InterStim® Amplitude Study

Medtronic

Status: Completed

Conditions: Urinary Urge Incontinence

Treatments: Device: InterStim Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03335761

MDT17030

Details and patient eligibility

About

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

Full description

This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.

Enrollment: 97 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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97 participants in 3 patient groups

Amplitude Setting #1

Experimental group

Description:

InterStim Therapy will be set to amplitude parameter #1.

Treatment:

Device: InterStim Therapy

Amplitude Setting #2

Experimental group

Description:

InterStim Therapy will be set to amplitude parameter #2.

Treatment:

Device: InterStim Therapy

Amplitude Setting #3

Experimental group

Description:

InterStim Therapy will be set to amplitude parameter #3.

Treatment:

Device: InterStim Therapy