search
Back to results

Previously Implanted Pudendal Nerve Stimulation

Primary Purpose

Urinary Retention, Underactive Bladder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medtronic Interstim II Model 3058 Neurostimulator
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Urinary Retention focused on measuring Pudendal nerve mapping, Nerve stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cystometrogram

Arm Description

The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.

Outcomes

Primary Outcome Measures

Evoked bladder contractions of at least 20 centimeters of water (cmH2O)
At least 50% of participants

Secondary Outcome Measures

Full Information

First Posted
July 13, 2020
Last Updated
July 20, 2023
Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT04473469
Brief Title
Previously Implanted Pudendal Nerve Stimulation
Official Title
Previously Implanted Pudendal Nerve Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institutes of Health (NIH)

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention, Underactive Bladder
Keywords
Pudendal nerve mapping, Nerve stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cystometrogram
Arm Type
Experimental
Arm Description
The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.
Intervention Type
Device
Intervention Name(s)
Medtronic Interstim II Model 3058 Neurostimulator
Intervention Description
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).
Primary Outcome Measure Information:
Title
Evoked bladder contractions of at least 20 centimeters of water (cmH2O)
Description
At least 50% of participants
Time Frame
Visit 1, approximately 1 week after consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mackenzie Moore, MPH
Phone
734-647-8568
Email
mooremac@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Bruns, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Priyanka Gupta, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mackenzie Moore, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://sparc.science/data?type=dataset
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT04236596
Description
Related Pudendal Nerve Stimulation Study

Learn more about this trial

Previously Implanted Pudendal Nerve Stimulation

We'll reach out to this number within 24 hrs