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

Sponsor
Abant Izzet Baysal University (Other)
Overall Status
Completed
CT.gov ID
NCT05617417
Collaborator
(none)
30
1
1
4
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Local applied injectable platelet-rich fibrin in women with stress urinary incontinence
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Thirty patients with pure stress urinary incontinence were included in the study. Autologously prepared injectable platelet-rich fibrin from the patients was applied locally. The procedure was repeated for the same patient three times with an interval of one month. The severity of urinary incontinence was evaluated and recorded by filling out questionnaires before and after the procedure.Thirty patients with pure stress urinary incontinence were included in the study. Autologously prepared injectable platelet-rich fibrin from the patients was applied locally. The procedure was repeated for the same patient three times with an interval of one month. The severity of urinary incontinence was evaluated and recorded by filling out questionnaires before and after the procedure.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of the Efficacy of Locally Administered Autologous Injectable Platelet-rich Fibrin in Women With Stress Urinary Incontinence
Actual Study Start Date :
May 5, 2021
Actual Primary Completion Date :
Aug 26, 2021
Actual Study Completion Date :
Sep 5, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bolu Abant Izzet Baysal University, Faculty of Medicine Bolu Gölköy Turkey 14030

Sponsors and Collaborators

  • Abant Izzet Baysal University

Investigators

  • Principal Investigator: Ülkü Mete Ural, Bolu Abant Izzet Baysal University, Faculty of Medicine, Department of Obstetrics and Gynecology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ulku Mete Ural, Professor Doctor, Abant Izzet Baysal University
ClinicalTrials.gov Identifier:
NCT05617417
Other Study ID Numbers:
  • BAIBU-MF-OG-UMU-001
First Posted:
Nov 15, 2022
Last Update Posted:
Nov 15, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ulku Mete Ural, Professor Doctor, Abant Izzet Baysal University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 15, 2022