Tamsulosin for Urinary Retention

No longer recruiting at 1 trial location

Overseen By M Gabra, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Arizona

Disqualifiers: Bladder malignancy, Ureteral injury, 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: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a single dose of tamsulosin, administered before surgery, can help women urinate sooner and leave the hospital faster after a minimally invasive hysterectomy. Tamsulosin typically treats urinary issues, and researchers aim to determine if it can speed up recovery after this surgery. Participants will receive either tamsulosin or a placebo (a harmless pill with no active ingredients) to compare effects. Women planning to undergo this specific hysterectomy and without certain bladder issues might be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tamsulosin is generally safe for use. In a study with 1,783 patients taking tamsulosin, participants tolerated it well. Common side effects include dizziness, headaches, and ejaculation problems. Serious allergic reactions are rare but possible. The FDA has approved tamsulosin for treating an enlarged prostate, supporting its safety for other conditions.

While some side effects require attention, many people have used tamsulosin safely. It is important to consult a doctor about any concerns, especially if other health conditions or medications are involved. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard methods for managing post-hysterectomy urinary retention, which often involve catheterization, Tamsulosin offers a unique approach by targeting the muscles in the urinary tract. Tamsulosin works as an alpha-blocker, relaxing the bladder neck and prostate muscles to potentially facilitate quicker spontaneous voiding. Researchers are excited about Tamsulosin because it could reduce recovery times and the need for additional interventions, making the post-surgery experience smoother and more comfortable for patients.

What evidence suggests that tamsulosin might be an effective treatment for reducing time to void and discharge after minimally invasive hysterectomy?

Research shows that tamsulosin, which participants in this trial may receive, can improve urine flow. In past studies with individuals experiencing urinary issues, 80.7% responded positively after six years of using the medication. Tamsulosin primarily treats an enlarged prostate by relaxing the muscles in the prostate and bladder neck, facilitating urination. The drug is generally safe, with uncommon side effects such as dizziness. Although researchers are still studying its use for reducing the time it takes to urinate after a hysterectomy, its known effects on urinary muscles suggest potential benefits in this situation as well. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

Women 18-80 undergoing outpatient minimally invasive hysterectomy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative

Participants receive a one-time dose of tamsulosin before minimally invasive hysterectomy

1 day

Post-operative

Participants undergo a void trial post-operatively to assess time to spontaneous void

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tamsulosin

How Is the Trial Designed?

Group I: Tamsulosin- intervention group Experimental Treatment 1 Intervention

Group II: Placebo group Placebo Group 1 Intervention

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?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Published Research Related to This Trial

Elderly patients with renal failure taking dabigatran are at a higher risk of bleeding, highlighting the need for careful monitoring in this population.

Agomelatine is associated with elevated liver enzymes, indicating a potential safety concern that requires attention during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pharmacovigilance update]. Livio, F.[2015]

A population pharmacokinetic model for tamsulosin hydrochloride (HCl) was developed in 189 pediatric patients aged 2-16 years, showing that body weight and alpha(1)-acid glycoprotein significantly influence the drug's clearance and distribution.

The study found no major differences in the pharmacokinetics of tamsulosin HCl between pediatric patients and adults when adjusted for body weight, indicating that weight-based dosing can achieve similar drug exposure levels in children as seen in healthy adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder. Tsuda, Y., Tatami, S., Yamamura, N., et al.[2021]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1477608/

Long-Term Efficacy and Safety of Tamsulosin for Benign ... Of patients completing 6 years of treatment, 80.7% demonstrated consistent positive response with extremely low incidence of orthostasis.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2014481/

A 6-month large-scale study into the safety of tamsulosin We conclude that tamsulosin has a good safety profile relative to AE rates in the placebo arms of previous studies on tamsulosin even in the presence of most ...

3. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2005/020579s016lbl.pdf

Flomax® Capsules, 0.4 mg - accessdata.fda.gov Following the first dose of double-blind medication in Study 1, a positive orthostatic test result at 4 hours post-dose was observed in 7% of patients (37 of ...

4. youtube.com youtube.com/watch?v=w2H7A8pnrjo

TAMSULOSIN (Flomax Relief /Flomaxtra XL) for BENIGN ... It actually helps with sleep quality because of the less-frequent trips to the bathroom. I hope that helps someone.

5. urotoday.com urotoday.com/volume-2-2009/vol-2-issue-1/26733-longterm-efficacy-of-tamsulosin-in-the-treatment-of-lower-urinary-tract-symptoms-suggestive-of-benign-prostatic-hyperplasia-in-reallife-practice-2219640.html

Long-Term Efficacy of Tamsulosin in the Treatment ... Results: Of these patients, 72 (64%) remained on tamsulosin (12 to 48 months of treatment) and 41 (36%) withdrew after a mean of 17.4 months on average. Reasons ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/tamsulosin-oral-route/description/drg-20068275

Tamsulosin (oral route) - Side effects & dosage This medicine may rarely cause a severe allergic reaction (swelling of face, tongue, or throat, difficulty breathing, and blistering of the skin ...

7. webmd.com webmd.com/drugs/2/drug-1592/tamsulosin-oral/details

Tamsulosin (Flomax) - Uses, Side Effects, and More The risk of side effects, such as dizziness and low blood pressure, may be increased if you drink alcohol while taking tamsulosin. Does ...

8. goodrx.com goodrx.com/tamsulosin/what-is?srsltid=AfmBOoraZaYY7azT9Wt0vsonay6qStna5xGBHPNv-tZZDlhnA9ndwHf_

Tamsulosin (Flomax): Uses, Side Effects, Dosage & More Flomax, often used to treat symptoms of an enlarged prostate, can cause side effects. These include dizziness, ejaculation issues, and headaches.