Tamsulosin for Urinary Retention

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: TriHealth Inc.

Must not be taking: Alpha blockers

Disqualifiers: Hypotension, Syncope, POTS, Pregnancy, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to determine if taking tamsulosin preoperatively decreases your chances of being discharged after surgery with a Foley catheter (flexible tube that drains urine from the bladder into a collection bag).

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 already taking an alpha blocker.

What data supports the effectiveness of the drug Tamsulosin for urinary retention?

Research shows that Tamsulosin helps men with urinary retention due to an enlarged prostate by relaxing bladder muscles, making it easier to urinate. In one study, men taking Tamsulosin had a much lower risk of needing surgery for urinary retention compared to those using herbal treatments.

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Is tamsulosin safe for treating urinary retention?

Tamsulosin has been found to be safe for long-term use, as shown in an 8-year study where it significantly reduced the risk of acute urinary retention compared to herbal treatments. It is generally well-tolerated and helps in reducing the need for surgery in patients with urinary retention.

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

Tamsulosin is unique because it is an alpha blocker that works by relaxing the muscles in the bladder neck, making it easier to urinate. It is particularly effective in reducing the risk of acute urinary retention in men with benign prostatic hyperplasia (BPH) and is used preemptively to prevent urinary retention after surgeries, unlike herbal treatments or other medications that may not specifically target muscle relaxation in the bladder.

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Eligibility Criteria

This trial is for individuals scheduled for same-day urogynecology surgery who are at risk of urinary retention post-operation. Specific eligibility details aren't provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.

Inclusion Criteria

I am having surgery for pelvic organ prolapse or incontinence.

Exclusion Criteria

Non-English speaker or interpreter unavailable for Spanish-speaking patient

Pregnancy

I have a history of fainting.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Treatment

Participants receive tamsulosin preoperatively to assess its impact on postoperative voiding

1 day

Postoperative Assessment

Participants undergo a voiding trial on the day of surgery to determine if they can be discharged without a Foley catheter

Day of surgery

Follow-up

Participants are monitored for secondary postoperative urinary retention and urinary tract infections

4 weeks

Participant Groups

The study is testing whether taking tamsulosin before surgery can reduce the need for a Foley catheter after surgery. Participants will be randomly given either tamsulosin or a placebo to assess the drug's effectiveness in preventing urinary retention.

Group I: Study Arm Active Control 1 Intervention

Group II: Control Arm Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

TriHealth Cincinnati, OH

Who Is Running the Clinical Trial?

TriHealth Inc. Lead Sponsor

References

1. 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.

2. 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).

3. Germany pubmed.ncbi.nlm.nih.gov

Perioperative use of tamsulosin significantly decreases rates of urinary retention in men undergoing pelvic surgery. [2018] Urinary retention is a common complication of pelvic surgery, leading to urinary tract infection and prolonged hospital stays. Tamsulosin is an alpha blocker that works by relaxing bladder neck muscles. It is used to treat benign prostatic hypertrophy and retention. We aim to investigate the potential benefits of preemptive tamsulosin use on rates of urinary retention in men undergoing pelvic surgery.

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

Results of treatment with tamsulosin in men with acute urinary retention. [2019] The aim of this study was to prospectively assess the outcome in men treated with temporary catheter drainage and tamsulosin after an episode of acute urinary retention (AUR).

5. 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.

6. Poland pubmed.ncbi.nlm.nih.gov

Comparison of tamsulosin and silodosin in the management of acute urinary retention secondary to benign prostatic hyperplasia in patients planned for trial without catheter. A prospective randomized study. [2022] We present a prospective randomized study to compare the efficacy of tamsulosin and silodosin in patients suffering from acute urinary retention caused by benign prostatic hyperplasia, planned for trial without catheter.

7. Germany pubmed.ncbi.nlm.nih.gov

The use of tamsulosin to prevent postoperative urinary retention in laparoscopic inguinal hernia repair: a randomized double-blind placebo-controlled study. [2021] The rate of postoperative urinary retention (POUR) in laparoscopic inguinal hernia repairs is 1-22%. POUR may cause patient anxiety, discomfort, and increased hospital costs. Currently there is no standard prophylaxis for POUR. Preoperative administration of tamsulosin has been shown to decrease POUR rates in urologic studies. This study aims to evaluate the efficacy of tamsulosin on the incidence of POUR in patients undergoing totally extraperitoneal (TEP) LIHR.