Urinary Incontinence, UrgeNCT02434874
Sacral Nerve Stimulation to Treat Urgency Urinary Incontinence With Wireless Neuromodulation
A study testing StimGuard Sacral Nerve Stimulator System in people with Urinary Incontinence, Urge, run by Uro Medical Corporation at 1 site in United States.
Trial summary
The purpose of this pivotal study is to illustrate the safety and effectiveness of the StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge incontinence. This is a prospective, randomized, controlled, multi-center, study in which 92 subjects will receive a StimGuard SNS System. 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?
- StimGuard Sacral Nerve Stimulator System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2020to Dec 2022
- 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; B. Women and men ≥ 18 years of age; C. At least 4 incontinent episodes associated with urge on a 3 day voiding diary with at least 1 each 24 hour day; D. Self-reported bladder symptoms present > 6 months; E. Self-reported failed conservative care > 6 months (i.e., pharmacology, dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.); F. Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment; G. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor; H. Normal upper urinary tract function; I. Capable of giving informed consent; J. Capable and willing to follow all study related procedures.
Who cannot join
- Any active implantable electronic device regardless of whether stimulation is ON or OFF; B. Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period; C. Less than 1 year post partum and/or are breast-feeding; D. Neurogenic bladder; E. Botox use in bladder or pelvic floor muscles in the past six months; F. Taking alpha-blocker therapy; G. Have a PVR >150 cc at baseline; H. Primary complaint of stress urinary incontinence; I. Current urinary tract infection (UTI); J. Previous treatment with sacral neuromodulation; K. Previous treatment with tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days; L. Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures; M. Inability to operate the StimGuard SNS System; N. Diabetes with peripheral nerve involvement or have severe uncontrolled diabetes (HbA1C 8.5 or greater); O. History of coagulopathy or bleeding disorder; P. History of pelvic pain as primary diagnosis (VAS score of > 4); Q. Anatomical restrictions such that device placement is not possible; R. Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function; S. Life expectancy of less than 5 years; T. Inability to independently comprehend and complete the questionnaires and diaries; U. Unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology
The purpose of this pivotal study is to illustrate the safety and effectiveness of the StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge incontinence. This is a prospective, randomized, controlled, multi-center, study in which 92 subjects will receive a StimGuard SNS System.
Read the detailed description
The StimGuard SNS System is utilized for the treatment of refractory urgency urinary incontinence as defined by the International Continence Society (ICS) Standardization of Terminology Committees Joint Report as the observation of involuntary leakage from the urethra synchronous with the sensation of a sudden, compelling desire to void that is difficult to defer. The system provides treatment by delivering small controlled electrical pulses to the sacral nerves, as these nerves have been shown to regulate the micturition cycle.
In this study, subjects will be randomized into one of two groups with a 1:1 ratio after enrollment. Subjects will either be randomized to an immediate or a delayed activation group. An intraoperative test will be performed, and all subjects will receive a permanent implant if they have an appropriate motor nerve root response without significant discomfort at 5 mA amplitude or less.
- Conditions
- Urinary Incontinence, Urge
- Being tested
- StimGuard Sacral Nerve Stimulator System
- 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.
StimGuard Sacral Nerve Stimulator SystemDevice
The StimGuard Sacral Nerve Stimulator System is a wirelessly powered neurostimulator for urge urinary incontinence. This technology includes a quadripolar stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin and to the receiver.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Activation | Experimental | Subjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated immediately. Receives: Device: StimGuard Sacral Nerve Stimulator System |
| Delayed Activation | Other | Subjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated after 90 days. Receives: Device: StimGuard Sacral Nerve Stimulator System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of urge related incontinence episodes
Self reported on a 3-day voiding diary
Measured: 3 Months
Incidence and severity of adverse events
Measured: Up to 12 months
Secondary outcomes (3)
Proportion of subjects with a reduction in the degree of urgency as measured by PPIUS
Self reported on a 3-day voiding diary
Measured: 3 Months
Proportion of subjects with a reduction in the number of voids compared to baseline
Self reported on a 3-day voiding diary
Measured: 3 Months
Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)
Quesionnaire
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startMar 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Study will no longer take place, the study did not begin or accrue subjects.
