PRP & PDO Threads in Treatment of Stress Incontinence | NCT06885463

Studies
PRP & PDO Threads in Treatment of Stress Incontinence

NCT06885463

Sponsor

Al-Azhar University

Status

Recruiting

Last Update Posted

Mar 20, 2025Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Stress Incontinence, Female

Interventions

platelets rich plasma combined with PDO threads

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

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2025Actual

Primary Completion Date

Jun 30, 2025Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Mar 12, 2025

First Submission Date that Met QC Criteria

Mar 18, 2025

First Posted Date

Mar 20, 2025Actual

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

Mar 18, 2025

Last Update Posted Date

Mar 20, 2025Actual

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

The study will include 10 women with pure or predominant SUI symptoms, with severe urodynamic stress incontinence on urodynamics defined as loss of urine with sudden increases in abdominal pressure: eg, coughing, sneezing, or laughing). This will be conducted at the Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University. The purpose of study is to evaluate the efficacy and safety of platelets rich plasma combined with PDO threads in the treatment of stress incontinence in Egyptian women.

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

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
platelets rich plasma combined with PDO threads	Experimental		Procedure: platelets rich plasma combined with PDO threads

Interventions

Name	Type	Description	Arm Group Labels	Other Names
platelets rich plasma combined with PDO threads	Procedure	Injections of platelets-rich plasma in the Anterior Vaginal Wall. PDO thread placement in the paraurethral, lateral urethrovaginal, and suburethral areas

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evaluation of reported SUI symptoms	subjective evaluation of reported SUI symptoms, indicated by the patient's response to question of the ICIQ-FLUTS questionnaire: "Does urine leak when you are physically active, exert yourself, cough or sneeze?"	After 4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Nonpregnant Women with SUI
Age between 20 to 45 years
Patients had a history of failed conservative treatment
Patients were on the waiting list for surgical treatment of SUI

Exclusion Criteria:

Under anti-platelet agent treatment
Under NSAIDs
Platelet dysfunction syndrome
Critical thrombocytopenia
Hypofibrionogenaemia
Sepsis
Acute and chronic infections
Chronic liver disease
Anti-coagulation therapy
History of malignancy
Pregnancy
history of active malignant pathology
mental disorders making them unable to give consent
genitourinary fistula
pelvic organs prolapse stage >2 according to the Pelvic Organ Prolapse Quantification system, and detrusor overactivity on urodynamics.

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

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Faculty of Medicine, Al-Azhar University.	Recruiting	Cairo			Egypt

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