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Clinical Trial Summary

OBJECTIVE: To find out the effectiveness of physical therapy for stages I and II pelvic organ prolapse. DESIGN: Randomized, controlled and single blinded clinical trial. Patients will be randomly assigned to one of these groups: Experimental group: physical therapy + training in lifestyle advice; Control group: just training in means of lifestyle advice. In both groups several physical therapy assessments will be undertaken: 1st before intervention; 2nd immediately after completing intervention; 3rd, 4th, 5th and 6th after 3, 6, 12 and 24 months. SUBJECTS: Women with previously untreated prolapse of stage I or II (confirmed by their gynaecologist using the POP-Q) in Príncipe de Asturias Hospital, provided that there is no contraindication for physical therapy, and after reading, understanding and freely signing an informed consent form. SAMPLE SIZE: A total of 120 subjects will be included in the study (60 subjects in each group). DATA ANALYSIS: A descriptive analysis will be done of all the variables, as well as bivariate analysis in order to find all the possible relationships between the variables. A confidence level of 95% (p<0.05) will be established for all the cases. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between visits.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT03244397
Study type Interventional
Source University of Alcala
Contact
Status Completed
Phase N/A
Start date August 8, 2017
Completion date February 28, 2020

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