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Condition Guide

New Treatments & Clinical Trials for Benign Prostatic Hyperplasia

Last updated May 2026Data from ClinicalTrials.gov164 active trials
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Benign prostatic hyperplasia (BPH) is a non-cancerous enlargement of the prostate gland that causes urinary symptoms — difficulty starting urination, weak stream, and frequent nighttime trips to the bathroom — in most men over 60. Treatment ranges from medications to minimally invasive procedures.

What's actually going on in research

Minimally invasive procedures including UroLift (prostatic urethral lift), Rezum (water vapor therapy), and iTind are being compared with transurethral resection in trials for symptom control and sexual side effect preservation. The phosphodiesterase-5 inhibitor tadalafil is being studied in combination with alpha-blockers for additive symptom benefit. Newer office-based procedures delivering targeted energy or mechanical devices are in active trials.

Minimally invasive procedures

Prostatic urethral lift (UroLift), water vapor ablation (Rezum), and aquablation are being compared in head-to-head trials for symptom improvement, ejaculatory function preservation, and durability.

Combination drug therapy

Combining alpha-blockers with PDE5 inhibitors like tadalafil targets both smooth muscle tone and pelvic blood flow, with trials showing additive symptom improvement over either alone.

Aquablation

Robotic waterjet ablation of prostate tissue guided by real-time ultrasound is in trials comparing it to standard transurethral resection for large prostates.

What to know before you search

Eligibility depends on IPSS symptom score, prostate volume by ultrasound, peak urinary flow rate, and prior medical therapy.

What types of trials are currently open

  • Procedural trialsComparing minimally invasive procedures (UroLift, Rezum, Aquablation) with TURP for symptom control and sexual function.
  • Drug trialsTesting combination drug approaches and novel medications for lower urinary tract symptom relief.
  • Surgical trialsEvaluating prostatectomy approaches and energy delivery methods for larger prostate glands.
  • Watchful waiting trialsTesting active monitoring protocols versus early treatment in men with mild to moderate symptoms.
  • Observational studiesTracking progression of BPH and associated bladder dysfunction over time.

Recently added Benign Prostatic Hyperplasia trials

RecruitingPost-approval monitoring

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

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.

Banī Suwayf, Beni Suweif Governorate, Egypt
RecruitingPost-approval monitoring

Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary Retention

This randomized controlled trial will compare three medication strategies before trial without catheter in men with acute urinary retention due to benign prostatic hyperplasia who were already taking tamsulosin 0.4 mg once daily before the retention episode. After urethral catheterization, eligible participants will be randomly assigned to one of three groups for 7 days: continuation of tamsulosin 0.4 mg once daily, escalation to tamsulosin 0.8 mg once daily, or switching to silodosin 8 mg once daily. The urethral catheter will be removed on Day 7, and the ability to void successfully without re-catheterization will be assessed. Follow-up will continue to Day 30, with additional recording of catheter-free status, recurrent urinary retention, urinary flow, post-void residual urine, symptom scores, adverse drug events, catheter-related complications, and the need for later benign prostatic hyperplasia-related surgery.

Banī Suwayf, Beni Suweif Governorate, Egypt
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