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InterStim® Amplitude Study

Primary Purpose

Urinary Urge Incontinence

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

InterStim Therapy

About this trial

This is an interventional basic science trial for Urinary Urge Incontinence focused on measuring Urinary, Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Academic Urology & Urogynecology of Arizona
East Coast Institute for Research
Pinellas Urology
Florida Urology Partners
Minnesota Urology Fridley
Minnesota Urology Woodbury
Adult Pediatric Urology and Urogynecology
Urologic Research & Consulting
Carolina Urology Partners
Chattanooga Hamilton County Hospital Authority d/b/a Erlanger Health System
Vanderbilt University Medical Center
Aurora Research Institute - Aurora West Allis Women's Pavilion
UZ Leuven - Campus Gasthuisberg - Department Urology
University Urology Associates, Toronto Western Hospital
CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
Azienda Ospedaliera Universitaria Integrata Verona
Erasmus MC
University College London Hospitals NHS Foundation Trust - University College Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Amplitude Setting #1

Amplitude Setting #2

Amplitude Setting #3

Arm Description

InterStim Therapy will be set to amplitude parameter #1.

InterStim Therapy will be set to amplitude parameter #2.

InterStim Therapy will be set to amplitude parameter #3.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT03335761

First Posted

October 23, 2017

Last Updated

December 14, 2020

Sponsor

MedtronicNeuro

1. Study Identification

Unique Protocol Identification Number

NCT03335761

Brief Title

InterStim® Amplitude Study

Official Title

InterStim® Amplitude Study

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

February 27, 2018 (Actual)

Primary Completion Date

November 6, 2019 (Actual)

Study Completion Date

November 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedtronicNeuro

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Urge Incontinence

Keywords

Urinary, Incontinence

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amplitude Setting #1

Arm Type

Experimental

Arm Description

InterStim Therapy will be set to amplitude parameter #1.

Arm Title

Amplitude Setting #2

Arm Type

Experimental

Arm Description

InterStim Therapy will be set to amplitude parameter #2.

Arm Title

Amplitude Setting #3

Arm Type

Experimental

Arm Description

InterStim Therapy will be set to amplitude parameter #3.

Intervention Type

Device

Intervention Name(s)

InterStim Therapy

Intervention Description

Device Programming

Primary Outcome Measure Information:

Title

Change in Urinary Urge Incontinence (UUI) Episodes Per Day From Baseline to 12 Weeks.

Description

Symptoms related to OAB were evaluated using paper voiding diaries. Subjects were trained to complete the urinary voiding diaries for 3-days.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

12 weeks

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Facility Information:

Facility Name

Academic Urology & Urogynecology of Arizona

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85027

Country

United States

Facility Name

East Coast Institute for Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32216

Country

United States

Facility Name

Pinellas Urology

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33710

Country

United States

Facility Name

Florida Urology Partners

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Facility Name

Minnesota Urology Fridley

City

Fridley

State/Province

Minnesota

ZIP/Postal Code

55432

Country

United States

Facility Name

Minnesota Urology Woodbury

City

Woodbury

State/Province

Minnesota

ZIP/Postal Code

55125

Country

United States

Facility Name

Adult Pediatric Urology and Urogynecology

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Urologic Research & Consulting

City

Englewood

State/Province

New Jersey

ZIP/Postal Code

07631

Country

United States

Facility Name

Carolina Urology Partners

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28025

Country

United States

Facility Name

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

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-2765

Country

United States

Facility Name

Aurora Research Institute - Aurora West Allis Women's Pavilion

City

West Allis

State/Province

Wisconsin

ZIP/Postal Code

53227

Country

United States

Facility Name

UZ Leuven - Campus Gasthuisberg - Department Urology

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

University Urology Associates, Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

City

Rouen

Country

France

Facility Name

Azienda Ospedaliera Universitaria Integrata Verona

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

Erasmus MC

City

Rotterdam

ZIP/Postal Code

3015 GD

Country

Netherlands

Facility Name

University College London Hospitals NHS Foundation Trust - University College Hospital

City

London

ZIP/Postal Code

W1G 8PH

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

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InterStim® Amplitude Study

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