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

NCT ID: NCT05617417

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-05
• Study Completion Date: 2021-09-05

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.

Conditions

Urinary Incontinence; Treatment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

The women with stress urinary incontinence administered injectable platelet-rich fibrin

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.

Group Type: OTHER

Local applied injectable platelet-rich fibrin in women with stress urinary incontinence

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Ulku Mete Ural

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ülkü Mete Ural

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant Izzet Baysal University, Faculty of Medicine, Department of Obstetrics and Gynecology

Locations

Bolu Abant Izzet Baysal University, Faculty of Medicine

Bolu, Gölköy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BAIBU-MF-OG-UMU-001

Identifier Type: -

Identifier Source: org_study_id