Skip to main content
OpenTrials
Completed

NCT Number: NCT04473469

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Underactive Bladder Urinary Bladder Diseases Urinary Bladder, Underactive Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medtronic Interstim II Model 3058 Neurostimulator

Device

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 outcomes

  1. Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram

    Time frame: 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 outcomes

  1. Selective Stimulation of Pudendal Nerve Branches

    Time frame: 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.

  2. Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 16, 2020
Registry last updated
Jun 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.