NCT07366762
Completed
Phase 3
Comparison Between the Effect of Periurethral Injection of Platelet-rich Plasma VS Platelet Rich Fibrin in Treatment of Female Stress Urinary Incontinence
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Kafrelsheikh University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 75 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
group one who had received PRP injections
Active Comparator
Intervention: Platelet Rich Plasma (Biological)
group two who had received i-PRF injections
Active Comparator
Intervention: Platelet rich fibrin (Biological)
Outcomes
Primary Outcomes
changes in the severity of SUI measured by Incontinence Impact Questionnaire (IIQ7)
Time Frame: baseline and three and six months follow up
Secondary Outcomes
- changes in the severity of SUI using 10 point visual analogue scale(baseline and three and six months follow up)
Investigators
Marwa Reda Mohamed Gebril
obstetrics and gynecology resident
Kafrelsheikh University
Study Sites (1)
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