NCT01009333

InterStim Therapy Programming Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: MedtronicNeuro · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-11-06
• Last updated: 2013-05-27
• Results posted: 2012-05-02

Locations

1 site across 1 country: United States