InterStim® Amplitude Study

NCT03335761 | Completed Results FDA Device

• 1 other identifier: MDT17030
• Study Type: interventional
• Target: 97
• Locations: 7 countries
• Sites: 18

Brief Summary

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

Conditions

Urinary Urge Incontinence

Keywords

Urinary; Incontinence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in QoL Using ICIQ-OAB QOL From Baseline to 12 Weeks.

  12 weeks

Study Arms (3)

Amplitude Setting #1

EXPERIMENTAL

InterStim Therapy will be set to amplitude parameter #1.

Device: InterStim Therapy

Amplitude Setting #2

EXPERIMENTAL

InterStim Therapy will be set to amplitude parameter #2.

Device: InterStim Therapy

Amplitude Setting #3

EXPERIMENTAL

InterStim Therapy will be set to amplitude parameter #3.

Device: InterStim Therapy

Interventions

InterStim Therapy DEVICE

Device Programming

Amplitude Setting #1; Amplitude Setting #2; Amplitude Setting #3

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (18)

Academic Urology & Urogynecology of Arizona

Phoenix, Arizona, 85027, United States

Location

East Coast Institute for Research

Jacksonville, Florida, 32216, United States

Location

Pinellas Urology

St. Petersburg, Florida, 33710, United States

Location

Florida Urology Partners

Tampa, Florida, 33606, United States

Location

Minnesota Urology Fridley

Fridley, Minnesota, 55432, United States

Location

Minnesota Urology Woodbury

Woodbury, Minnesota, 55125, United States

Location

Adult Pediatric Urology and Urogynecology

Omaha, Nebraska, 68114, United States

Location

Urologic Research & Consulting

Englewood, New Jersey, 07631, United States

Location

Carolina Urology Partners

Concord, North Carolina, 28025, United States

Location

Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System

Chattanooga, Tennessee, 37421, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2765, United States

Location

Aurora Research Institute - Aurora West Allis Women's Pavilion

West Allis, Wisconsin, 53227, United States

Location

UZ Leuven - Campus Gasthuisberg - Department Urology

Leuven, 3000, Belgium

Location

University Urology Associates, Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

Rouen, France

Location

Azienda Ospedaliera Universitaria Integrata Verona

Verona, 37126, Italy

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

University College London Hospitals NHS Foundation Trust - University College Hospital

London, W1G 8PH, United Kingdom

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mylène Champs (Sr Clinical Research Specialist)
• Organization: Medtronic

mylene.champs@medtronic.com

+17635261627

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: November 8, 2017
• Study Start: February 27, 2018
• Primary Completion: November 6, 2019
• Study Completion: November 6, 2019
• Last Updated: January 8, 2021
• Results First Posted: January 8, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); FR (1); NL (1); IT (1); GB (1); CA (1); BE (1)