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 trials — Comparing minimally invasive procedures (UroLift, Rezum, Aquablation) with TURP for symptom control and sexual function.
- Drug trials — Testing combination drug approaches and novel medications for lower urinary tract symptom relief.
- Surgical trials — Evaluating prostatectomy approaches and energy delivery methods for larger prostate glands.
- Watchful waiting trials — Testing active monitoring protocols versus early treatment in men with mild to moderate symptoms.
- Observational studies — Tracking progression of BPH and associated bladder dysfunction over time.
Recently added Benign Prostatic Hyperplasia trials
Thulium Laser Enucleation With Bladder Neck Incision for Small-Volume Benign Prostatic Hyperplasia
This study will evaluate the safety and effectiveness of thulium laser enucleation of the prostate combined with bladder neck incision in men with small-volume benign prostatic hyperplasia (BPH). Small-volume BPH may still cause significant bladder outlet obstruction and bothersome lower urinary tract symptoms, and the optimal surgical treatment for these patients remains uncertain. In this multicenter, randomized, single-blind, controlled trial, 426 eligible men aged 40 to 80 years will be assigned in a 1:1:1 ratio to one of three groups: thulium laser enucleation of the prostate combined with bladder neck incision, thulium laser enucleation alone, or transurethral resection of the prostate. The main goal is to compare the incidence of bladder neck contracture at 6 months after surgery. Other outcomes include symptom improvement, urinary flow, pain score, sexual function, and safety outcomes during follow-up.
HoLEP-ThuLEP - Comparing Lasers for BPH Surgery
Benign prostatic hyperplasia (BPH) is a very common condition in older men. As the prostate enlarges, it can press on the urethra and make urination difficult. Typical symptoms include a weak urinary stream, frequent urination, getting up at night to urinate, and a feeling that the bladder is not fully empty. When medication is no longer sufficient, surgical removal of the inner part of the prostate ("enucleation") is the recommended treatment. Two modern laser techniques are used for this operation. Holmium Laser Enucleation of the Prostate (HoLEP) is currently considered the reference standard, with very good long-term results and a low rate of re-operations. Thulium Laser Enucleation of the Prostate (ThuLEP) using a pulsed thulium laser is a newer alternative. Because the laser energy is delivered in short pulses, ThuLEP may allow more precise tissue cutting and better control of bleeding during surgery. So far, only limited high-quality randomized data directly compare the two techniques, particularly for patient-reported outcomes such as urinary symptoms, continence, and erectile function. Purpose of the study The HoT-Trial investigates whether ThuLEP is as effective as HoLEP for men who need surgery for an enlarged prostate, and whether there are differences in recovery, complication rates, urinary symptoms, continence, and erectile function after surgery. Research question Does ThuLEP lead to a similar improvement in lower urinary tract symptoms (LUTS) as HoLEP 12 months after surgery, measured by the change in the International Prostate Symptom Score (IPSS)? How the study works A total of 150 men aged 18 years or older with clinically relevant BPH, an IPSS of 8 or higher, a prostate volume above 40 ml, and an indication for surgery will take part. Each participant will be randomly assigned (1:1) to either ThuLEP or HoLEP. Participants are blinded to the assigned technique (single-blind design). Both procedures are established, guideline-recommended treatments; taking part in the study does not add any risks beyond standard care. Before surgery, participants complete standardized questionnaires (IPSS, ICIQ-SF, IIEF) and undergo uroflowmetry and residual urine measurement. Surgery is performed according to randomization. Participants are then followed up in the urology outpatient clinic at discharge and at 3, 6, and 12 months after surgery. The same measurements and questionnaires are repeated at each visit. Primary outcome Change in IPSS from baseline to 12 months after surgery. Secondary outcomes Maximum urinary flow rate (Qmax) and post-void residual urine; continence (ICIQ-SF) and erectile function (IIEF); operative time, laser time, blood loss, transfusion rate; catheter indwelling time and length of hospital stay; peri- and postoperative complications graded by the Clavien-Dindo classification; and the rate of re-intervention or re-catheterization within 12 months. Setting and timeline The study is conducted as a single-center trial at the Department of Urology, Ludwig-Maximilians-University Munich, Germany. Recruitment runs for approximately two years, with up to 12 months of follow-up per participant. The total study period is planned from April 2026 to April 2029. By directly comparing the two laser enucleation techniques in a randomized setting, the HoT-Trial aims to help patients and physicians choose the most suitable surgical treatment for benign prostatic hyperplasia.
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