Clinical trial NCT03335761: InterStim® Amplitude Study
Official title: InterStim® Amplitude Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Urge Incontinence
Keywords: Urinary
Incontinence
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2017-11-08
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Detailed description: This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.

Eligibility criteria: Inclusion Criteria:

1. Primary diagnosis of urinary urge incontinence (UUI) as demonstrated on a 3-day baseline voiding diary demonstrating at least 3 UUI episodes
2. Female subjects 18 years of age or older
3. Candidate for InterStim Lead Placement
4. 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)
5. Willing and able to provide signed and dated informed consent
6. Willing to maintain current regimen (dosage and frequency) of any overactive bladder (OAB) medication

Exclusion Criteria:

1. Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury
2. History of diabetes unless the diabetes is well-controlled through diet and/or medications
3. Symptomatic urinary tract infection (UTI)
4. Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
5. Treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study
6. Implanted with a neurostimulator, pacemaker, or defibrillator
7. 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
8. Women who are pregnant or planning to become pregnant
9. Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
10. 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).

Primary outcomes:
measure: Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Academic Urology & Urogynecology of Arizona
state: Arizona
city: Jacksonville
country: United States
facility: East Coast Institute for Research
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Fridley
country: United States
facility: Minnesota Urology Fridley
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Urology Woodbury
state: Minnesota
city: Omaha
country: United States
facility: Adult Pediatric Urology and Urogynecology
state: Nebraska
city: Englewood
country: United States
facility: Urologic Research & Consulting
state: New Jersey
city: Concord
country: United States
facility: Carolina Urology Partners
state: North Carolina
city: Chattanooga
country: United States
facility: Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: West Allis
country: United States
facility: Aurora Research Institute - Aurora West Allis Women's Pavilion
state: Wisconsin
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg - Department Urology
city: Toronto
country: Canada
facility: University Urology Associates, Toronto Western Hospital
state: Ontario
city: Rouen
country: France
facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust - University College Hospital
Study officials:
References: