Urinary Incontinence, UrgePROTECTNCT02577302
CAN-Stim Compared to SNS in Treatment of Urinary Urgency Incontinence With Wireless Neuromodulation Technology
A study testing CAN-Stim - Protect CAN-Stim System and SNS - InterStim® System in people with Urinary Incontinence, Urge, run by Uro Medical Corporation at 15 sites in United States.
Trial summary
This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system. Subjects from both groups will immediately start with therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Incontinence, Urge
- What is being tested?
- CAN-Stim - Protect CAN-Stim System and SNS - InterStim® System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Jun 2018to Oct 2025
- Phase
- Interventional
- 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
- Diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence (urge and stress) with predominate urge, as confirmed by the MESA questionnaire;
- Women and men ≥ 18 years of age;
- Women of child-bearing age willing to practice birth control;
- At least 4 incontinent episodes associated with urgency on a 3-day voiding diary;
- At least 10 voids per day;
- Average urgency score of at least 2 as measured with IUSS on a 3-day voiding diary;
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- Self-reported bladder symptoms present > 6 months;
- Documented failure of an adequate trial of first and second line therapy;
- Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment;
- If on Tricyclic antidepressants, dosage must be stabilized for at least 3 months;
- Have no active urethral obstruction/stricture, bladder calculi or bladder tumor based on medical history;
- Normal upper urinary tract function based on medical history;
- Based on the medical opinion of the Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
- Based on the medical opinion of the Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
- Based on the medical opinion of the Investigator, subject is a good surgical subject for the implant procedure;
- Capable of giving informed consent;
- Capable and willing to follow all study related procedures.
Who cannot join
- An active implantable electronic device regardless of whether stimulation is ON or OFF;
- Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period;
- Primary complaint of stress urinary incontinence;
- Less than 1 year post-partum and/or are breast-feeding;
- Neurogenic bladder (i.e. Multiple sclerosis, Parkinson's, Spinal Cord Injury);
- Patients with spinal hardware that would limit access to the sacrum;
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- Botox use in bladder or pelvic floor muscles in the past nine months;
- Have a post-void residual urine volume >150 cc at baseline;
- Current urinary tract infection (UTI);
- Previous treatment with sacral neuromodulation;
- Previous treatment with percutaneous tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days;
- Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures;
- Inability to operate the CAN-Stim System or InterStim System;
- Diabetes with peripheral nerve compromise or severe uncontrolled diabetes (HbA1C 8.5 or greater);
- History of coagulopathy or bleeding disorder;
- History of pelvic pain as primary diagnosis (VAS score of > 4) at baseline;
- Anatomical restrictions such that device placement is not possible;
- Are currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function;
- Have a life expectancy of less than 1 year;
- Cannot independently comprehend and complete the questionnaires and diaries;
- Deemed unsuitable for enrollment by the investigator based on history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy);
- Dependent on wearable, transcutaneous, or other therapeutic medical device (examples: glucose monitor, TENS) for treatment of a disease or disorder.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites, 13 recruiting
- Recruiting
Integrated Pain Specialists
Columbus, Ohio, 43240
Melissa Simons, 614-383-6450 ext. 5, msimons.ips@gmail.com
Rachel Garey, 614-264-7070, rgarey@centralohiourology.com
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Allison Beaver, 214-645-8787, Allison.Beaver@UTSouthwestern.edu
Gary Lemack, MD
- Recruiting
Advanced Urology Institute
Daytona Beach, Florida, 32114
Jonelle Horsley, 386-239-8500, jonelle.horsley@auihealth.com
Jorge Rodriguez, 386-239-8500, jorge.rodriguez@auihealth.com
- Recruiting
Tilda Research Inc
Laguna Hills, California, 92653
Justin Deck, 949-680-3490, jdeck@tilda.bio
Kenneth Deck, MD
- Recruiting
Kaiser Permanente
Los Angeles, California, 90027
Isabel Gallegos, 323-783-5081, Isabel.Gallegos@kp.org
Christopher Tenggardjaja
- Withdrawn
Baptist Health Miami Cancer Institute
Miami, Florida, 33176
- Recruiting
Urology - Iris Cantor Men's Health Center
New York, New York, 10065
Ahra Cho, 646-962-9395, ahc4001@med.cornell.edu
Bilal Chughtai, MD
- Active, not recruiting
University of Oklahoma health Sciences Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Adult & Pediatric Urology, P.C.
