Comparison Between Two Techniques in Treatment of Female... | NCT07366762

Studies
Comparison Between Two Techniques in Treatment of Female Stress Urinary Incontinence

NCT07366762

Sponsor

Kafrelsheikh University

Status

Completed

Last Update Posted

Jan 26, 2026Actual

Enrollment

40Actual

Phase

Phase 3

Conditions

Female Stress Urinary Incontinence

Interventions

Platelet Rich Plasma
Platelet rich fibrin

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

Jan 2026

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

Jul 10, 2024Actual

Primary Completion Date

May 1, 2025Actual

Completion Date

Jan 2, 2026Actual

First Submitted Date

Jan 8, 2026

First Submission Date that Met QC Criteria

Jan 16, 2026

First Posted Date

Jan 26, 2026Actual

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 16, 2026

Last Update Posted Date

Jan 26, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marwa Reda Mohamed Gebril, obstetrics and gynecology resident, Kafrelsheikh UniversityPrincipal Investigator

Lead Sponsor

Kafrelsheikh UniversityOTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

compare the therapeutic effect of periurethral injection of autologous platelet-rich plasma (PRP) and injectable platelet rich fibrin (i-PRF) in treatment of female stress urinary incontinence and comparing the need for re-injection in the two groups.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group one who had received PRP injections	Active Comparator		Biological: Platelet Rich Plasma
group two who had received i-PRF injections	Active Comparator		Biological: Platelet rich fibrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Platelet Rich Plasma	Biological	Approximately 5 mL of PRP will be injected at three points (on both sides of the urethra and urethrovaginal space) under local anesthesia. Injections will be performed by gynecologist in the outpatient clinic.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)		baseline and three and six months follow up

Secondary Outcomes

Measure	Description	Time Frame
changes in the severity of SUI using 10 point visual analogue scale		baseline and three and six months follow up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female patients with primary symptoms of SUI confirmed by patient's medical history and clinical examination, including a focused incontinence evaluation
- Age range of 30-75 years
- Females unfit for surgery
- Females with SUI recurrence after previous surgical procedure by suburethal sling
- Females refusing surgical interventions

Exclusion Criteria:

Residual urine volume exceeding 100 cc after excretion
Evidence of detrusor over-activity on the urodynamic test
Active urinary tract or vaginal infection
Malignancies of the genitourinary system
Patients with genitourinary fistula or urethral diverticulum

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

stress urinary incontinence in females

Minimum Age

30 Years

Maximum Age

75 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
Kafr Elsheikh University Hospital		Kafr ash Shaykh			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided