InterStim® Amplitude Study

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

Study Overview

• Status: Completed
• Conditions: Urinary Urge Incontinence
• Intervention / Treatment: Device: InterStim Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • UZ Leuven - Campus Gasthuisberg - Department Urology
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • University Urology Associates, Toronto Western Hospital
• France
  • Rouen, France
    • CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
• Italy
  • Verona, Italy, 37126
    • Azienda Ospedaliera Universitaria Integrata Verona
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC
• United Kingdom
  • London, United Kingdom, W1G 8PH
    • University College London Hospitals NHS Foundation Trust - University College Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85027
      • Academic Urology & Urogynecology of Arizona
  • Florida
    • Jacksonville, Florida, United States, 32216
      • East Coast Institute for Research
    • Saint Petersburg, Florida, United States, 33710
      • Pinellas Urology
    • Tampa, Florida, United States, 33606
      • Florida Urology Partners
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Urology Fridley
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Urology Woodbury
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Adult Pediatric Urology and Urogynecology
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Urologic Research & Consulting
  • North Carolina
    • Concord, North Carolina, United States, 28025
      • Carolina Urology Partners
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System
    • Nashville, Tennessee, United States, 37232-2765
      • Vanderbilt University Medical Center
  • Wisconsin
    • West Allis, Wisconsin, United States, 53227
      • Aurora Research Institute - Aurora West Allis Women's Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Amplitude Setting #1; InterStim Therapy will be set to amplitude parameter #1.	Device: InterStim Therapy; Device Programming
EXPERIMENTAL: Amplitude Setting #2; InterStim Therapy will be set to amplitude parameter #2.	Device: InterStim Therapy; Device Programming
EXPERIMENTAL: Amplitude Setting #3; InterStim Therapy will be set to amplitude parameter #3.	Device: InterStim Therapy; Device Programming

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in QoL Using ICIQ-OAB QOL From Baseline to 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.	12 weeks

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 27, 2018
• Primary Completion (ACTUAL): November 6, 2019
• Study Completion (ACTUAL): November 6, 2019

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (ACTUAL): November 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 8, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Incontinence; Urinary
• Additional Relevant MeSH Terms: Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Urinary Incontinence; Urinary Incontinence, Urge
• Other Study ID Numbers: MDT17030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes