Anterior Vaginal Wall Repair With Mesh in Combination Wit... | NCT01507714

Studies
Anterior Vaginal Wall Repair With Mesh in Combination With TVT-O to Reduce Urinary Stress Incontinence

NCT01507714

Sponsor

HaEmek Medical Center, Israel

Status

Unknown status

Last Update Posted

Jan 11, 2012Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Pelvic Organ Prolapse

Interventions

Preventive transobturator tension free vaginal tape

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

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Jan 2014Estimated

Completion Date

Jan 2014Estimated

First Submitted Date

Jan 2, 2012

First Submission Date that Met QC Criteria

Jan 8, 2012

First Posted Date

Jan 11, 2012Estimated

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

Jan 8, 2012

Last Update Posted Date

Jan 11, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Urinary stress incontinence is defined as leakage of urine during stress. Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence.

The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.

Detailed Description

Urinary stress incontinence is defined as leakage of urine during stress (cough, lough, sneezing, coitus, heavy lifting, physical activity). Urinary stress incontinence is a health problem with social, economic and psychological consequences. The appearance of Urinary stress incontinence post vaginal wall prolapse repair is a known phenomena. Part of the cases relate to pre-surgical occult Urinary stress incontinence which has been asymptomatic, and part of the cases relate to de-novo urinary stress incontinence post surgery. Latest studies have demonstrated 11-22% rate of post surgical urinary stress incontinence.

The CARE study has examined the efficacy of preventive BURCH RETROPUBIC URETHROPEXY among women who underwent abdominal sacrocolpopexy. According to this study, the BURCH procedure reduced the rate of post surgery urinary stress incontinence. The authors recommend to offer those women the preventive surgery. Those results cannot be relied on when considering vaginal wall repair by the vaginal approach.

The aim of this study is to examine the efficacy of transobturator tension free vaginal tape (TVT-O) among women who intend to undergo vaginal wall repair by a vaginal approach.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control arm	No Intervention	vaginal wall repair surgery will be done to women in this arm, with no treatment for stress incontinence
TVT-O arm	Active Comparator	the women in this arm will have a TVT-O procedure in addition to the vaginal wall repair	Procedure: Preventive transobturator tension free vaginal tape

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preventive transobturator tension free vaginal tape	Procedure	during the vaginal wall repair surgery, a TVT-O procedure will be done	TVT-O arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress incontinence	The women will be classified as continent or not continent according to: the Pelvic Floor Distress Inventory stress test need to other treatment for stress incontinence	One year post operation

Secondary Outcomes

Measure	Description	Time Frame
Surgical complications	Surgical complication	one year
post surgery urgency or urge incontinence	urgency or urge incontinence	one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with vaginal wall prolapse grade 2 and more
no contraindication to vaginal wall repair or tvt-o
No stress incontinence

Exclusion Criteria:

urinary tract malformations
past urinary stress incontinence surgical procedure
UDI - question 17 or 18 - positive answer
Occult urinary stress incontinence

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 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
MEIRAV BRAVERMAN, MD	HaEmek Medical Center, Afula, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dep of OG/GYN, Emek Medical Center		Afula			Israel

Condition Browse Module

MeSH Terms

ID	Term
D056887	Pelvic Organ Prolapse
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D014549	Urinary Incontinence

Browse Leaves

Not provided

Browse Branches

Not provided