Evaluation of Fractional CO2 Laser Treatment Efficacy and Comparison to Vaginal Estrogen Therapy in Postmenopausal Women With Vulvovaginal Atrophy
Study Details
Study Description
Brief Summary
Forty-five women will be included in a double-blind randomized trial in order to compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for Vulvovaginal Atrophy (VVA) and determine the efficacy and possible adverse effects CO2 laser treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Vulvovaginal atrophy (VVA) symptoms are strongly associated with declining ovarian function and estrogen levels in postmenopausal women, having a considerable impact on women's life quality. Topical hormonal therapy and hormonal replacement are widely used to alleviate VVA symptoms. In this context, minimal invasive fractional CO2 laser emerges as an alternative non-hormonal therapy, especially in patients that present contraindications to hormonal therapy. Objective: Compare fractional CO2 laser treatment, local estrogen therapy and the combination of both treatments for VVA and determine the efficacy and possible adverse effects CO2 laser treatment. Materials and Methods: Forty-five postmenopausal women will be randomized in three double-blinded groups of treatment consisting of CO2 laser and placebo of estrogen vaginal cream, placebo of CO2 laser and estrogen vaginal cream and CO2 laser and estrogen vaginal cream. Assessment of baseline characteristics and follow-up will be obtained through self-completion questionnaires (Female Sex Function Index, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Vulvovaginal Symptom Questionnaire and The Menopause-Specific Quality of Life (MENQOL)). Frost Index and Vaginal Health Index (VHI) are part of objective clinical and histologic analyses. Colposcopy, vaginal cytology and middle third lateral vaginal wall biopsy will also be performed at baseline and at week 17.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CO2 laser & Estrogen Effective fractional CO2 laser therapy and effective estrogen vaginal cream |
Device: CO2 laser
SMARTXIDE2 V2LR (DEKA-Pulse) was used in each application using minimal parameters suggested by the laser's software ( Power of 30 W, 1000us emission time, 1000um spacing and a level of SmartStack 2)
Other Names:
Drug: Estrogen
Topical estrogen cream treatment: Estriol 1mg daily.
Other Names:
|
| Active Comparator: CO2 laser & Placebo of Estrogen Effective fractional CO2 laser therapy and placebo of estrogen vaginal cream. |
Device: CO2 laser
SMARTXIDE2 V2LR (DEKA-Pulse) was used in each application using minimal parameters suggested by the laser's software ( Power of 30 W, 1000us emission time, 1000um spacing and a level of SmartStack 2)
Other Names:
Drug: Placebo of Estrogen
Placebo of topical estrogen cream.
|
| Sham Comparator: Placebo of CO2 laser & Estrogen Placebo fractional CO2 laser therapy and effective estrogen vaginal cream. |
Drug: Estrogen
Topical estrogen cream treatment: Estriol 1mg daily.
Other Names:
Device: Placebo of CO2 laser
SMARTXIDE2 V2LR (DEKA-Pulse) was used in each applications using minimal parameters suggested by the laser's software but power of 0.5 W was stipulated for the placebo intervention and other parameters remained unchanged.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Change from Baseline in Vulvovaginal Symptom Questionnaire [Baseline, week 10 and week 17]
Vulvovaginal Symptom Questionnaire will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Secondary Outcome Measures
- Vaginal Cytology Improvement [Baseline, week 10 and week 17]
Vaginal cytology will be obtained from the middle third lateral vaginal wall in order to evaluate initial conditions of the vaginal wall and modifications after treatment. Frost Index, Karyopyknotic Index and Eosinophilic Index will be applied to each sample to measure improvement of vaginal atrophy.
- Change from Baseline in Female Sex Function Index [Baseline, week 10 and week 17]
Female Sex Function Index will be used to evaluate improvement of vulvovaginal atrophy symptoms.
- Change from Baseline in The Menopause-Specific Quality of Life [Baseline, week 10 and week 17]
The Menopause-Specific Quality of Life will be used to evaluate improvement of vulvovaginal atrophy symptoms.
Other Outcome Measures
- Urinary Incontinence Improvement [Baseline, week 10 and week 17]
Incontinence Questionnaire-Short Form (ICIQ-SF) will be used in order to evaluate urinary incontinence improvement after treatment.
- Vaginal Health Index Improvement [Baseline, week 10 and week 17]
Evaluation of vaginal wall conditions such as pH, elasticity, bleeding signs, secretion type and consistency and hydration.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
45-65 women with amenorrhea for over 24 months.
-
Clinical vaginal atrophy diagnosis.
Exclusion Criteria:
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BMI > 35.
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Previous use of oral estrogen therapy in the last 6 months.
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History or current diagnosis of cancer.
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Altered cervical smear in the last 12 months.
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Renal or hepatic insufficiency.
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Drug-induced menopause.
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Previous use of steroids.
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Previous vaginal radiotherapy therapy.
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Vulvovaginitis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centro de Atencao a Saude da Mulher | Sao Bernardo | Sao Paulo | Brazil | 09770-210 |
Sponsors and Collaborators
- Faculdade de Medicina do ABC
Investigators
- Principal Investigator: Vera L da Cruz, MD, Faculdade de Medicina do ABC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 39495014.0.0000.0082