Fecal IncontinencePhase 1NCT01666405
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
A Phase 1 study testing Urgent(R) PC Neuromodulation System in people with Fecal Incontinence, run by Uroplasty, Inc at 6 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Urgent(R) PC Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 6 sitesUnited States
- Study dates
- Aug 2012to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter)
- Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.)
Who cannot join
- Pregnancy or intention to become pregnant during the course of the study
- Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.)
- Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function
- Prone to excessive bleeding or bleeding diathesis
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Lindner Center for Research and Education at The Christ Hospital
Cincinnati, Ohio, 45219
Colorectal Surgical Asociates
Houston, Texas, 77054
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
Minnesota Colon and Rectal Surgery Associates, Ltd.
Minneapolis, Minnesota, 55407
UCSF Center for Colorectal Surgery
San Francisco, California, 94158
Providence Health and Services
Spokane, Washington, 99204
About this study
Official title: A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).
Read the detailed description
Pilot Study
- Conditions
- Fecal Incontinence
- Being tested
- Urgent(R) PC Neuromodulation System
- Keywords
- Fecal Incontinence, Bowel Incontinence
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urgent(R) PC Neuromodulation SystemDevice
The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS).
| Study group | Role | What they receive |
|---|---|---|
| Urgent(R) PC Neuromodulation System | Experimental | Urgent(R) PC Neuromodulation System Receives: Device: Urgent(R) PC Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline
Measured: 18 weeks
Safety
To characterize adverse events experienced throughout the study
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: business reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uroplasty, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666405
- Sponsor's protocol ID
- UPC032012
- Status last verified
- Oct 2015
- First submitted
- 10 Aug 2012
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal Incontinence
- ClinicalTrials.gov ID
- NCT01666405
- Acronym / sponsor ID
- UPC032012
- Conditions
- Fecal Incontinence
- Keywords
- Fecal Incontinence, Bowel Incontinence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: business reasons
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Uroplasty, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of percutaneous tibial nerve stimulation (PTNS) therapy with the Urgent® PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA) for the treatment of fecal incontinence (FI).
Detailed description
Pilot Study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urgent(R) PC Neuromodulation System | Experimental | Device: Urgent(R) PC Neuromodulation SystemUrgent(R) PC Neuromodulation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient history of chronic FI of more than staining for at least 6 months; staining defined as less than the size of a 25¢ piece (quarter)
- Patient reported and/or failed ≥ 2 conservative therapies (e.g., diet/fiber modification, anti-diarrheal medication, pelvic floor muscle training, biofeedback, medical management, etc.)
Key exclusion criteria (4 listed)
- Pregnancy or intention to become pregnant during the course of the study
- Implanted electro-medical device (i.e., pacemaker, defibrillator, deep brain stimulator, etc.)
- Clinically significant neurological diseases or nerve damage impacting tibial nerve or pelvic floor function
- Prone to excessive bleeding or bleeding diathesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urgent(R) PC Neuromodulation SystemThe Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS). | Device | Urgent(R) PC Neuromodulation System |
Primary outcome
Effectiveness
Time frame: 18 weeks
To assess the effectiveness of PTNS by measuring the proportion of patients with ≥50% decrease in the number of fecal incontinence episodes per week based on the results of the 14-day bowel diary at 18 weeks compared to baseline
Safety
Time frame: 18 weeks
To characterize adverse events experienced throughout the study
Results and safety
The study was stopped early (reason given: business reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
Related trials for Fecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Urgent(R) PC Neuromodulation System in people with Fecal Incontinence, run by Uroplasty, Inc at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: business reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.