Previously Implanted Pudendal Nerve Stimulation

Sponsor

University of Michigan (Other)

Overall Status

Recruiting

CT.gov ID

NCT04473469

Collaborator

National Institutes of Health (NIH) (NIH)

Enrollment

Location

Arm

31.4

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Retention Underactive Bladder	Device: Medtronic Interstim II Model 3058 Neurostimulator	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Previously Implanted Pudendal Nerve Stimulation

Actual Study Start Date :

Jan 19, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Evoked bladder contractions of at least 20 centimeters of water (cmH2O) [Visit 1, approximately 1 week after consent]
At least 50% of participants

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

University of Michigan
National Institutes of Health (NIH)

Investigators

Principal Investigator: Tim Bruns, Ph.D., University of Michigan
Principal Investigator: Priyanka Gupta, M.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Pudendal Nerve Stimulation Study

Publications

None provided.

Responsible Party:

Timothy Bruns, Associate Professor of Biomedical Engineering, Medical School, University of Michigan

ClinicalTrials.gov Identifier:

NCT04473469

Other Study ID Numbers:

HUM00180124
OT2OD028191

First Posted:

Jul 16, 2020

Last Update Posted:

Aug 22, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Timothy Bruns, Associate Professor of Biomedical Engineering, Medical School, University of Michigan

Pudendal nerve mapping

Nerve stimulation

Additional relevant MeSH terms:

Urinary Retention

Urinary Bladder, Underactive

Study Results

No Results Posted as of Aug 22, 2022