NCT04473469

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 19, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 3, 2024

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

July 13, 2020

Results QC Date

May 2, 2024

Last Update Submit

May 30, 2024

Conditions

Urinary RetentionUnderactive Bladder

Keywords

Pudendal nerve mappingNerve stimulation

Outcome Measures

Primary Outcomes (1)

  • Evoked Bladder Contractions of at Least 20 Centimeters of Water (cmH2O) During Cystometrogram

    The results reflects the number of participants who experienced an evoked bladder contraction of at least 20 centimeters of water during stimulation of the pudendal nerve. Bladder contractions were evoked by applying nerve stimulation to the pudendal nerve through testing of the participant's implanted stimulator.

    Visit 1, approximately 1 week after consent

Secondary Outcomes (2)

  • Selective Stimulation of Pudendal Nerve Branches

    2 hours

  • Measurement of Effect of Selective Pudendal Nerve Stimulation (PNS) on Urethral Leak Point Pressure (ULPP)

    2 hours

Study Arms (1)

Cystometrogram

EXPERIMENTAL

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

Device: Medtronic Interstim II Model 3058 Neurostimulator

Interventions

Medtronic Interstim II Model 3058 NeurostimulatorDEVICE

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).

Cystometrogram

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Links

MeSH Terms

Conditions

Urinary RetentionUrinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological 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, Medical School

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 16, 2020

Study Start

January 19, 2021

Primary Completion

May 2, 2023

Study Completion

May 2, 2023

Last Updated

June 3, 2024

Results First Posted

June 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will share

All de-identified IPD collected during the trial will be available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Will be available twelve months following publication of study findings, or earlier.
Access Criteria
Anyone who wishes to access the data.
More information

Locations

US(1)