Clinical trials: Urinary Incontinence
Urinary Incontinence
This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Overnight in the Home Setting.
This post-market study will assess the performance of and user satisfaction with the PureWick® Male External Catheter in a home setting.
- Trial name
- PUREST-M (NCT06850259)
- Testing
- PureWick® Urine Collection System, UltraFlex™ Self-Adhering Male External Catheter
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- C. R. Bard
Urinary Incontinence, Stress
A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence
The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device…
- Trial name
- NCT04115605
- Testing
- Altis Single Incision Sling
- Where
- 33 sites in Belgium, France and 3 more
- Volunteers
- 598 people
- Sponsor
- Coloplast A/S
Urinary Incontinence,Stress, Urinary Incontinence, Urge
RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application
This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health…
- Conditions
- Urinary Incontinence,Stress, Urinary Incontinence, Urge, Urinary Incontinence, Overactive Bladder Syndrome
- Trial name
- DINKS (NCT06389838)
- Testing
- Kranus Mictera
- Where
- Germany
- Volunteers
- 194 people
- Sponsor
- Kranus Health GmbH
Stress Urinary Incontinence
Pippa Pessary Study (Clinical Trial)
This is an open label, interventional, single arm, multi-clinic study where each adult female participant with stress urinary incontinence (SUI) serves as her own control (vaginal pessary use vs. no vaginal pessary).
- Trial name
- NCT05611970
- Testing
- Vaginal pessary
- Where
- 3 sites in United States
- Volunteers
- 7 people
- Sponsor
- Liv Labs Inc.
Stress Urinary Incontinence
Artificial Urinary Sphincter Clinical Outcomes
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
- Trial name
- AUSCO (NCT04088331)
- Testing
- AMS 800 Artificial Urinary Sphincter
- Where
- 18 sites in United States, Australia
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Urologic Diseases, Urodynamics
Modern Urodynamics System Efficacy (MUSE) Study
The goal of this prospective trial is to evaluate the feasibility, efficacy, and safety of the Glean Urodynamics System (GUS) for use in the clinic to collect vesical pressure data in adult males and females with lower urinary…
- Trial name
- MUSE (NCT05959655)
- Testing
- Glean Urodynamics System
- Where
- 5 sites in United States
- Volunteers
- 38 people
- Sponsor
- Bright Uro
Urinary Incontinence
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator…
- Trial name
- CP341 (NCT05224544)
- Testing
- Investigational prototype device, Comparator device
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Urinary Urgency Incontinence
Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases.
- Trial name
- NCT04232696
- Testing
- Neuspera Implantable Sacral Nerve Stimulation System
- Where
- 34 sites in United States, Belgium and 1 more
- Volunteers
- 331 people
- Sponsor
- Neuspera Medical, Inc.
Urge Incontinence
Effectiveness of eCoin at Sensory and Subsensory Amplitudes
The goal of this prospective, multi-center, double-blinded randomized controlled is to learn about effectiveness and QOL with eCoin at two different amplitude settings in subjects with urge urinary incontincence (UUI).
- Trial name
- ESSENCE (NCT05882318)
- Testing
- eCoin Peripheral Neurostimulator System
- Where
- 7 sites in United States
- Volunteers
- 38 people
- Sponsor
- Valencia Technologies Corporation
Urinary Incontinence, Urge
Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt
The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed…
- Trial name
- ARTISAN-SNM (NCT03327948)
- Testing
- Axonics Sacral Neuromodulation System (SNM) System
- Where
- 4 sites in United States, Netherlands and 1 more
- Volunteers
- 129 people
- Sponsor
- Axonics, Inc.
Overactive Bladder, Urge Incontinence
Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence
This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI).
- Conditions
- Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
- Trial name
- NCT03556891
- Testing
- eCoin Tibial Nerve Stimulation
- Where
- 15 sites in United States
- Volunteers
- 133 people
- Sponsor
- Valencia Technologies Corporation
Urinary Retention, Urinary Urge Incontinence
Axonics SacRal NeuromodulaTIon System RegisTRY Study
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
- Conditions
- Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence
- Trial name
- ARTISTRY (NCT05064384)
- Where
- 27 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Axonics, Inc.
Urinary Incontinence, Retention, Urinary
Performance of a Single-use Intermittent Micro-hole Zone Catheter
The goal of this randomized, controlled crossover study was to assess the performance of a new micro-hole zone catheter compared to a conventional 2-eyelet catheter in 42 male intermittent catheter users.
- Trial name
- NCT05485922
- Testing
- Investigational device - intermittent catheter with a micro-hole zone, Comparator device -VaPro intermittent catheter
- Where
- Denmark
- Volunteers
- 42 people
- Sponsor
- Coloplast A/S
Overactive Bladder, Urinary Frequency
FREEOAB Study for Overactive Bladder
This is a prospective, multicenter study that was conducted to evaluate the safety and efficacy of a novel, closed-loop, continuous-sensing wearable neuromodulation system for Overactive Bladder symptom control.
- Conditions
- Overactive Bladder, Urinary Frequency, Urinary Incontinence, Urge, Urinary Urgency
- Trial name
- NCT04547920
- Testing
- Wearable Bladder Modulation System
- Where
- 9 sites in United States
- Volunteers
- 96 people
- Sponsor
- Avation Medical, Inc.
Urinary Incontinence
Clinical Trial of New Intermittent Single-use Catheter
A multi-centre, open-labelled, randomised, crossover design. The total study duration for the individual subject will be approximately 4 weeks, consisting of four site visits and two 2-week test periods at home.
- Trial name
- NCT05814211
- Testing
- Investigational device - newly developed intermittent catheter, Comparator device #1 - SpeediCath Eve, Comparator device #2 - SpeediCath Compact Plus Female
- Where
- 11 sites in Denmark, France and 1 more
- Volunteers
- 82 people
- Sponsor
- Coloplast A/S
Urinary Incontinence
Clinical Trial of New Single-use Compact Intermittent Catheter
The study is a randomised, single-blinded, controlled crossover study. The total study duration for the individual subject will be between two days - two weeks, consisting of three site visits.
- Trial name
- NCT05841004
- Testing
- Investigational device, Comparator device
- Where
- Denmark
- Volunteers
- 73 people
- Sponsor
- Coloplast A/S
Stress Urinary Incontinence
Stress Incontinence Trial With Elitone Device
This is a randomized controlled study in which subjects are assigned to either a treatment group or a control (sham) group. Pre- and post-study outcome measures evaluate the change in incontinence episodes on women with…
- Trial name
- NCT03782116
- Testing
- Transcutaneous electrical stimulation (Elitone)
- Where
- United States
- Volunteers
- 87 people
- Sponsor
- Elidah, Inc.
Urge Incontinence
Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women
The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence.
- Trial name
- NCT04752709
- Testing
- ELITONE UUI
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Elidah, Inc.
Overactive Bladder, Fecal Incontinence
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
- Conditions
- Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention
- Trial name
- ELITE (NCT04506866)
- Testing
- InterStim Micro
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 148 people
- Sponsor
- MedtronicNeuro
Overactive Bladder (OAB)
Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)
The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.
- Trial name
- PILLAR (NCT02216214)
- Testing
- Mirabegron
- Where
- 120 sites in United States, Canada
- Volunteers
- 888 people
- Sponsor
- Astellas Pharma Global Development, Inc.