BPH (Benign Prostatic Hyperplasia)

13

Review clinical trials related to BPH (Benign Prostatic Hyperplasia). Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Predicting BPH Surgery Outcomes Using a Preoperative Scoring System

This study aims to develop and validate a preoperative predictive scoring system for surgical outcomes in patients with benign prostatic hyperplasia (BPH) undergoing prostate surgery (including but not limited to transurethral resection of the prostate, laser enucleation, photoselective vaporization, or robot-assisted simple prostatectomy). It is a multicenter retrospective study involving patients from four hospitals in China. Preoperative multidimensional objective indicators, including clinical data, prostate MRI parameters, and urodynamic measurements, will be collected. The primary outcome is a favorable surgical response defined by a postoperative-to-preoperative International Prostate Symptom Score (IPSS) ratio ≤ 0.5 at 6 months after surgery. Multivariable logistic regression, restricted cubic splines, and bootstrap internal validation will be used to construct and evaluate the scoring system. The goal is to provide an objective, individualized tool for optimizing surgical decision-making in BPH patients.

Participants needed: 2,000
Trial details
Age: 30-100Biological sex: MaleType: ObservationalSponsor: First Affiliated Hospital of Fujian Medical UniversityUpdated: Jun 3, 2026
Eligibility criteria

- Postoperative pathological diagnosis of benign prostatic hyperplasia (BPH) [+6]

- Concomitant prostate cancer or other malignancies [+6]

Status: Recruiting

A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia

This single-center, single-arm, prospective clinical study aims to preliminarily evaluate the safety and effectiveness of ultra-minimally invasive prostatic dilation using a prostate dilation catheter under real-time transrectal ultrasound (TRUS) guidance in male patients with significant bladder outlet obstruction secondary to benign prostatic hyperplasia (BPH). A total of 5 eligible male subjects aged 40 to 80 years with symptomatic BPH, International Prostate Symptom Score (IPSS) ≥13, maximum urinary flow rate (Qmax) of 5-10 mL/s, prostate volume \<30 mL measured by TRUS, and evident bladder outlet obstruction will be enrolled. All subjects will undergo prostatic balloon dilation with the study device under real-time TRUS guidance. Follow-up assessments will be conducted at 1, 3, and 6 months after treatment. The primary effectiveness endpoint is the change in IPSS from baseline at 1, 3, and 6 months. The primary safety endpoints include bladder neck contracture, retrograde ejaculation, device-related severe urinary retention persisting for more than 14 days after healing, new-onset stress urinary incontinence, device-related bleeding requiring transfusion, and device-related urethral or prostatic capsular rupture requiring surgical intervention. Secondary endpoints include responder rates based on different thresholds of IPSS improvement (≥30%, ≥40%, and ≥50%), changes in Qmax, and changes in visual analogue scale (VAS) scores. Exploratory endpoints include changes in postvoid residual urine volume (PVR) and sexual function assessed by the International Index of Erectile Function (IIEF-5) and the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD). This exploratory study is intended to provide preliminary clinical evidence supporting the safety and potential clinical benefit of TRUS-guided ultra-minimally invasive prostatic dilation for BPH-related obstruction and to inform future larger-scale clinical studies.

Participants needed: 5
Trial details
Age: 40-80Biological sex: MaleType: InterventionalSponsor: Qing YuanUpdated: May 13, 2026Locations: 1
Eligibility criteria

Male subjects aged 40 to 80 years with symptomatic benign prostatic hyperplasia... [+5]

Subjects who are unable or unwilling to sign the informed consent form (ICF) and... [+7]

Status: Recruiting

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.

Participants needed: 150
Trial details
Age: 18+Biological sex: MaleType: InterventionalSponsor: Ludwig-Maximilians - University of MunichUpdated: May 7, 2026Locations: 1
Eligibility criteria

Male, age ≥ 18 years [+4]

Proven or suspected prostate cancer [+3]

Status: Not yet recruiting

Prospective Post Market Clinical Registry for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH Spring System Registry

The purpose of this registry is to collect information on how the Zenflow Spring System works in everyday medical practice. The registry will track how the Spring System performs during the implant procedure, and at follow-up visits at 1, 3, 6, and 12 months. We will look at how symptoms improve, how quickly patients return to normal activities, how satisfied they are with treatment, and whether there are any problems or side effects related to the device.

