Clinical trials: Lower Urinary Tract Symptom
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Efficacy and Safety of Two Fixed-dose Combinations in Men With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia. (BENIPRO)
The clinical trial to evaluate the fixed-dose combination (N0728), with the aim of providing the Brazilian market with an alternative, potentially effective, safe and convenient therapeutic approach for the treatment of Lower…
- Trial name
- BENIPRO (NCT06546735)
- Testing
- N0728, Vesomni®
- Where
- Brazil
- Volunteers
- 816 people
- Sponsor
- Eurofarma Laboratorios S.A.
Stress Urinary Incontinence
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female Stress Incontinence
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in…
- Trial name
- CELLEBRATE (NCT03104517)
- Testing
- AMDC-USR (iltamiocel)
- Where
- 21 sites in United States, United Kingdom
- Volunteers
- 96 people
- Sponsor
- Cook MyoSite
Urinary Incontinence, Urge, Urinary Bladder, Overactive
INTIBIA Pivotal Study
Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
- Conditions
- Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases
- Trial name
- NCT05250908
- Testing
- INTIBIA Therapeutic, INTIBIA Non-Therapeutic
- Where
- 22 sites in United States, Netherlands
- Volunteers
- 208 people
- Sponsor
- Coloplast A/S
Benign Prostatic Hyperplasia (BPH)
REZŪM vs. Dual Drug Therapy for Symptomatic Benign Prostatic Hyperplasia in Sexually Active Men
The study objective is to compare water vapor thermotherapy with the REZŪM™ System to dual drug therapy for the treatment of symptomatic benign prostatic hyperplasia refractory to alpha-blocker monotherapy in sexually active men.
- Trial name
- VAPEUR (NCT04838769)
- Testing
- REZŪM, alpha blocker and 5-alpha reductase inhibitor
- Where
- 21 sites in Australia, France
- Volunteers
- 155 people
- Sponsor
- Boston Scientific Corporation
Urinary Incontinence, Urinary Incontinence,Stress
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a…
- Trial name
- NCT04248283
- Testing
- Adjustable Continence Therapy for Women (ACT)
- Where
- 8 sites in United States, France
- Volunteers
- 167 people
- Sponsor
- Uromedica
Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia
Evaluation of the Safety, Tolerability, and Efficacy of the Omega System for the Treatment of LUTS Due to BPH
This is a prospective, two-stage, multi-center, pilot clinical study to evaluate the safety/tolerability/efficacy of the Omega System device.
- Trial name
- Omega (NCT05757687)
- Testing
- Omega device
- Where
- 5 sites in Georgia
- Volunteers
- 11 people
- Sponsor
- ProArc Medical
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH
The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH.
- Trial name
- NCT04627701
- Testing
- Omega
- Where
- 4 sites in Israel, New Zealand
- Volunteers
- 26 people
- Sponsor
- ProArc Medical
Lower Urinary Tract Symptoms (LUTS)
Effects of Macanity on Urinary Health in Males With Lower Urinary Tract Symptoms
The goal of this study is to evaluate the effects of Macanity on urinary health in males experiencing LUTS. Males aged over 40 years of age who experience LUTS will be recruited and assigned to a study treatment which they will…
- Trial name
- NCT07816172
- Testing
- Maca Root
- Where
- Australia
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- RDC Clinical Pty Ltd
Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
The Efficacy and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia
Objective: To evaluate the efficacy and safety of Silodosin Capsules in the treatment of Benign Prostatic Hyperplasia (BPH) with Lower Urinary Tract Symptoms (LUTS) compared with Tamsulosin Hydrochloride Sustained Release…
- Trial name
- NCT05551221
- Testing
- Silodosin Capsules, Tamsulosin
- Where
- 8 sites in China
- Volunteers
- 110 people
- Sponsor
- Xintian Pharmaceutical
BPH With Symptomatic Lower Urinary Tract Symptoms
ProVIDE Studies Post Exit Analysis
A study to collect data on the post-study exit incidence of secondary reintervention using alternate surgical LUTS therapy.
- Trial name
- NCT07680543
- Testing
- ProVee Urethral Expander System
- Volunteers
- 25 people
- Sponsor
- ProVerum Medical
BPH (Benign Prostatic Hyperplasia)
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…
- Trial name
- NCT07538622
- Testing
- Zenflow Spring System
- Where
- 8 sites in United States
- Volunteers
- 300 people
- Sponsor
- Zenflow, Inc.