Omaha, Nebraska, 10707
Amy Nelson, 402-399-7892, Anelson@adultpediatricuro.com
Rebecca McCrery, MD
- Recruiting
University of California Irvine Medical Center
Orange, California, 92868
Phuong Linh Huynh, MPH, 714-456-6155, plhuynh@uci.edu
Felicia Lane, MD
- Recruiting
Westview Clinical Research
Placentia, California, 92870
Uyen Kim Hoang, 562-343-7181, uyenhoang@wcr8.com
Albert Lai, MD
- Recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
Amanda Schonhoff, RN, 248-551-1225, Amanda.Schonhoff@beaumont.org
Angela Waldvogel, RN, (248) 551 2572, Angela.Waldvogel@beaumont.org
- Recruiting
St. Louis Pain Consultants
St Louis, Missouri, 63017
Kermit Mclauchlin, kermet.mclauchlin@stl-pain.com
Kim Scally, 314-315-9905, kimS@metrourology.net
- Recruiting
Stony Brook University Medical Center
Stony Brook, New York, 11794
Margaret Brand, 631-813-0540, Margaret.brand@stonybrookmedicine.edu
Jason Kim, MD
- Recruiting
Florida Urology Partners
Tampa, Florida, 33615
Linda Seibert, 239-223-4488, linda@gulfcoastcta.com
Osvaldo Padron
About this study
Official title: Multi-center, Prospective, Randomized, Controlled, Non-Inferiority, Clinical Trial of Chronic Afferent Nerve Stimulation (CAN-Stim) of the Tibial Nerve Versus Sacral Nerve Stimulation (SNS) in the Treatment of Urinary Urgency Incontinence Resulting From Refractory Overactive Bladder (OAB)
This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system. Subjects from both groups will immediately start with therapy. The primary endpoint is a ≥ 50% reduction in number of incontinence episodes associated with urgency at the 3-month visit, with additional measurements assessed at 14 days, 1, 6, 9 and 12-months.
Read the detailed description
Subjects will be randomized at baseline to either CAN-Stim or SNS InterStim® after inclusion and exclusion criteria have been met, 150 subjects will be randomized in to either arm of the study (89 subjects each arm).
At the following visit, CAN-Stim subjects will be immediately implanted unilaterally with a permanent device (implantation side up to investigators discretion). During implantation, the subject should feel pulsation in their foot with or without toe flexion, confirming stimulation of the tibial nerve. Subjects not achieving this motor response will not have the device implanted and will be exited from the study. Implanted subjects will be educated on the use of the transmitter and programmer. Programming parameters will be set and therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Programming changes can be done as needed during this time period to maximize clinical response. At the 2-week visit, diaries will be reviewed and confirmed for accuracy and discrepancies and the number of urgency incontinence episodes will be calculated and compared to baseline diaries. Subjects who are considered a responder at the 2-week follow-up visit (>50% improvement in urgency related incontinence episodes) will continue therapy and followed for a total of 12 months with primary outcomes assessed at 3 months. Non-responders will be offered an explant of the device and will exit the study. Subjects having less than 50% improvement may choose to keep the device. These subjects will be followed for adverse events with phone calls at 3, 6 and 12 months.
Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study. Subjects, who respond intraoperatively, will have the extension lead connected and externalized in the standard fashion. Subjects may have their InterStim® activated 24 hours/day, but a minimum of 8 hours per day for 2 weeks is required to remain in the study. Programming changes can be done as needed during this time period to maximize the clinical effect. At the 2-week visit, diaries will be reviewed and confirmed for accuracy and clarified for discrepancies and the number of urgency incontinence episodes will be calculated and compared to baseline diaries. Patients achieving a clinical response (>50% improvement in urgency related incontinence episodes) will undergo implantation of a pulse generator and removal of the percutaneous extension lead. The IPG will be programmed in the standard fashion using settings that were working for the patient during the 2-week trial. Subjects implanted with the InterStim® device will be monitored for a total of 12 months with primary outcomes assessed at 3 months. Non-responders will be offered an explant of the device and will exit the study. Subjects having less than 50% improvement may choose to keep the device. These subjects will be followed for adverse events with phone calls at 3, 6 and 12 months.
