Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon... | NCT01387685

Studies
Treatment of Pelvic Organ Prolapse by PIVS Versus Surgeon Cut Mesh

NCT01387685

Sponsor

Western Galilee Hospital-Nahariya

Status

Withdrawn

Last Update Posted

Jun 20, 2014Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Pelvic Floor Prolapse

Interventions

Not provided

Countries

Israel

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 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jan 2013Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Jun 29, 2011

First Submission Date that Met QC Criteria

Jun 30, 2011

First Posted Date

Jul 4, 2011Estimated

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 19, 2014

Last Update Posted Date

Jun 20, 2014Estimated

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

Women with pelvic floor prolapse who underwent surgery with mesh will be enrolled. The investigators will compare data from the chart, telephone interviews and physical examinations between those who underwent mesh placement to those who underwent placement of PIVS.

Detailed Description

Not provided

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

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Satisfaction with study outcome		six to twelve months after surgery

Secondary Outcomes

Measure	Description	Time Frame
Side effects of the surgery: pain, vaginal erosion by tape, bleeding		Within six to twelve months after study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who underwent surgery for pelvic floor prolapse

Exclusion Criteria:

Women who did not have surgery for pelvic floor prolapse.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Women who underwent surgery for pelvic floor prolapse who underwent surgery by eithe surgeon-cut-mesh or by PIVS

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Western Galilee Hospital		Nahariya			Israel
Dr Neuman clinic