InterStim Therapy Programming Study

NCT01009333 | Completed Results

• 1 other identifier: 1650
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study assessed the effect of different InterStim rate settings on voiding diary outcomes. Specifically, the study evaluated how 3 different rate settings affected the number of urinary incontinent episodes per day collected through a voiding diary. The study also evaluated how the 3 different rate settings affected other voiding diary measures including number of voids per day, degree of urgency before each void, number of pads used per day, and number of fecal incontinent episodes, questionnaires, and adverse events.

Conditions

Urgency Frequency; Urinary Urge Incontinence

Keywords

urgency frequency; urinary urge incontinence; InterStim Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Urinary Incontinent Episodes Per Day

  In a diary, subjects are asked to rate each urine leaking episode at 'None', 'Slight', 'Moderate' or 'Heavy'. The urinary incontinence was counted if there is any degree of leaking, from 'Slight' to 'Heavy'. The total number of urinary incontinence was calculated per day.

  three weeks

Secondary Outcomes (2)

• Number of Voids Per Day

  three weeks

• Number of Pads Per Day

  three weeks

Study Arms (3)

Low InterStim rate setting at 5.2 Hz

EXPERIMENTAL

Device: InterStim Therapy at rate 5.2 Hz

Medium InterStim rate setting at 14 Hz

EXPERIMENTAL

Device: InterStim Therapy at rate 14 Hz

High InterStim rate setting at 25 Hz

EXPERIMENTAL

Device: InterStim Therapy

Interventions

InterStim Therapy at rate 5.2 Hz DEVICE

All subjects enrolled in this study were programmed to this rate setting for a 1-week period.

Low InterStim rate setting at 5.2 Hz

InterStim Therapy at rate 14 Hz DEVICE

All subjects enrolled in this study were programmed to this rate setting for a 1-week period.

Medium InterStim rate setting at 14 Hz

InterStim Therapy DEVICE

All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.

High InterStim rate setting at 25 Hz

Eligibility Criteria

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

You may qualify if:

• Implanted with either Neurostimulator Model 3023 (InterStim) or Neurostimulator Model 3058 (InterStim II) for at least 3 months - Implanted with tined lead models 3889 or 3093
• Tined lead is located in S2, S3, or S4
• Diagnosis before InterStim implant included urgency frequency (an average of 8 or more voids per day) and any amount of urinary urge incontinence over the voiding diary reporting period. The diary reporting period must be at least 2 days.
• Able to tolerate (ie, no complaint of pain or discomfort) acute high InterStim rate setting
• Able to tolerate (ie, no complaint of pain or discomfort) acute medium InterStim rate setting
• Able to tolerate (ie, no complaint of pain or discomfort) acute low InterStim rate setting
• Must be willing to maintain their current regimen (dosage and frequency) of any overactive bladder medication (anticholinergic or antimuscarinic) or tricyclic antidepression medication over the study duration
• Female subject 18 years of age or older
• Willing and able to accurately complete voiding diaries and questionnaires, attend visits, and comply with the study protocol that includes maintenance of InterStim programming settings over the course of the study.
• Able to consent to participate by signing the Informed Consent Form

You may not qualify if:

• Multiple sclerosis
• Reiter's syndrome
• Exclude diabetics unless the subject's diabetes is well-controlled with diet or medication
• History of spinal cord injury or a cerebral vascular accident (CVA)
• Active symptomatic urinary tract infection (UTI)
• Stress incontinence as the primary diagnosis
• Pelvic pain of uncertain etiology that is not associated with a voiding dysfunction or where pelvic pain is the primary complaint/diagnosis
• Interstitial cystitis as the primary diagnosis
• Urinary retention as the primary diagnosis
• Treatment of urinary symptoms with botulinum toxin in the past 12 months or any plan to have botulinum toxin treatment during the study
• Bilateral lead placement
• Have other implantable neurostimulator, pacemaker, or defibrillator
• Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
• Have an anticipated system modification within the next 1 month
• Women who are pregnant or planning to become pregnant or women of child-bearing potential who are not using a medically-acceptable method of birth control. Women of child-bearing age potential must undergo a pregnancy test, with a clear negative result, no more than 7 days prior to randomization visit.

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (1)

Kenneth Peters, MD

Royal Oak, Michigan, 48073, United States

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: Maureen McGuire, Sr. Program Manager
• Organization: Medtronic Neuromodulation

maureen.mcguire@medtronic.com

763-526-8425

Study Officials

• Maureen McGuire, Ph.D.

  MedtronicNeuro

  STUDY DIRECTOR

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
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2009
• First Posted: November 6, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 27, 2013
• Results First Posted: May 2, 2012

Record last verified: 2013-05

Locations

US (1)