Urinary Retention PostoperativePhase 4NCT03808155
Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty
A Phase 4 study testing Tamsulosin in people with Urinary Retention Postoperative and Arthropathy of Knee, run by Kantonsspital Graubünden at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention Postoperative, Arthropathy of Knee, Arthropathy of Hip
- What is being tested?
- Tamsulosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2019to 4 Mar 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male adults undergoing elective hip- or knee arthroplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Tamsulosin, Placebo Oral Tablet
- Keywords
- Urinary retention, Tamsulosin
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Pradif
The drug ist taken once a day per os five days prior to the operation and two days after the operation.
Placebo Oral TabletDrug
The placebo ist taken once a day per os five days prior to the operation and two days after the operation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of urinary retention
The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.
Measured: 48 hours postoperatively
Secondary outcomes (4)
Type of anaesthesia
Did the patient undergo general anaesthesia, spinal anaesthesia or regional anaesthesia
Measured: 48 hours postoperatively
Preoperative residual volume
Preoperatively the residual volume will be measured in milliliters (mL) by ultrasound.
Measured: Minimum 6 days before the planned operation.
Prostate size
Preoperatively the prostate volume will be measured in milliliters (mL) by ultrasound.
Measured: 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).
Measured: Minimum 6 days before the planned operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Aug 2019
- Primary completion22 Oct 2024
- Study completion4 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Retention PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Graubünden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med. Räto T. Strebel, Kantonsspital Graubünden
- Investigators
- Räto T. Strebel, PD Dr. med., Principal investigator, Kantonsspital Graubünden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808155
- Sponsor's protocol ID
- GR20192021
- Status last verified
- Oct 2024
- First submitted
- 15 Jan 2019
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty
- ClinicalTrials.gov ID
- NCT03808155
- Acronym / sponsor ID
- GR20192021
- Keywords
- Urinary retention, Tamsulosin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Kantonsspital GraubündenUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 17 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamsulosin | Active comparator | Drug: TamsulosinThe 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. |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletThe placebo is taken once a day per os five days prior to the operation and two days after the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male adults undergoing elective hip- or knee arthroplasty
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinAlso: PradifThe drug ist taken once a day per os five days prior to the operation and two days after the operation. | Drug | Tamsulosin |
| Placebo Oral TabletThe placebo ist taken once a day per os five days prior to the operation and two days after the operation. | Drug | Placebo Oral Tablet |
Primary outcome
Occurrence of urinary retention
Time frame: 48 hours postoperatively
The primary outcome is the occurrence of urinary retention during the 48 postoperative hours.
4 secondary outcomes
Type of anaesthesia
Time frame: 48 hours postoperatively
Preoperative residual volume
Time frame: Minimum 6 days before the planned operation.
Prostate size
Time frame: Minimum 6 days before the planned operation.
International prostate symptom score (IPSS).
Time frame: Minimum 6 days before the planned operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Urinary Retention Postoperative
Not yet recruitingPhase 4
Ceasing Alpha-blockers Early After Resection of the Prostate (The CLEAR Trial)
Benign Prostatic Hyperplasia
Recruiting
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
Urinary Catheters, Rectal Cancer
RecruitingPhase 3
Prophylactic Use of Tamsulosin in the Prevention of Post-operative Urinary Retention in Men After Rectum Resection
Urinary Retention, Colorectal Surgery
RecruitingEarly Phase 1
Post Operative Urinary Retention (POUR) Following Thoracic Oncological Surgery
Urinary Retention
Recruiting
Electroacupuncture on Postoperative Urinary Retention After Radical Surgery for Cervical Cancer
Postoperative Urinary Retention (POUR)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Räto T. Strebel, PD Dr. med. principal investigator
Kantonsspital Graubünden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tamsulosin in people with Urinary Retention Postoperative and Arthropathy of Knee, run by Kantonsspital Graubünden at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of urinary retention (time frame: 48 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.