Tamsulosin for Urinary Retention

Overseen By Gisele C Moran, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: TriHealth Inc.

Must not be taking: Alpha blockers

Disqualifiers: Hypotension, Syncope, POTS, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

166 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether taking tamsulosin before surgery can reduce the need for a catheter after surgery. It targets individuals undergoing surgery for pelvic organ problems or incontinence. Ideal candidates are those not currently taking specific medications for blood pressure or heart issues. Participants will receive either tamsulosin or a placebo (a harmless pill with no active medicine) to determine which is more effective. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking an alpha blocker.

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

Research has shown that tamsulosin is generally safe to use. One study using real-world data from the FDA found that tamsulosin has a good safety record. Another study involving male veterans undergoing major colorectal surgery also found that tamsulosin use resulted in few serious side effects.

Tamsulosin was tested for six months and demonstrated a safety profile similar to a placebo, which contains no active drug. Long-term studies, lasting up to six years, have also shown that tamsulosin is safe and well-tolerated. Overall, these findings suggest that tamsulosin is well-tolerated, with few reports of serious side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Tamsulosin is unique because it specifically targets the smooth muscles in the prostate and bladder neck, helping to relax them and ease urinary retention. Unlike other treatments such as catheterization or more invasive procedures, Tamsulosin offers a non-surgical, medication-based approach that can potentially improve symptoms without the need for interventions that might be uncomfortable or carry more risks. Researchers are excited about Tamsulosin because it may provide a faster and less intrusive solution compared to traditional methods, potentially improving patient quality of life with fewer side effects.

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

Research has shown that tamsulosin, which participants in this trial may receive, can reduce the need for a catheter after surgery. Studies indicate that taking tamsulosin around the time of surgery lowers the risk of urinary retention, a condition where the bladder cannot be emptied. In one study, only 4.7% of patients who took tamsulosin experienced urinary retention, compared to 9.2% who did not take it. Another study found that using tamsulosin immediately after certain surgeries decreased the chances of needing a catheter. Overall, these findings suggest that tamsulosin can smooth recovery by aiding urination after surgery. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals scheduled for same-day urogynecology surgery who are at risk of urinary retention post-operation. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.

Inclusion Criteria

I am having surgery for pelvic organ prolapse or incontinence.

Exclusion Criteria

Non-English speaker or interpreter unavailable for Spanish-speaking patient

Pregnancy

I have a history of fainting.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Treatment

Participants receive tamsulosin preoperatively to assess its impact on postoperative voiding

1 day

Postoperative Assessment

Participants undergo a voiding trial on the day of surgery to determine if they can be discharged without a Foley catheter

Day of surgery

Follow-up

Participants are monitored for secondary postoperative urinary retention and urinary tract infections

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tamsulosin

Trial Overview

The study is testing whether taking tamsulosin before surgery can reduce the need for a Foley catheter after surgery. Participants will be randomly given either tamsulosin or a placebo to assess the drug's effectiveness in preventing urinary retention.

How Is the Trial Designed?

Group I: Study Arm Active Control 1 Intervention

Group II: Control Arm Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

TriHealth Inc.

Lead Sponsor

Trials

103

Recruited

54,100+

Published Research Related to This Trial

In a study of 149 men with acute urinary retention (AUR) due to benign prostatic hyperplasia (BPH), those treated with tamsulosin were significantly more likely to successfully void after catheter removal compared to those receiving a placebo (48% vs 26%).

The side effects of tamsulosin were similar to those of the placebo, indicating a favorable safety profile, which supports its use in reducing the need for re-catheterization in men with AUR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia. Lucas, MG., Stephenson, TP., Nargund, V.[2022]

A study of 185 men undergoing pelvic surgery found that preemptive use of tamsulosin significantly reduced urinary retention rates from 25% in the control group to 6.7% in the tamsulosin group, indicating its efficacy in preventing this complication.

The research suggests that using tamsulosin before and after surgery can be particularly beneficial for patients with distal rectal cancer, as it was identified as a strong predictor of urinary retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. Poylin, V., Curran, T., Cataldo, T., et al.[2018]

In an 8-year study involving 665 men with stage I prostatic adenoma, those treated with tamsulosin (Omnic) had a significantly lower incidence of acute urinary retention (6.45%) compared to those using herbal preparations (36.2%).

Tamsulosin not only reduced the risk of acute urinary retention by 5.6 times but also decreased the need for surgical intervention from 27.8% to 6.3%, demonstrating its safety and efficacy as a long-term treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[INCIDENCE OF ACUTE URINARY RETENTION IN PATIENTS WITH PROSTATIC ADENOMA AND 8-YEAR LONG TAMSULOSIN THERAPY]. Davidov, MI., Lokshin, KL., Gorbunova, IS.[2018]

In a study of 90 men with acute urinary retention due to benign prostatic hyperplasia, tamsulosin showed a slightly higher success rate in catheter removal (43.2%) compared to alfuzosin (35.2%) and placebo (26.3%), although these differences were not statistically significant.

Both tamsulosin and alfuzosin were found to be equally effective in facilitating successful trial without catheter (TWOC), suggesting that the choice between these two medications may not significantly impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study on the use of tamsulosin versus alfuzosin in spontaneous micturition recovery after transurethral catheter removal in patients with benign prostatic growth. Maldonado-Ávila, M., Manzanilla-García, HA., Sierra-Ramírez, JA., et al.[2021]

In a study of 169 males undergoing laparoscopic inguinal hernia repairs, the overall rate of postoperative urinary retention (POUR) was found to be 9%, with no significant difference between those receiving tamsulosin (7.9%) and those receiving a placebo (9.9%).

While tamsulosin did not significantly reduce the incidence of POUR, it was associated with a quicker discharge time, reducing it by 4 to 68 minutes compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of tamsulosin to prevent postoperative urinary retention in laparoscopic inguinal hernia repair: a randomized double-blind placebo-controlled study. Caparelli, ML., Shikhman, A., Runyan, B., et al.[2021]

In a study of 160 patients with acute urinary retention due to benign prostatic hyperplasia, both tamsulosin and silodosin were found to be similarly effective for trial without catheter, with success rates of 67.5% and 60%, respectively.

While tamsulosin showed a slightly higher efficacy for trial without catheter, there were no significant differences in patient outcomes measured by the international prostate symptom score (IPSS), post void residual volume (PVR), and peak flow rate (PFR) between the two medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of tamsulosin and silodosin in the management of acute urinary retention secondary to benign prostatic hyperplasia in patients planned for trial without catheter. A prospective randomized study. Patil, SB., Ranka, K., Kundargi, VS., et al.[2022]

In a study of 33 men with acute urinary retention (AUR), treatment with tamsulosin significantly helped 88% of participants to void successfully after temporary catheter drainage, suggesting its efficacy in managing AUR.

After 3 months, 27% of the men required further interventions like surgery, indicating that while tamsulosin is beneficial, some patients may still need additional treatment based on their initial symptom severity and postvoid residual volume.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of treatment with tamsulosin in men with acute urinary retention. Kim, HL., Kim, JC., Benson, DA., et al.[2019]

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