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Trial Outcomes & Findings for Previously Implanted Pudendal Nerve Stimulation (NCT NCT04473469)

NCT ID: NCT04473469

Last Updated: 2024-06-03

Results Overview

The results reflects the number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during stimulation of the pudendal nerve. Bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Visit 1, approximately 1 week after consent

Results posted on

2024-06-03

Participant Flow

Participant milestones

Participant milestones
Measure
Cystometrogram
The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).
Overall Study
STARTED
5
Overall Study
COMPLETED
5
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Previously Implanted Pudendal Nerve Stimulation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Cystometrogram
n=5 Participants
The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).
Age, Continuous
58.00 years
STANDARD_DEVIATION 14.68 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 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
4 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=5 Participants

PRIMARY outcome

Timeframe: Visit 1, approximately 1 week after consent

The results reflects the number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during stimulation of the pudendal nerve. Bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator.

Outcome measures

Outcome measures
Measure
Cystometrogram
n=5 Participants
The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).
Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram
1 Participants

SECONDARY outcome

Timeframe: 2 hours

Population: No participants had selective external urethral sphincter stimulation.

Selective stimulation of pudendal nerve branches for external urethral sphincter closure determined by comparing sensor recordings from distal pudendal nerve branches. The intention was to measure the effect of selective PNS, configured for selective external urethral sphincter stimulation on ULPP, but this selective stimulation for this nerve bundle, as described in the protocol, proved to not be feasible within the experimental sessions. Thus, no data was gathered.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 hours

Population: No participants had selective external urethral sphincter stimulation.

Measurement of effect of selective PNS on ULPP using PNS configured for external urethral sphincter selectivity. The intention was to measure the effect of selective PNS, configured for selective external urethral sphincter stimulation on ULPP, but this selective stimulation for this nerve bundle, as described in the protocol, proved to not be feasible within the experimental sessions. Thus, no data was gathered.

Outcome measures

Outcome data not reported

Adverse Events

Cystometrogram

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

Timothy Bruns

University of Michigan

Phone: (734) 647-8727

Results disclosure agreements

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