Urodynamic Study and Stress Incontinence | NCT03300973

Studies
Urodynamic Study and Stress Incontinence

NCT03300973

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Oct 4, 2017Actual

Enrollment

125Estimated

Phase

Phase 2

Conditions

Stress Urinary Incontinence

Interventions

sling surgery

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

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2016Actual

Primary Completion Date

Oct 2017Estimated

Completion Date

Oct 2017Estimated

First Submitted Date

Sep 21, 2017

First Submission Date that Met QC Criteria

Sep 28, 2017

First Posted Date

Oct 4, 2017Actual

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

Sep 28, 2017

Last Update Posted Date

Oct 4, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

sarah mohamed hassan, lecturer of obstetrics and gynecology Cairo university, Kasr El Aini HospitalPrincipal Investigator

Lead Sponsor

Kasr El Aini HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

Detailed Description

group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
urodynamics study group	Active Comparator	65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery	Procedure: sling surgery
surgery only group	Active Comparator	60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study	Procedure: sling surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
sling surgery	Procedure	transoburator vaginal tape ,inside out procedure under spinal anathesia	surgery only group urodynamics study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cure of stress incontinence	by clinical assessment	1 week after surgery

Secondary Outcomes

Measure	Description	Time Frame
cure of stress incontinence	by clinical assessment	one month after surgery
cure of stress incontinence	by clinical assessment	3 months after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stress urinary incontinence

Exclusion Criteria:

mixed incontinence
recurrent cases

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah M Hassan, lecturer	Contact	01003733671		saramohamed7880@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr El Ainiy Hospital	Recruiting	Cairo		11562	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014550	Urinary Incontinence, Stress

Ancestor Terms

ID	Term
D014549	Urinary Incontinence
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided