Clinical trials: Incontinence
Stress Urinary Incontinence
ProACT Post-Approval Study
The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation.
- Trial name
- NCT03767595
- Testing
- ProACT Adjustable Continence Therapy for Men
- Where
- 14 sites in United States
- Volunteers
- 145 people, healthy volunteers welcome
- Sponsor
- Uromedica
Stress Urinary Incontinence, Pelvic Organ Prolapse
Ethicon Pelvic Mesh Post Market Clinical Follow-up Registry
The objective of this post market, clinical registry is to evaluate the performance of the products of the TVT family of products or vaginal vault or uterine prolapse repair (with laparotomic or laparoscopic approach including…
- Trial name
- NCT04829175
- Testing
- Intervention
- Where
- 10 sites in United States, Austria and 5 more
- Volunteers
- 1,000 people
- Sponsor
- Ethicon, Inc.
Urinary Incontinence
A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy
The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of solifenacin succinate versus placebo in participants who are incontinent after Robotic Assisted Radical Prostatectomy.
- Trial name
- NCT01371994
- Testing
- solifenacin succinate
- Where
- 60 sites in United States, Canada
- Volunteers
- 640 people
- Sponsor
- Astellas Pharma Inc
Urinary Incontinence, Overactive Bladder With Urinary Incontinence
BOTOX® Intravesical Instillation in Participants With Overactive Bladder and Urinary Incontinence
This study will evaluate the efficacy and safety of BOTOX® intravesical instillation in participants with overactive bladder and urinary incontinence.
- Trial name
- APOLLO (NCT03320850)
- Testing
- OnabotulinumtoxinA and Hydrogel admixture
- Where
- 63 sites in United States, Canada
- Volunteers
- 383 people
- Sponsor
- Allergan
Fecal Incontinence
A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)
The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.
- Trial name
- LIFE (NCT01655498)
- Testing
- vaginal bowel control system (LivSure)
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Pelvalon, Inc.
Urinary Incontinence
Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.
- Trial name
- NCT03942484
- Testing
- rPMS device
- Where
- 5 sites in United States
- Volunteers
- 45 people
- Sponsor
- BTL Industries Ltd.
Stress Urinary Incontinence
Desara ® One Single Incision Sling 522 Study
A post-market study to compare the safety and effectiveness of the Desara® One Single Incision Sling (SIS), when compared to that of an FDA cleared transobturator sling over a period of 36 months.
- Trial name
- NCT04772131
- Testing
- Desara® One Single Incision Sling, Desara® Blue Transobturator Sling
- Where
- 15 sites in United States
- Volunteers
- 300 people
- Sponsor
- Caldera Medical, Inc.
Urge Incontinence
Protect Chronic Tibial Nerve Stimulator (CTNS) System
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.
- Trial name
- NCT02781636
- Testing
- Device: StimGuard Protect System
- Where
- Belgium
- Volunteers
- 10 people
- Sponsor
- Uro Medical Corporation
Fecal Incontinence
Effects of an Anal Insert Device in Fecal Incontinence
The purpose of this research is to test the effects of an inserted anal device on fecal incontinence (accidental bowel leakage) in patients who have persistent symptoms despite other conservative therapy.
- Trial name
- NCT03898778
- Testing
- Minnesota Medical Technologies Anal Insert Device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Minnesota Medical Technologies
Urinary Incontinence, Urinary Frequency
A Single-Arm Exploratory Study of NatureU Pelvic Health Pumpkin Seed in Women With Urinary Frequency and Leakage Symptoms
This was a single-center, open-label, single-arm, exploratory human study evaluating NatureU Pelvic Health Pumpkin Seed in adult women with urinary frequency and urinary leakage symptoms.
- Trial name
- NUPHPS (NCT07571616)
- Testing
- NatureU Pelvic Health Pumpkin Seed
- Where
- China
- Volunteers
- 19 people
- Sponsor
- OmniSolutions Laboratory Holdings Limited
Urinary Incontinence, Overactive Bladder
Tactile Imaging and Electromyography
Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate of 27.2% among man and 43.1% among women…
- Trial name
- NCT03477214
- Testing
- Biomechanical and electromyography mapping
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Advanced Tactile Imaging, Inc.
Urinary Incontinence, Overactive Bladder
Dysport® Treatment of Urinary Incontinence in Adults Subjects With Neurogenic Detrusor Overactivity (NDO) Due to Spinal Cord Injury or Multiple Sclerosis - Study 1
The purpose of this study is to provide confirmatory evidence of the safety and efficacy of two Dysport® (AbobotulinumtoxinA) doses (600 units [U] and 800 U), compared to placebo in reducing urinary incontinence (UI) in adult…
- Trial name
- CONTENT1 (NCT02660138)
- Testing
- Botulinum toxin type A
- Where
- 81 sites in United States, Canada and 8 more
- Volunteers
- 227 people
- Sponsor
- Ipsen
Fecal Incontinence
Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence
This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed…
- Trial name
- NCT05616208
- Testing
- Bioengineered Internal Anal Sphincter
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cellf Bio LLC
Incontinence
Impact on Elderly Skin Due to Wet Pad Application.
The clinical study aims to measure the changes in the stratum corneum on older healthy participants due to the application of a wet pad on the forearm.
- Trial name
- NCT06248255
- Testing
- Pads
- Where
- Sweden
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Essity Hygiene and Health AB
Urinary Incontinence
Conveen Optima Urisheaths With Collecting Bags Versus Absorbents
The objective of this investigation is to asses with validated scales, the impact on the quality of life of men suffering of moderate to severe incontinence of the use of Conveen Optima urisheath in comparison with their usual…
- Trial name
- NCT01056666
- Testing
- Conveen Optima is a urisheath to be used together with a collecting bag for urine, absorbent protection
- Volunteers
- 61 people
- Sponsor
- Coloplast A/S
Fecal Incontinence
Safety and Tolerability of a Single Intra-anal Dose of NRL001 in Healthy Volunteers
This study is conducted to explore the safety and tolerability and plasma pharmacokinetics of NRL001 after single intra-anal dose of 1mL cream at increasing concentrations.
- Trial name
- NCT01406925
- Testing
- NRL001 cream
- Where
- Bulgaria
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Norgine
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.
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
Urinary Incontinence, Urinary Bladder, Overactive
An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder
This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms have not been adequately managed by oral…
- Trial name
- GRACE (NCT02161159)
- Testing
- botulinum toxin Type A
- Where
- 54 sites in Germany, Spain and 2 more
- Volunteers
- 515 people
- Sponsor
- Allergan
Urinary Incontinence
Data Collection for Development of a Bladder Sensor During Urodynamics
This is an explorative, single-center, feasibility study using a prototype of a future Bladder Sensor to collect data during urodynamics.
- Trial name
- NCT05305846
- Testing
- TENA-PROTO2
- Where
- Netherlands
- Volunteers
- 66 people
- Sponsor
- Essity Hygiene and Health AB