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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Tamsulosin, a medication for urinary issues, can reduce the time needed to overcome urinary retention after pelvic surgery. Urinary retention refers to difficulty urinating post-surgery, which can be uncomfortable and inconvenient. Participants will receive either Tamsulosin or a placebo (a pill with no active medicine) once daily for up to 10 days. The trial seeks individuals who have experienced urinary retention after surgery and can comfortably take pills. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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

Research has shown that Tamsulosin is generally safe and well-tolerated. Studies have found that Tamsulosin can lower the risk of urinary retention after surgery. For instance, one study showed that only about 9% of patients taking Tamsulosin experienced urinary retention issues, compared to about 26% of those taking a placebo.

Tamsulosin is already approved by the FDA for treating other urinary problems in men, indicating its safety for general use. Most side effects are mild and may include dizziness or a slight drop in blood pressure, especially when standing up quickly. Overall, the evidence supports Tamsulosin as a safe option for people experiencing urinary retention after surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for urinary retention?

Tamsulosin is unique because it targets urinary retention by relaxing the muscles in the bladder and prostate, which can help improve urine flow and reduce retention. Unlike other treatments that might focus on catheterization or more invasive procedures, Tamsulosin offers a non-invasive, oral medication option. Researchers are excited because it has the potential to quickly resolve acute postoperative urinary retention in just a matter of days, making recovery smoother and more comfortable for patients.

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 lower the risk of urination difficulties after surgery. Studies indicate that tamsulosin reduces the need for a catheter (a tube to assist with urination) following pelvic surgery. While tamsulosin effectively prevents these issues, its effectiveness in treating existing problems remains less certain. However, early results suggest promise for its use in easing urinary issues post-surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Lindsay Turner, MD

Principal Investigator

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

Are You a Good Fit for This Trial?

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.

Willing and able to provide informed consent

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24642148/

Effectiveness of tamsulosin in prevention of post-operative ... This study suggests that short perioperative treatment with tamsulosin can reduce the incidence of urinary retention and the need for catheterization.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405857223001286

Preoperative tamsulosin effect on postoperative urinary ... Conclusion. Tamsulosin may be effective in preventing postoperative urinary retention (POUR), but its effectiveness in treating established POUR is uncertain.

3. 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.

4. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2022.930707/full

Prophylactic tamsulosin can reduce the risk of urinary ... Prophylactic tamsulosin can reduce the risk of urinary retention after surgery in male patients: A systematic review and meta-analysis.

5. icurology.org icurology.org/DOIx.php?id=10.4111/icu.20200523

Preventive effects of tamsulosin for postoperative urinary ... Tamsulosin administration immediately after lower limb arthroplasty reduced the incidence of urinary retention and diminished the need for long- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11661766/

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.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10389420/

Can prophylactic tamsulosin reduce the risk of urinary ... The current meta-analysis suggested that prophylactic tamsulosin contributed to the prevention of postoperative urinary retention. Younger ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05657990?term=AREA%5BConditionSearch%5D(%22Urinary%20Retention%22)&rank=9

Post Operative Urinary Retention (POUR) Following ... This is a feasibility study looking at whether the use of Tamsulosin could lower the high incidence of postoperative urinary retention (POUR) in older men ...

9. ajog.org ajog.org/article/S0002-9378(21)00466-X/abstract

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 ...