Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-14

Study Completion Date

2023-06-08

Brief Summary

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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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Detailed Description

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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.

Conditions

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Urinary Retention Underactive Bladder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Study participants

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No