Previously Implanted Pudendal Nerve Stimulation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-19

Study Completion Date

2023-05-02

Brief Summary

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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.

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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, 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.

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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Cystometrogram

The bladder will be filled to different volumes and electrical stimulation will be applied to the pudendal nerve via the implanted neurostimulator.

Group Type EXPERIMENTAL

Medtronic Interstim II Model 3058 Neurostimulator

Intervention Type 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).

Interventions

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Medtronic Interstim II Model 3058 Neurostimulator

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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No