Clinical trial NCT05617417: The Efficacy of Injectable Platelet-rich Fibrin in the Treatment of the Female Stress Urinary Incontinence
Official title: Evaluation of the Efficacy of Locally Administered Autologous Injectable Platelet-rich Fibrin in Women With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Treatment
Keywords: Urinary Stress Incontinence
Platelet-Rich Fibrin
Questionnaire
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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).
timeFrame: Change in urinary incontinence severity before and 6 months after treatment
Secondary outcomes:
measure: 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).
timeFrame: Change in urinary incontinence severity before and 6 months after treatment
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal University, Faculty of Medicine
state: Gölköy
Study officials:
affiliation: Bolu Abant Izzet Baysal University, Faculty of Medicine, Department of Obstetrics and Gynecology
name: Ülkü Mete Ural
role: PRINCIPAL_INVESTIGATOR
References: