NCT04279210

Platelet-rich Plasma for Stress Urinary Incontinence

The Effect of Platelet-rich Plasma on the Female Stress Urinary Incontinence

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Stress urinary incontinence (SUI) is defined by the International Continence Society (ICS) as "the complaint of any involuntary loss of urine on effort or physical exertion or on sneezing or coughing. The treatment varies from Kegel exercise, bulking agents, vaginal LASER, to surgery. Platelet-rich plasma (PRP) stimulates angiogenesis, promoting vascular in-growth and fibroblast proliferation, enhancing wound-healing in both soft and hard tissue. PRP regulates tissue reconstruction and has been previously used in orthopedics and plastic surgery. The previous study revealed some promising results for PRP use in pelvic floor dysfunction, including SUI. We aim to evaluate the effect of PRP on female SUI.

Detailed description

Women with SUI were enrolled. Pre-treatment evaluation included Overactive Bladder Symptom Score (OABSS), International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), Female Sexual Function Index (FSFI), Urinary Distress Inventory Short Form (UDI-6), Incontinence Impact Questionnaire, Short Form (IIQ-7), pelvic examination, and urodynamic study (UDS) (including pad test). 10 milliliter blood was taken from each participant. The RegenKit-THT (RegenLab SA, Switzerland) was used to separation of plasma and blood cells. 3 milliliter PRP was extracted from the bottom of the plasma. PRP was injected into anterior vaginal wall, near external urethral sphincter, and into endopelvic fascia. The participants received one treatment per month for three times. Follow-up schedule is as below: 1st month (transperineal ultrasound and questionnaires), 3rd month (UDS and questionnaires), 6th month (questionnaires), and 12th month (questionnaires).

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	Platelet-rich plasma	The RegenKit-THT (RegenLab SA, Switzerland) was used to separation of plasma and blood cells. 3mL PRP was extracted from the bottom of the plasma. PRP was injected into anterior vaginal wall, near external urethral sphincter, and into endopelvic fascia.

Timeline

• Start date: 2017-06-29
• Primary completion: 2018-10-03
• Completion: 2018-10-03
• First posted: 2020-02-21
• Last updated: 2020-02-24

Locations

1 site across 1 country: Taiwan