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

Primary Purpose

Genitourinary Syndrome of Menopause

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Platelet Rich Plasma treatment

Vaginal Hyaluronic Acid supplement

About this trial

This is an interventional treatment trial for Genitourinary Syndrome of Menopause focused on measuring genitourinary syndrome, menopause, platelet rich plasma, vaginal atrophy

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Kanuni Sultan Suleyman Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Menopause patients having genitourinary syndrome (PRP)

vaginal hyluronic acid supplement for GSM

Arm Description

Preparation of PRP sample from the patient's own blood and then the volume immediately above the erythrocyte layer was collected. Calcium gluconate in conc. 1:9 will be used as an activator. After activation, in a period of less than 2 min, approximately 4 ml of the PRP will be injected into the vaginal wall. ( at 3,6 and 9 o clock)It will be repeated once a month for 3 times.

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

Outcomes

Primary Outcome Measures

Vaginal health index score (VHIS)

evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration

The Vulvovaginal Symptom Questionnaire (VSQ)

symptoms, emotions, life-impact, and sexual impact of vulvovaginal symptoms.

Day-to-Day Impact of Vaginal Aging Questionnaire

Measure of the Impact of Vaginal Symptoms on Functioning and Well-being in Postmenopausal Women

vaginal maturation index

objective, qualitative assessment of vaginal response to hormones as well as overall hormonal environment.

vaginal health index

clinical tool that, by evaluating 5 parameters (vaginal elasticity, vaginal secretions, pH, epithelial mucous membrane, vaginal hydration)

Secondary Outcome Measures

Full Information

NCT ID

NCT05571527

First Posted

October 4, 2022

Last Updated

March 7, 2023

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05571527

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2023 (Anticipated)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Genitourinary Syndrome of Menopause

Keywords

genitourinary syndrome, menopause, platelet rich plasma, vaginal atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Menopause patients having genitourinary syndrome (PRP)

Arm Type

Experimental

Arm Description

Arm Title

vaginal hyluronic acid supplement for GSM

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Platelet Rich Plasma treatment

Intervention Description

Patients receive platelet-rich plasma via injection into the vaginal area.

Intervention Type

Drug

Intervention Name(s)

Vaginal Hyaluronic Acid supplement

Intervention Description

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

Primary Outcome Measure Information:

Title

Vaginal health index score (VHIS)

Description

evaluation of vaginal elasticity, secretions, pH, the presence of petechiae on the epithelial mucosa, and hydration

Time Frame