Status:
COMPLETED
InterStim® Amplitude Study
Lead Sponsor:
MedtronicNeuro
Conditions:
Urinary Urge Incontinence
Eligibility:
FEMALE
18+ years
Phase:
NA
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
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
February 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2019
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03335761
Start Date
February 27 2018
End Date
November 6 2019
Last Update
January 8 2021
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
Academic Urology & Urogynecology of Arizona
Phoenix, Arizona, United States, 85027
2
East Coast Institute for Research
Jacksonville, Florida, United States, 32216
3
Pinellas Urology
St. Petersburg, Florida, United States, 33710
4
Florida Urology Partners
Tampa, Florida, United States, 33606