Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

University of Michigan

Status: Completed

Conditions: Urinary Retention; Underactive Bladder

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04236596

OT2OD028191 (U.S. NIH Grant/Contract)

HUM00165005

Details and patient eligibility

About

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.

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 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Study participants

Experimental group

Description:

Study participants received an implanted neurostimulator at their pudendal nerve as part of normal clinical care. This was not an intervention study as clinical care was not modified based on study participation. Participants consented to undergo in the research study steps towards mapping of the pudendal nerve.

Treatment:

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