Pudendal Nerve Mapping Towards Improved Neuromodulation for Urinary Retention

NCT04236596 | Completed Results FDA Device

• 2 other identifiers: HUM00165005OT2OD028191
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Underactive Bladder; Urinary Retention

Keywords

pudendal nerve mapping

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During the Stage-4 Test

  The primary outcome measure in this study was an evoked bladder contraction of at least 20 centimeters of water (cmH2O) during the cystometrogram. These bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator. Measure reflects number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during nerve stimulation.

  Visit 4, approximately 10 weeks after consent

Secondary Outcomes (3)

• Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Participant Stimulation

  Visit 2: Stage-1 (approximately 3 weeks after consent)

• Selectivity Index (SI) for Selective Stimulation of Pudendal Nerve Branches for Simulated Model Stimulation

  Approximately one year and four months after consent

• Measurement of Effect of Pudendal Nerve Stimulation on Urethral Leak Point Pressure During the Stage-4 Test

  Visit 4, approximately 10 weeks after consent

Study Arms (1)

Study participants

EXPERIMENTAL

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.

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

Interventions

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

Study participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Chen PJ, Lagunas AC, Soriano V, Gupta P, Bruns TM. Perineal and Rectal Nerve Recruitment Order Varies During Pudendal Neurostimulator Implant Surgery. Neurourol Urodyn. 2025 Apr;44(4):851-859. doi: 10.1002/nau.70010. Epub 2025 Feb 10.

  PMID: 39927446 DERIVED

MeSH Terms

Conditions

Urinary Retention; Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Timothy Bruns
• Organization: University of Michigan

bruns@umich.edu

(734) 647-8727

Study Officials

• Tim Bruns, Ph.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Priyanka Gupta, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Biomedical Engineering

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 22, 2020
• Study Start: September 14, 2020
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: August 20, 2024
• Results First Posted: August 20, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Will be available starting twelve months following publication of study findings.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)