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InterStim® Amplitude Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335761
Recruitment Status : Completed
First Posted : November 8, 2017
Last Update Posted : April 14, 2020
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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

Condition or disease Intervention/treatment Phase
Urinary Urge Incontinence Device: InterStim Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: InterStim® Amplitude Study
Actual Study Start Date : February 27, 2018
Actual Primary Completion Date : November 6, 2019
Actual Study Completion Date : November 6, 2019

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




Primary Outcome Measures :
  1. Characterize effect on Urinary Urge Incontinence [ Time Frame: 12 weeks ]
    Change from baseline in urinary urge incontinence (UUI) episodes per day at 12 weeks.


Secondary Outcome Measures :
  1. Characterize effect on Quality of Life (QoL) [ Time Frame: 12 weeks ]
    Change from baseline on QoL using ICIQ-OAB QOL at 12 weeks. (Coyne K, Revicki D, Hunt T, et al. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002;11(6):563-574.)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335761


Locations
Show Show 18 study locations
Sponsors and Collaborators
MedtronicNeuro
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT03335761    
Other Study ID Numbers: MDT17030
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by MedtronicNeuro:
Urinary
Incontinence
Additional relevant MeSH terms:
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Urinary Incontinence, Urge
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms