Tamsulosin for Urinary Retention

Recruiting in Palo Alto (17 mi)

Overseen by Lindsay Turner, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Approved in 5 Jurisdictions

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}

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.

Trial 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 (Drug)
• Tamsulosin (Alpha-1 Adrenergic Receptor Antagonist)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

West Penn Hospital Pittsburgh, PA

Who Is Running the Clinical Trial?

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

Johns Hopkins University Collaborator

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] To compare the efficacy and safety of tamsulosin and alfuzosin in patients with acute urinary retention (AUR) secondary to benign prostatic hyperplasia (BPH).

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] This report introduces results of an 8-year study estimating the risk of acute urinary retention in patients with stage I prostatic adenoma. Patients were randomly assigned into two groups. The first group consisted of 331 men was regularly taking Omnic (tamsulosin) 0.4 mg 1 time daily for 8 years as a means of medical therapy. The second group consisted of 334 patients treated with herbal preparations (Gentos, Tadenan or Speman). In the case of acute urinary retention patients were taken to the urological department to release urine from the urinary bladder by catheterization or by the surgical procedure. The incidence of acute urinary retention in group 1 ranged from 0.3 to 1.2% per year and, for a total of 8 years of follow-up was 6.45%. In the second group, it ranged from 1.8 to 7.3% per year, making a total of 36.2%. Therefore, the risk of acute urinary retention in patients receiving Omnic (tamsulosin) was reduced by 5.6 times in comparison with the group of patients treated with herbal medications. Thus, the need for surgery decreased from 27.8 to 6.3%. According to the results of an 8-year long tamsulosin was found as a safe and highly effective means to reduce the risk of acute urinary retention.

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] To compare the efficacy and safety of single (tamsulosin) and double dose (tamsulosin + alfuzosin) alpha-blocker therapy for treating catheterized patients with acute urinary retention (AUR) due to benign prostatic hyperplasia (BPH).

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] The objective of this study was to evaluate the safety and efficacy of tamsulosin hydrochloride 0.2 mg (TAM) and its combination with solifenacin succinate 5 mg (SOL) after transurethral resection of the prostate (TURP).

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] Tamsulosin MR has been on the market for the treatment of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) for many years. Recently, tamsulosin OCAS was introduced, which has improved pharmacokinetics.

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] Objective : Prospective randomized study to compare the efficacy and safety of alfuzosin and tamsulosin in patients suffering from acute urinary retention caused by benign prostatic hyperplasia (BPH). Methods : Patients with acute urinary retention (AUR) due to BPH (total 150) were catheterized and randomized into three groups: Group A: alfuzosin 10 mg (50 patients), Group B: tamsulosin 0.4 mg (50 patients), Group C: placebo (50 patients). After three days, catheter was removed, and patients were put on trial without catheter (TWOC). Patients with successful TWOC were followed up for three months, taking into account the prostate symptom score (AUA Score), post-void residual urine volume (PVRV), and peak flow rate (PFR). ANOVA was used for statistical analysis. Results : Both group A (alfuzosin) and group B (tamsulosin) had similar results of TWOC (group A - 66%, group B - 70%), which were significantly superior than group C (placebo) - 36%. In follow up, three (9.1%) patients in group A, three (8.6%) patients in group B and eight (44.4%) patients in group C had retention of urine, requiring recatheterization. These patients were withdrawn from the study. After three months, alfuzosin- or tamsulosin-treated patients showed a significant decrease in AUA score and PVRV; and a significant increase in PFR as compared to placebo. Conclusions : TWOC was more successful in men treated with either alfuzosin or tamsulosin and the subsequent need for recatheterization was also reduced. Tamsulosin was comparable to alfuzosin in all respects, except a small but significant side effect of retrograde ejaculation.

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

Tamsulosin in the management of patients in acute urinary retention from benign prostatic hyperplasia. [2022] To evaluate the efficacy of tamsulosin compared to placebo for treating catheterized patients with acute urinary retention (AUR) caused by benign prostatic hyperplasia (BPH), by comparing the numbers of patients who voided successfully after removing their catheter.