Clinical trials: Fecal Incontinence
Fecal Incontinence
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal…
- Trial name
- DigniFI (NCT05776277)
- Testing
- Iltamiocel
- Where
- 25 sites in United States
- Volunteers
- 200 people
- Sponsor
- Cook MyoSite
Overactive Bladder, Fecal Incontinence
Pelvic Health Electrically Evoked Recording (PEER) 2 Study
To collect physiological signals at several timepoints during the therapy evaluation period.
- Conditions
- Overactive Bladder, Fecal Incontinence, Urinary Retention
- Trial name
- PEER 2 (NCT05200923)
- Testing
- Sacral Neuromodulation
- Where
- 7 sites in United States
- Volunteers
- 300 people
- Sponsor
- MedtronicNeuro
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)
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.
Fecal Incontinence
Axonics R20 Post-Market Clinical Follow-up (PMCF) Study for the Indication of Fecal Incontinence
Single-Arm, multi-center, prospective, open-label registry study for commercially available rechargeable implantable neurostimulator (INS model 5101); also referred to as R20.
- Trial name
- NCT07499258
- Testing
- Axonics SNM System INS Model 5101 (R20)
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 55 people
- Sponsor
- Axonics, Inc.
Incontinence, Urinary, Incontinence, Fecal
Testing the Protective and Caring Effect of a Water-in-oil Formulation in Patients Suffering From Urinary and/or Fecal Incontinence and Requiring Incontinence Care Products
The aim of this study is to test the protecting and caring effect of a protective balm on patients suffering from urinary and/or fecal incontinence and need incontinence care products.
- Trial name
- NCT06924502
- Testing
- Protective Balm
- Where
- Germany
- Volunteers
- 33 people
- Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
Fecal Incontinence
Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence
The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction…
- Trial name
- Fidelia (NCT04976153)
- Testing
- aSMDC
- Where
- 34 sites in Austria, Bulgaria and 10 more
- Volunteers
- 290 people
- Sponsor
- Innovacell GmbH
Fecal Incontinence
Safety and Performance of a Silicone Implant for Fecal Incontinence Treatment (SimplyFI)
The purpose of the clinical investigation is to verify that the device under investigation (SimplyFI) is appropriate to significantly improve fecal incontinence in patients in whom its use is indicated.
- Trial name
- NCT05708612
- Testing
- Medical Device (SimplyFI)
- Where
- 5 sites in Austria, Germany and 1 more
- Volunteers
- 36 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Fecal Incontinence (FI)
Safety and Feasibility Evaluation of ALVIV Laser Based Treatment for Fecal Incontinence
The purpose if this interventional First in Human study is to assess the Safety and Performance of the ALVIV System laser based treatment in patients diagnosed with Fecal Incontinence.
- Trial name
- NCT07436676
- Testing
- ALVIV Laser Treatment
- Where
- Israel
- Volunteers
- 12 people
- Sponsor
- Alviv Ltd.
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
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.
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
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
Urinary Incontinence, Urinary Incontinence, Urge
Safety and Performance of UCon Patch Electrode
UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder/bowel musculature e.g.…
- Conditions
- Urinary Incontinence, Urinary Incontinence, Urge, Nocturia, Urinary Frequency More Than Once at Night
- Trial name
- NCT06754189
- Testing
- Time Limited stimulation
- Where
- 3 sites in Denmark
- Volunteers
- 180 people
- Sponsor
- InnoCon Medical
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
Dermatitis
A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)
The purpose of this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis.
- Trial name
- NCT02724449
- Testing
- Cavilon Advanced Barrier Film
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC
Neurogenic Bowel (Disorder), Fecal Constipation
Comparing Transanal Irrigation With Navina Smart vs. Standard Bowel Care in Patients With Multiple Sclerosis
A randomized, superiority, controlled, interventional, prospective, multicentre, post-market study of TAI with Navina™ Smart versus Standard Bowel Care performed in a population of 92 subjects suffering from Multiple Sclerosis…
- Conditions
- Neurogenic Bowel (Disorder), Fecal Constipation, Fecal Incontinence, Multiple Sclerosis
- Trial name
- NCT04707976
- Testing
- Navina Smart, Standard Bowel Care
- Where
- 9 sites in Denmark, France and 4 more
- Volunteers
- 92 people
- Sponsor
- Wellspect HealthCare
Fecal Incontinence
Autologous Cell Therapy for Treatment of Fecal Incontinence
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment…
- Trial name
- NCT01600755
- Testing
- Iltamiocel
- Where
- 2 sites in Canada, United Kingdom
- Volunteers
- 53 people
- Sponsor
- Cook MyoSite
Urinary Incontinence, Fecal Incontinence
Safety and Performance of UCon for the Treatment of the Symptoms of Overactive Bladder (OAB) / Bowel Dysfunction (BD)
This clinical investigation is a single-arm, prospective, multicentre, early feasibility study, which is used to evaluate the device design of UCon with respect to initial clinical safety and device performance in a small number…
- Conditions
- Urinary Incontinence, Fecal Incontinence, Urge Incontinence, Nocturia
- Trial name
- NCT05368246
- Testing
- UCon
- Where
- 3 sites in Denmark
- Volunteers
- 80 people
- Sponsor
- InnoCon Medical
Fecal Incontinence
A Feasibility Study of a Fecal Incontinence Management System for Medical Use
The purpose of this feasibility study is to evaluate the performance and skin-friendliness of the barrier of the Fecal Incontinence Management System.
- Trial name
- NCT00556972
- Testing
- Fecal Incontinence Management System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Coloplast A/S