Urinary Retention PostoperativePhase 2NCT04859660
Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
A Phase 2 study testing Tamsulosin in people with Urinary Retention Postoperative, run by University of Arizona at 2 sites in United States.
Trial summary
The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Urinary Retention Postoperative
- What is being tested?
- Tamsulosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2021to 24 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18-80 undergoing outpatient minimally invasive hysterectomy
Who cannot join
- Inability to provide informed consent
- Bladder malignancy
- Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization
- Plan for sling or anterior repair
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Banner University Medical Center- Phoenix
Phoenix, Arizona, 85006
Banner University Medical Center- Tucson
Tucson, Arizona, 85718
About this study
Official title: Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial
The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.
- Conditions
- Urinary Retention Postoperative
- Being tested
- Tamsulosin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.
PlaceboDrug
Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Tamsulosin- intervention group | Experimental | Not described Receives: Drug: Tamsulosin |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Spontaneous Void
Each participant underwent a void trial post-operatively by backfilling their bladder with 200cc normal saline at the conclusion of the case and removing the foley. Patients needed to void at least 100cc to be considered to have "passed" their void trial.
Measured: 8 weeks
Secondary outcomes (1)
Time to Discharge From the Post-anesthesia Care Unit
The time from the patient leaving the OR to the time they were discharged home from the Post-anesthesia care unit was recorded to determine the Time to discharge.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start16 Apr 2021
- Primary completion24 Jun 2023
- Study completion24 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Retention PostoperativeStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859660
- Sponsor's protocol ID
- 2102483026
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2021
- Last updated
- 29 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gabra M, Hall C, McCann L, Shah J, Jones I, Masjedi A, Runke S, Hsu CH, Aguirre A. Tamsulosin and Time to Spontaneous Void After Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2024 Dec 1;144(6):810-816. doi: 10.1097/AOG.0000000000005724. Epub 2024 Sep 12.
PubMed 39265173
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04859660
- Acronym / sponsor ID
- 2102483026
- Conditions
- Urinary Retention Postoperative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 24 Jun 2023 (actual)
- Study completion
- 24 Jun 2023 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Posted 29 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.
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 |
|---|---|---|
| Tamsulosin- intervention group | Experimental | Drug: Tamsulosin |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women 18-80 undergoing outpatient minimally invasive hysterectomy
Key exclusion criteria (4 listed)
- Inability to provide informed consent
- Bladder malignancy
- Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization
- Plan for sling or anterior repair
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 |
|---|---|---|
| TamsulosinParticipants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded. | Drug | Tamsulosin- intervention group |
| PlaceboParticipants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded. | Drug | Placebo group |
Primary outcome
Time to Spontaneous Void
Time frame: 8 weeks
Each participant underwent a void trial post-operatively by backfilling their bladder with 200cc normal saline at the conclusion of the case and removing the foley. Patients needed to void at least 100cc to be considered to have "passed" their void trial.
1 secondary outcome
Time to Discharge From the Post-anesthesia Care Unit
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39265173Gabra M, Hall C, McCann L, Shah J, Jones I, Masjedi A, Runke S, Hsu CH, Aguirre A. Tamsulosin and Time to Spontaneous Void After Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2024 Dec 1;144(6):810-816. doi: 10.1097/AOG.0000000000005724. Epub 2024 Sep 12.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamsulosin in people with Urinary Retention Postoperative, run by University of Arizona at 2 sites 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 4 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 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Time to Spontaneous Void (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859660, which also lists 1 linked publication.
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 29 Feb 2024.