Urinary RetentionEarly Phase 1NCT04232683
Preoperative Tamsulosin to Prevent Postoperative Urinary Retention After Surgery For Pelvic Floor Disorders
A Early Phase 1 study testing Tamsulosin 0.4Mg Capsule in people with Urinary Retention, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Tamsulosin 0.4Mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2019to 11 Oct 2025
- Phase
- Early Phase 1
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient undergoing surgery for prolapse with or without mid-urethral sling procedure.
- Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings
Who cannot join
- Diagnosis of urinary retention preoperatively (post void residual >150ml)
- Malignancy
- History of neurological disease
- History of spinal cord injuries
- Allergy to Tamsulosin
- Perioperative complications requiring prolonged postoperative bladder drainage
- Incontinence procedures other than mid-urethral slings
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders
Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.
Read the detailed description
This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.
- Conditions
- Urinary Retention
- Being tested
- Tamsulosin 0.4Mg Capsule, Placebo oral tablet
- Keywords
- Female Pelvic Floor Disorders, Postoperative 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.
Tamsulosin 0.4Mg CapsuleDrug
Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased
Placebo oral tabletDrug
Also called Preoperative Placebo
Placebo pill given preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Preoperative Tamsulosin | Experimental | The study group will receive one oral dose .4mg of Tamsulosin prior to surgery. Receives: Drug: Tamsulosin 0.4Mg Capsule |
| Preoperative Placebo | Placebo comparator | The control group will receive one oral dose of placebo pill prior to surgery. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tamsulosin Effect
Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively.
Measured: Up to 4 hours after surgery while patient is in post-anesthesia care unit.
Secondary outcomes (2)
Postoperative Narcotic Use
Amount of postoperative narcotic use will be tracked to assess if increased narcotic use has an effect on postoperative voiding trial (The amount of narctoic use will be measured in milligrams)
Measured: Up to 4 hours after surgery while patient is in post-anesthesia care unit.
Effect of Tamsulosin on postoperative blood pressure
A side effect of Tamsulosin in hypotension, therefore, postoperative blood pressure will be evaluated to see if Tamsulosin had a significant impact on blood pressure
Measured: Up to 4 hours after surgery while patient is in post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start18 Dec 2019
- Primary completion11 Oct 2025
- Study completion11 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Hurtado, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232683
- Sponsor's protocol ID
- FLA 19-073
- Status last verified
- May 2026
- First submitted
- 8 Jan 2020
- Last updated
- 26 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders
- ClinicalTrials.gov ID
- NCT04232683
- Acronym / sponsor ID
- FLA 19-073
- Conditions
- Urinary Retention
- Keywords
- Female Pelvic Floor Disorders, Postoperative Urinary Retention, Tamsulosin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 11 Oct 2025 (actual)
- Study completion
- 11 Oct 2025 (actual)
- First posted
- 18 Jan 2020 (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.
Our hypothesis is that patients receiving preoperative Tamsulosin will have decrease rates of postoperative urinary retention (POUR) after surgery in females for pelvic floor disorders.
Detailed description
This study is a prospective randomized control trial. Patients undergoing pelvic surgery will randomized into two groups. The study group will receive one oral dose of .4mg of Tamsulosin preoperatively.The control group will receive one placebo pill preoperatively. Success or failure of initial voiding trial in postoperative period will be measured. Patients who fail the voiding trial will be discharged home with Foley catheter as is standard protocol at our institution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Tamsulosin | Experimental | Drug: Tamsulosin 0.4Mg CapsuleThe study group will receive one oral dose .4mg of Tamsulosin prior to surgery. |
| Preoperative Placebo | Placebo comparator | Drug: Placebo oral tabletThe control group will receive one oral dose of placebo pill prior to surgery. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing surgery for prolapse with or without mid-urethral sling procedure.
- Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings
Key exclusion criteria (7 listed)
- Diagnosis of urinary retention preoperatively (post void residual >150ml)
- Malignancy
- History of neurological disease
- History of spinal cord injuries
- Allergy to Tamsulosin
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 |
|---|---|---|
| Tamsulosin 0.4Mg CapsuleTamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased | Drug | Preoperative Tamsulosin |
| Placebo oral tabletAlso: Preoperative PlaceboPlacebo pill given preoperatively | Drug | Preoperative Placebo |
Primary outcome
Tamsulosin Effect
Time frame: Up to 4 hours after surgery while patient is in post-anesthesia care unit.
Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively.
2 secondary outcomes
Postoperative Narcotic Use
Time frame: Up to 4 hours after surgery while patient is in post-anesthesia care unit.
Effect of Tamsulosin on postoperative blood pressure
Time frame: Up to 4 hours after surgery while patient is in post-anesthesia care unit
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 26 May 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tamsulosin 0.4Mg Capsule in people with Urinary Retention, run by The Cleveland Clinic at 1 site in United States.
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 2 inclusion and 7 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 26 May 2026. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Tamsulosin Effect (time frame: Up to 4 hours after surgery while patient is in post-anesthesia care unit.). 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 26 May 2026.