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Vaginal Atrophy clinical trials

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NCT ID: NCT06028009 Recruiting - Vaginal Atrophy Clinical Trials

PRP Injections for Genitourinary Syndrome of Menopause

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Platelet-rich plasma (PRP) is autologous blood which has been centrifuged to separate the supernatant resulting in a solution with high concentration of platelets. Injection of PRP stimulates cell growth and can has been proven safe and effective for uses in orthopedics, dermatology, and gynecology. Despite the relative paucity of data, the use of PRP as a therapy for sexual dysfunction and genitourinary symptoms in the setting of menopause has been patented as the O-Shot and V-Shot. This is a single-blinded randomized control trial to determine if PRP injections into the anterior vaginal wall improve sexual functioning in women diagnosed with the genitourinary syndrome of menopause (GSM) characterized by vaginal dryness/irritation.

NCT ID: NCT06000202 Recruiting - Vaginal Atrophy Clinical Trials

Elastographic Improvement of Vaginal Atrophy Treated by Erbium Yag Laser

Start date: August 21, 2023
Phase: N/A
Study type: Interventional

This study is a randomized controlled sham applied study. Its aim is to evaluate the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women. In this study, demonstration of the efficacy of Er:YAG laser for the treatment of atrophic vaginitis in postmenopausal women is intended with Maturation Index (MI), vaginal pH measurement, Female Sexual Function Index (FSFI), Vaginal Health Index (VaHI), Visual Analogue Scale (VAS) and ultrasonographic elastography

NCT ID: NCT05953090 Recruiting - Vaginal Atrophy Clinical Trials

VALOR: Vaginal Atrophy & Long-term Observation of Recovery

VALOR
Start date: October 30, 2023
Phase: N/A
Study type: Interventional

Vulvovaginal skin conditions, namely vaginal atrophy, lichen sclerosus, lichen simplex chronicus and lichen planus affecting the female adult population will be treated with a novel gel dressing to test the short- and long-term safety and efficacy of the device.

NCT ID: NCT05335317 Recruiting - Vaginal Atrophy Clinical Trials

Treatment of Vaginal Atrophy With Low Intensity Nanosecond Neodymium Laser

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

The aim of study is characteristic of changes in the vaginal wall after treatment of neodymium laser radiation with a wavelength of 1064 nm. To assess the condition of the vaginal walls before and after laser treatment, the following methods will be used: vaginal health index, perineometry, measurement of the vaginal wall thickness by ultrasound, Doppler sonography of the vaginal walls vessels, optical coherence tomography, biopsy, cytological and immunocytochemical methods. The King's Health Questionnaire will be used to collect feedback on changes in the participants life quality. Total up to 100 participants with and 20 participants without postmenopausal atrophy will be involved in the study. Participants will be divided into three groups: laser treatment (study group), topical hormones treatment (control group 1) and no treatment (control group 2) by 70, 30 and 20 participants in each group respectively. The time intervals between special tests and the tests themselves will be the same for all groups. Thus, a direct comparison between conventional treatment (topical hormones), laser treatment of the vaginal atrophy and normal condition without treatment will be made. The main hypothesis of the study is improvement in condition of the vaginal walls after laser treatment compared with the initial state of not less than thirty percent of participants, and improvement in condition on average compared with the control group.

NCT ID: NCT04807894 Recruiting - Vaginal Atrophy Clinical Trials

Prevention of Recurrent UTI Using Vaginal Testosterone Versus Placebo Placebo

PIVoT
Start date: November 1, 2020
Phase: Phase 4
Study type: Interventional

Women over the age of 60 years have an estimated 10 to 15 % risk of recurrent urinary tract infections (UTI). This is believed to be due to hormonally induced changes in the vaginal flora associated with menopause. After menopause, there is a chemical changes in the vagina that may predispose to bacterial infections. The role of vaginal estrogen creams to restore vaginal atrophy and prevent urinary tract infections has been well characterized. Vaginal testosterone (VT) application use in postmenopausal breast cancer patients on aromatase inhibitors have been shown to improve vaginal pH, vaginal atrophy symptom scores, dyspareunia, and vaginal dryness. Although testosterone has been used to improve sexual function in postmenopausal women, the effects of VT on vaginal flora and recurrent UTIs are unknown. The purpose of this study is to determine whether topically applied vaginal testosterone cream is more effective than placebo in reducing the incidence of urinary tract infections in postmenopausal women with recurrent urinary tract infections and to ascertain the effects of topical estrogen on the vaginal pH and flora.

NCT ID: NCT04081805 Recruiting - Breast Cancer Clinical Trials

LASER and Radiofrequency for Treatment of Vaginal Vulvar Atrophy (VVA) in Women Treated for Breast Cancer (EPMLARF-arm2)

EPMLARF
Start date: September 30, 2019
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to evaluate the use of LASER, Micro Ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.

NCT ID: NCT03956563 Recruiting - Vaginal Atrophy Clinical Trials

Effect of Hybrid Laser 10600+1540 nm on GSM

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

The primary objective of the study is to clinically confirm, by comparison with a control group, the performance of the 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 3 months after the last laser treatment. The secondary objectives are: 1. Confirm the performance of 10600 +1540 nm laser in the improvement of atrophic vaginal epithelium at 9 months post-laser treatment, and compare it with the results at 3 months. 2. Evaluate the improvement of the GSM urinary symptoms and urinary incontinence (UI) and their impact on the Quality of Life, at each timepoint after the first laser treatment. 3. To assess the Patient's Global Impression of Improvement (PGI) with the laser treatment - For the GSM symptoms - For the urinary symptoms and UI 4. To assess the patient's satisfaction with the laser treatment. - For the GSM symptoms - For the urinary symptoms and UI.

NCT ID: NCT03738605 Recruiting - Breast Cancer Clinical Trials

Vaginal Laser Therapy in Breast Cancer Survivors

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of vaginal CO2 laser therapy in breast cancer survivors with symptoms of Genitourinary Syndrome of Menopause. Half of participants will receive active laser therapy, while the other half placebo therapy.

NCT ID: NCT03520426 Recruiting - Clinical trials for Stress Urinary Incontinence

Evaluation of Efficacy and Safety of Votiva for Vaginal Rejuvenation

Start date: March 12, 2018
Phase: N/A
Study type: Interventional

This is a multi-site, randomized, prospective study designed to evaluate the safety and efficacy of the Votiva device headpieces through radiofrequency for vaginal rejuvenation. An anticipated 50 subjects will undergo 3 treatments of the vulvovaginal area using radiofrequency unit or radiofrequency placebo. Study duration for each subject is approximately six months (including screening, 3 treatment sessions 3-4 weeks apart and 2 follow-up visit at 3 and 6 months post initiation of treatment (4 and 12 weeks after completion of last treatment). Efficacy will be measured and evaluated by validated questionnaires to include: The Vulvovaginal Symptoms Questionnaire, Vaginal Laxity Questionnaire (VLQ), Urogenital Distress Short Form (UDI-6) and Incontinence Impact Questionnaire Short Form (IIQ-7), Female Sexual Function Index (FSFI) and the Female Sexual Distress Scale-Revised (FSDS-R).