJ, Soppe S, Teufelberger G, Tedaldi R, Graf N, Bieri M, Nocito A. Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study protocol. BMJ Open. 2021 Dec 07;11(12):e048911. doi: 10.1136/bmjopen-2021-048911. PMID: 34876420; PMCID: PMC8655554.
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BMJ Open. 2021 Dec 07;11(12):e048911. doi: 10.1136/bmjopen-2021-048911.

Randomised, quadruple blinded, placebo controlled, multicentre trial investigating prophylactic tamsulosin in prevention of postoperative urinary retention in men after endoscopic total extraperitoneal inguinal hernia repair (STOP-POUR trial): a study protocol.

BMJ open

Uwe Bieri, Juliette Slieker, Lukas John Hefermehl, Sebastian Soppe, Gerfried Teufelberger, Regula Tedaldi, Nicole Graf, Marco Bieri, Antonio Nocito

Affiliations

  1. Department of Urology, University Hospital Zurich, Zurich, Switzerland.
  2. Department for General, Visceral and Vascular Surgery, Kantonsspital Baden, Baden, Switzerland.
  3. Department of Surgery, Division of Urology, Kantonsspital Baden, Baden, Switzerland.
  4. Department of General Surgery, Spital Muri, Muri, Switzerland.
  5. Graf Biostatistics, Winterthur, Switzerland.
  6. Commissioning and Qualification Engineer, Rotkreuz, Switzerland.
  7. Department for General, Visceral and Vascular Surgery, Kantonsspital Baden, Baden, Switzerland [email protected].

PMID: 34876420 PMCID: PMC8655554 DOI: 10.1136/bmjopen-2021-048911

Abstract

INTRODUCTION: Postoperative urinary retention (POUR) is a common complication after inguinal hernia repair with a reported incidence up to 34%. It can be described as the inability to initiate urination or insufficient bladder emptying following surgery. It usually requires the use of catheterisation to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief from pain. Tamsulosin is a medication that is commonly used in men with urinary symptoms related to an enlarged prostate. There is some evidence to suggest that it may also potentially be beneficial for preventing POUR.

METHODS AND ANALYSIS: This is a multicentre, blinded, prospective, phase IV randomised controlled trial with parallel allocation. Six hundred and thirty-four patients scheduled for elective endoscopic inguinal hernia repair surgery will be recruited. There will be effective (concealed) randomisation of the subjects to the intervention/control groups. Group assignment will be performed using a covariate-adaptive allocation procedure to provide a balance for selected covariates. The interventional group receives 0.4 mg tamsulosin hydrochloride and the control-group receives one placebo capsule matching the active study drug, both daily, starting from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. The primary outcome is any need for urinary catheterisation postoperatively as a binary outcome. Secondary outcome measures include postoperative pain, change in International Prostate Symptom Score from baseline prior to surgery to after surgery and hospital stay.

ETHICS AND DISSEMINATION: The study has been approved by the Northwestern and Central Switzerland Ethics Committee (2020-00569) and it is being conducted in accordance with the Declaration of Helsinki and Good Clinical Practice. Study results will be disseminated through peer-reviewed journals and national and international scientific conferences.

TRIAL REGISTRATION NUMBERS: SNCTP000003904. NCT04491526.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Keywords: adult surgery; bladder disorders; clinical trials; urology

Conflict of interest statement

Competing interests: None declared.

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