Comparison Between Two Techniques in Treatment of Female Stress Urinary Incontinence

Kafrelsheikh University

Status and phase: Completed; Phase 3

Conditions: Female Stress Urinary Incontinence

Treatments: Biological: Platelet rich fibrin; Biological: Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT07366762

KFSIRB200-320

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

group one who had received PRP injections

Active Comparator group

Treatment:

Biological: Platelet Rich Plasma

group two who had received i-PRF injections

Active Comparator group

Treatment:

Biological: Platelet rich fibrin