Previously Implanted Pudendal Nerve Stimulation

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.

Study Overview

• Status: Completed
• Conditions: Urinary Retention; Underactive Bladder
• Intervention / Treatment: Device: Medtronic Interstim II Model 3058 Neurostimulator

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cystometrogram; The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Tim Bruns, Ph.D., University of Michigan; Principal Investigator: Priyanka Gupta, M.D., University of Michigan

Publications and helpful links

Helpful Links

• Related Pudendal Nerve Stimulation Study

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2021
• Primary Completion (Actual): May 2, 2023
• Study Completion (Actual): May 2, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2024
• Last Update Submitted That Met QC Criteria: May 30, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pudendal nerve mapping; Nerve stimulation
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention; Urinary Bladder, Underactive
• Other Study ID Numbers: HUM00180124; OT2OD028191 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All de-identified IPD collected during the trial will be available.
• IPD Sharing Time Frame: Will be available twelve months following publication of study findings, or earlier.
• IPD Sharing Access Criteria: Anyone who wishes to access the data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes