Bladder Outlet Obstruction

7

Review clinical trials related to Bladder Outlet Obstruction. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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.

Participants needed: 615
Trial details
Age: 40-80Biological sex: MaleType: InterventionalSponsor: Chinese PLA General HospitalUpdated: Jun 18, 2026Locations: 1
Eligibility criteria

Male patients aged 40-80 years. [+4]

Inability or refusal to provide written informed consent, or inability to comply... [+11]

Status: Recruiting

A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate

This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (\>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL/s) who failed medical therapy will be randomized 1:1:1 into three groups of 30. Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively. Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.

Participants needed: 90
Trial details
Biological sex: MaleType: InterventionalSponsor: Tanta UniversityUpdated: Jun 5, 2026Locations: 1
Eligibility criteria

Male patients diagnosed with BPH [+5]

Prostate cancer (current or history). [+8]

Status: Recruiting

Concomitant Renal and Urinary Bladder Allograft Transplantation

The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

Participants needed: 30
Trial details
Phase: Early Phase 1Age: 1-60Biological sex: AllType: InterventionalSponsor: Mayo ClinicUpdated: Apr 23, 2026Locations: 2
Eligibility criteria

Male or female patients between 1 yr. and 60 years of age. [+10]

They are pregnant or breastfeeding, or planning a pregnancy during the course of... [+22]

Status: Not yet recruiting

High Intensity Focused Ultrasound (HIFU) Ablation for Treatment of Prostate Tissue in Bladder Outlet Obstruction

Objectives: To assess the efficacy of HIFU therapy for benign prostatic tissue ablation in patients with lower urinary tract symptoms (LUTS) due to bladder outlet obstruction (BOO) that caused by Benign prostatic hyperplasia (BPH). The primary objective of the study is to determine the efficacy of HIFU therapy by assessing the changes in IPSS score in 6-month post HIFU procedure for BPH with compared to baseline. The secondary objectives of this study are as follow: * To assess any adverse events related to the procedure or device. * To assess the operation related characteristics including: total operation time and ablation time required in HIFU procedure for BPH, total catheterization time after the HIFU procedure for BPH, and categorical ablation zone * To assess the patient's post operative pain level at different post op time points. * To assess the urinary flow and symptoms improvement by studying the changes in IPSS, Qmax, and PVR at different post op time points compared to the baseline. * To assess the effectiveness of HIFU by studying the changes in PSA levels, types of medication for BPH or any urologic condition, proportion of patients who are taking BPH medication, prostate volume, and prostate calcification level and the reoperation rate within 12-month post-op. * To assess changes in patients' sexual function at different post op time points. The hypothesis is that a HIFU ablation is a safe and effective treatment for patients with LUTS due to BOO from BPH.

Participants needed: 17
Trial details
Age: 45-80Biological sex: MaleType: InterventionalSponsor: Icahn School of Medicine at Mount SinaiUpdated: Apr 9, 2026Locations: 1
Eligibility criteria

Males aged 45 - 80 diagnosed with LUTS due to BOO from BPH. [+6]

BMI > 42 [+27]

Status: Recruiting

Fetal Cystoscopy for Severe Lower Urinary Tract Obstruction

The purpose of the study is to study the outcomes of maternal and fetal patients who are undergoing fetal intervention for severe isolated lower urinary tract obstruction (LUTO).

Participants needed: 10
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Rodrigo RuanoUpdated: Feb 24, 2026Locations: 2
Eligibility criteria

Pregnant women [+11]

Fetal anomaly unrelated to LUTO [+14]

Status: Not yet recruiting

Predictors of Trifecta Achievement After HoLEP

Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment option for men experiencing bothersome lower urinary tract symptoms due to an enlarged prostate. Researchers predict that specific participant or operator-dependent conditions before or during HoLEP may influence the trifecta outcome, based on similar studies. Therefore, the aim of this study is to understand what these conditions are. Trifecta success indicates a high-quality surgery based on three essential criteria: the treatment's effectiveness, ease of recovery, and the absence of serious side effects. In this study, trifecta is defined as relief from bothersome symptoms validated by international symptom score questionnaires, no urinary incontinence, and no serious events occurring within three months after HoLEP.

Participants needed: 604
Trial details
Age: 40+Biological sex: MaleType: InterventionalSponsor: Ondokuz Mayıs UniversityUpdated: Feb 24, 2026Locations: 1
Eligibility criteria

All male patients aged ≥ 40 years who are candidates for surgical treatment for... [+1]

Clinically proven active condition(s) that require another intervention other th... [+2]

Status: Not yet recruiting

Urinary CTGF in Benign Prostatic Obstruction

Benign prostatic obstruction (BPO) is one of the most common causes of bladder outlet obstruction (BOO) and may lead to progressive structural and functional alterations in the bladder over time. Prolonged obstruction triggers a bladder remodeling process characterized by detrusor hypertrophy, ischemia-reperfusion injury, smooth muscle loss, and progressive fibrosis. These pathological changes may result in impaired detrusor contractility, increased post-void residual volume, and suboptimal functional recovery following surgical treatment. Connective tissue growth factor (CTGF) is a matricellular protein that plays a key role in fibrogenesis and is markedly upregulated under hypoxic, ischemia-reperfusion, and inflammatory conditions. Experimental and cellular studies have demonstrated that CTGF promotes fibroblast proliferation, extracellular matrix production, and collagen deposition, thereby contributing to bladder fibrosis. Increased CTGF expression has also been associated with fibrotic differentiation of bladder smooth muscle cells. The aim of this observational study is to evaluate the relationship between urinary CTGF levels, bladder fibrosis, and functional response to surgical treatment in patients with benign prostatic obstruction. Preoperative urinary CTGF levels will be assessed and correlated with postoperative functional outcomes and clinical improvement. This study aims to determine whether urinary CTGF may serve as a non-invasive biomarker of bladder fibrosis and a potential predictor of surgical treatment response in patients with BPO.

Participants needed: 50
Trial details
Age: 40+Biological sex: MaleType: ObservationalSponsor: Tarik Emre SenerUpdated: Feb 18, 2026
Eligibility criteria

Diagnosis of benign prostatic obstruction (BPO), with or without an indwelling c... [+1]

Age < 40 years [+11]