Injecting Plasma-rich Platelets & Hyaluronic Acid for Pat... | NCT06012370

Studies
Injecting Plasma-rich Platelets & Hyaluronic Acid for Patients With Stress Urinary Incontinence

NCT06012370

Sponsor

Kasr El Aini Hospital

Status

Unknown status

Last Update Posted

Aug 25, 2023Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Stress Incontinence, Female

Interventions

PRP injection

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

Aug 2023

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

Sep 1, 2023Estimated

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Aug 14, 2023

First Submission Date that Met QC Criteria

Aug 19, 2023

First Posted Date

Aug 25, 2023Actual

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 19, 2023

Last Update Posted Date

Aug 25, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

suzy abdelaziz Abdelhamid, Assistant professor doctor, Kasr El Aini HospitalPrincipal Investigator

Lead Sponsor

Kasr El Aini HospitalOTHER

Collaborators

Not provided

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

Injection of PRP and hyaluronic acid in stress incontinence patients

Detailed Description

Operative details Dissection of the ant vag wall from the urethra and lower part of the bladder Identify the bladder neck using Foly s catheter injection of 1.5 to 2 ml PRP combined with Hyaluronic acid suburethra almost at the level of mid urethra (avoiding the bl neck) then closure of the vag wall ( after removal of the excess vag tissue.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stress incontinence patients	Other	PRP injection	Procedure: PRP injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PRP injection	Procedure	Injection of PRP and hyaluronic acid	Stress incontinence patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress incontinence change	Visual Assessment System assessment	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

stress incontinence patients

Exclusion Criteria:

prolapse patients

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

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