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This is a pilot study to assess the feasibility and safety to run a randomized controlled trial that compared the effectivity of erbium:yag vaginal laser versus pelvic floor training in women with mild to moderate stress urinary incontinence.
This pilot study attempts to demonstrated the feasibility and security to run a randomized controlled study that compared the effectivity of erbium:yag laser used vaginally versus pelvic floor training, coached by a physiotherapist expert in pelvic floor disorders.
Patients are going to be randomized to pelvic floor exercises (10 sessions) or erbium:yag laser (2 sessions), and assess the results at 6 and 12 moths later on.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erbium:Yag Laser | Experimental | Patients allocated to the erbium:yag laser are going to undergo 2 sessions of vaginal laser, separated by one month each other. |
|
| Pelvic floor training | Active Comparator | Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erbium Yag Laser | Device | Subjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life | In order to measure quality of life, we are going to use the International Consultation on Incontinence Questionnaire Short Form (ICQI-SF), validate to spanish and in Chile. A higher score in this scale means a worse outcome for the patient. | The questionnaire will be applied at baseline, 6 month and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Pad test | A 24 h Pad test will be applied. The pad will be weighted after 24 h of use and the difference between the dry pad and the wet pad is going to be recorded. A great difference means a worse outcome for the patient. | at baseline, 6 month and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victor A Miranda, MD | Contact | +56988291697 | vmirandah@med.puc.cl | |
| Sebastian Viguera, MD | Contact | +56993316816 | sebastian.viguera@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico de La Florida | Recruiting | Santiago | Chile |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female 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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randomized controlled trial
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| Pelvic Floor Training | Behavioral | Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |