Tamsulosin With or Without Tadalafil for Trial Without Catheter After Acute Urinary Retention Due to Benign Prostatic Hyperplasia

NCT07654413 | Recruiting Phase 4

• 1 other identifier: BSU FMBSUREC07062026CBADAWY
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

Acute urinary retention is a common emergency in men with benign prostatic hyperplasia. After bladder drainage with a urethral catheter, patients usually undergo a trial without catheter to determine whether they can pass urine again without recatheterization. This study will evaluate whether adding tadalafil 5 mg once daily to tamsulosin 0.4 mg once daily improves the chance of successful trial without catheter in men with first-episode acute urinary retention due to presumed benign prostatic hyperplasia. Participants will be randomly assigned to receive either tamsulosin plus tadalafil or tamsulosin plus a matching placebo. Study medication will start within 24 hours after catheterization. The catheter will be removed on Day 7. If the first trial without catheter fails, the catheter will be reinserted and a second rescue trial without catheter will be performed on Day 14. The main outcome is overall catheter-free success by Day 14. Participants will also be followed for recurrent urinary retention, post-void residual urine, urinary flow, catheter-related complications, drug-related adverse events, and the need for benign prostatic hyperplasia-related surgery within 3 months.

Conditions

Acute Urinary Retention; Benign Prostatic Hyperplasia; Benign Prostatic Obstruction

Keywords

Trial Without Catheter; TWOC; Tamsulosin; Tadalafil; Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Overall Catheter-Free Success by Day 14

  Proportion of participants who achieve successful spontaneous voiding after either the scheduled Day-7 trial without catheter or the rescue Day-14 trial without catheter. Success is defined as spontaneous voiding after catheter removal, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, no recatheterization within 24 hours after the relevant trial without catheter attempt, and remaining catheter-free until Day 14 for participants who initially pass the Day-7 trial without catheter.

  Day 14

Secondary Outcomes (4)

• Successful Day-7 Trial Without Catheter

  Day 7

• Successful Rescue Day-14 Trial Without Catheter Among Day-7 Failures

  Day 14

• Recurrent Acute Urinary Retention Within 30 Days

  30 days

• Need for Benign Prostatic Hyperplasia-Related Surgery Within 3 Months

  3 months

Study Arms (2)

Tamsulosin Plus Placebo

PLACEBO COMPARATOR

Participants will receive tamsulosin 0.4 mg once daily plus a matching placebo once daily. Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.

Drug: Tamsulosin; Drug: Tadalafil Placebo

Tamsulosin Plus Tadalafil

EXPERIMENTAL

Participants will receive tamsulosin 0.4 mg once daily plus tadalafil 5 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue the assigned treatment until the rescue trial without catheter on Day 14.

Drug: Tamsulosin; Drug: Tadalafil

Interventions

Tamsulosin DRUG

Tamsulosin 0.4 mg will be administered orally once daily as open-label background therapy in both study arms. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.

Tamsulosin Plus Placebo; Tamsulosin Plus Tadalafil

Tadalafil DRUG

Tadalafil 5 mg will be administered orally once daily in the experimental arm in addition to open-label tamsulosin 0.4 mg once daily. Treatment will start within 24 hours after urethral catheterization and continue until the scheduled Day-7 trial without catheter. Participants who fail the Day-7 trial without catheter will continue treatment until the rescue trial without catheter on Day 14.

Tamsulosin Plus Tadalafil

Tadalafil Placebo DRUG

A matching placebo tablet will be administered orally once daily in the placebo comparator arm in addition to open-label tamsulosin 0.4 mg once daily. The placebo will be identical to tadalafil in appearance, packaging, and labeling to maintain blinding.

Tamsulosin Plus Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male patient aged 50 years or older.
• First episode of spontaneous painful acute urinary retention.
• Successful urethral catheterization at presentation.
• Drained urine volume at presentation of at least 300 mL.
• Clinical impression of benign prostatic obstruction or benign prostatic hyperplasia based on history, digital rectal examination, and/or ultrasound evidence of enlarged prostate.
• Ability to provide written informed consent.

You may not qualify if:

• Previous episode of acute urinary retention.
• Chronic painless urinary retention phenotype.
• Active urinary tract infection or sepsis.
• Gross hematuria with clot retention.
• Suspected or known urethral stricture.
• Neurogenic bladder or major neurologic disease affecting voiding.
• History of prostate cancer or bladder cancer.
• Previous prostate surgery.
• Current use of nitrates or guanylate cyclase stimulators.
• Contraindication to tadalafil or tamsulosin.
• Severe hypotension or unstable cardiovascular disease.
• Severe renal impairment.
• Severe hepatic impairment.
• Current or recent use of phosphodiesterase type 5 inhibitors before enrollment.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, 02456, Egypt

RECRUITING

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin; Tadalafil

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants will receive open-label tamsulosin 0.4 mg once daily. Participants will be randomized to receive either tadalafil 5 mg once daily or a matching placebo once daily. Tadalafil and placebo tablets will be identical in appearance, packaging, and labeling. Participants, treating physicians, investigators, study coordinators, outcome assessors, and data analysts will remain blinded to tadalafil/placebo allocation. Emergency unblinding will be permitted only when knowledge of treatment allocation is essential for participant safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel treatment groups: tamsulosin 0.4 mg once daily plus tadalafil 5 mg once daily, or tamsulosin 0.4 mg once daily plus matching placebo.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 17, 2026
• Study Start: June 8, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)