Benign Prostatic Hyperplasia (BPH), Obstructive Lower Urinary Tract Symptoms (LUTS)
Prospective Post Market Clinical Trial for the Zenflow Spring System - A Minimally Invasive Treatment for LUTS Associated With BPH.
This is a prospective, randomized, open-label, parallel-group post-market clinical trial (PMCT). The overall objective of this PMCT is to compare the effectiveness, durability, and patient-centered outcomes of the Zenflow Spring…
- Conditions
- Benign Prostatic Hyperplasia (BPH), Obstructive Lower Urinary Tract Symptoms (LUTS), Enlarged Prostate
- Trial name
- NCT07797348
- Testing
- Zenflow Arm: Zenflow Spring System implant procedure, Medical Therapy Tamsulosin
- Volunteers
- 110 people
- Sponsor
- Zenflow, Inc.
Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia)
Sonablate HIFU International Registry for PC & BPH Patients
The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system.
- Conditions
- Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia), Prostate Cancer; Benign Prostatic Hyperplasia
- Trial name
- SONAFUSION (NCT07757490)
- Testing
- High Intensity Focused Ultrasound
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- Sonablate
BPH With Symptomatic Lower Urinary Tract Symptoms
ProVee Urethral Expander System IDE Study (ProVIDE)
A study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia…
- Trial name
- ProVIDE (NCT05186740)
- Testing
- ProVee Urethral Expander System, Urethral Access Sheath
- Where
- 16 sites in United States, Canada and 1 more
- Volunteers
- 221 people, healthy volunteers welcome
- Sponsor
- ProVerum Medical
Lower Urinary Tract Symptoms (LUTS)
Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy Adults
A prospective, open-label, single arm interventional trial to establish normative reference ranges for urodynamics parameters in healthy adult participants using using the Glean Urodynamics System.
- Trial name
- NCT07485205
- Testing
- Glean Urodynamics System
- Where
- 3 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Bright Uro
BPH With Symptomatic Lower Urinary Tract Symptoms
ProVIDE II Bridging Study
The purpose of the ProVIDE II Bridging Study is to evaluate the performance of the Generation II delivery system when deploying the ProVee expander in subjects with symptomatic urinary obstruction secondary to BPH.
- Trial name
- NCT06236802
- Testing
- ProVee device
- Where
- 8 sites in United States, Ireland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- ProVerum Medical
Benign Prostatic Hyperplasia
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms
The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the…
- Trial name
- RAPID-III (NCT06849258)
- Testing
- FloStent
- Where
- 20 sites in United States, Australia
- Volunteers
- 215 people
- Sponsor
- Rivermark Medical
Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
Irreversible Electroporation (IRE) for the Treatment of Lower Urinary Tract Symptoms (LUTS) in Men With Benign Prostatic Hyperplasia (BPH)
This study will evaluate the safety and effectiveness of using Irreversible Electroporation (IRE) for the treatment of symptomatic benign prostatic hyperplasia (BPH).
- Trial name
- RELIEF (NCT07640776)
- Testing
- Irreversible Electroporation
- Volunteers
- 40 people
- Sponsor
- Angiodynamics, Inc.
BPH (Benign Prostatic Hyperplasia), Lower Urinary Tract Symptoms (LUTS)
Butterfly Pivotal Study
A prospective, multicenter, blind randomized (2:1) controlled study comparing the International Prostate Symptom Score (IPSS) of the Active arm to the IPSS of the control arm at the 3 months follow-up and active arm IPSS score…
- Trial name
- NCT05341661
- Testing
- Butterfly Prostatic Retraction Device
- Where
- 3 sites in United States
- Volunteers
- 245 people
- Sponsor
- Butterfly Medical Ltd.
Urethral Stricture
ROBUST III- Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease
ROBUST III is a prospective, multi-center, randomized controlled adaptive sample size clinical trial to establish the safety and effectiveness for the Optilume Stricture Drug Coated Balloon (DCB).
- Trial name
- ROBUST-III (NCT03499964)
- Testing
- Optilume Drug Coated Balloon (DCB), Control Treatment
- Where
- 22 sites in United States, Canada
- Volunteers
- 127 people
- Sponsor
- Urotronic Inc.