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A Cost Analysis of Interstim Therapy

Primary Purpose

Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency)

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Interstim therapy
Sponsored by
MedtronicNeuro
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Patients implanted with an Interstim Therapy for Urinary Control or undergoing test stimulation for potential placement of Interstim Therapy during the period of June 1, 2002 through June 30, 2004 and who are enrolled with Kaiser-Permanente of Southern California.

Sites / Locations

  • Southern California Permanente Medical Group

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
July 24, 2008
Sponsor
MedtronicNeuro
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1. Study Identification

Unique Protocol Identification Number
NCT00200031
Brief Title
A Cost Analysis of Interstim Therapy
Official Title
Interstim Therapy Retrospective Cost Analysis and Quality of Life
Study Type
Observational

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedtronicNeuro

4. Oversight

5. Study Description

Brief Summary
A study to examine the impact that Interstim Therapy for Urinary Control has on health care utilization and costs within a health care system and the satisfaction with treatment expressed by patients using this therapy.
Detailed Description
A retrospective administrative data analysis combined with a prospective health related quality of life/satisfaction with treatment survey designed to examine the impact that Interstim Therapy for Urinary Control has had on health care utilization and costs for the Kaiser Permanente system and the satisfaction with treatment expressed by patients using this therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Retention and Symptoms of Overactive Bladder (Urge, Frequency)

7. Study Design

Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Interstim therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Patients implanted with an Interstim Therapy for Urinary Control or undergoing test stimulation for potential placement of Interstim Therapy during the period of June 1, 2002 through June 30, 2004 and who are enrolled with Kaiser-Permanente of Southern California.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif Aboseif, MD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California Permanente Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18158016
Citation
Aboseif SR, Kim DH, Rieder JM, Rhee EY, Menefee SA, Kaswick JR, Ree MH. Sacral neuromodulation: cost considerations and clinical benefits. Urology. 2007 Dec;70(6):1069-73; discussion 1073-4. doi: 10.1016/j.urology.2007.07.073.
Results Reference
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Learn more about this trial

A Cost Analysis of Interstim Therapy

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