Comparison Between Two Techniques in Treatment of Female Stress Urinary Incontinence

NCT07366762 | Completed Phase 3

• 1 other identifier: KFSIRB200-320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Female Stress Urinary Incontinence

Keywords

PRP- i-PRF- SUI

Outcome Measures

Primary Outcomes (1)

• changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)

  baseline and three and six months follow up

Secondary Outcomes (1)

• changes in the severity of SUI using 10 point visual analogue scale

  baseline and three and six months follow up

Study Arms (2)

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

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.

group one who had received PRP injections

Platelet rich fibrin BIOLOGICAL

Approximately 5 mL of i-PRF 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

group two who had received i-PRF injections

Eligibility Criteria

• Age: 30 Years - 75 Years
• Gender Eligibility Details: stress urinary incontinence in females
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: obstetrics and gynecology resident

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 26, 2026
• Study Start: July 10, 2024
• Primary Completion: May 1, 2025
• Study Completion: January 2, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

EG (1)