The Efficacy of Injectable Platelet-rich Fibrin in the Treatment of the Female Stress Urinary Incontinence

Not Applicable

Completed

• Conditions: Treatment; Urinary Incontinence
• Interventions: Other: Local applied injectable platelet-rich fibrin in women with stress urinary incontinence

• Registration Number: NCT05617417
• Lead Sponsor: Abant Izzet Baysal University

Brief Summary

We aimed to evaluate the efficacy of locally applied injectable platelet-rich fibrin in women with stress urinary incontinence. We searched whether there was a decrease in the severity of urinary incontinence after the injection of platelet-rich fibrin.

The participants will answer questionnaires about urinary incontinence before and after the injectable platelet-rich fibrin treatment.

Detailed Description

Female patients with pure stress urinary incontinence who gave written informed consent after being informed about the study were included in the study. Two tubes of venous blood samples taken from the patients were centrifuged and injectable platelet-rich fibrin was prepared. The obtained autologous material was injected into the patient within one minute after preparation, without applying a local anesthetic. The injection was given to the anterior wall of the vagina, approximately 1.5 cm below the urethral meatus, coinciding with the mid-urethral region, and the dose was applied to three adjacent points. The procedure was repeated three times at one-month intervals. Before and after the procedure, ICIQ-SF, UDI-6, and IIQ-7 questionnaires were filled and the severity of urinary incontinence was recorded.

Study Timeline

• Study Start: 2021-05-05
• Primary Completion: 2021-08-26
• Study Completion: 2021-09-05
• Study First Submitted: 2022-10-25
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-15
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• The patient who has pure stress urinary incontinence

Exclusion Criteria

• The patient who had previous surgery for stress urinary incontinence
• Known platelet dysfunction
• Anti-coagulant users
• Critical thrombocytopenia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
The women with stress urinary incontinence administered injectable platelet-rich fibrin	Local applied injectable platelet-rich fibrin in women with stress urinary incontinence	Injectable platelet-rich fibrin was prepared by centrifuging venous blood samples from women with stress urinary incontinence. The obtained autologous material was injected into the anterior vaginal wall, approximately 1.5 cm below the urethral meatus, without applying a local anesthetic. The procedure was repeated for the same patient three times with an interval of one month. The severity of urinary incontinence was evaluated by filling out questionnaires before and after the procedure.

Primary Outcome Measures

Name	Time	Method
Changes in urinary incontinence severity before and 6 months after injectable platelet-rich fibrin application were evaluated with International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF).	Change in urinary incontinence severity before and 6 months after treatment	ICIQ-SF evaluates the severity of urinary incontinence symptoms and their impact on health-related quality of life. It is scored on a scale from 0-21. A higher score indicates greater impairment from incontinence. Stress urinary incontinence grade according to ICIQ-SF: slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).

Secondary Outcome Measures

Name	Time	Method
Changes in quality of life in patients with urinary incontinence before and 6 months after injectable platelet-rich fibrin application were evaluated with Urogenital Distress Inventory-6 (UDI-6) and Incontinence Impact Questionnaire-7 (IIQ-7).	Change in urinary incontinence severity before and 6 months after treatment	UDI-6 is a short version of a condition-specifc quality of life instrument. Higher scores in UDI-6 indicate higher disability. Total score is from 0 to 100.; IIQ-7 is a urinary incontinence-specific psychometric questionnaire. This questionnaire assesses the psychosocial impact of UI in women. Higher scores in UDI-6 indicate higher disability. Total score ranges from 0 to 100.

Trial Locations

Locations (1)

Bolu Abant Izzet Baysal University, Faculty of Medicine; 🇹🇷 Bolu, Gölköy, Turkey