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: 0

166 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).

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.

What data supports the effectiveness of the drug Tamsulosin for urinary retention?

Research shows that Tamsulosin helps men with urinary retention due to an enlarged prostate by relaxing bladder muscles, making it easier to urinate. In one study, men taking Tamsulosin had a much lower risk of needing surgery for urinary retention compared to those using herbal treatments. ^{1 2 3 4 5}

Is tamsulosin safe for treating urinary retention?

Tamsulosin has been found to be safe for long-term use, as shown in an 8-year study where it significantly reduced the risk of acute urinary retention compared to herbal treatments. It is generally well-tolerated and helps in reducing the need for surgery in patients with urinary retention. ^{1 2 3 5 6}

How does the drug Tamsulosin differ from other treatments for urinary retention?

Tamsulosin is unique because it is an alpha blocker that works by relaxing the muscles in the bladder neck, making it easier to urinate. It is particularly effective in reducing the risk of acute urinary retention in men with benign prostatic hyperplasia (BPH) and is used preemptively to prevent urinary retention after surgeries, unlike herbal treatments or other medications that may not specifically target muscle relaxation in the bladder. ^{1 3 5 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia. [2022]

2. Netherlands 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. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Results of treatment with tamsulosin in men with acute urinary retention. [2019]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[INCIDENCE OF ACUTE URINARY RETENTION IN PATIENTS WITH PROSTATIC ADENOMA AND 8-YEAR LONG TAMSULOSIN THERAPY]. [2018]

6. Poland 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. [2022]

7. Germany 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. [2021]