Previously Implanted Pudendal Nerve Stimulation

Not Applicable

Completed

• Conditions: Underactive Bladder; Urinary Retention
• Interventions: Device: Medtronic Interstim II Model 3058 Neurostimulator

• Registration Number: NCT04473469
• Lead Sponsor: University of Michigan

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Study Start: 2021-01-19
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-02
• Status Verified: 2024-05
• Results First Submitted: 2024-05-02
• Results First Submitted QC: 2024-05-30
• Last Update Submitted: 2024-05-30
• Results First Posted: 2024-06-03
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cystometrogram	Medtronic Interstim II Model 3058 Neurostimulator	The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.

Primary Outcome Measures

Name	Time	Method
Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram	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.

Secondary Outcome Measures

Name	Time	Method
Selective Stimulation of Pudendal Nerve Branches	2 hours	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.
Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)	2 hours	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States