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

Urinary Incontinence Clinical Trial

Official title:

Evaluation of the Efficacy of Locally Administered Autologous Injectable Platelet-rich Fibrin in Women With Stress Urinary Incontinence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05617417
• Other study ID #: BAIBU-MF-OG-UMU-001
• Status: Completed
• Phase: N/A
• Start date: May 5, 2021
• Est. completion date: September 5, 2021

Study information

• Verified date: November 2022
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 5, 2021
• Est. primary completion date: August 26, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Treatment
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Other:
• Local applied injectable platelet-rich fibrin in women with stress urinary incontinence
Injectable platelet-rich fibrin was prepared by centrifuging venous blood taken from women with stress urinary incontinence and applied locally to the anterior vaginal wall of the patients.

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet Baysal University, Faculty of Medicine	Bolu	Gölköy

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	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).	Change in urinary incontinence severity before and 6 months after treatment
Secondary	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).	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.	Change in urinary incontinence severity before and 6 months after treatment