Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair

NCT04434378 | Terminated Phase 4 FDA Drug

• 1 other identifier: 17-19
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effect of tamsulosin on the development of post-operative urinary retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the rate of urinary retention necessitating straight catheterization or insertion of foley catheter prior to discharge.

Conditions

Post Operative Urinary Retention

Keywords

laparoscopic inguinal hernia repair; tamsulosin

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative urinary retention.

  Patients undergoing laparoscopic inguinal hernia repair will be assessed for postoperative urinary retention in the post anesthesia care unit. Postoperative urinary retention will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing \>400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort).

  Within 24 hours of surgery

Secondary Outcomes (1)

• Incidence of risk factors for postoperative urinary retention in patients undergoing laparoscopic inguinal hernia repair.

  within 24 hours of surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Patients undergoing laparoscopic inguinal hernia repair will randomized to one dose of placebo in the preoperative holding area 2 hours before surgery.

Drug: Placebo

Interventional

EXPERIMENTAL

Patients undergoing laparoscopic inguinal hernia repair will be randomized to one dose of 0.4 mg tamsulosin in the preoperative holding area 2 hours before surgery.

Drug: Tamsulosin

Interventions

Tamsulosin DRUG

0.4 mg tamsulosin will be given to a randomized group of patients

Interventional

Placebo DRUG

placebo will be given to a randomized group of patients

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing elective laparoscopic inguinal hernia repair, unilateral or bilateral.
• ≥18 years of age.
• Patients must leave the operating room without at indwelling urinary catheter.

You may not qualify if:

• History of neurogenic bladder requiring routine intermittent catheterization
• Emergent laparoscopic hernia repair.
• Elective laparoscopic hernia repair in conjuncture with an additional operation (e.g. nephrectomy, pelvic surgery) that requires the patient to have a planned, indwelling urinary catheter in the postoperative period.
• Pregnant women.

Sponsors & Collaborators

• Jewish Hospital, Cincinnati, Ohio: lead

Study Sites (1)

Jewish Hospital

Cincinnati, Ohio, 45236, United States

Location

Related Publications (4)

• Garg P, Rajagopal M, Varghese V, Ismail M. Laparoscopic total extraperitoneal inguinal hernia repair with nonfixation of the mesh for 1,692 hernias. Surg Endosc. 2009 Jun;23(6):1241-5. doi: 10.1007/s00464-008-0137-0. Epub 2008 Sep 24.

  PMID: 18813990 BACKGROUND

• Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19.

  PMID: 22741052 BACKGROUND

• Shaw MK, Pahari H. The role of peri-operative use of alpha-blocker in preventing lower urinary tract symptoms in high risk patients of urinary retention undergoing inguinal hernia repair in males above 50 years. J Indian Med Assoc. 2014 Jan;112(1):13-4, 16.

  PMID: 25935942 BACKGROUND

• Sivasankaran MV, Pham T, Divino CM. Incidence and risk factors for urinary retention following laparoscopic inguinal hernia repair. Am J Surg. 2014 Feb;207(2):288-92. doi: 10.1016/j.amjsurg.2013.06.005. Epub 2013 Nov 5.

  PMID: 24200291 BACKGROUND

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

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: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: One group will be randomized to tamsulosin and the second group randomized to placebo

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: June 16, 2020
• Study Start: November 16, 2017
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)