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InterStim Therapy Programming Study

NCT01009333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2013-05-27

Study results available
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Summary

This study assessed the effect of different InterStim rate settings on voiding diary outcomes. Specifically, the study evaluated how 3 different rate settings affected the number of urinary incontinent episodes per day collected through a voiding diary. The study also evaluated how the 3 different rate settings affected other voiding diary measures including number of voids per day, degree of urgency before each void, number of pads used per day, and number of fecal incontinent episodes, questionnaires, and adverse events.

Conditions

  • Urgency Frequency
  • Urinary Urge Incontinence

Interventions

DEVICE

InterStim Therapy at rate 5.2 Hz

All subjects enrolled in this study were programmed to this rate setting for a 1-week period.

DEVICE

InterStim Therapy at rate 14 Hz

All subjects enrolled in this study were programmed to this rate setting for a 1-week period.

DEVICE

InterStim Therapy

All subjects enrolled in this study were programmed to each rate setting (low, medium, high) for a 1-week period.

Sponsors & Collaborators

  • MedtronicNeuro

    lead INDUSTRY

Principal Investigators

  • Maureen McGuire, Ph.D. · MedtronicNeuro

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01009333 on ClinicalTrials.gov