Trials Sponsors Conditions Drugs Pricing

Conditions

Overactive Bladder Urinary Incontinence, Urgency-frequency

Keywords

overactive bladder, urinary incontinence, incontinence,Urgency-frequency

Outcome Measures

Primary Outcomes (2)

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.
6 months
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.
5 years

Secondary Outcomes (2)

All Implanted Cohort: Tined Lead Migration Rate
5 years
All Implanted Cohort: Infection Rate Associated With the Tined Lead
5 years

Study Arms (2)

1

OTHER

InterStim Therapy

Device: InterStim

2

ACTIVE COMPARATOR

Standard Medical Therapy

Drug: Standard Medical Therapy

Interventions

InterStimDevice

Standard Medical TherapyDrug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Have a diagnosis of OAB including urinary urge incontinence or urgency-frequency
Be male or female at least 18 years of age or older

Sponsors & Collaborators

MedtronicNeuro
Industrylead

Related Publications (1)

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.
PMID: 24415559DERIVED

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder Diseases

Limitations and Caveats

Predominantly female and Caucasian subjects could detract from generalizability. Centers followed individual protocols for peri-op antibiotics, lead choice, and procedure techniques. Lack of standardization may have impacted overall study results.

Results Point of Contact

Title: Shenita Bolstrom
Organization: Pelvic Health & Gastric Therapies

Study Officials

Steven Siegel, MD
Metro Urology
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

571 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 22, 2007

Study Start

October 2007

Date type not reported

This date has not been verified as actual or estimated.

InSite for Over Active Bladder

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record