Clinical trial NCT04236596: Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
Official title: Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Underactive Bladder
Keywords: pudendal nerve mapping
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-01-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test
timeFrame: Visit 4, approximately 10 weeks after consent
Secondary outcomes:
measure: Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Participant Stimulation
timeFrame: Visit 2: Stage-1 (approximately 3 weeks after consent)
measure: Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Simulated Model Stimulation
timeFrame: Approximately one year and four months after consent
measure: Measurement of Effect of Pudendal Nerve Stimulation on Urethral Leak Point Pressure During the Stage-4 Test
timeFrame: Visit 4, approximately 10 weeks after consent
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tim Bruns, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Priyanka Gupta, M.D.
role: PRINCIPAL_INVESTIGATOR
References: