InSite for Over Active Bladder (InSite - OAB)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro
ClinicalTrials.gov Identifier:
NCT00547378
First received: October 18, 2007
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.

Condition Intervention Phase
Urinary Incontinence, Urgency-frequency,
Overactive Bladder
Device: InterStim
Drug: Standard Medical Therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)

Resource links provided by NLM:


Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:
  • Improvement in OAB symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To demonstrate that the OAB therapeutic success rate at 6 months is greater for the InterStim therapy group than for the Standard Medical Therapy group.

  • Safety of the tined lead [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 33%.


Secondary Outcome Measures:
  • To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 571
Study Start Date: October 2007
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
InterStim Therapy
Device: InterStim
Active Comparator: 2
Standard Medical Therapy
Drug: 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547378

  Show 22 Study Locations
Sponsors and Collaborators
MedtronicNeuro
Investigators
Study Chair: Steven Siegel, MD Metro Urology
  More Information

No publications provided

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT00547378     History of Changes
Obsolete Identifiers: NCT00549094
Other Study ID Numbers: Protocol 1634
Study First Received: October 18, 2007
Last Updated: June 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by MedtronicNeuro:
overactive bladder, urinary incontinence, incontinence,Urgency-frequency

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 22, 2014