Tamsulosin for Urinary Retention

Overseen By AHN Clinical Trials Contact

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Must not be taking: Alpha antagonists

Disqualifiers: Severe dementia, End stage renal, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10 days

154 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of the study is to determine the effectiveness of postoperative Tamsulosin in reducing the duration of acute postoperative urinary retention (POUR) following pelvic reconstructive surgery through a double blind, randomized placebo-controlled trial.

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 currently using alpha antagonist medication for high blood pressure.

Is tamsulosin safe for humans?

Tamsulosin, also known by names like Flomax and Omnic, has been studied for many years and is generally considered safe for treating urinary issues. An 8-year study showed it significantly reduced the risk of acute urinary retention (difficulty urinating) compared to herbal treatments, with a low incidence of side effects. ^{1 2 3 4 5}

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

Tamsulosin is unique because it specifically targets the muscles in the prostate and bladder neck to improve urine flow, and it has been shown to significantly reduce the risk of acute urinary retention compared to herbal treatments. Additionally, Tamsulosin is available in a modified release form, which can improve its absorption and effectiveness. ^{1 2 5 6 7}

Research Team

Lindsay Turner, MD

Principal Investigator

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Eligibility Criteria

This trial is for adults who can consent, speak English, and swallow pills. They must have postoperative urinary retention after pelvic surgery but no history of it before surgery. Excluded are those with allergies to Tamsulosin or sulfa drugs, on alpha antagonists for high blood pressure, severe dementia, end-stage kidney/liver disease, or recent severe heart issues.

Inclusion Criteria

I have trouble urinating after surgery.

I can swallow pills.

I am 18 years old or older.

Exclusion Criteria

I have had issues with not being able to fully empty my bladder before surgery.

I have severe memory loss that affects my daily life.

I have end-stage kidney or liver disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to receive either Tamsulosin or placebo daily for up to 10 days or until resolution of postoperative urinary retention

10 days

Daily medication administration

Follow-up

Participants are monitored for urinary retention resolution, urinary tract infections, and quality of life

6 weeks

Follow-up visits at 2 weeks and 6 weeks

Treatment Details

Interventions

• Placebo
• Tamsulosin

Trial Overview The study aims to see if Tamsulosin helps reduce the time patients experience acute urinary retention after pelvic reconstructive surgery compared to a placebo. Participants will be randomly assigned to receive either Tamsulosin or a placebo in a double-blind setup where neither they nor the researchers know who gets what.

Participant Groups

Group I: Tamsulosin Experimental Treatment 1 Intervention

10 capsules will be distributed to subjects to be taken daily. Each capsule contains 0.4mg of Tamsulosin. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

Group II: Placebo Placebo Group 1 Intervention

10 capsules will be distributed to subjects to be taken daily. Subjects will take the capsule once daily until the end of the 10 day course or until the resolution of acute postoperative urinary retention. Both study drug and placebo will appear identical and will be prepared by the pharmacy.

Tamsulosin is already approved in European Union, United States, Canada, Japan, Switzerland for the following indications:

Approved in European Union as Flomax for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Approved in United States as Flomax for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Approved in Canada as Tamsulosin for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Approved in Japan as Tamsulosin for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Approved in Switzerland as Tamsulosin for:

• Benign prostatic hyperplasia
• Postoperative urinary retention

Who Is Running the Clinical Trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Lead Sponsor

Trials

52

Recruited

13,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Findings from Research

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 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 70 men with acute urinary retention due to benign prostatic hyperplasia, those treated with a double dose of alpha-blockers (tamsulosin + alfuzosin) had a significantly higher success rate in avoiding re-catheterization (77%) compared to those on a single dose of tamsulosin (54%).

The efficacy of the double dose therapy was also reflected in higher free-flow success rates (48% vs. 40%), while the safety profiles were similar between both treatment groups, indicating that double dose alpha-blockers are a safe and effective option for managing AUR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is the double dose alpha-blocker treatment superior than the single dose in the management of patients suffering from acute urinary retention caused by benign prostatic hyperplasia? Kara, O., Yazici, M.[2020]

In a study involving 116 men who underwent transurethral resection of the prostate (TURP), the addition of tamsulosin hydrochloride (TAM) or a combination of TAM and solifenacin succinate (SOL) did not significantly improve overall lower urinary tract symptoms compared to TURP alone during the early recovery period.

While there were some minor improvements in specific scores (like the IPSS storage and voiding scores) for the groups receiving TAM and SOL, these changes were not substantial enough to indicate a clear benefit over TURP alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tamsulosin hydrochloride 0.2 mg and combination of tamsulosin hydrochloride 0.2 mg plus solifenacin succinate 5 mg after transurethral resection of the prostate: a prospective, randomized controlled trial. Shin, YS., Zhang, LT., You, JH., et al.[2018]

Tamsulosin OCAS 0.4 mg effectively improves lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and maintains these benefits over the long term, making it a reliable treatment option.

Tamsulosin OCAS is better tolerated than the traditional tamsulosin MR formulation, with a comparable efficacy profile and a lower risk of cardiovascular side effects, suggesting it should be the preferred choice for symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Schulman, CC.[2019]

In a study of 150 patients with acute urinary retention due to benign prostatic hyperplasia, both alfuzosin and tamsulosin significantly improved the success rate of trial without catheter (TWOC) compared to placebo, with success rates of 66% and 70% respectively versus 36% for placebo.

Both alfuzosin and tamsulosin led to significant improvements in urinary symptoms and flow rates after three months, but tamsulosin was associated with a small but notable side effect of retrograde ejaculation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized study comparing alfuzosin and tamsulosin in the management of patients suffering from acute urinary retention caused by benign prostatic hyperplasia. Agrawal, MS., Yadav, A., Yadav, H., et al.[2021]

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]

References

1. 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]

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

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

3. Iran pubmed.ncbi.nlm.nih.gov

Is the double dose alpha-blocker treatment superior than the single dose in the management of patients suffering from acute urinary retention caused by benign prostatic hyperplasia? [2020]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of tamsulosin hydrochloride 0.2 mg and combination of tamsulosin hydrochloride 0.2 mg plus solifenacin succinate 5 mg after transurethral resection of the prostate: a prospective, randomized controlled trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Tamsulosin modified release and oral controlled absorption system in the management of lower urinary tract symptoms suggestive of benign prostatic hyperplasia. [2019]

6. India pubmed.ncbi.nlm.nih.gov

A prospective randomized study comparing alfuzosin and tamsulosin in the management of patients suffering from acute urinary retention caused by benign prostatic hyperplasia. [2021]

7. England pubmed.ncbi.nlm.nih.gov

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