Tamsulosin for Urinary Retention After Pelvic Surgery

Overseen By Eric Hurtado

Age: Any Age

Sex: Female

Trial Phase: Phase < 1

Sponsor: The Cleveland Clinic

Disqualifiers: Urinary retention, Malignancy, Neurological, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether taking Tamsulosin before surgery can reduce urinary retention (difficulty peeing) after pelvic surgeries for conditions like prolapse. Participants will receive either Tamsulosin (a medication) or a placebo (a harmless pill with no medicine) before their surgery. This trial targets women undergoing certain pelvic surgeries, such as vaginal or laparoscopic procedures, who do not already have trouble urinating. As an Early Phase 1 trial, the research aims to understand how Tamsulosin works in people, offering participants the opportunity to contribute to groundbreaking medical research.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that Tamsulosin is likely to be safe for humans?

Research has shown that Tamsulosin is generally safe for people. Studies with male veterans undergoing major surgeries found that Tamsulosin was well-tolerated, with no major safety issues reported. Another study found that taking Tamsulosin before surgery lowered the risk of urinary retention without significant side effects.

This trial is in an early stage, primarily to assess the safety of Tamsulosin for this new use. The FDA has already approved Tamsulosin for a different condition, indicating its well-established safety. However, as with any treatment, individual reactions can vary, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Tamsulosin for urinary retention after pelvic surgery because it offers a targeted approach. Unlike standard treatments that might involve catheterization or more invasive procedures, Tamsulosin works by relaxing the muscles in the prostate and bladder neck, making it easier to urinate. This medication could potentially reduce the need for catheters and improve patient comfort and recovery time. The hope is that by administering this drug preoperatively, the risk of postoperative urinary retention can be minimized, making recovery smoother and less complicated for patients.

What evidence suggests that Tamsulosin might be an effective treatment for postoperative urinary retention?

Research has shown that Tamsulosin, which participants in this trial may receive, can reduce the risk of urinary problems after surgery. One study found that patients taking Tamsulosin had an 8.8% chance of experiencing these issues, compared to 25.8% for those on a placebo (a pill with no active medicine). Another study reported similar results, with Tamsulosin users having an 8.7% chance of problems, while the placebo group had a 24.6% chance. These findings suggest that Tamsulosin may be particularly helpful for surgeries involving the pelvic area. However, evidence indicates that a single dose might not be as effective for all types of pelvic surgeries. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have had surgery for pelvic organ prolapse or incontinence.

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

Exclusion Criteria

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

I have been diagnosed with urinary retention before surgery.

I have been diagnosed with cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative

Participants receive one oral dose of Tamsulosin or placebo prior to surgery

1 day

Postoperative

Participants undergo a voiding trial to assess urinary retention and are monitored for narcotic use and blood pressure

Up to 4 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo oral tablet
• Tamsulosin 0.4Mg Capsule

Trial Overview 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.

How Is the Trial Designed?

Group I: Preoperative Tamsulosin Experimental Treatment 1 Intervention

The study group will receive one oral dose .4mg of Tamsulosin prior to surgery.

Group II: Preoperative Placebo Placebo Group 1 Intervention

The control group will receive one oral dose of placebo pill prior to surgery.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33894146/

Tamsulosin vs placebo to prevent postoperative urinary ... Tamsulosin was associated with a lower rate of postoperative urinary retention than placebo (5 patients [8.8%] vs 16 patients [25.8%]; odds ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05753670

Effect of Preoperative Tamsulosin on Postoperative Urinary ... Previous studies have demonstrated a postoperative urinary retention rate decrease of 65-88% after various tamsulosin protocols. However, the effect of single ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553465020304544

Tamsulosin to Prevent Urinary Retention Following Female ... Tamsulosin users had a significantly lower rate of urinary retention compared to placebo (8.7% vs 24.6%, p=0.03). Postoperative urinary tract infection and ...

4. link.springer.com link.springer.com/article/10.1007/s00192-025-06120-2

Effect of Preoperative Tamsulosin on Postoperative Urinary ... These results suggest that single-dose preoperative tamsulosin might not have an effect on postoperative urinary retention after MUS placement.

5. ajog.org ajog.org/article/S0002-9378(24)00207-2/pdf

Tamsulosin for prevention of postoperative urinary ... use was associated with decreased rates of postoperative urinary retention in women undergoing vaginal surgery for pelvic organ prolapse after adjusting for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36445826/

Tamsulosin for prevention of postoperative urinary retention Conclusion: Administration of tamsulosin before and/or after surgery significantly reduced the risk of POUR and improved maximum urinary flow ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02486653

Prevention of Post-operative Urinary Retention (POUR) The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery.

8. journals.lww.com journals.lww.com/aosopen/fulltext/2024/12000/evaluating_the_safety_of_empiric_tamsulosin_to.17.aspx

Evaluating the Safety of Empiric Tamsulosin to Prevent... The purpose of this study was to evaluate the safety of empiric tamsulosin in male veterans undergoing major colorectal surgery.

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961024006792

Does prophylactic tamsulosin use with ERAS protocol ... The urinary retention rate was notably lower in patients who received tamsulosin during hospitalization (9.2 ​% vs. 4.7 ​%, p ​= ​0.01).

10. ajog.org ajog.org/article/S0002-9378(24)00207-2/fulltext

Tamsulosin for prevention of postoperative urinary ... In this retrospective study, preoperative tamsulosin use was associated with decreased rates of postoperative urinary retention in women undergoing vaginal ...