InterStim® Amplitude Study

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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).

Arm && Interventions

Group	Intervention	Description
Amplitude Setting #1	InterStim Therapy	InterStim Therapy will be set to amplitude parameter #1.
Amplitude Setting #2	InterStim Therapy	InterStim Therapy will be set to amplitude parameter #2.
Amplitude Setting #3	InterStim Therapy	InterStim Therapy will be set to amplitude parameter #3.

Primary Outcome Measures

Name	Time	Method
Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.	12 weeks	Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.

Secondary Outcome Measures

Name	Time	Method
Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.	12 weeks	International Consultation on Incontinence Modular Questionnaire - Overactive Bladder Symptoms Quality of Life Questionnaire The questionnaire consists of 4 subscales and a single item on urinary symptom interference. The four subscales of Concern (7 items), Coping (8 items), Sleep (5 items), and Social (5 items) are measured on a scale from 0-100 using a range percentile transformation on the summed value from individual listed items. The Health-Related Quality of Life (HRQL) score is a calculated score with a range from 0 to 100 using a range percentile transformation on the summed value from the subscales. Subjects were asked a urinary symptom interference question. "Interference" was measured on a scale from 0-10. A positive change in Concern, Coping, Sleep, Social, and HRQL indicates improvement in Quality of Life; a negative change in Interference indicates improvement in Quality of Life.

Locations (18): Pinellas Urology
🇺🇸
Saint Petersburg, Florida, United States
University College London Hospitals NHS Foundation Trust - University College Hospital
🇬🇧
London, United Kingdom
Minnesota Urology Woodbury
🇺🇸
Woodbury, Minnesota, 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
University Urology Associates, Toronto Western Hospital
🇨🇦
Toronto, Ontario, Canada
Academic Urology & Urogynecology of Arizona
🇺🇸
Phoenix, Arizona, United States
Minnesota Urology Fridley
🇺🇸
Fridley, Minnesota, United States
Adult Pediatric Urology and Urogynecology
🇺🇸
Omaha, Nebraska, United States
UZ Leuven - Campus Gasthuisberg - Department Urology
🇧🇪
Leuven, Belgium
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹
Verona, Italy
Erasmus MC
🇳🇱
Rotterdam, Netherlands
CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
🇫🇷
Rouen, France
Florida Urology Partners
🇺🇸
Tampa, Florida, United States
East Coast Institute for Research
🇺🇸
Jacksonville, Florida, United States
Carolina Urology Partners
🇺🇸
Concord, North Carolina, United States
Urologic Research & Consulting
🇺🇸
Englewood, New Jersey, United States