Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Sponsor
University of Arizona (Other)
Overall Status
Recruiting
CT.gov ID
NCT04859660
Collaborator
(none)
200
2
2
20.5
100
4.9
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial
Actual Study Start Date
:
Apr 16, 2021
Anticipated Primary Completion Date
:
Dec 30, 2022
Anticipated Study Completion Date
:
Dec 30, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tamsulosin- intervention group
|
Drug: Tamsulosin
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.
|
| Placebo Comparator: Placebo group
|
Drug: Placebo
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.
|
Outcome Measures
Primary Outcome Measures
- Time to spontaneous void [8 weeks]
Secondary Outcome Measures
- Time to discharge from the hospital [8 weeks]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Women 18-80 undergoing outpatient minimally invasive hysterectomy
Exclusion Criteria:
-
Inability to provide informed consent
-
Bladder malignancy
-
Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization
-
Plan for sling or anterior repair
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner University Medical Center- Phoenix | Phoenix | Arizona | United States | 85006 |
| 2 | Banner University Medical Center- Tucson | Tucson | Arizona | United States | 85718 |
Sponsors and Collaborators
- University of Arizona
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University of Arizona
ClinicalTrials.gov Identifier:
NCT04859660
Other Study ID Numbers:
- 2102483026
First Posted:
Apr 26, 2021
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms: