Skip to main content
OpenTrials
Completed

NCT Number: NCT07366762

Comparison Between Two Techniques in Treatment of Female Stress Urinary Incontinence

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Female Stress Urinary Incontinence

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kafr Elsheikh University Hospital

Kafr ash Shaykh, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Primary outcomes

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

    Time frame: baseline and three and six months follow up

Secondary outcomes

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

    Time frame: baseline and three and six months follow up

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Official study title

Comparison Between the Effect of Periurethral Injection of Platelet-rich Plasma VS Platelet Rich Fibrin in Treatment of Female Stress Urinary Incontinence

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.