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| ClinicalTrials.gov Identifier: NCT04232683 |
Recruitment Status : Active, not recruiting First Posted : January 18, 2020 Last Update Posted : October 6, 2022 |
Sponsor:
Information provided by [Responsible Party]:
Eric Hurtado, The Cleveland Clinic
Brief Summary:
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.
| Urinary Retention | Drug: Tamsulosin 0.4Mg Capsule Drug: Placebo oral tablet | Early Phase 1 |
Detailed Description:
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.
Layout table for study information| Study Type : | Interventional [Clinical Trial] |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single [Participant] |
| Primary Purpose: | Prevention |
| Official Title: | Preoperative Tamsulosin to Prevent Postoperative Urinary Retention in Females After Surgery For Pelvic Floor Disorders |
| Actual Study Start Date : | December 18, 2019 |
| Estimated Primary Completion Date : | February 11, 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
| Experimental: Preoperative Tamsulosin The study group will receive one oral dose .4mg of Tamsulosin prior to surgery. | Drug: Tamsulosin 0.4Mg Capsule Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased |
| Placebo Comparator: Preoperative Placebo The control group will receive one oral dose of placebo pill prior to surgery. | Drug: Placebo oral tablet Placebo pill given preoperatively Other Name: Preoperative Placebo |
Primary Outcome Measures :
- Tamsulosin Effect [ Time Frame: Up to 4 hours after surgery while patient is in post-anesthesia care unit. ]
Assess the effect of Tamsulosin in preventing POUR, defined by failure of initial voiding trial postoperatively.
Secondary Outcome Measures :
- Postoperative Narcotic Use [ Time Frame: Up to 4 hours after surgery while patient is in post-anesthesia care unit. ]
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]
- Effect of Tamsulosin on postoperative blood pressure [ Time Frame: Up to 4
hours after surgery while patient is in post-anesthesia care unit ]
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
Information from the National Library of Medicine
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier [NCT number]: NCT04232683
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| United States, Florida | |
| Cleveland Clinic Florida | |
| Weston, Florida, United States, 33331 |
The Cleveland Clinic
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| Responsible Party: | Eric Hurtado, Principal Investigator, The Cleveland Clinic |
| ClinicalTrials.gov Identifier: | NCT04232683 |
| Other Study ID Numbers: | FLA 19-073 |
| First Posted: | January 18, 2020 Key Record Dates |
| Last Update Posted: | October 6, 2022 |
| Last Verified: | October 2022 |
| Individual Participant Data [IPD] Sharing Statement: | |
| Plan to Share IPD: | No |
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| 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.: | Yes |
Keywords provided by Eric Hurtado, The Cleveland Clinic:
| Female Pelvic Floor Disorders Postoperative Urinary Retention Tamsulosin |
Additional relevant MeSH terms:
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| Urinary Retention Pelvic Floor Disorders Urination Disorders Urologic Diseases Pregnancy Complications Tamsulosin Adrenergic alpha-1 Receptor Antagonists | Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |