Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy

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

161 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if giving a single dose of tamsulosin before surgery can help women who are having a minimally invasive hysterectomy to urinate sooner and leave the hospital faster. Tamsulosin has been studied for its effectiveness in reducing postoperative urinary retention in various surgeries.

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 Tamsulosin generally safe for humans?

A study involving over 10,000 patients treated with Tamsulosin in general medical practice was conducted to observe its safety and effectiveness, indicating it has been evaluated for safety in humans. ^{1 2 3 4 5}

What makes the drug Tamsulosin unique compared to other treatments for benign prostatic hyperplasia (BPH)?

Tamsulosin is unique because it specifically targets alpha1 receptors in the prostate, helping to relax muscles in the bladder neck and prostate, which improves urine flow. Additionally, the new formulation Contiflo ICON 400 µg is designed to maintain consistent drug levels in the body over 24 hours and is not affected by food intake, offering a more stable treatment option. ^{6 7 8 9 10}

Eligibility Criteria

Inclusion Criteria

Women 18-80 undergoing outpatient minimally invasive hysterectomy

Timeline

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

Treatment Details

Interventions

• Placebo
• Tamsulosin

Participant Groups

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+

Findings from Research

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Pharmacovigilance update]. [2015]

2. England pubmed.ncbi.nlm.nih.gov

The pharmacovigilance of tamsulosin: event data on 12484 patients. [2022]

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

Clinical experience with diltiazem in Japan. [2019]

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

Colonic toxicity of administered drugs and chemicals. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Pharmacovigilance update]. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

A pharmacokinetic and bioequivalence study of Contiflo ICON 400 µg tablets in healthy Indian subjects. [2019]

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

Population pharmacokinetics of tamsulosin hydrochloride in paediatric patients with neuropathic and non-neuropathic bladder. [2021]

8. 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]

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

Modified SST-USST for tamsulosin-associated intraoperative [corrected] floppy-iris syndrome. [2018]

10. 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]