Previously Implanted Pudendal Nerve Stimulation

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University of Michigan

Status

Completed

Conditions

Urinary Retention
Underactive Bladder

Treatments

Device: Medtronic Interstim II Model 3058 Neurostimulator

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04473469
HUM00180124
OT2OD028191 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

5 participants in 1 patient group

Cystometrogram
Experimental group
Description:
The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.
Treatment:
Device: Medtronic Interstim II Model 3058 Neurostimulator

Trial contacts and locations

1

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Central trial contact

Mackenzie Moore, MPH

Data sourced from clinicaltrials.gov

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