Previously Implanted Pudendal Nerve Stimulation

Urinary Retention Clinical Trial

Official title:

Previously Implanted Pudendal Nerve Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473469
• Other study ID #: HUM00180124
• Secondary ID: OT2OD028191
• Status: Completed
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study seeks to examine the response of the bladder to different pudendal nerve stimulation frequencies, by studying patients who have been previously-implanted with pudendal nerve neurostimulators.

Description:

The pudendal nerve goes to the urethra, anus, and other areas of the pelvic floor. Electrical stimulation of this nerve can help with bladder, bowel, and sexual problems, and pelvic pain. Researchers do not fully understand how the nerve helps with these functions or how the anatomy is different between people. Successful stimulation of the pudendal nerve may help improve medical care for future patients with bladder problems, pelvic pain, bowel problems, and/or sexual problems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 2, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previously received an implanted neurostimulator at the pudendal nerve

• Adult (18 or older), capable of providing own informed consent and communicating clearly with the research team

• Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English.

• Capable of attending the experimental session

Exclusion Criteria:

• Pregnant or planning to become pregnant during study. If a woman of child- bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy

• Currently has a urinary tract infection (UTI)

• Currently has or tested positive in the last 14 days for COVID-19, or is symptomatic for COVID-19

• Unwilling to allow de-identified data to be stored for future use or shared with other researchers

Related Conditions & MeSH terms

• Underactive Bladder
• Urinary Bladder, Underactive
• Urinary Retention

Intervention

Device:
• Medtronic Interstim II Model 3058 Neurostimulator
Patients will undergo stimulation of the pudendal nerve. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram	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.	Visit 1, approximately 1 week after consent
Secondary	Selective Stimulation of Pudendal Nerve Branches	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.	2 hours
Secondary	Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)	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.	2 hours

External Links

•   Related Pudendal Nerve Stimulation Study