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Patients with a primary complaint of vaginal looseness and sexual dysfunction, visiting a sexual dysfunction clinic at a tertiary medical center will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.
Patients suffering from vaginal looseness and sexual dysfunction, as a primary sexual dysfunction complaint will be recruited, sign an informed consent and will receive a thorough explanation regarding the side effects and possible beneficial affects the laser treatments may bestow.
Patients will undergo randomization to either a series of 3 laser treatments or 3 sham treatments, and the effect of these treatments will be measured by several validated questionaires and by means of gynecological examination.
Follow up after treatment cessation will be for 12 months post-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erbium laser treatment | Experimental | Women with vaginal looseness and sexual dysfunction treated with real laser. |
|
| Sham laser treatment | Sham Comparator | Women with vaginal looseness and sexual dysfunction treated with sham laser. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erbium laser | Device | Erbium laser device |
| |
| Sham Laser |
| Measure | Description | Time Frame |
|---|---|---|
| Female sexual function index. | Female sexual function index scores pre- and post-treatment. Minimal score is 2, maximal score is 36. Thee higher the score, the improved the sexual function is. | From recruitment up to 15 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal health index | Vaginal health index score. The total VHI scores range between 5 and 25. A higher score indicates increased vaginal health. | From recruitment up to 15 months. |
| Pelvic floor disability index. |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Affiliation | Role |
|---|---|---|
| Roy Lauterbach, MD | Rambam healthcare campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam health care campus | Haifa | Israel |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Device |
Sham laser device |
|
Changes in the pelvic floor disability index scores pre- and post-treatment. Minimal score is 0, maximal score is 300. The higher the score, the improved the worse pelvic floor dysfunction is.
| From recruitment up to 15 months. |
| Vaginal laxity questionnaire. | Changes in the vaginal laxity questionnaire scores pre- and post-treatment. Minimal score is 1, maximal score is 7. The lower the score, the worse vaginal laxity is. | From recruitment up to 15 months. |
| Monthly sexual intercourse rate | Average monthly sexual intercourse rates. | From recruitment up to 15 months. |