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| ID | Type | Description | Link |
|---|---|---|---|
| N/1 | Other Identifier | UOC di Ostetricia e Ginecologia, Ospedale di Stato della Repubblica di San Marino, Istituto per la Sicurezza Sociale (I |
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This study evaluated a new treatment for postmenopausal women suffering from vulvo-vaginal atrophy (VVA), a condition that causes dryness, burning, and pain. Researchers tested whether combining COâ‚‚ laser therapy with a collagen-based cream could improve symptoms more effectively than laser treatment alone.
Sixty women participated in the study. Results showed that the combination treatment provided greater relief from discomfort and helped restore vaginal health, with fewer side effects. This approach may offer a safe and effective alternative for women who cannot use hormone-based therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laser Therapy Only (Control Group) | Active Comparator | Participants receive fractional COâ‚‚ laser therapy according to the standard protocol for vulvo-vaginal atrophy. No additional topical treatment is applied. Laser sessions are performed at baseline (Day 0), Day 30, and Day 60. Follow-up visits include clinical evaluation and microbiome sampling at each time point. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SmartXide2 treatment plus the application of Palingen cream | Device | Patients will be randomized into two groups: one called the "control" group, in which patients will receive only the SmartXide2 treatment, and the second called "PALINGEN," in which patients will receive SmartXide2 treatment plus the application of Palingen cream. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in VVA (Vulvo-Vaginal Atrophy) symptoms | Assessed after 30 and 60 days of treatment using the Visual Analogue Scale (VAS). The VAS was used to quantify symptom intensity such as burning, dryness, itching, dyspareunia, and pain. Improvement was measured as the difference in VAS scores before and after treatment. | Outcome: Improvement in symptoms associated with vulvo-vaginal atrophy (VVA) Assessment Tool: Visual Analogue Scale (VAS) Time Frame: Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal Microbiome Composition | Analysis before and after 30 and 60 days of treatment. Parameters included: Biodiversity (Observed Operational Taxonomic Units, OTUs). Relative abundance of Lactobacillus genus and its species (L. crispatus, L. iners, etc.). Relative amounts of pathogenic bacteria (Gardnerella vaginalis, Atopobium vaginae, etc.). | Baseline (Day 0) - before treatment Visit 1 (Day 30) - after first month of treatment Visit 2 (Day 60) - after second month / end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
• Pregnancy or breastfeeding;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC di Ostetricia e Ginecologia, Ospedale di Stato della Repubblica di San Marino, Istituto per la Sicurezza Sociale (ISS) | San Marino | Borgo Maggiore | 47893 | San Marino |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29381086 | Background | Mueck AO, Ruan X, Prasauskas V, Grob P, Ortmann O. Treatment of vaginal atrophy with estriol and lactobacilli combination: a clinical review. Climacteric. 2018 Apr;21(2):140-147. doi: 10.1080/13697137.2017.1421923. Epub 2018 Jan 30. |
| Label | URL |
|---|---|
| Related Info | View source |
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This is an interventional, single-center study. Patients will be randomized into two groups: one called the "control" group, in which patients will receive only the SmartXide2 treatment, and the second called "PALINGEN," in which patients will receive SmartXide2 treatment plus the application of Palingen cream. It should be noted that both SmartXide2 and Palingen cream (and their combination) have been part of the standard clinical practice at the experimental center for several years.
The effectiveness of the combined action of the two treatments will be evaluated by analyzing the associated symptoms using a Visual Analogue Scale (VAS) from 1 to 10 for each symptom, as well as through analysis of the vaginal microbiome. Additionally, all adverse events will be recorded.
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|
| Laser Therapy Only (Control Group) | Device | Participants receive fractional COâ‚‚ laser therapy according to the standard protocol for vulvo-vaginal atrophy. No additional topical treatment is applied. Laser sessions are performed at baseline (Day 0), Day 30, and Day 60. Follow-up visits include clinical evaluation and microbiome sampling at each time point. |
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| Symptom improvement at intermediate time points | Comparison of VAS scores at Visit 1 (30 days) and Visit 2 (60 days) against baseline. | Baseline → Visit 1 (Day 30) Baseline → Visit 2 (Day 60) |
| Adverse Events Monitoring | Frequency and severity of side effects (e.g., redness, mild bleeding, burning, swelling) were recorded throughout the study. | Continuous from first laser session (Day 0) through 30 days and 60 days post-treatment |
| ID | Term |
|---|---|
| D001284 | Atrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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