Tamsulosin for Postoperative Urinary Retention

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Thomas L. Bauer

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Hackensack Meridian Health

Must not be taking: Tamsulosin, Boceprevir

Disqualifiers: Hypotension, CHF, Prostate surgery, others

No Placebo Group

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

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 who undergo an oncological thoracic surgical procedure for suspected or confirmed cancer. In addition, the study will try to identify the time of resumption of presurgical urinary function post Tamsulosin administration.

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 using Tamsulosin or Boceprevir.

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

Research shows that Tamsulosin, an alpha blocker, helps relax bladder neck muscles, reducing the risk of urinary retention after surgeries. Studies have found it effective in preventing urinary retention in both men and women after various types of surgeries, including pelvic and urologic procedures. ^{1 2 3 4 5}

Is Tamsulosin safe for humans?

Tamsulosin has been studied for various conditions and is generally considered safe for humans. An 8-year study showed that it effectively reduced the risk of acute urinary retention with a low incidence of side effects, making it a safe option for long-term use. ^{2 3 4 5 6}

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

Tamsulosin is unique because it is a selective alpha blocker that specifically targets alpha-1A and alpha-1B-adrenoceptors, which helps relax the muscles in the bladder neck and reduce bladder outlet resistance. This makes it effective in preventing postoperative urinary retention, especially when used preemptively, unlike other treatments that may not specifically target these receptors. ^{1 2 7 8 9}

Eligibility Criteria

This trial is for men aged 55 or older who are scheduled to have thoracic cancer surgery and haven't used Tamsulosin before. They shouldn't have low blood pressure, a history of heart failure, valvular heart disease, or previous prostate surgery.

Inclusion Criteria

I am scheduled for a minimally invasive chest cancer surgery.

My surgery is scheduled for more than a week after I give consent.

I am a man aged 55 or older.

Exclusion Criteria

You are allergic to Tamsulosin or sulfa drugs.

I am currently taking Boceprevir.

Your blood pressure drops significantly when you stand up from sitting, as measured after standing for 2 minutes.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Treatment

Participants receive Tamsulosin for 7 days prior to scheduled thoracic oncological surgery

1 week

1 visit (in-person) for prescription and instructions

Post-operative Monitoring

Participants are monitored for postoperative urinary retention (POUR) and undergo bladder scanning

1 day

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tamsulosin (Alpha-1 Blocker)

Trial Overview The study tests if Tamsulosin can reduce the high rates of urinary retention after thoracic cancer surgery in older men and how quickly it helps resume normal urinary function post-surgery.

Participant Groups

Group I: Pre-operative Tamsulosin administration Experimental Treatment 1 Intervention

Subjects will be provided with a prescription for Tamsulosin (generic) to be taken 7 days prior to scheduled surgery for thoracic cancer. Tamsulosin dose is set at 0.4mg/day and should be taken daily for seven days prior to their planned surgery date. Study subjects will also be given a diary to record their daily usage. Study subjects should take Tamsulosin on the day of the surgery with a sip of water.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

South Ocean University Medical Center Manahawkin, NJ

Riverview Medical Center Red Bank, NJ

Jersey Shore University Medical Center Neptune, NJ

Ocean University Medical Center Brick, NJ

Who Is Running the Clinical Trial?

Hackensack Meridian Health Lead Sponsor

References

1. India pubmed.ncbi.nlm.nih.gov

Evaluation the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery. [2022] Postoperative urinary retention (POUR) is defined as a disability in urinary excision after surgery. There are several strategies to prevent POUR, such as tamsulosin, which is a selective antagonist at alpha-1A and alpha-1B-adrenoceptors which reduces the bladder outlet resistance. The aim of this study was to investigate the efficacy of prophylactic tamsulosin in preventing acute urinary retention and other obstructive urinary symptoms following colporrhaphy surgery.

2. 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.

3. Brazil pubmed.ncbi.nlm.nih.gov

Prophylactic effects of alpha-blockers, Tamsulosin and Alfuzosin, on postoperative urinary retention in male patients undergoing urologic surgery under spinal anaesthesia. [2018] Postoperative urinary retention (POUR) is one of the most common complications after surgical procedures under spinal anaesthesia. Recent studies have shown the beneficial effects of alpha-adrenergic blockers in preventing POUR. The aim of this prospective study was to investigate and compare the prophylactic effects of tamsulosin and alfuzosin on POUR after urologic surgical procedures under spinal anaesthesia.

4. 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.

5. 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).

6. 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).

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

Preoperative Tamsulosin to Prevent Postoperative Urinary Retention: A Randomized Controlled Trial. [2021] The purpose of this study was to evaluate the efficacy of tamsulosin, administered preoperatively, for the prevention of postoperative urinary retention (POUR). POUR is a common complication of abdominal surgery, leading to the use of urinary catheters, which are a risk factor for urinary tract infection. Tamsulosin is a uroselective alpha-1a blocker used for the treatment of lower urinary tract symptoms.

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

Tamsulosin reduces the incidence of acute urinary retention following early removal of the urinary catheter after radical retropubic prostatectomy. [2019] To determine the efficacy of tamsulosin in preventing acute urinary retention following early catheter removal after radical retropubic prostatectomy.

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

Urinary retention in early urinary catheter removal after colorectal surgery. [2019] High urinary infection (UTI) rate (12%) for our rectal surgery prompted practice change to early catheter removal (postoperative day 2) and prophylactic tamsulosin. Here we report urinary retention (UR) and UTI after this change.