Acute Urinary Retention, Benign Prostatic Hyperplasia, Benign Prostatic Obstruction
Conditions
Keywords
Trial Without Catheter, TWOC, Tamsulosin, Tadalafil, Benign Prostatic Hyperplasia
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.
Interventions
DRUGTamsulosin
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.
DRUGTadalafil
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.
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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Catheter-Free Success by Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Successful Day-7 Trial Without Catheter | Day 7 | Proportion of participants who achieve successful spontaneous voiding after catheter removal on Day 7. Success is defined as spontaneous voiding, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, and no recatheterization within 24 hours. |
| Successful Rescue Day-14 Trial Without Catheter Among Day-7 Failures | Day 14 | Proportion of participants who fail the Day-7 trial without catheter and subsequently achieve successful rescue trial without catheter on Day 14 using the same predefined success criteria: spontaneous voiding, voided volume of at least 100 mL, post-void residual urine less than 150 mL measured within 10-15 minutes after voiding, and no recatheterization within 24 hours. |
| Recurrent Acute Urinary Retention Within 30 Days | 30 days | Proportion of participants who develop recurrent painful acute urinary retention requiring recatheterization within 30 days after randomization. |
| Need for Benign Prostatic Hyperplasia-Related Surgery Within 3 Months | 3 months | Proportion of participants who require surgical intervention for benign prostatic hyperplasia or benign prostatic obstruction within 3 months after randomization. |
Countries
Egypt
Contacts
CONTACTHany F Badawy, MD
Outcome results
None listed