Phase 4 N=147 Randomized Treatment

InSite for Over Active Bladder

Urinary Incontinence, Urgency-frequency · Overactive Bladder

Bottom Line

View on ClinicalTrials.gov: NCT00547378 ↗

Enrolled (actual)

147

Serious AEs

29.2%

Results posted

Dec 2017

Primary outcome: Primary: Randomized Cohort: OAB Therapeutic Response — 61; 42 percentage of participants with response — p=0.016

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: InterStim (Device); Standard Medical Therapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MedtronicNeuro
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Randomized Cohort: OAB Therapeutic Response	61; 42	0.016 sig
PRIMARY All Implanted Cohort: Adverse Events Related to the Tined Lead That Require Surgery	0.224	—
SECONDARY All Implanted Cohort: Tined Lead Migration Rate	0.059	—
SECONDARY All Implanted Cohort: Infection Rate Associated With the Tined Lead	0.012	—

Summary

The purposes of this study are: 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. To fulfill the requirements of the FDA-mandated post-approval study of the safety of the tined lead using a minimally invasive approach.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00547378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.