Postoperative Urinary Retention (POUR)Phase 3NCT06843538
Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery
A Phase 3 study testing Tamsulosin in people with Postoperative Urinary Retention (POUR), run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Urinary Retention (POUR)
- 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
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 1 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing any pelvic organ prolapse repair or incontinence surgery
Who cannot join
- Any surgery involving a non-urogynecologist
- Patients already on an alpha blocker
- Baseline hypotension
- History of syncope
- Postural orthostatic tachycardia syndrome (POTS)
- Non-English speaker or interpreter unavailable for Spanish-speaking patient
Show all 11Show fewer
- Impaired cognition impeding proper consenting
- Any other medical contraindication for tamsulosin use
- History of urinary retention requiring continuous or intermittent catheterization
- Patients consented for the study but then due to intraoperative complication, routine voiding trial no longer indicated due to requiring indwelling catheter or intermittent catheterization on discharge will be excluded from primary outcome analysis
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
TriHealth
Cincinnati, Ohio, 45220
Jenny Hodge, RN, 513-862-2056, Jennifer_Hodge2@trihealth.com
Catrina Crisp, MD, MSc
About this study
Official title: Peri-operative Tamsulosin and Impact on Voiding Trial Following Outpatient Urogynecology Surgery: a Randomized Controlled Trial
The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).
- Conditions
- Postoperative Urinary Retention (POUR)
- Being tested
- Tamsulosin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Also called Flomax
This intervention will investigate if tamsulosin will decrease postoperative urinary retention. Subjects will be directed to start taking the medication 5-7 days prior to their procedure; as previous studies have shown, this is when tamsulosin reaches its steady state. Patients will continue to take their assigned pills for 7 days postoperatively.
PlaceboDrug
This intervention will ensure blinding and an accurate measure of the real effect of tamsulosin.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm | Active comparator | Not described Receives: Drug: Tamsulosin |
| Control Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Voiding trial on postoperative day 0
Whether or not patients pass or fail their postoperative voiding trial
Measured: Day of surgery
Secondary outcomes (2)
Secondary postoperative urinary retention
Patients who develop urinary retention after discharge
Measured: 2 weeks following surgery
Postoperative urinary tract infection
Patients who develop a urinary tract infection after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start3 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Urinary Retention (POUR)Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843538
- Sponsor's protocol ID
- 24-108
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Tamsulosin and Impact on Voiding Trial Following Outpatient Urogynecology Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06843538
- Acronym / sponsor ID
- 24-108
- Conditions
- Postoperative Urinary Retention (POUR)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 25 Feb 2025 (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.
The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Arm | Active comparator | Drug: Tamsulosin |
| Control Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing any pelvic organ prolapse repair or incontinence surgery
Key exclusion criteria (11 listed)
- Any surgery involving a non-urogynecologist
- Patients already on an alpha blocker
- Baseline hypotension
- History of syncope
- Postural orthostatic tachycardia syndrome (POTS)
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: FlomaxThis intervention will investigate if tamsulosin will decrease postoperative urinary retention. Subjects will be directed to start taking the medication 5-7 days prior to their procedure; as previous studies have shown, this is when tamsulosin reaches its steady state. Patients will continue to take their assigned pills for 7 days postoperatively. | Drug | Study Arm |
| PlaceboThis intervention will ensure blinding and an accurate measure of the real effect of tamsulosin. | Drug | Control Arm |
Primary outcome
Voiding trial on postoperative day 0
Time frame: Day of surgery
Whether or not patients pass or fail their postoperative voiding trial
2 secondary outcomes
Secondary postoperative urinary retention
Time frame: 2 weeks following surgery
Postoperative urinary tract infection
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin in people with Postoperative Urinary Retention (POUR), run by TriHealth Inc. 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 1 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 25 Feb 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 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gisele C Moran, MD, MPH (513-862-1123, gisele_moran@trihealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voiding trial on postoperative day 0 (time frame: Day of surgery). 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 25 Feb 2025.