- Conditions
- Urinary Incontinence, Urge
- Being tested
- CAN-Stim - Protect CAN-Stim System, SNS - InterStim® System
- Keywords
- Chronic Tibial nerve stimulation, Wireless PNS, neuromodulation
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN-Stim - Protect CAN-Stim SystemDevice
CAN-Stim subjects will be implanted unilaterally (implantation side is up to the investigators discretion) with the CAN-Stim System. Subjects will be educated on the use of the transmitter and programmer. Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will continue therapy and followed for a total of 12 months.
SNS - InterStim® SystemDevice
Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study.Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will receive a full implant and followed for a total of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| CAN-Stim Group - CAN-Stim System | Experimental | Intervention: tibial medical device
Subjects randomized to this group will have the Protect CAN-Stim System tibial medical device implanted for the duration of the study. Receives: Device: CAN-Stim - Protect CAN-Stim System |
| SNS Group - Interstim® System | Active comparator | Intervention: SNS Medical device
Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study. Receives: Device: SNS - InterStim® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
The primary efficacy endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 3 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is taken as an average of two 3-day consecutive bladder diaries, with at least 24 hours between when the first diary ends and the second diary begins
Measured: 3 Months
device- and procedure-related Adverse Events (AE)
The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 3 months in the CAN-Stim and SNS groups.
Measured: 3 Months
Secondary outcomes (4)
Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
The endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 6 and 12 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is collected with a voiding diary.
Measured: 6,12 Months
device- and procedure-related Adverse Events (AE)
The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 6 and 12 months in the CAN-Stim and SNS groups.
Measured: 6,12 Months
Voiding Frequency
The achievement in each subject of a ≥ 50% reduction in the number of voids or a return to normal voiding frequency (< 8 voids/day) from baseline to 3-, 6-, and 12-month follow-up in the CAN-stim group compared to the InterStim® group;
Measured: 3, 6,12 Months
Reduction in degree of urgency
A reduction in the degree of urgency as measured with the Indevus Urgency Severity Scale (IUSS) in the CAN-Stim group compared to the InterStim® group.
Measured: 3, 6,12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start21 Jun 2018
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, UrgeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Controlled, Non-Inferiority
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uro Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577302
- Sponsor's protocol ID
- 30-00137
- Acronym
- PROTECT
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2015
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: upon study completion
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Randomized, Controlled, Non-Inferiority, Clinical Trial of Chronic Afferent Nerve Stimulation (CAN-Stim) of the Tibial Nerve Versus Sacral Nerve Stimulation (SNS) in the Treatment of Urinary Urgency Incontinence Resulting From Refractory Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT02577302
- Acronym / sponsor ID
- PROTECT / 30-00137
- Conditions
- Urinary Incontinence, Urge
- Keywords
- Chronic Tibial nerve stimulation, Wireless PNS, neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Uro Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 16 Oct 2015 (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.
This is a prospective, randomized, controlled, multi-center, study in which 150 evaluable subjects will be randomized 1:1 to receive either a Protect CAN-Stim or SNS InterStim® system. Subjects from both groups will immediately start with therapy. The primary endpoint is a ≥ 50% reduction in number of incontinence episodes associated with urgency at the 3-month visit, with additional measurements assessed at 14 days, 1, 6, 9 and 12-months.
Detailed description
Subjects will be randomized at baseline to either CAN-Stim or SNS InterStim® after inclusion and exclusion criteria have been met, 150 subjects will be randomized in to either arm of the study (89 subjects each arm).
At the following visit, CAN-Stim subjects will be immediately implanted unilaterally with a permanent device (implantation side up to investigators discretion). During implantation, the subject should feel pulsation in their foot with or without toe flexion, confirming stimulation of the tibial nerve. Subjects not achieving this motor response will not have the device implanted and will be exited from the study. Implanted subjects will be educated on the use of the transmitter and programmer. Programming parameters will be set and therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Programming changes can be done as needed during this time period to maximize clinical response. At the 2-week visit, diaries will be reviewed and confirmed for accuracy and discrepancies and the number of urgency incontinence episodes will be calculated and compared to baseline diaries. Subjects who are considered a responder at the 2-week follow-up visit (>50% improvement in urgency related incontinence episodes) will continue therapy and followed for a total of 12 months with primary outcomes assessed at 3 months. Non-responders will be offered an explant of the device and will exit the study. Subjects having less than 50% improvement may choose to keep the device. These subjects will be followed for adverse events with phone calls at 3, 6 and 12 months.
Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study. Subjects, who respond intraoperatively, will have the extension lead connected and externalized in the standard fashion. Subjects may have their InterStim® activated 24 hours/day, but a minimum of 8 hours per day for 2 weeks is required to remain in the study. Programming changes can be done as needed during this time period to maximize the clinical effect. At the 2-week visit, diaries will be reviewed and confirmed for accuracy and clarified for discrepancies and the number of urgency incontinence episodes will be calculated and compared to baseline diaries. Patients achieving a clinical response (>50% improvement in urgency related incontinence episodes) will undergo implantation of a pulse generator and removal of the percutaneous extension lead. The IPG will be programmed in the standard fashion using settings that were working for the patient during the 2-week trial. Subjects implanted with the InterStim® device will be monitored for a total of 12 months with primary outcomes assessed at 3 months. Non-responders will be offered an explant of the device and will exit the study. Subjects having less than 50% improvement may choose to keep the device. These subjects will be followed for adverse events with phone calls at 3, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Controlled, Non-Inferiority
| Arm | Type | Receives |
|---|---|---|
| CAN-Stim Group - CAN-Stim System | Experimental | Device: CAN-Stim - Protect CAN-Stim SystemIntervention: tibial medical device Subjects randomized to this group will have the Protect CAN-Stim System tibial medical device implanted for the duration of the study. |
| SNS Group - Interstim® System | Active comparator | Device: SNS - InterStim® SystemIntervention: SNS Medical device Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Diagnosis of overactive bladder with urgency urinary incontinence or mixed incontinence (urge and stress) with predominate urge, as confirmed by the MESA questionnaire;
- Women and men ≥ 18 years of age;
- Women of child-bearing age willing to practice birth control;
- At least 4 incontinent episodes associated with urgency on a 3-day voiding diary;
- At least 10 voids per day;
Key exclusion criteria (22 listed)
- An active implantable electronic device regardless of whether stimulation is ON or OFF;
- Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period;
- Primary complaint of stress urinary incontinence;
- Less than 1 year post-partum and/or are breast-feeding;
- Neurogenic bladder (i.e. Multiple sclerosis, Parkinson's, Spinal Cord Injury);
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 |
|---|---|---|
| CAN-Stim - Protect CAN-Stim SystemCAN-Stim subjects will be implanted unilaterally (implantation side is up to the investigators discretion) with the CAN-Stim System. Subjects will be educated on the use of the transmitter and programmer. Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will continue therapy and followed for a total of 12 months. | Device | CAN-Stim Group - CAN-Stim System |
| SNS - InterStim® SystemSubjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators ("bellows" response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study.Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will receive a full implant and followed for a total of 12 months. | Device | SNS Group - Interstim® System |
Primary outcome
Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
Time frame: 3 Months
The primary efficacy endpoint is defined as a ≥ 50% reduction in number of urgency related incontinence episodes at 3 months post-implant of the CAN-Stim system compared to SNS InterStim® system therapy. The number of urgency incontinent episodes per day is taken as an average of two 3-day consecutive bladder diaries, with at least 24 hours between when the first diary ends and the second diary begins
device- and procedure-related Adverse Events (AE)
Time frame: 3 Months
The safety endpoint is the device- and procedure-related Adverse Events (AE) rate at 3 months in the CAN-Stim and SNS groups.
4 secondary outcomes
Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes
Time frame: 6,12 Months
device- and procedure-related Adverse Events (AE)
Time frame: 6,12 Months
Voiding Frequency
Time frame: 3, 6,12 Months
Reduction in degree of urgency
Time frame: 3, 6,12 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: Yes. upon study completion
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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.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAN-Stim - Protect CAN-Stim System and SNS - InterStim® System in people with Urinary Incontinence, Urge, run by Uro Medical Corporation at 15 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 17 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miriam Chery (888-691-0585, contact@micronmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate: a ≥ 50% reduction in number of urgency related incontinence episodes (time frame: 3 Months). 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 4 Oct 2023.