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

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.

Study Overview

• Status: Recruiting
• Conditions: Arthropathy of Knee; Arthropathy of Hip; Urinary Retention Postoperative
• Intervention / Treatment: Drug: Tamsulosin; Drug: Placebo Oral Tablet

Detailed Description

Study Category and rationale:

This study uses a well-known drug (tamsulosin) which is authorised in Switzerland and widely used to treat obstructive voiding problems. In our case the indication is different from that specified in the prescribing information, but it is within the same disease group, which in our case is to prevent urinary retention. Therefore according to the legal ordinance on clinical trials (ClinO), this study is classified as a clinical trial, research with collection of health-related personal data and placebo controlled of the category B.

Objective:

Our goal is to reduce the rate of postoperative urinary retention after lower limb arthroplasty. For this purpose, we plan to investigate whether an already known drug (Tamsulosin), which is widely used for bladder emptying disorders, could reduce the rate of postoperative urinary retention.

Outcomes:

The primary outcome is the occurrence of urinary retention during the 48 postoperative hours. The secondary outcome is the influence of other clinical factors on the occurrence of urinary retention as type of anaesthesia, preoperative residual volume, prostate size and international prostate symptom score (IPSS).

Measurement and procedures:

Once the decision for lower limb arthroplasty is made during the planned orthopaedic consultation, the patient will receive a participant information sheet and the informed consent. If the patient is interested to take part in the study he will receive an appointment in the urological clinic at least six days before the operation. During the appointment a urological specialist will explain the entire study. A uroflowmetry with sonographic measurement of residual volume and prostate volume will be performed. Furthermore, the patient will fill out an IPSS-questionnaire. After the appointment the drug/placebo will be handed out to the patient, which should be taken once a day five days prior to the operation, on the day of surgery and two days thereafter.

Study product:

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.

Control intervention:

Placebo.

Number of participants with rationale:

The number of participants projected for the entire study is 170. Thus 85 patients in the drug-treatment group and 85 patients for the placebo-treatment group.

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Räto T. Strebel, PD Dr. med.; Phone Number: +41 81 256 62 35; Email: raeto.strebel@ksgr.ch

Study Locations

• Switzerland
  • Graubünden
    • Chur, Graubünden, Switzerland, 7000
      • Recruiting
      • Kantonsspital Graubünden
      • Contact: Räto T Strebel, PD Dr. med.; Phone Number: +41812566237; Email: raeto.strebel@ksgr.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

- male adults undergoing elective hip- or knee arthroplasty

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tamsulosin; 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; The drug ist taken once a day per os five days prior to the operation and two days after the operation.; Other Names: Pradif
Placebo Comparator: Placebo Oral Tablet; 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; The placebo ist taken once a day per os five days prior to the operation and two days after the operation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of urinary retention	The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of anaesthesia	Did the patient undergo general anaesthesia, spinal anaesthesia or regional anaesthesia	48 hours postoperatively
Preoperative residual volume	Preoperatively the residual volume will be measured in milliliters (mL) by ultrasound.	Minimum 6 days before the planned operation.
Prostate size	Preoperatively the prostate volume will be measured in milliliters (mL) by ultrasound.	Minimum 6 days before the planned operation.
International prostate symptom score (IPSS).	The International Prostate Symptom Score (I-PSS) is based on the answers to seven questions concerning urinary symptoms and one question concerning quality of life. Each question concerning urinary symptoms allows the patient to choose one out of six answers indicating increasing severity of the particular symptom. The answers are assigned points from 0 to 5. The total score can therefore range from 0 to 35 (asymptomatic to very symptomatic).	Minimum 6 days before the planned operation.

Collaborators and Investigators

• Sponsor: Kantonsspital Graubünden
• Investigators: Principal Investigator: Räto T. Strebel, PD Dr. med., Kantonsspital Graubünden

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 17, 2019

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Urinary retention; Tamsulosin
• Additional Relevant MeSH Terms: Urologic Diseases; Musculoskeletal Diseases; Urination Disorders; Joint Diseases; Urinary Retention; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Tamsulosin
• Other Study ID Numbers: GR20192021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No