InSite for Urinary Urgency-Frequency - Full Text View

Sponsor:	MedtronicNeuro
Information provided by:	MedtronicNeuro
ClinicalTrials.gov Identifier:	NCT00549094

Purpose

The purposes of this study are:

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.
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 Bladder, Overactive	Device: InterStim Therapy Drug: Standard Medical Therapy	Phase IV

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, Randomized, Parallel-Group Trial Comparing the Safety and Efficacy of InterStim® Therapy to Standard Medical Therapy for Subjects With Urgency-Frequency Symptoms of Overactive Bladder

Further study details as provided by MedtronicNeuro:

Primary Outcome Measures:

Decrease in urinary frequency [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Long-term surgical rate to assess safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	325
Study Start Date:	October 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 InterStim Therapy	Device: InterStim Therapy drug therapy
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

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 or urgency-frequency alone or in combination, in subjects who have failed or could not tolerate more conservative treatments.

This protocol will be close approximately June 1, 2010. All subjects enrolled in this protocol will be followed under protocol 1634 for OAB.

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 255 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.

Please reference protocol 1634 for a more detailed description.

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 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

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). Upon completion of therapy for UTI, or if the subject is receiving prophylaxis for UTI, the subject can be considered for study entry if he/she is symptom-free for one month prior to randomization.
Have implantable neurostimulators, pacemakers, or defibrillators
Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component
Have a primary diagnosis of Interstitial Cystitis
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549094

Show 26 Study Locations

Sponsors and Collaborators

MedtronicNeuro

Investigators

Study Chair:

InSite Team

Medtronic

More Information

No publications provided

Responsible Party:	Gena Schwasinger, Medtronic Neuromodulation
ClinicalTrials.gov Identifier:	NCT00549094 History of Changes
Other Study ID Numbers:	Protocol 1635
Study First Received:	October 18, 2007
Last Updated:	April 21, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by MedtronicNeuro:

urgency-frequency, overactive bladder, urgency frequency

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012