A Cost Analysis of Interstim Therapy | NCT00200031

Studies
A Cost Analysis of Interstim Therapy

NCT00200031

Sponsor

MedtronicNeuro

Status

Completed

Last Update Posted

Jul 28, 2008Estimated

Enrollment

150

Phase

Not provided

Conditions

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

Interventions

Interstim therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2008

Last Update Posted Date

Jul 28, 2008Estimated

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

150

Name	Type	Description	Arm Group Labels	Other Names
Interstim therapy	Device

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sherif Aboseif, MD	Kaiser Permanente	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern California Permanente Medical Group		Los Angeles	California	90027	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18158016	Result	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.

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications