Treatment Outcomes of Vaginal Prolapse Repair | NCT00679276

Studies
Treatment Outcomes of Vaginal Prolapse Repair

NCT00679276

Sponsor

Corewell Health East

Status

Completed

Last Update Posted

Jun 7, 2010Estimated

Enrollment

291Actual

Phase

Not provided

Conditions

Vaginal Prolapse

Interventions

Prolift

Countries

Not provided

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

Jun 2010

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

May 2008

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

May 14, 2008

First Submission Date that Met QC Criteria

May 14, 2008

First Posted Date

May 16, 2008Estimated

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

Jun 4, 2010

Last Update Posted Date

Jun 7, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital.

Detailed Description

Chart review conducted on all patients having had Prolift surgery since 2005 by Dr. Lary Sirls, Dr. Predeep Nagaraju and Dr. Kenneth Peters at William Beaumont Hospital. Preoperative, intraoperative and post-operative data will be collected from the hospital and physician medical records. A questionnaire will be mailed to patients whose charts have been reviewed to assess urinary and bowel function, satisfaction with treatment and changes in sexual function. Completion of the questionnaire is voluntary.

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

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

291Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients having surgical repair of a vaginal prolapse .	Procedure: Prolift

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prolift	Procedure	surgical repair of vaginal prolapse	1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women having Prolift repair at William Beaumont Hospital

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients having prolift surgery at William Beaumont Hospital by Dr. Lary Sirls, Dr. Predeep Nagaraju, and Dr. Kenneth Peters.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Predeep Nagaraju, MD	Corewell Health East	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014596	Uterine Prolapse

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided