BridgeMD
New treatment option for Urinary Urge Incontinence
Official title Study of 30-Minute Stimulation With the Neuspera Sacral Neuromodulation (SNM) System
ClinicalTrials.gov ID: NCT07247136
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- 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 how well it works or intolerable side effects), or not a good candidate for...
- 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...
- Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary.
You likely can't join if
- 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...
- Has skin, orthopedic, neurological, or hematological (bleeding disorder) or anatomical limitations that could prevent successful placement of the...
See the full eligibility criteria
- 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 how well it works or intolerable side effects), or not a good candidate for (as determined by treating physician) at least one (1) antimuscarinic...
- 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...
- 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.
- 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...
- Has skin, orthopedic, neurological, or hematological (bleeding disorder) or anatomical limitations that could prevent successful placement of the neurostimulator.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- West Columbia, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include West Columbia, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.