Tamsulosin for Urinary Retention

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Alpha antagonists, CYP3A4 inhibitors

Disqualifiers: Bladder dysfunction, Urologic surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8-12 days

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if tamsulosin can reduce urinary retention and shorten hospital stays after spine surgery. Researchers are testing tamsulosin to see if it can ease recovery for patients undergoing specific spine operations, such as laminectomy or spinal fusion. Patients who have had spine surgery and are not taking certain medications or have specific medical conditions might be suitable candidates. As a Phase 4 trial, tamsulosin is already FDA-approved and proven effective. This research seeks to understand its benefits for more patients, offering an opportunity to contribute to broader medical knowledge.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking alpha-antagonists or strong inhibitors of CYP3A4. If you are on these medications, you would need to stop them to join the trial.

What is the safety track record for tamsulosin?

Research has shown that tamsulosin is generally safe and well-tolerated. In studies involving patients who underwent surgery, tamsulosin reduced urinary problems without causing major side effects. Another study with male veterans undergoing major surgeries found tamsulosin safe for them as well. Additionally, both men and women have used tamsulosin safely to manage urinary issues. These findings suggest that tamsulosin is a safe option for many people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for urinary retention, such as catheterization or surgery, focus on relieving symptoms without addressing the underlying muscle tension. Tamsulosin is unique because it targets the alpha-1-adrenergic receptors in the bladder neck and prostate, relaxing these muscles and improving urine flow. This mechanism allows Tamsulosin to treat urinary retention more effectively and comfortably than traditional methods. Researchers are excited about Tamsulosin because it offers a non-invasive option that could potentially reduce the need for more invasive procedures.

What is the effectiveness track record for tamsulosin in reducing urinary retention after spine surgery?

Research has shown that tamsulosin, which participants in this trial may receive, can reduce urination problems after surgery. In one study, only 4.7% of patients taking tamsulosin experienced trouble urinating, compared to 9.2% of those who did not take it. Another study found that the number of patients with urination issues decreased from 15% to 2.5% when using tamsulosin. Additionally, it appears to help patients leave the hospital sooner. These findings suggest that tamsulosin can prevent urination problems and aid in faster recovery after surgery. ^{2 4 6 7 8}

Who Is on the Research Team?

Michelle Clarke, MD, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients who are experiencing urinary retention after spine surgery. Participants should be adults who have undergone certain types of spinal operations and are now facing difficulties in urination.

Inclusion Criteria

I have had surgery to remove part of a bone in my neck.

I have had surgery to fuse the bones in my neck.

I have had a fusion surgery in my neck.

Exclusion Criteria

Mental disability or prisoner

Pregnancy (for anesthesia purposes)

Patients with history of allergy or sensitivity to tamsulosin or other alpha-antagonist

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tamsulosin or placebo postoperatively to reduce urinary retention

8-12 days

Inpatient hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of urinary retention and UTIs

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tamsulosin

Trial Overview The study is testing whether tamsulosin, a uroselective alpha-1-adrenergic receptor antagonist, can reduce the occurrence and length of urinary retention post-spine surgery compared to a placebo.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive uroselective alpha-1-adrenergic receptor antagonist Tamsulosin

Group II: Control Group Placebo Group 1 Intervention

Neurosurgical patients undergoing decompressive laminectomy and/or spinal fusion who will receive a placebo

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24642148/

Effectiveness of tamsulosin in prevention of post-operative ... This study suggests that short perioperative treatment with tamsulosin can reduce the incidence of urinary retention and the need for catheterization.

2. facs.org facs.org/for-medical-professionals/news-publications/news-and-articles/acs-brief/january-7-2025-issue/tamsulosin-with-eras-protocols-reduces-rates-of-urinary-retention-after-colorectal-surgery/

Tamsulosin with ERAS Protocols Reduces Rates of Urinary ... Urinary retention was documented in 9.2% of the control group compared to 4.7% of the treatment group. The authors concluded that use of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02486653

Prevention of Post-operative Urinary Retention (POUR) The purpose of this study is to determine if tamsulosin ("FLOMAX") is effective in preventing post-operative urinary retention following abdominal surgery.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002961024006792

Does prophylactic tamsulosin use with ERAS protocol ... Tamsulosin significantly reduced urinary retention in colorectal surgery (4.7 ​% vs. 9.2 ​%, p ​= ​0.01). · Length of hospital stay was shorter with tamsulosin ( ...

5. icurology.org icurology.org/DOIx.php?id=10.4111/kju.2012.53.6.419

Preventive Effect of Tamsulosin on Postoperative Urinary ... This protocol resulted in the reduction of urinary retention from 15% in the controls to 2.5% in the treatment group.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36445826/

Tamsulosin for prevention of postoperative urinary retention Conclusion: Administration of tamsulosin before and/or after surgery significantly reduced the risk of POUR and improved maximum urinary flow ...

7. journals.lww.com journals.lww.com/aosopen/fulltext/2024/12000/evaluating_the_safety_of_empiric_tamsulosin_to.17.aspx

Evaluating the Safety of Empiric Tamsulosin to Prevent... The purpose of this study was to evaluate the safety of empiric tamsulosin in male veterans undergoing major colorectal surgery.

8. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(21)00015-9/fulltext

Preoperative Tamsulosin to Prevent Postoperative Urinary ... The purpose of this study was to evaluate the efficacy of tamsulosin, administered preoperatively, for the prevention of postoperative urinary retention (POUR).