Urinary Urge IncontinenceNCT07247136
Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
A study testing Neuspera Implantable Sacral Neuromodulation System in people with Urinary Urge Incontinence, run by Neuspera Medical, Inc. at 1 site in United States.
Trial summary
Single-arm study conducted in participants for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Urinary Urge Incontinence
- What is being tested?
- Neuspera Implantable Sacral Neuromodulation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male or female 22 years of age or older.
- Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
- Has failed, could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects), or not a good candidate for (as determined by treating physician) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.
- Is willing and able to washout (at least five half-lives) from OAB medications for a period determined appropriate based on type of OAB medication prior to the baseline bladder diary and remain off OAB medications through the study duration OR must be willing to maintain medication through the study duration.
- Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary.
- Has a positive stimulation trial with a 50% reduction in UUI episodes.
Who cannot join
- Has a contraindication for the Neuspera SNM System per the device labeling.
- Has a hemoglobin A1c of >8%.
- Has glucosuria.
- Has diabetic neuropathy.
- Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain, or recurrent symptomatic urinary tract infections.
- Has skin, orthopedic, neurological, or hematological (bleeding disorder) or anatomical limitations that could prevent successful placement of the neurostimulator.
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- Has broken, blistered skin or compromised circulation in the area of the neurostimulator implant.
- Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident.
- Has documented urinary retention within 6 months prior to the screening baseline visit date.
- Has clinically significant bladder outlet obstruction.
- Is currently undergoing or has previously undergone pelvic irradiation.
- Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture, or cancer.
- Has current grade 3 or 4 pelvic organ prolapse including cystocele, rectocele, enterocele, procidentia or vaginal vault prolapse.
- Has received tibial nerve stimulation (TNS) in the past 3 months for the treatment of overactive bladder or unwilling to stay off TNS therapy for the study duration.
- Has received treatment of urinary symptoms with any botulinum neurotoxin type-A (BoNT-A) agent in the past 6 months; (e.g. obotulinumtoxinA, Botox,® abobotulinumtoxinA, Dysport® IncobotulinumtoxinA, Xeomin®).
- Is a woman who is pregnant or planning to become pregnant during this clinical study or is a woman of child-bearing potential who is not using a medically acceptable method of birth control. Women of child-bearing potential must undergo a pregnancy test, with clear negative result.
- Has previously had SNM therapy.
- Has active implantable medical devices such as neurostimulators, drug pumps, pacemakers, or internal defibrillators since compatibility has not been assessed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Southern Urogynecology, LLC
West Columbia, South Carolina, 29169
Jessica Rueb, MD, 803-457-7000 ext. 6
Tina McGready, 803-457-7000 ext. 6, tmcgready@southurogyn.com
About this study
Official title: Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
Single-arm study conducted in participants for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments.
The objective of the study is to assess the effectiveness of 30-minutes daily therapeutic stimulation with the Neuspera System.
Read the detailed description
The study is intended to investigate the potential for controlling UUI symptoms with thirty minutes of stimulation per day.
Subjects will be enrolled in a single-arm study and followed for 6 months post implant. Subjects will undergo a trial stimulation period, followed by a permanent implant. If subjects do not receive appropriate benefits with the shorter duration of stimulation, they can increase the duration of stimulation anytime as needed. Subjects may also decrease stimulation after one month to 15 minutes per day if desired.
Up to 30 subjects will be implanted.
- Conditions
- Urinary Urge Incontinence
- Being tested
- Neuspera Implantable Sacral Neuromodulation 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.
Neuspera Implantable Sacral Neuromodulation SystemDevice
Stimulation of the Sacral Nerve
| Study group | Role | What they receive |
|---|---|---|
| Neuspera Implantable Sacral Nerve Stimulation System | Other | Implantation of the stimulator to assess effectiveness with shorter duration of stimulation Receives: Device: Neuspera Implantable Sacral Neuromodulation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint- Proportion of Subjects experiencing a device- and/or procedure-related AEs
Proportion of Subjects experiencing a device- and/or procedure-related Adverse events
Measured: 6 months
Primary Effectiveness Endpoint-Percentage of all implanted subjects who experience an improvement in UUI episodes.
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more, relative to the number of UUI episodes at baseline.
Measured: 1, 3 and 6 months post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start19 Nov 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Urge 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuspera Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jessica Reub, MD, Principal investigator, Southern Urogynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247136
- Sponsor's protocol ID
- Neuspera Medical (NSM-006)
- Status last verified
- Mar 2026
- First submitted
- 19 Nov 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)
- ClinicalTrials.gov ID
- NCT07247136
- Acronym / sponsor ID
- Neuspera Medical (NSM-006)
- Conditions
- Urinary Urge Incontinence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Neuspera Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- 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.
Single-arm study conducted in participants for the treatment of urinary urge incontinence in patients who have failed, could not tolerate, or were not a candidate for more conservative treatments.
The objective of the study is to assess the effectiveness of 30-minutes daily therapeutic stimulation with the Neuspera System.
Detailed description
The study is intended to investigate the potential for controlling UUI symptoms with thirty minutes of stimulation per day.
Subjects will be enrolled in a single-arm study and followed for 6 months post implant. Subjects will undergo a trial stimulation period, followed by a permanent implant. If subjects do not receive appropriate benefits with the shorter duration of stimulation, they can increase the duration of stimulation anytime as needed. Subjects may also decrease stimulation after one month to 15 minutes per day if desired.
Up to 30 subjects will be implanted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuspera Implantable Sacral Nerve Stimulation System | Other | Device: Neuspera Implantable Sacral Neuromodulation SystemImplantation of the stimulator to assess effectiveness with shorter duration of stimulation |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Is male or female 22 years of age or older.
- Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date.
- Has failed, could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects), or not a good candidate for (as determined by treating physician) at least one (1) antimuscarinic or β3 adrenoceptor agonist medication.
- Is willing and able to washout (at least five half-lives) from OAB medications for a period determined appropriate based on type of OAB medication prior to the baseline bladder diary and remain off OAB medications through the study duration OR must be willing to maintain medication through the study duration.
- Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary.
Key exclusion criteria (18 listed)
- Has a contraindication for the Neuspera SNM System per the device labeling.
- Has a hemoglobin A1c of >8%.
- Has glucosuria.
- Has diabetic neuropathy.
- Has interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines, chronic pelvic pain, or recurrent symptomatic urinary tract infections.
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 |
|---|---|---|
| Neuspera Implantable Sacral Neuromodulation SystemStimulation of the Sacral Nerve | Device | Neuspera Implantable Sacral Nerve Stimulation System |
Primary outcome
Primary Safety Endpoint- Proportion of Subjects experiencing a device- and/or procedure-related AEs
Time frame: 6 months
Proportion of Subjects experiencing a device- and/or procedure-related Adverse events
Primary Effectiveness Endpoint-Percentage of all implanted subjects who experience an improvement in UUI episodes.
Time frame: 1, 3 and 6 months post implant
Percentage of all implanted subjects who experience an improvement in UUI episodes of at least 50% or more, relative to the number of UUI episodes at baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Neuspera Medical web pageLink provided by the sponsor.
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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.
Jessica Reub, MD principal investigator
Southern Urogynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuspera Implantable Sacral Neuromodulation System in people with Urinary Urge Incontinence, run by Neuspera Medical, Inc. 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 6 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 5 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Vollmer (408-433-3839, mark.vollmer@neuspera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint- Proportion of Subjects experiencing a device- and/or procedure-related AEs (time frame: 6 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 5 Mar 2026.