Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

N/AActive Not RecruitingNCT04232696

Neuspera Medical, Inc.331 enrolled

Overview

Prospective, multi-center, single-arm, seamless phase-pivotal study conducted in participants diagnosed with UUI who have failed or could not tolerate more conservative treatment. The trial will be conducted in two phases. Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial. Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints.

Neuspera's Implantable Sacral Nerve Stimulation (SNS) System is indicated to treat participants with UUI who have failed or could not tolerate more conservative treatments. The study will be conducted in two phases: Phase I of the study will be conducted at up to 9 clinical study sites in the US and Europe. Phase II of the study will be conducted in up to 35 clinical sites in the US and Europe, inclusive of the Phase I centers. Prospective, multi-center, single-arm, seamless phase-pivotal study. Objective of Phase I: To assess the utilization of the system during the Sacral Nerve Stimulation (SNS) trial period and to help inform the length of hours of daily stimulation to be used in Phase II of the trial. Objective of Phase II: To assess the safety and efficacy of the Neuspera SNS System at 6-months for the primary efficacy endpoint and at 12 months for secondary safety and efficacy endpoints. All participants will receive the same length of device stimulation as determined in Phase I testing. Phase I will enroll up to 55 participants. Phase II will enroll up to 255 participants.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

331

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Has a Body Mass Index (BMI) between 18 and 40. 2. Has a diagnosis of UUI for greater than or equal to 6 months prior to the screening baseline visit date. 3. Has failed or was not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification). 4. Has failed or 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. 5. Has a diagnosis of UUI with at least 4 UUI episodes on a 72-hour diary, and minimum of one (1) UUI episode per 24-hour period. Exclusion Criteria: 1. Has a hemoglobin A1c of greater than 8 percent, or has diabetes mellitus with glucosuria. 2. Has diabetic neuropathy. 3. 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. 4. Has neurogenic bladder dysfunction such as traumatic or atraumatic myelopathy, multiple sclerosis, Parkinsonism, or history of cerebrovascular accident. 5. Has documented urinary retention within 6 months prior to the screening baseline visit date. 6. Has clinically significant bladder outlet obstruction. 7. Is a subject with a mechanical obstruction such as benign prostatic hypertrophy, urethral stricture or cancer. 8. Has primary stress incontinence or mixed incontinence where the stress component predominates or has been treated surgically for stress urinary incontinence within 6 months prior to the screening baseline visit date. 9. 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 12-month period following implant.

Outcomes

Primary Outcomes

Primary Efficacy Endpoint: Percentage of Participants Who Experience a 50 Percent or More Change in Urinary Urgency Incontinence Episodes.

Change in Urinary Urgency Incontinence episodes at six months, relative to the number of Urinary Urgency Incontinence episodes at baseline.

Time frame: 6 months

Primary Safety Endpoint: Defined as the Proportion of Subjects Experiencing a Device-related Serious Adverse Events.

The analysis of the endpoint is the proportion of subjects experiencing a device-related SAE through the 6-month post-implant.

Time frame: 6 months

Secondary Outcomes

Phase II Change in Quality of Life: Measured From Baseline as Measured and Assessed by the Total and Subset International Consultation on Incontinence Questionnaire Overactive Bladder Quality of Life Score.

Change from baseline in qualify of life. Total score (25 min,160 max) with higher score indicating increase impact on quality of life.

Time frame: 6 and 12 months

Phase II Efficacy Endpoint: Defined as the Percentage of Participants Who Experience a 50 Percent or More Change in Urinary Urgency Incontinence.

Change in Urinary Urgency Incontinence episodes at 12 months post-completion of the trial phase, relative to the number of Urinary Urgency Incontinence episodes at baseline prior to the trial phase.

Time frame: 12 months

Phase II Urgent Voids Per Day

Change in urgent voids per day from baseline to 6-months and 12 months. Calculated across all diary episodes with at least mild urgency.

Time frame: 6 and 12 months

Phase II Change in Average Number of Daily Voids

Change in average number of daily voids from baseline in subjects with at least 8 voids at baseline.

Time frame: 6 and 12 months

Phase II Comprehensive Summary of All Adverse Events

The incidence of adverse events will be reported.

Time frame: 6 and 12 months

Phase II Device Parameter Information Collected

Device amplitude will be collected in volts.

Time frame: 6 and 12 months

Phase II Physician and Subject User Experience Questionnaire

Physician and subject satisfaction will be obtained by answering questions on the use of the device using a five point scale:strongly agree, agree, neither agree nor disagree, disagree, strongly disagree. Answers towards strongly agree indicate a better outcome.

Time frame: 6 and 12 months

Phase II Urinary Tract Symptoms Questionnaire: International Consultation on Incontinence Questionnaire Female & Male Lower Urinary Tract Symptoms Modules

Change in female lower urinary tract symptoms questionnaire. Male questionnaire score ranges from 0-52 and female questionnaire score ranges from 0-48. Higher number indicates worse outcome.

Time frame: 6 and 12 months

Phase II Safety Endpoint: Defined as the Incidence of Device-related Serious Adverse Events in the Post-trial Period Follow-up.

The number of serious adverse events related to the device.

Time frame: 12 months

Phase II Urinary Output

Total urinary output as measured by 72-hour bladder diary.

Time frame: 6 and 12 months

Phase II Fecal Incontinence Measured by Wexner Scale

Wexner scale total points 0-20, higher the score the worse the outcome. Fecal incontinence as measured by the Wexner Scale compared to baseline.

Time frame: 6 months

Phase II Patient Global Impression of Improvement

Patient Global Impression of Improvement measured after implant during follow-up. Single question answered on a seven point scale: very much better, much better, a little better, no change, a little worse, much worse, very much worse. Selection of very much better is the best outcome.

Time frame: 6 and 12 months

Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI)

Overview

Conditions

Interventions

Eligibility

Locations (34)

Outcomes

Primary Outcomes

Secondary Outcomes