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InSite for Over Active Bladder (InSite - OAB)

Primary Purpose

Urinary Incontinence, Urgency-frequency, Overactive Bladder

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

InterStim

Standard Medical Therapy

About this trial

This is an interventional treatment trial for Urinary Incontinence, Urgency-frequency focused on measuring overactive bladder, urinary incontinence, incontinence,Urgency-frequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Arm Description

InterStim Therapy

Standard Medical Therapy

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

All Implanted Cohort: Tined Lead Migration Rate

To estimate the suspected cumulative tined lead migration rate at 5 years in subjects with a full system implant. Suspected tined lead migration resulting in an adverse event of lead migration/dislodgement meets the definition of this endpoint.

All Implanted Cohort: Infection Rate Associated With the Tined Lead

To characterize the cumulative infection rate at 5 years associated with the tined lead in subjects with a full system implant.

Full Information

NCT ID

NCT00547378

First Posted

October 18, 2007

Last Updated

November 6, 2017

Sponsor

MedtronicNeuro

1. Study Identification

Unique Protocol Identification Number

NCT00547378

Brief Title

InSite for Over Active Bladder

Acronym

InSite - OAB

Official Title

Prospective, Multicenter Trial Evaluating the Safety and Efficacy of InterStim® Therapy in Subjects With Symptoms of Overactive Bladder (InSite OAB)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MedtronicNeuro

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Incontinence, Urgency-frequency, Overactive Bladder

Keywords

overactive bladder, urinary incontinence, incontinence,Urgency-frequency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

571 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

InterStim Therapy

Arm Title

Arm Type

Active Comparator

Arm Description

Standard Medical Therapy

Intervention Type

Device

Intervention Name(s)

InterStim

Intervention Type

Drug

Intervention Name(s)

Standard Medical Therapy

Intervention Description

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 Outcome Measure Information:

Title

Randomized Cohort: OAB Therapeutic Response

Description

Time Frame

6 months

Title

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

Description

Time Frame

5 years

Secondary Outcome Measure Information:

Title

All Implanted Cohort: Tined Lead Migration Rate

Description

Time Frame

5 years

Title

All Implanted Cohort: Infection Rate Associated With the Tined Lead

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Siegel, MD

Organizational Affiliation

Metro Urology

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

24415559

Citation

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.

Results Reference

derived

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InSite for Over Active Bladder

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