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Completed

NCT Number: NCT04236596

Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

This study is to map the pudendal nerve. In this study the researchers will examine subjects who are already receiving an implanted stimulator at their pudendal nerve as part of their normal clinical care.

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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 problems and pelvic pain. Researchers do not understand how the nerve anatomy is different between people. Successfully mapping the pudendal nerve may help improve the medical care for future patients with bladder problems, pelvic pain, bowel problems, and sexual problems.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinically referred as having bladder problems that have not responded to conservative treatment. Normal clinical care includes referral to implant of Medtronic Interstim neurostimulator at the pudendal nerve. Fully eligible to receive an Interstim implant.
  • Adult (18 or older), capable of providing own informed consent and communicating clearly with research team
  • Capable of speaking, reading, and understanding English, as all study questionnaires are standardized assessments only available in English
  • Capable of attending all experimental sessions (Visit 1: pre-stage-1 imaging, Visit 2: stage-1 surgery, Visit 3: CT after stage-2 surgery, Visit 3: cystometrogram test)

Exclusion

  • Implanted materials that prohibit magnetic imaging
  • Any medical problems that prevent an individual from laying flat in an MRI or CT scanner, are are claustrophobic.
  • Areflexive or atonic bladder
  • Pregnant or planning to become pregnant. If a woman of child-bearing potential wishes to participate in this study, they will be pre-screened with a test to detect pregnancy.
  • Diagnosed neurogenic bladder, pudendal nerve damage, lower motor dysfunction, or other conditions that would affect the neural circuits involved in micturition.
  • Unwilling to allow de-identified data to be stored for future use or shared with other researchers.

Treatment and study plan

Participants received a Neurostimulator, which was used to map the pudendal nerve

Device

Participants in study received neurostimulator at their pudendal nerve as part of their normal clinical care. This neurostimulator was used to map the nerve.

Primary outcomes

  1. Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test

    Time frame: Visit 4, approximately 10 weeks after consent

    The primary outcome measure in this study was an evoked bladder contraction of at least 20 centimeters of water (cmH2O) during the cystometrogram. These bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator. Measure reflects number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during nerve stimulation.

Secondary outcomes

  1. Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Participant Stimulation

    Time frame: Visit 2: Stage-1 (approximately 3 weeks after consent)

    Selectivity refers to the degree in which a nerve could be stimulated without stimulating other nerves. SI was calculated for each sensor recording from locations innervated by distal pudendal nerve branches during the visit-2 implant procedure. This includes pressure sensors in the urethra innervated by the perineal nerve and anal electromyography (EMG) innervated by the ischeal rectal nerve. The SI calculation used here is on a scale of 0 to 1, with 0 indicating no response at all from the nerve. The closer the number is to 1, the more selective the nerve stimulated.

  2. Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Simulated Model Stimulation

    Time frame: Approximately one year and four months after consent

    Selectivity is the degree to which part of a nerve could be stimulated without stimulating other nerve parts. For each participant who had successful MRI and CT images, a computational model was created to simulate electrical stimulation of axons distributed in two primary pudendal fascicles: perineal and rectal. The SI of stimulation does not indicate a positive or negative result in this outcome; rather, it shows the relative potential for activating just a single nerve fascicle. The negative/positive designation identifies the regional nerve activation, with -1 representing only perineal fascicle activation, +1 representing only rectal activation, and 0 indicating equal activation of both fascicles.

  3. Measurement of Effect of Pudendal Nerve Stimulation on Urethral Leak Point Pressure During the Stage-4 Test

    Time frame: Visit 4, approximately 10 weeks after consent

    A secondary outcome measure was a goal to examine the effect of selective pudendal nerve stimulation on urethral leak point pressure during the cystometrogram.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2020
Registry last updated
Aug 20, 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.

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