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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Tamsulosin | Experimental | The study group will receive one oral dose .4mg of Tamsulosin prior to surgery. |
|
| Preoperative Placebo | Placebo Comparator | The control group will receive one oral dose of placebo pill prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin 0.4Mg Capsule | Drug | Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tamsulosin Effect | Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively. | Up to 4 hours after surgery while patient is in post-anesthesia care unit. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Up to 4 hours after surgery while patient is in post-anesthesia care unit. |
| Effect of Tamsulosin on postoperative blood pressure |
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Inclusion Criteria:
i. Patient undergoing surgery for prolapse with or without mid-urethral sling procedure.
ii. Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings
Exclusion Criteria:
i. Diagnosis of urinary retention preoperatively (post void residual >150ml)
ii. Malignancy
iii. History of neurological disease
iv. History of spinal cord injuries
v. Allergy to Tamsulosin
vi. Perioperative complications requiring prolonged postoperative bladder drainage
vii. Incontinence procedures other than mid-urethral slings
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Placebo oral tablet | Drug | Placebo pill given preoperatively |
|
|
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 |
| Up to 4 hours after surgery while patient is in post-anesthesia care unit |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |