An interventional study of Erbium Yag Laser and Pelvic Floor Training in Stress Urinary Incontinence, sponsored by Pontificia Universidad Catolica de Chile. Status unknown at 1 site in Chile. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Treatment
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 60 is close to the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients allocated to the erbium:yag laser are going to undergo 2 sessions of vaginal laser, separated by one month each other.
Device: Erbium Yag Laser
Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist.
Behavioral: Pelvic Floor Training
Subjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month
Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist
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.
Time frame: The questionnaire will be applied at baseline, 6 month and 1 year
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.
Time frame: at baseline, 6 month and 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Pontificia Universidad Catolica de Chile