Participants needed: 300
Trial details
Age: 18+Biological sex: MaleType: ObservationalSponsor: Zenflow, Inc.Updated: Apr 20, 2026Locations: 2Duration: 12 Months
Eligibility criteria

Treatment with Zenflow Spring System will be conducted in accordance with the ap...

Treatment with Zenflow Spring System will be conducted in accordance with the ap...

Status: Recruiting

New Treatment Strategies and Epigenetic Biomarker for Management of Benign Prostatic Hyperplasia

SRD5A2 is a critical enzyme for prostatic development and growth, and the SRD5A2 inhibitor, finasteride, is used to treat benign prostatic hyperplasia (BPH). SRD5A2 is absent in 30% of normal adult men, which explains the resistance of a subset of patients to this commonly prescribed drug. This project proposes new combination therapies (5-ARI+raloxifene) and evaluates novel non-invasive biomarkers, based on alternative pathways that lead to prostatic enlargement.

Participants needed: 242
Trial details
Phase: Phase 2Age: 18+Biological sex: MaleType: InterventionalSponsor: Beth Israel Deaconess Medical CenterUpdated: Mar 23, 2026Locations: 1
Eligibility criteria

≥18 yrs old on the day of study consent; [+4]

Active or past history of venous thromboembolism, including deep vein thrombosis... [+14]

Status: Not yet recruiting

Tadalafil 5 mg on Storage Lower Urinary Tract Symptoms After Anatomical Endoscopic Enucleation of the Prostate

The aim of this study is to evaluate the impact of daily tadalafil 5 mg on storage lower urinary tract symptoms (LUTS) during the early postoperative period following Anatomical endoscopic enucleation of prostate in a randomized controlled clinical trial.

Participants needed: 40
Trial details
Phase: Phase 1Biological sex: MaleType: InterventionalSponsor: Assiut UniversityUpdated: Mar 12, 2026
Eligibility criteria

Must be able to swallow tablets [+2]

Contraindications to tadalafil (e.g., nitrate use, severe hepatic/renal impairme...

Status: Recruiting

INTUPRO in the Treatment of Benign Prostatic Hyperplasia-Related Symptoms

The goal of this clinical trial is to determine whether INTUPRO can improve the quality of life in patients with Benign Prostate Hyperplasia (BPH). The main questions it aims to answer are: Can INTUPRO treatment lead to the removal of the Foley catheter? Can INTUPRO treatment improve urinary flow? Can INTUPRO treatment lower or minimize waking during sleep to urinate? Can INTUPRO reduce urinary hesitancy, urgency and frequency? Participants will: Receive INTUPRO treatment on Day 1. Visit at Day 30 and Day 90 for checkups, tests and Prostate MRI.

Participants needed: 31
Trial details
Age: 45+Biological sex: MaleType: InterventionalSponsor: inTumo Therapeutics, Inc.Updated: Feb 2, 2026Locations: 1
Eligibility criteria

• Male patient aged 45 years or older [+6]

Urethral stricture [+14]

Status: Not yet recruiting

Comparison of Holmium, Thulium:YAG, and Thulium Fiber Lasers in Prostate Enucleation

Benign prostatic hyperplasia (BPH) is a common condition in aging men and may require surgical treatment when medical therapy is ineffective. Anatomical prostate enucleation using different laser technologies is a well-established surgical approach for the treatment of BPH. The purpose of this prospective randomized study is to compare the efficiency and safety of three commonly used laser systems-Holmium:YAG, Thulium:YAG, and Thulium Fiber Laser (TFL)-during anatomical prostate enucleation. The primary objective of the study is to evaluate laser efficiency by measuring grams of enucleated prostate tissue per joule (g/J) using intraoperative laser device data. Secondary outcomes include changes in International Prostate Symptom Score (IPSS) and the occurrence of postoperative urinary incontinence. All laser systems used in this study are part of routine clinical practice, and no additional diagnostic procedures or treatments will be performed for study purposes

