Study to Prevent Postoperative Urinary Retention

NCT04491526 | Terminated Phase 4 DMC

• 1 other identifier: 2020-00569
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative urinary retention (POUR) is a common complication after inguinal hernia repair with a reported incidence up 34%. It can be described as the inability to initiate urination or properly empty one's bladder following surgery. It is usually self-limited, but it requires the use of catheterization to empty the bladder in order to prevent further injury to the bladder or kidneys and to relief the discomfort of a full bladder. 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 post-operative urinary retention. The purpose of this study is to determine if tamsulosin ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") is effective in preventing post-operative urinary retention following endoscopic total extraperitoneal inguinal hernia repair and its impact on hospital length of stay.

Conditions

Urinary Retention; Inguinal Hernia

Keywords

Urinary Retention; Inguinal Hernia Repair; alpha-1 adrenergic receptor antagonists; IPSS

Outcome Measures

Primary Outcomes (1)

• Post operative urinary retention (Need for any catheterization postoperatively)

  Need for any catheterization postoperatively (Yes/No)

  up to 3 days after surgery

Secondary Outcomes (23)

• Time to first voiding after surgery

  up to 3 days after surgery

• Urinary Volume measurement at defined points in time (n)

  up to 12 hours after surgery

• Volume of first micturition after surgery

  up to 12 hours after surgery

• Post-operative Pain (Quantity of Pain / VAS-Score)

  up to 3 days after surgery

• Need for opioid analgesics post operatively

  up to 3 days after surgery

Study Arms (2)

Tamsulosin Arm

EXPERIMENTAL

p.o.

Drug: TAMSULOSIN Mepha Ret Depocaps 0.4 mg

Placebo Arm

PLACEBO COMPARATOR

p.o.

Drug: Control Intervention

Interventions

TAMSULOSIN Mepha Ret Depocaps 0.4 mg DRUG

0.4mg/day Tamsulosin hydrochloride ("TAMSULOSIN Mepha Ret Depocaps 0.4 mg") from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)

Also known as: Verum

Tamsulosin Arm

Control Intervention DRUG

One placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)

Also known as: Placebo

Placebo Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males
• ≥60 years old
• Planned uni- or bilateral endoscopic total extraperitoneal inguinal hernia repair
• Surgery scheduled more than 6 days from the time of consent
• Informed Consent as documented by signature (Appendix Informed Consent Form)

You may not qualify if:

• Orthostatic hypotension (feeling of dizziness after getting up from a sitting or lying position)
• Severe liver disease (Child Pugh C)
• Taking strong inhibitors of CYP3A4 (ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir/ritonavir, lopinavir, or conivaptan)
• Being on alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, or silodosin) or a combination product containing alpha-blocker (duodart)
• History of allergy or sensitivity to tamsulosin or other alpha-blockers (alfuzosin, doxazosin, prazosin, terazosin, or phenoxybenzamine)
• Long term Indwelling urinary or suprapubic catheter
• Status post cystectomy
• Inability to provide informed consent
• Known or suspected non-compliance, drug or alcohol abuse,
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Participation in another study with investigational drug within the 30 days preceding and during the present study,
• Previous enrolment into the current study

Sponsors & Collaborators

• Antonio Nocito, MD: lead

Study Sites (1)

Kantonsspital Baden

Baden, Canton of Aargau, 5404, Switzerland

Location

Related Publications (1)

• 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 7;11(12):e048911. doi: 10.1136/bmjopen-2021-048911.

  PMID: 34876420 DERIVED

MeSH Terms

Conditions

Urinary Retention; Hernia, Inguinal

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Nocito, Prof

  Kantonsspital Baden AG, Im Ergel 1, 5404 Baden, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Antonio Nocito, Director of the Department of General, Visceral and Vascular Surgery and Chief Physician Surgery

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 29, 2020
• Study Start: November 1, 2020
• Primary Completion: February 9, 2026
• Study Completion: February 9, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)