Trial Outcomes & Findings for Comparison of Motor and Sensory Response With Interstim Stimulation (NCT NCT00943904)

NCT ID: NCT00943904

Last Updated: 2021-10-06

Results Overview

Percent change in improvement of symptoms after reprogramming in terms of number of leaks reported. Nocturia refers to leaks that happened while asleep. Incontinence refers to both stress and urge leaks. Urgency refers to only urge leaks. Positive values represent more improvement of symptoms and therefore less leaks. Negative values represent less improvement and therefore more leaks.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: 6 months following enrollment
• Results posted on: 2021-10-06

Participant Flow

Participant milestones

Measure	Interstim Stimulation Patients who receive the interstim implant in order to evaluate effectiveness of treatment Interstim implant for SNS: stimulates third sacral nerve root
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Motor and Sensory Response With Interstim Stimulation

Baseline characteristics by cohort

Measure	Interstim Stimulation n=31 Participants Patients who receive the interstim implant in order to evaluate effectiveness of treatment Interstim implant for SNS: stimulates third sacral nerve root
Age, Continuous	65 years STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months following enrollment

Percent change in improvement of symptoms after reprogramming in terms of number of leaks reported. Nocturia refers to leaks that happened while asleep. Incontinence refers to both stress and urge leaks. Urgency refers to only urge leaks. Positive values represent more improvement of symptoms and therefore less leaks. Negative values represent less improvement and therefore more leaks.

Outcome measures

Measure	Interstim Stimulation n=31 Participants Patients who receive the interstim implant in order to evaluate effectiveness of treatment Interstim implant for SNS: stimulates third sacral nerve root
Percent of Symptoms With Improvement of Leaks Reported Nocturia	14.4 Percent change in leaks
Percent of Symptoms With Improvement of Leaks Reported Incontinence	19.8 Percent change in leaks
Percent of Symptoms With Improvement of Leaks Reported Urgency	18.2 Percent change in leaks

Adverse Events

Interstim Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Karen Noblett

University of California, Riverside

Phone: (951) 827-7581

Email: karen.noblett@ucr.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place