PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) for Urinary Tract Infections

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Urinary Tract Infections+6 More
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the effects of sacral neuromodulation on bladder function & quality of life in patients w/ acute spinal cord injury.

Eligible Conditions
  • Urinary Tract Infections
  • Spinal Cord
  • Incontinence
  • Neurogenic Urinary Bladder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Urinary Tract Infections

Study Objectives

3 Primary · 17 Secondary · Reporting Duration: 3, 6, 9, 12 months

12 months
Number of urinary tract infections per year
Urodynamic determined maximum cystometric capacity
3 months
Urodynamics determined maximum cystometric capacity
3, 12 months
Presence of detrusor overactivity during urodynamics
Urodynamics determined bladder compliance
Urodynamics determined detrusor pressure at first detrusor contraction
Urodynamics determined volume at first detrusor contraction
Month 12
24 hour pad weight test
Average catheterization volume
Number of daily catheterizations
Quality of Life differences measured by mean SCI-QoL
Urinary incontinence episodes per day
continous, 12 months
Development of hydronephrosis
Hospitalizations
Need for anticholinergic medication
Need for device explanation
Need for device revision
Need for onabotulinum toxin A injection
Urologic related surgeries
continuous, 12 months
Death

Trial Safety

Safety Progress

1 of 3

Other trials for Urinary Tract Infections

Trial Design

2 Treatment Groups

Standard care
1 of 2
Sacral neuromodulation
1 of 2
Active Control
Experimental Treatment

48 Total Participants · 2 Treatment Groups

Primary Treatment: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) · No Placebo Group · N/A

Sacral neuromodulation
Device
Experimental Group · 1 Intervention: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) · Intervention Types: Device
Standard careNoIntervention Group · 1 Intervention: Standard care · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3, 6, 9, 12 months

Who is running the clinical trial?

Rancho Research Institute, Inc.OTHER
6 Previous Clinical Trials
405 Total Patients Enrolled
University of MichiganOTHER
1,616 Previous Clinical Trials
6,330,821 Total Patients Enrolled
3 Trials studying Urinary Tract Infections
475 Patients Enrolled for Urinary Tract Infections
University of UtahLead Sponsor
990 Previous Clinical Trials
1,768,900 Total Patients Enrolled
1 Trials studying Urinary Tract Infections
2,674 Patients Enrolled for Urinary Tract Infections
Wake Forest University Health SciencesOTHER
1,113 Previous Clinical Trials
1,129,621 Total Patients Enrolled
2 Trials studying Urinary Tract Infections
264 Patients Enrolled for Urinary Tract Infections
Jeremy B Myers, MDPrincipal InvestigatorUniversity of Utah

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 5th, 2021

Last Reviewed: October 3rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%