This trial is active, not recruiting.

Conditions urinary incontinence, urgency-frequency,, overactive bladder
Treatments interstim, standard medical therapy
Phase phase 4
Sponsor MedtronicNeuro
Start date October 2007
End date October 2016
Trial size 571 participants
Trial identifier NCT00547378, NCT00549094, Protocol 1634


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
InterStim Therapy
(Active Comparator)
Standard Medical Therapy
standard medical therapy
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

Primary Outcomes

Improvement in OAB symptoms
time frame: 6 months
Safety of the tined lead
time frame: 5 years

Secondary Outcomes

To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant.
time frame: 5 years
To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)
Description Approximately 30 million Americans meet the criteria for overactive bladder (OAB). Urinary voiding dysfunction symptoms impose a significant physical and psychosocial impact on individuals, including loss of self-esteem and a decrease in the ability to maintain an independent lifestyle. These symptoms can substantially affect a subject's daily activities. Patients with OAB are managed with diet modification, bladder training or retraining, pelvic muscle rehabilitation, medication and biofeedback. Medications are used as the first-line therapy for urgency frequency and urinary urge incontinence. InterStim Therapy utilizes sacral nerve stimulation and is indicated in the US for the treatment of urinary retention and the symptoms of OAB, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments. InSite OAB Protocol 1634 consists of two phases; Phase I which is the randomized portion of the trail and Phase II the non-randomized portion. Phase 1: A minimum of 60 subjects randomized to InterStim and a minimum of 60 subjects randomized to SMT. Phase 2: Non-randomized, all qualified subjects will receive InterStim, approximately 297 enrolled Subjects previously enrolled in Protocol 1634 for Urinary Urge Incontinence and Protocol 1635 for Urgency-Frequency will be included in Phase I of the new Protocol 1634 of OAB.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by MedtronicNeuro.