Tamsulosin for Urinary Retention After Pelvic Surgery

Phase < 1

Waitlist Available

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Specific surgical procedures include all vaginal, laparoscopic and robotic reconstructive or obliterative surgeries including the use of mid-urethral slings

Patient undergoing surgery for prolapse with or without mid-urethral sling procedure

Must not have

Perioperative complications requiring prolonged postoperative bladder drainage

Diagnosis of urinary retention preoperatively (post void residual >150ml)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 hours after surgery while patient is in post-anesthesia care unit

Summary

This trial will test whether the drug Tamsulosin can reduce the rates of POUR in female patients after surgery for pelvic floor disorders.

Who is the study for?

This trial is for female patients undergoing surgery for pelvic floor disorders, including various vaginal, laparoscopic, and robotic surgeries. Candidates must not have preoperative urinary retention, cancer, neurological diseases or spinal cord injuries. They also can't be allergic to Tamsulosin or need long-term post-surgery bladder drainage.

What is being tested?

The study tests if taking Tamsulosin before surgery reduces the chances of having difficulty urinating after pelvic floor disorder surgery. Participants will either receive Tamsulosin or a placebo tablet without knowing which one they are getting.

What are the potential side effects?

Tamsulosin may cause dizziness, headache, sleepiness, nausea, low blood pressure upon standing up (which can make you feel faint), and in rare cases a painful erection that won’t go away.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery for pelvic organ prolapse or incontinence.

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I am having surgery for prolapse, possibly with a sling procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I needed long-term bladder support after surgery due to complications.

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I have been diagnosed with urinary retention before surgery.

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I have been diagnosed with cancer.

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I have a history of neurological disease.

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I have had a spinal cord injury in the past.

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I have had incontinence treatment that wasn't a mid-urethral sling.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 hours after surgery while patient is in post-anesthesia care unit.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 hours after surgery while patient is in post-anesthesia care unit.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 hours after surgery while patient is in post-anesthesia care unit. for reporting.