InSite for Over Active Bladder

NCT00547378 | Completed Phase 4 Results

• 1 other identifier: Protocol 1634
• Study Type: interventional
• Target: 571
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purposes of this study are:

1. 1.To provide evidence from a randomized controlled trial that InterStim Therapy provides better relief of symptoms of OAB than standard medical treatments in current use.
2. 2.To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.

Conditions

Urinary Incontinence, Urgency-frequency; Overactive Bladder

Keywords

overactive bladder, urinary incontinence, incontinence,Urgency-frequency

Outcome Measures

Primary Outcomes (2)

• Randomized Cohort: OAB Therapeutic Response

  To demonstrate that the OAB therapeutic response rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group. OAB therapeutic response rate was calculated as number of subjects with OAB therapeutic response divided by number of subjects included in the analysis. OAB therapeutic response was defined as: * at least 50% or greater improvement in average leaks/day from baseline for subjects with urinary incontinence at baseline or * at least 50% improvement in average voids/day from baseline or a return to normal voiding frequency (\<8 voids/day) for subjects with urgency-frequency at baseline.

  6 months

• All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery

  To demonstrate that the upper bound of the 95% CI for the cumulative five-year rate of adverse events related to the tined lead that require surgery is less than 0.33. Adverse events on or after neurostimulator implant with an etiology of lead and with an intervention of surgical intervention/revision are the event of interest.

  5 years

Secondary Outcomes (2)

• All Implanted Cohort: Tined Lead Migration Rate

  5 years

• All Implanted Cohort: Infection Rate Associated With the Tined Lead

  5 years

Study Arms (2)

1

OTHER

InterStim Therapy

Device: InterStim

2

ACTIVE COMPARATOR

Standard Medical Therapy

Drug: Standard Medical Therapy

Interventions

InterStim DEVICE

1

Standard Medical Therapy DRUG

Oxybutynin 2.5mg, 5mg Oxybutynin extended release 5 mg, 10mg, 15mg Oxybutynin transdermal 3.9mg Solifenacin 5mg, 10mg Tolterodine 1mg, 2mg Tolterodine extended release 2mg, 4mg Trospium 20mg Darifenacin extended release 7.5mg, 15mg fesoterodine Fumarate 4mg, 8mg

2

Eligibility Criteria

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

You may qualify if:

• Have a diagnosis of OAB including urinary urge incontinence or urgency-frequency
• Be male or female at least 18 years of age or older
• Be able to consent to participate by signing the Informed Consent
• Be willing and able to attend visits and comply with the study protocol including adequate operation of equipment
• Have failed or are not a candidate for more conservative treatment (e.g. pelvic floor training, biofeedback, behavioral modification)
• Have failed or could not tolerate (stopped taking medication due to lack of efficacy or intolerable side effects) at least one anticholinergic or antimuscarinic medication AND have at least one anticholinergic or antimuscarinic medication not yet attempted
• Have been on current regiment of OAB medications or have not been on any OAB medications, for at least 4 weeks prior to beginning the baseline voiding diary

You may not qualify if:

• Have severe or uncontrolled diabetes or diabetes with peripheral nerve involvement
• Have concomitant medical conditions which would limit the success of the study procedure
• Have skin, orthopedic or neurologic anatomical limitations that could prevent successful placement of an electrode
• Have neurological diseases such as multiple sclerosis, clinically significant peripheral neuropathy or complete spinal cord injury (e.g., paraplegia)
• Have knowledge of planned MRIs, diathermy, microwave exposure, high output ultrasonic exposure, or RF energy exposure
• Have urinary tract mechanical obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture
• Have symptomatic urinary tract infection (UTI)
• Have implantable neurostimulators, pacemakers, or defibrillators
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
• Have had treatment of urinary symptoms with botulinum toxin therapy in the past 12 months
• Be a woman who is pregnant or planning to become pregnant or are a woman of child-bearing potential who is not using a medically-acceptable method of birth control
• Have a life expectancy of less than one year
• Have plans to enroll in another investigation device or drug trial during their participation in this trial, or currently enrolled in an investigational device or drug trial

Sponsors & Collaborators

• MedtronicNeuro: lead

Related Publications (1)

• Siegel S, Noblett K, Mangel J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Bennett J, Zylstra S, Berg KC, Kan F, Irwin CP. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015 Mar;34(3):224-30. doi: 10.1002/nau.22544. Epub 2014 Jan 10.

  PMID: 24415559 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

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; Urinary Bladder Diseases

Limitations and Caveats

Predominantly female and Caucasian subjects could detract from generalizability. Centers followed individual protocols for peri-op antibiotics, lead choice, and procedure techniques. Lack of standardization may have impacted overall study results.

Results Point of Contact

• Title: Shenita Bolstrom
• Organization: Pelvic Health & Gastric Therapies

shenita.bolstrom@medtronic.com

763-526-8254

Study Officials

• Steven Siegel, MD

  Metro Urology

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2007
• First Posted: October 22, 2007
• Study Start: October 1, 2007
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 12, 2017
• Results First Posted: December 12, 2017

Record last verified: 2017-11