Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause

Genitourinary Syndrome of Menopause Clinical Trial

Official title:

Comparison of Vaginal Hyaluronic Acid Treatment Over Autologous Platelet Rich Plasma Treatment for Genitourinary Syndrome of Menopause

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05571527
• Other study ID #: KanuniSSEAH3
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Ozan Karadeniz, MD
• Phone: +905333663003
• Email: dr.ozankrdnz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Genitourinary syndrome of menopause (GSM) is a collection of symptoms and signs caused by hypoestrogenic changes to the labia majora/minora, clitoris, vestibule/introitus, vagina, urethra, and bladder that occur in menopausal patients.

Platelet-rich plasma is produced by collecting approximately 60-90 ml (4-6 tablespoons) of blood from the vein in patient's arm. The blood is spun using a centrifuge that separates the plasma and red blood cells.

The treatment included vaginal estrogen supplement, vaginal hyaluronic acid supplement, vaginal laser, platelet-rich plasma, etc. The observational cohort study will be used for the study design. Questionnaires, pelvic examination, vaginal pap smear with maturation index (MI), vaginal pH, and other methods will be used to evaluate the effectiveness and side effects.

Description:

PRIMARY OBJECTIVE:

To determine the safety and feasibility of using platelet-rich plasma (PRP) treatment in menopausal patients with genitourinary syndrome

SECONDARY OBJECTIVE:

To determine the preliminary efficacy in the treatment of vaginal atrophy, urinary symptoms, assessment of sexual function, quality of life symptoms

VSQ, Vaginal health index, Vaginal maturation index, and Day-to-Day Impact of Vaginal Aging score will be used for assessments.

OUTLINE:

Patients receive platelet-rich plasma via injection into the vaginal area after obtaining plasma into PRP tubes

After 3 sessions of PRP treatment, patients are followed up for 6 months.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Women with menopause

• Patients with symptoms of genitourinary syndrome of menopause

Exclusion Criteria:

• Genitourinary bleeding or infection without a definitive diagnosis

• Coagulopathy

• Allergy to medication or therapy related to the treatment

• Chronic disease that might influence the outcome

• Using medication that might influence the outcome in 30 days

• Using hormone or steroid within 8 weeks

• Personal history of vulvovaginal conditions such as lichen sclerosis, lichen planus, vulvovaginal condyloma, vaginal intraepithelial neoplasia, vaginal carcinoma, history of cervical or other gynecologic cancer, radical pelvic surgery, acute or recurrent urinary tract infection, genital infection, history of vaginal or pelvic radiation

• Chronic pelvic pain, current pelvic tension myalgia/muscle hypertonicity

• Pelvic organ prolapse greater than stage II

• Pelvic surgery within 6 months

• Known allergy to lidocaine or prilocaine

• Use of vaginal moisturizers, lubricants, or homeopathic preparations within 2 weeks of therapy

• Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy.

Related Conditions & MeSH terms

• Genitourinary Syndrome of Menopause
• Syndrome

Intervention

Biological:
• Platelet Rich Plasma treatment
Patients receive platelet-rich plasma via injection into the vaginal area.

Drug:
• Vaginal Hyaluronic Acid supplement
Patients receive Vaginal Hyaluronic Acid supplement for 10 days, then once a week for 3 months.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Suleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal health index score (VHIS)	evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration	[ Time Frame: 6 months after intervention ]
Primary	The Vulvovaginal Symptom Questionnaire (VSQ)	symptoms, emotions, life-impact, and sexual impact of vulvovaginal symptoms.	[ Time Frame: 6 months after intervention ]
Primary	Day-to-Day Impact of Vaginal Aging Questionnaire	Measure of the Impact of Vaginal Symptoms on Functioning and Well-being in Postmenopausal Women	[ Time Frame: 6 months after intervention ]
Primary	vaginal maturation index	objective, qualitative assessment of vaginal response to hormones as well as overall hormonal environment.	[ Time Frame: 6 months after intervention ]
Primary	vaginal health index	clinical tool that, by evaluating 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration)	[ Time Frame: 6 months after intervention ]