Trial Outcomes & Findings for Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment (NCT NCT02357784)

NCT ID: NCT02357784

Last Updated: 2023-02-16

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 1 participants
• Primary outcome timeframe: Baseline and 3 months Post-Treatment
• Results posted on: 2023-02-16

Participant Flow

Participant milestones

Measure	Current Perception Threshold Testing The subjects in this study will undergo Current Perception Threshold Testing and fill out several questionnaires both before their Sacral Nerve Modulator device implantation and again 3 months after the device implantation. Neurometer: The purpose of Current Perception Threshold (CPT) testing is to help physicians better understand how Sacral Neuromodulation affects the nerves of patients with dual incontinence. CPT Testing involves the use of a portable battery-operated machine which will stimulate the subject's nerves via an electrical stimulation. Electrodes will be placed via a catheter in to the subject's urethra and rectum, and the electrical current will be increased gradually until the subject feels the onset of tingling, buzzing, or warmth at the site of the electrode. The electrical current will then gradually decrease until no sensation of stimulation is felt. The procedure will then be repeated where the subject will be asked to hold the test button to increase the stimulus intensity above their sensory threshold (above the point where they can feel it) until the device automatically shuts off.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Current Perception Threshold Testing The subjects in this study will undergo Current Perception Threshold Testing and fill out several questionnaires both before their Sacral Nerve Modulator device implantation and again 3 months after the device implantation. Neurometer: The purpose of Current Perception Threshold (CPT) testing is to help physicians better understand how Sacral Neuromodulation affects the nerves of patients with dual incontinence. CPT Testing involves the use of a portable battery-operated machine which will stimulate the subject's nerves via an electrical stimulation. Electrodes will be placed via a catheter in to the subject's urethra and rectum, and the electrical current will be increased gradually until the subject feels the onset of tingling, buzzing, or warmth at the site of the electrode. The electrical current will then gradually decrease until no sensation of stimulation is felt. The procedure will then be repeated where the subject will be asked to hold the test button to increase the stimulus intensity above their sensory threshold (above the point where they can feel it) until the device automatically shuts off.

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment

Baseline characteristics by cohort

Measure	Current Perception Threshold Testing n=1 Participants The subjects in this study will undergo Current Perception Threshold Testing and fill out several questionnaires both before their Sacral Nerve Modulator device implantation and again 3 months after the device implantation. Neurometer: The purpose of Current Perception Threshold (CPT) testing is to help physicians better understand how Sacral Neuromodulation affects the nerves of patients with dual incontinence. CPT Testing involves the use of a portable battery-operated machine which will stimulate the subject's nerves via an electrical stimulation. Electrodes will be placed via a catheter in to the subject's urethra and rectum, and the electrical current will be increased gradually until the subject feels the onset of tingling, buzzing, or warmth at the site of the electrode. The electrical current will then gradually decrease until no sensation of stimulation is felt. The procedure will then be repeated where the subject will be asked to hold the test button to increase the stimulus intensity above their sensory threshold (above the point where they can feel it) until the device automatically shuts off.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	1 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	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months Post-Treatment

Population: No data were collected

Outcome measures

Outcome data not reported

Adverse Events

Current Perception Threshold Testing

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. Margaret Mueller

Northwestern University

Phone: 13124723874

Email: mgmueller@nm.org

Results disclosure agreements

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