NCT04473469

Previously Implanted Pudendal Nerve Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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, 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

• Urinary Retention
• Underactive Bladder

Interventions

Type	Name	Description
DEVICE	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).

Timeline

• Start date: 2021-01-19
• Primary completion: 2023-05-02
• Completion: 2023-05-02
• First posted: 2020-07-16
• Last updated: 2024-06-03
• Results posted: 2024-06-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study