Participants needed: 159
Trial details
Age: 50-80Biological sex: MaleType: InterventionalSponsor: Ankara UniversityUpdated: Jan 20, 2026Locations: 1
Eligibility criteria

Patients diagnosed with benign prostatic hyperplasia (BPH) and scheduled for ana... [+2]

History or suspicion of prostate cancer [+4]

Status: Not yet recruiting

Comparison of Convective Water Vapor Ablation (Convective Water Vapor Energy, WAVE™) With the Rezum™ System Versus Holmium Laser Enucleation of the Prostate (HoLEP) Versus Bipolar Transurethral Resection of the Prostate (TUR-P) in Patients With Benign Prostatic Syndrome (BPS) - A Randomized Study

Benign prostatic enlargement (BPH/BPS) is one of the most common benign diseases in adult men. About 50% of men are affected by the age of 50, and between the ages of 70 and 80 the prevalence rises to 70-80%. There are various surgical procedures available for the treatment of BPH. In this study, we are investigating three surgical procedures which, based on the current data, appear to be relatively equivalent; however, additional data are still needed to substantiate this. The aim of this study is to compare the three surgical methods REZUM vs. HoLEP vs. TUR-P for endoscopic transurethral subvesical de-obstruction with regard to both subjective and objective voiding function, as well as improvements in quality of life and sexual function. The goal of the study is to work out the possible advantages and disadvantages for future patient counseling, thereby defining more precisely the role of these surgical procedures within the armamentarium of urology. This is a single-center, randomized, prospective interventional study.

Participants needed: 198
Trial details
Phase: Phase 4Age: 18+Biological sex: MaleType: InterventionalSponsor: Medical University of GrazUpdated: Nov 19, 2025
Eligibility criteria

Age > 18 years [+2]

Emergency surgeries [+8]

Status: Not yet recruiting

Impact of Kegel Exercise on Patient Outcomes Post TURP

how kegel exercise will improve patient outcomes by reducing post TURP LUTs , improve patient performance status and improve patient self esteem

Participants needed: 92
Trial details
Age: 45-65Biological sex: MaleType: InterventionalSponsor: Assiut UniversityUpdated: Aug 1, 2025
Eligibility criteria

patient diagnosed with BPH and undergoing TURP [+2]

Status: Recruiting

Effetivity of Dutasteride and Aloe Vera Extract Combination on Angiogenesis and Obstruction on Benign Prostatic Hyperplasia

This study is a double blinded RCT with pre-post test design on the effect of combination of dutasteride and aloe vera, compared to dutasteride only, on uroflowmetry results, prostate volume, and VEGF serum level among patients with benign prostate hyperplasia. The treatment was given for 12 weeks

Participants needed: 84
Trial details
Phase: Phase 1Age: 50+Biological sex: MaleType: InterventionalSponsor: Universitas DiponegoroUpdated: Jul 15, 2025Locations: 1
Eligibility criteria

Diagnosed with BPH clinically or radiologically (prostate volume > 30 gram, Qmax... [+1]

Clinically or radiologically suspected of having prostatic cancer [+5]

Status: Recruiting

Feasibility and Safety of a Single Working Element for Bipolar and Laser Enucleation in Prostate Surgery: A Prospective Study

A prospective feasibility study would be a practical first step, focusing on real-time assessment and ensuring the new working element's integration is safe and effective before broader clinical trials.

Participants needed: 60
Trial details
Age: 50+Biological sex: MaleType: ObservationalSponsor: Menoufia UniversityUpdated: Jun 13, 2025Locations: 1
Eligibility criteria

Diagnosed with benign prostatic hyperplasia (BPH) requiring surgical interventio... [+2]

Patients with ongoing urinary tract infections. [+3]

Status: Not yet recruiting

Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH

The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP.

Participants needed: 114
Trial details
Age: 50-80Biological sex: MaleType: InterventionalSponsor: Assiut UniversityUpdated: Apr 11, 2025Locations: 1
Eligibility criteria

Male patients aged 50-80 years [+4]

• Prostate cancer [+3]