Clinical trials: Urge Incontinence
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
Urge Urinary Incontinence
Post Approval Effectiveness and Durability Evaluation of the Altaviva™ Tibial Device
The purpose of this prospective, multicenter study is to assess the long-term safety and effectiveness of the Altaviva™ system for the treatment of UUI
- Trial name
- ENDURANCE™ (NCT07456865)
- Testing
- Altaviva™ system
- Where
- 19 sites in United States
- Volunteers
- 256 people
- Sponsor
- MedtronicNeuro
Overactive Bladder, Urge Incontinence
A Real World Study of eCoin for Urgency Urinary Incontinence: Post Approval Evaluation (RECIPE)
A prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the eCoin® implanted tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
- Conditions
- Overactive Bladder, Urge Incontinence, Incontinence, Urinary, Urinary Urge Incontinence
- Trial name
- RECIPE (NCT05685433)
- Testing
- eCoin Tibial Nerve Stimulation
- Where
- 22 sites in United States
- Volunteers
- 200 people
- Sponsor
- Valencia Technologies Corporation
Urinary Urge Incontinence
Neuspera Revision Registry - Follow up Revision Experience and Evaluation of Device Outcomes Metrics
Single-arm study where subjects' responses to a questionnaire for the traditional Sacral Neuromodulation (SNM) devices will be compared to the responses regarding the Neuspera SNM System.
- Trial name
- NCT07383688
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neuspera Medical, Inc.
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
F15 Recharge Free Axonics SNM System Clinical Study
Multicenter, prospective, non randomized, single arm evaluation of patients with overactive bladder (OAB) and/or fecal incontinence (FI) employing the Axonics recharge free SNM System.
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI)
- Trial name
- NCT06186765
- Testing
- Axonics SNM System (Model 4101)
- Where
- 16 sites in United States, Netherlands and 1 more
- Volunteers
- 144 people
- Sponsor
- Axonics, Inc.
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Overactive Bladder (OAB)
- Trial name
- NCT06789406
- Testing
- Axonics SNM System INS Model 5101 (R20)
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 55 people
- Sponsor
- Axonics, Inc.
Urinary Urge Incontinence (UUI), Urinary Frequency (UF)
Aquarius Pilot Study to Evaluate the New Axonics Trial System
Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and/or fecal incontinence (FI).
- Conditions
- Urinary Urge Incontinence (UUI), Urinary Frequency (UF), Fecal Incontinence (FI), Overactive Bladder (OAB)
- Trial name
- NCT07335484
- Testing
- Axonics External Trial System (ETS)
- Where
- 5 sites in United States, Australia
- Volunteers
- 75 people
- Sponsor
- Axonics, Inc.
Urinary Incontinence, Urinary Obstruction
NXT Post-Market Clinical Follow-up
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
- Conditions
- Urinary Incontinence, Urinary Obstruction, Urinary Bladder, Overactive, Urinary Bladder, Neurogenic
- Trial name
- NCT06336304
- Testing
- Urodynamic procedure
- Where
- 5 sites in United States
- Volunteers
- 163 people
- Sponsor
- Laborie Medical Technologies Inc.
Urinary Urge Incontinence
RESTORE: An RCT to Evaluate the Efficacy of the Revi System
The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.
- Trial name
- NCT06217328
- Testing
- Revi System Treatment, Revi System - Delayed Activation
- Where
- 19 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- BlueWind Medical
Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI)
Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)
Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.
- Conditions
- Mixed Urinary Incontinence, Stress Urinary Incontinence (SUI), Chronic Pelvic Pain, Urge Urinary Incontinence
- Trial name
- AURA-4X (NCT06885931)
- Testing
- Pudendal neuromodulation
- Where
- 7 sites in Belgium, Netherlands and 1 more
- Volunteers
- 86 people
- Sponsor
- Amber Therapeutics Ltd
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
Urinary Urge Incontinence
Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
Single-arm study conducted in participants for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments.
- Trial name
- NCT07247136
- Testing
- Neuspera Implantable Sacral Neuromodulation System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Neuspera Medical, Inc.
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)
UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder/bowel musculature…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Fecal Incontinence, Fecal Incontinence With Fecal Urgency
- Trial name
- NCT06091566
- Testing
- UCon-Bar
- Where
- 3 sites in Denmark
- Volunteers
- 20 people
- Sponsor
- InnoCon Medical
Overactive Bladder, Overactive Bladder (OAB)
Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women
The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication.
- Conditions
- Overactive Bladder, Overactive Bladder (OAB), Urge Urinary Incontinence, Mixed Urinary Incontinence (Urge-Predominant)
- Trial name
- DENARA (NCT07209397)
- Testing
- Detrusor nerve radiofrequency ablation
- Where
- 9 sites in United States
- Volunteers
- 202 people
- Sponsor
- InMode MD Ltd.
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 Incontinence, Urge Incontinence
UCon Treatment of Overactive Bladder (OAB) in Males
UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired…
- Conditions
- Urinary Incontinence, Urge Incontinence, Nocturia, Urinary Frequency More Than Once at Night
- Trial name
- NCT05874375
- Testing
- Urge stimulation, Time limited stimulation
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- InnoCon Medical
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.
Overactive Bladder Syndrome, Urinary Urge Incontinence
Cycling Study With the Axonics System
A prospective, multi-center, study comparing continuous sacral neuromodulation (SNM) stimulation to daily cyclic stimulation of 2 hours "on" and 22 hours "off" using the Axonics System.
- Conditions
- Overactive Bladder Syndrome, Urinary Urge Incontinence, Sacral Neuromodulation
- Trial name
- NCT05543382
- Testing
- Axonics System
- Where
- 6 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Axonics, Inc.