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

Primary Purpose

Urinary Retention Postoperative, Arthropathy of Knee, Arthropathy of Hip

Status
Recruiting
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Tamsulosin
Placebo Oral Tablet
Sponsored by
Kantonsspital Graubünden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Retention Postoperative focused on measuring Urinary retention, Tamsulosin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Kantonsspital GraubündenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Tamsulosin

Placebo Oral Tablet

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Type of anaesthesia
Did the patient undergo general anaesthesia, spinal anaesthesia or regional anaesthesia
Preoperative residual volume
Preoperatively the residual volume will be measured in milliliters (mL) by ultrasound.
Prostate size
Preoperatively the prostate volume will be measured in milliliters (mL) by ultrasound.
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).

Full Information

First Posted
January 15, 2019
Last Updated
March 8, 2023
Sponsor
Kantonsspital Graubünden
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1. Study Identification

Unique Protocol Identification Number
NCT03808155
Brief Title
Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty
Official Title
Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Graubünden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention Postoperative, Arthropathy of Knee, Arthropathy of Hip
Keywords
Urinary retention, Tamsulosin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind.
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tamsulosin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Oral Tablet
Arm Type
Placebo Comparator
Arm Description
The placebo is taken once a day per os five days prior to the operation and two days after the operation.
Intervention Type
Drug
Intervention Name(s)
Tamsulosin
Other Intervention Name(s)
Pradif
Intervention Description
The drug ist taken once a day per os five days prior to the operation and two days after the operation.
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
The placebo ist taken once a day per os five days prior to the operation and two days after the operation.
Primary Outcome Measure Information:
Title
Occurrence of urinary retention
Description
The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.
Time Frame
48 hours postoperatively
Secondary Outcome Measure Information:
Title
Type of anaesthesia
Description
Did the patient undergo general anaesthesia, spinal anaesthesia or regional anaesthesia
Time Frame
48 hours postoperatively
Title
Preoperative residual volume
Description
Preoperatively the residual volume will be measured in milliliters (mL) by ultrasound.
Time Frame
Minimum 6 days before the planned operation.
Title
Prostate size
Description
Preoperatively the prostate volume will be measured in milliliters (mL) by ultrasound.
Time Frame
Minimum 6 days before the planned operation.
Title
International prostate symptom score (IPSS).
Description
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).
Time Frame
Minimum 6 days before the planned operation.

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
The participant has to be a genectic male with all male organs.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Räto T. Strebel, PD Dr. med.
Phone
+41 81 256 62 35
Email
raeto.strebel@ksgr.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Räto T. Strebel, PD Dr. med.
Organizational Affiliation
Kantonsspital Graubünden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Graubünden
City
Chur
State/Province
Graubünden
ZIP/Postal Code
7000
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Räto T Strebel, PD Dr. med.
Phone
+41812566237
Email
raeto.strebel@ksgr.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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

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