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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamsulosin- intervention group | Experimental |
| |
| Placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Center- Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Banner University Medical Center- Tucson |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39265173 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamsulosin- Intervention Group | Tamsulosin arm: Participants will receive a single dose of 0.4mg oral Tamsulosin capsule in the pre-op bay 1-2 hours before surgery. |
| FG001 | Placebo Group | Placebo arm: Participants will receive a single dose of oral placebo capsule in the pre-op bay 1-2 hours before surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamsulosin- Intervention Group | Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay |
| BG001 | Placebo Group | Placebo arm: Participants will be given Placebo the pre-op bay. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | hours | 8 weeks |
|
8 weeks
Participation in this study involves minimal risk
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tamsulosin- Intervention Group | Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospital admission | Cardiac disorders | Systematic Assessment | Exacerbation of heart failure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martina Gabra | University of Arizona | 520-626-6636 | mgabra2@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 19, 2023 | Feb 2, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo | Drug | 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. |
|
| Tucson |
| Arizona |
| 85718 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Median | Inter-Quartile Range | kg/m^2 |
|
| Current smoker | Count of Participants | Participants |
|
| Parity | Mean | Inter-Quartile Range | Living births |
|
| Charston Comorbidity index | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | hours | 8 weeks |
|
|
|
| 0 |
| 81 |
| 2 |
| 81 |
| 4 |
| 81 |
| EG001 | Placebo Group | Placebo arm: Participants will be given Placebo the pre-op bay. | 0 | 80 | 1 | 80 | 3 | 80 |
|
| Vaginal cuff dehiscence | Reproductive system and breast disorders | Systematic Assessment | Vaginal cuff dehiscence |
|
| Pelvic abscess | Reproductive system and breast disorders | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | Systematic Assessment | Emergency room visit for gastritis |
|
| Kidney stone | Renal and urinary disorders | Systematic Assessment | Emergency room visit for kidney stones |
|
| vaginal bleeding | Reproductive system and breast disorders | Systematic Assessment | Emergency room visit for vaginal bleeding |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |