Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty

NCT03808155 | Completed Phase 4

• 1 other identifier: GR20192021
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

Various studies have shown that the risk of suffering a urinary retention after knee or hip prosthesis surgery is 10-80%. The aim of the study is to reduce this riks. For this purpose, it is investigated whether a previously known drug (tamsulosin) which is used in bladder emptying disorders, can achieve a reduction in urinary retention after surgery. After the patients agree to participate in the study, they are examined in our urological clinic. Uroflowmetry is performed with sonographic residual volume measurement and prostate volume measurement. Furthermore, a standardized Voiding questionaire (IPSS) is completed. This study is conducted as a double-blind study using a placebo control group. The drug / placebo is taken once a day, five days before and two days after surgery. Subsequently, it is observed whether it comes to a urinary retention or not. After the operation, no further urological checks are planned or needed.

Conditions

Urinary Retention Postoperative; Arthropathy of Knee; Arthropathy of Hip

Keywords

Urinary retention; Tamsulosin

Outcome Measures

Primary Outcomes (1)

• Occurrence of urinary retention

  The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.

  48 hours postoperatively

Secondary Outcomes (4)

• Type of anaesthesia

  48 hours postoperatively

• Preoperative residual volume

  Minimum 6 days before the planned operation.

• Prostate size

  Minimum 6 days before the planned operation.

• International prostate symptom score (IPSS).

  Minimum 6 days before the planned operation.

Study Arms (2)

Tamsulosin

ACTIVE COMPARATOR

The study specific product Tamsulosin 0.4mg, a tablet which is taken once a day per os five days prior to the operation and two days after the operation.

Drug: Tamsulosin

Placebo Oral Tablet

PLACEBO COMPARATOR

The placebo is taken once a day per os five days prior to the operation and two days after the operation.

Drug: Placebo Oral Tablet

Interventions

Tamsulosin DRUG

The drug ist taken once a day per os five days prior to the operation and two days after the operation.

Also known as: Pradif

Tamsulosin

Placebo Oral Tablet DRUG

The placebo ist taken once a day per os five days prior to the operation and two days after the operation.

Placebo Oral Tablet

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The participant has to be a genectic male with all male organs.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- male adults undergoing elective hip- or knee arthroplasty

You may not qualify if:

• women
• underage patients
• pre-existing treatment with tamsulosin or other prostate affecting medication
• patients who underwent transurethral resection of the prostate or prostatectomy
• patients with urethral strictures
• patients with neurological bladder dysfunction
• Known allergy to tamsulosin
• Hypotensive disorder

Sponsors & Collaborators

• Kantonsspital Graubünden: lead

Study Sites (1)

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

Location

MeSH Terms

Conditions

Urinary Retention

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Räto T. Strebel, PD Dr. med.

  Kantonsspital Graubünden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Urology

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 17, 2019
• Study Start: August 1, 2019
• Primary Completion: October 22, 2024
• Study Completion: March 4, 2025
• Last Updated: September 3, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)