InterStim® Amplitude Study

Completed · Not applicable

Conditions studied: Urinary Urge Incontinence

In brief

This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).

Key facts

Study ID

NCT03335761

Run by

MedtronicNeuro

People needed

97

Starts

2018-02-27

Expected to finish

2019-11-06

Last updated by the study team

2021-01-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
• Female subjects 18 years of age or older
• Candidate for InterStim Lead Placement
• Willing and able to accurately complete voiding diaries, questionnaires, attend visits, and comply with the study protocol (which includes maintenance of InterStim II programming settings over the course of the study)
• Willing and able to provide signed and dated informed consent
• Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication

You may not qualify if…

• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
• History of diabetes unless the diabetes is well-controlled through diet and/or medications
• Symptomatic urinary tract infection (UTI)
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
• Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
• Implanted with a neurostimulator, pacemaker, or defibrillator
• Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or radio frequency (RF) energy exposure not included within the scanning conditions provided with the MRI Guidelines for InterStim Therapy
• Women who are pregnant or planning to become pregnant
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
• Currently enrolled or planning to enroll in a potentially confounding clinical study during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager (or designee).

Where it is running

• Academic Urology & Urogynecology of Arizona — Phoenix, Arizona, United States
• East Coast Institute for Research — Jacksonville, Florida, United States
• Pinellas Urology — St. Petersburg, Florida, United States
• Florida Urology Partners — Tampa, Florida, United States
• Minnesota Urology Fridley — Fridley, Minnesota, United States
• Minnesota Urology Woodbury — Woodbury, Minnesota, United States
• Adult Pediatric Urology and Urogynecology — Omaha, Nebraska, United States
• Urologic Research & Consulting — Englewood, New Jersey, United States
• Carolina Urology Partners — Concord, North Carolina, United States
• Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System — Chattanooga, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Aurora Research Institute - Aurora West Allis Women's Pavilion — West Allis, Wisconsin, United States
• UZ Leuven - Campus Gasthuisberg - Department Urology — Leuven, Belgium
• University Urology Associates, Toronto Western Hospital — Toronto, Ontario, Canada
• CHU Hôpitaux de Rouen - Hôpital Charles Nicolle — Rouen, France
• Azienda Ospedaliera Universitaria Integrata Verona — Verona, Italy
• Erasmus MC — Rotterdam, Netherlands
• University College London Hospitals NHS Foundation Trust - University College Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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