Trial Outcomes & Findings for Neuspera's Implantable Sacral Nerve Stimulation System in Patients With Symptoms of Urinary Urgency Incontinence (UUI) (NCT NCT04232696)

Results Overview

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

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

331 participants

Primary outcome timeframe

6 months

Results posted on

2025-11-03

Participant Flow

Ph I Study: Of 89 subjects consented, 39 subjects had implant attempted, 34 were successfully implanted. 35 subjects were screen failures, 11 withdrew consent, 1 withdrawn by investigator, 2 LTF, and 1 other withdrawal reason. Ph II Study: Of 242 subjects consented, 130 subjects had implant attempted and 128 were successfully implanted. 80 subjects were screen failure,16 withdrew consent, 3 withdrawn by investigator, 5 LTF, 4 due to site termination by sponsor, and 4 other withdrawal reasons.

Participant milestones

Participant milestones
Measure	Phase I, Neuspera Implantable Sacral Nerve Stimulation System Implantation of the Stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.	Phase II, Neuspera Implantable Sacral Nerve Stimulation System Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.
Overall Study STARTED	39	130
Overall Study COMPLETED	34	111
Overall Study NOT COMPLETED	5	19

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase I, Neuspera Implantable Sacral Nerve Stimulation System Implantation of the Stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.	Phase II, Neuspera Implantable Sacral Nerve Stimulation System Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.
Overall Study Implant attempted but not completed	5	2
Overall Study Not satisfied with therapy outcome	0	8
Overall Study Adverse Event	0	3
Overall Study Withdrawal by Subject	0	3
Overall Study Missed Visit	0	2
Overall Study Other reason	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: Neuspera Implantable Sacral Nerve Stimulation System n=39 Participants Implantation of the simulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.	Phase II: Neuspera Implantable Sacral Nerve Stimulation System n=130 Participants Implantation of the simulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.	Total n=169 Participants Total of all reporting groups
Age, Continuous	59.8 Years STANDARD_DEVIATION 12.6 • n=3 Participants	60.4 Years STANDARD_DEVIATION 10.2 • n=15 Participants	60.2 Years STANDARD_DEVIATION 10.8 • n=18 Participants
Sex: Female, Male Female	37 Participants n=3 Participants	128 Participants n=15 Participants	165 Participants n=18 Participants
Sex: Female, Male Male	2 Participants n=3 Participants	2 Participants n=15 Participants	4 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=3 Participants	10 Participants n=15 Participants	11 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=3 Participants	120 Participants n=15 Participants	158 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	1 Participants n=3 Participants	5 Participants n=15 Participants	6 Participants n=18 Participants
Race (NIH/OMB) White	38 Participants n=3 Participants	124 Participants n=15 Participants	162 Participants n=18 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants	0 Participants n=15 Participants	0 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants	1 Participants n=15 Participants	1 Participants n=18 Participants
Body Mass Index (BMI)	30 kg/m2 STANDARD_DEVIATION 5.4 • n=3 Participants	29.5 kg/m2 STANDARD_DEVIATION 5.1 • n=15 Participants	29.6 kg/m2 STANDARD_DEVIATION 5.2 • n=18 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Completers data: number of subjects with completed assessments for primary endpoint

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

Outcome measures

Outcome measures
Measure	Phase II, Neuspera Implantable Sacral Nerve Stimulation System n=111 Participants Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.	Phase I, Neuspera Implantable Sacral Nerve Stimulation System n=30 Participants Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.
Primary Efficacy Endpoint: Percentage of Participants Who Experience a 50 Percent or More Change in Urinary Urgency Incontinence Episodes.	95.5 percentage of participants Interval 89.8 to 98.5	93.3 percentage of participants Interval 77.9 to 99.2

PRIMARY outcome

Timeframe: 6 months

Population: All enrolled subjects

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

Outcome measures

Outcome measures
Measure	Phase II, Neuspera Implantable Sacral Nerve Stimulation System n=130 Participants Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.	Phase I, Neuspera Implantable Sacral Nerve Stimulation System n=39 Participants Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.
Primary Safety Endpoint: Defined as the Proportion of Subjects Experiencing a Device-related Serious Adverse Events.	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 and 12 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

The incidence of adverse events will be reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

Device amplitude will be collected in volts.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

The number of serious adverse events related to the device.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 and 12 months

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.

Outcome measures

Outcome data not reported

Adverse Events

Ph I, Neuspera Implantable Sacral Nerve Stimulation System

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Ph II, Neuspera Implantable Sacral Nerve Stimulation System

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ph I, Neuspera Implantable Sacral Nerve Stimulation System n=39 participants at risk Phase I, Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.	Ph II, Neuspera Implantable Sacral Nerve Stimulation System n=130 participants at risk Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.
Reproductive system and breast disorders Heavy menstrual bleeding	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Surgical and medical procedures Shoulder arthroplasty	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Surgical and medical procedures Shoulder Operation	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Nervous system disorders Numbness and tingling in left foot	2.6% 1/39 • Number of events 1 • At least 6 months post-implant	0.00% 0/130 • At least 6 months post-implant
Cardiac disorders Atrial Fibrillation	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Gastrointestinal disorders Intestinal Obstruction	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Infections and infestations Appendicitis	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Infections and infestations Breast Cellulitis	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Injury, poisoning and procedural complications Fall	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Injury, poisoning and procedural complications Lower Limb Fracture	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Injury, poisoning and procedural complications Post procedural stroke	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Nervous system disorders Cerebrovascular accident	0.00% 0/39 • At least 6 months post-implant	0.77% 1/130 • Number of events 1 • At least 6 months post-implant
Renal and urinary disorders Nephrolithiasis	0.00% 0/39 • At least 6 months post-implant	1.5% 2/130 • Number of events 2 • At least 6 months post-implant
Reproductive system and breast disorders Abnormal uterine bleeding	0.00% 0/39 • At least 6 months post-implant	1.5% 2/130 • Number of events 2 • At least 6 months post-implant

Other adverse events

Other adverse events
Measure	Ph I, Neuspera Implantable Sacral Nerve Stimulation System n=39 participants at risk Phase I, Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.	Ph II, Neuspera Implantable Sacral Nerve Stimulation System n=130 participants at risk Implantation of the stimulator. Neuspera Implantable Sacral Nerve Stimulation System: Stimulation of the Sacral Nerve.
General disorders Implant Site Pain	12.8% 5/39 • Number of events 7 • At least 6 months post-implant	0.00% 0/130 • At least 6 months post-implant
Musculoskeletal and connective tissue disorders Muscle Tightness	5.1% 2/39 • Number of events 2 • At least 6 months post-implant	0.00% 0/130 • At least 6 months post-implant
Product Issues Device Dislocation	7.7% 3/39 • Number of events 3 • At least 6 months post-implant	0.00% 0/130 • At least 6 months post-implant
Product Issues Device Breakage	5.1% 2/39 • Number of events 3 • At least 6 months post-implant	0.00% 0/130 • At least 6 months post-implant

Additional Information

Mark Vollmer

Neuspera Clinical Research

Phone: 612-281-4875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place