Outcomes After Sacrocolpopexy With and Without Burch to P... | NCT03609229

Studies
Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse

NCT03609229

Sponsor

Assiut University

Status

Completed

Last Update Posted

Aug 12, 2020Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Prolapse

Interventions

Burch
Abdominal Sacrocolpopexy

Countries

Egypt

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

Aug 2020

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

Sep 1, 2018Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Aug 1, 2020Actual

First Submitted Date

Jul 25, 2018

First Submission Date that Met QC Criteria

Jul 31, 2018

First Posted Date

Aug 1, 2018Actual

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

Aug 10, 2020

Last Update Posted Date

Aug 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who choose to undergo surgical management also choose to undergo continence surgery in order to prevent new onset urinary incontinence.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Study group	Experimental	Abdominal Sacrocolpopexy with burch technique	Procedure: Burch Procedure: Abdominal Sacrocolpopexy
control group	Active Comparator	Abdominal Sacrocolpopexy without burch technique	Procedure: Abdominal Sacrocolpopexy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Burch	Procedure	polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve	Study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the percentage of stress incontinence post operative	(symptoms, stress testing, or treatment)	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Women with 3rd and 4th degree Apical prolapse

Exclusion Criteria:

Patients with previous failed surgical intervention
Patients with medical disorders that may interfere with surgical interventions .
Patients with apical prolapsed complaining of stress urinary incontinence

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D011391	Prolapse

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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