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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uro Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434874
- Sponsor's protocol ID
- 06-00780
- Status last verified
- Sep 2020
- First submitted
- 30 Apr 2015
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Multi-Center Pivotal Study for Sacral Nerve Stimulation to Treat Refractory Urgency Urinary Incontinence With Wireless Neuromodulation Technology
- ClinicalTrials.gov ID
- NCT02434874
- Acronym / sponsor ID
- 06-00780
- Conditions
- Urinary Incontinence, Urge
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study will no longer take place, the study did not begin or accrue subjects.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Uro Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 5 May 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.
The purpose of this pivotal study is to illustrate the safety and effectiveness of the StimGuard Sacral Nerve Stimulation (SNS) System in the treatment refractory urge incontinence. This is a prospective, randomized, controlled, multi-center, study in which 92 subjects will receive a StimGuard SNS System.
Detailed description
The StimGuard SNS System is utilized for the treatment of refractory urgency urinary incontinence as defined by the International Continence Society (ICS) Standardization of Terminology Committees Joint Report as the observation of involuntary leakage from the urethra synchronous with the sensation of a sudden, compelling desire to void that is difficult to defer. The system provides treatment by delivering small controlled electrical pulses to the sacral nerves, as these nerves have been shown to regulate the micturition cycle.
In this study, subjects will be randomized into one of two groups with a 1:1 ratio after enrollment. Subjects will either be randomized to an immediate or a delayed activation group. An intraoperative test will be performed, and all subjects will receive a permanent implant if they have an appropriate motor nerve root response without significant discomfort at 5 mA amplitude or less.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Activation | Experimental | Device: StimGuard Sacral Nerve Stimulator SystemSubjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated immediately. |
| Delayed Activation | Other | Device: StimGuard Sacral Nerve Stimulator SystemSubjects randomized to this group will have the StimGuard Sacral Nerve Stimulator System activated after 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of overactive bladder with urgency urinary incontinence; B. Women and men ≥ 18 years of age; C. At least 4 incontinent episodes associated with urge on a 3 day voiding diary with at least 1 each 24 hour day; D. Self-reported bladder symptoms present > 6 months; E. Self-reported failed conservative care > 6 months (i.e., pharmacology, dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.); F. Off all antimuscarinics and beta-3 adrenergic agonists for at least 2 weeks prior to enrollment; G. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder tumor; H. Normal upper urinary tract function; I. Capable of giving informed consent; J. Capable and willing to follow all study related procedures.
Key exclusion criteria (1 listed)
- Any active implantable electronic device regardless of whether stimulation is ON or OFF; B. Pregnant as confirmed by a urine pregnancy test or plan to become pregnant during the following 12 months period; C. Less than 1 year post partum and/or are breast-feeding; D. Neurogenic bladder; E. Botox use in bladder or pelvic floor muscles in the past six months; F. Taking alpha-blocker therapy; G. Have a PVR >150 cc at baseline; H. Primary complaint of stress urinary incontinence; I. Current urinary tract infection (UTI); J. Previous treatment with sacral neuromodulation; K. Previous treatment with tibial nerve stimulation, pelvic floor muscle stimulation, or biofeedback within the past 60 days; L. Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures; M. Inability to operate the StimGuard SNS System; N. Diabetes with peripheral nerve involvement or have severe uncontrolled diabetes (HbA1C 8.5 or greater); O. History of coagulopathy or bleeding disorder; P. History of pelvic pain as primary diagnosis (VAS score of > 4); Q. Anatomical restrictions such that device placement is not possible; R. Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function; S. Life expectancy of less than 5 years; T. Inability to independently comprehend and complete the questionnaires and diaries; U. Unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including bleeding disorders or anticoagulant medications, and peripheral neuropathy).
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 |
|---|---|---|
| StimGuard Sacral Nerve Stimulator SystemThe StimGuard Sacral Nerve Stimulator System is a wirelessly powered neurostimulator for urge urinary incontinence. This technology includes a quadripolar stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin and to the receiver. | Device | Delayed Activation, Immediate Activation |
Primary outcome
Reduction in number of urge related incontinence episodes
Time frame: 3 Months
Self reported on a 3-day voiding diary
Incidence and severity of adverse events
Time frame: Up to 12 months
3 secondary outcomes
Proportion of subjects with a reduction in the degree of urgency as measured by PPIUS
Time frame: 3 Months
Proportion of subjects with a reduction in the number of voids compared to baseline
Time frame: 3 Months
Improved quality of life function via the Incontinence Quality of Life Scale (I-QOL)
Time frame: 3 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StimGuard Sacral Nerve Stimulator System in people with Urinary Incontinence, Urge, run by Uro Medical Corporation at 1 site 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction in number of urge 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 30 Sep 2020.