Trials / Completed
CompletedNCT03244397
Physical Therapy on Pelvic Organ Prolapse
Effectiveness of Physical Therapy on Pelvic Organ Prolapse Stages I & II
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- University of Alcala · Academic / Other
- Sex
- Female
- Age
- 25 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Physical therapy + educational strategy | See arm/group descriptions |
| BEHAVIORAL | Educational strategy | See arm/group descriptions |
Timeline
- Start date
- 2017-08-08
- Primary completion
- 2019-12-10
- Completion
- 2020-02-28
- First posted
- 2017-08-09
- Last updated
- 2020-04-07
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT03244397. Inclusion in this directory is not an endorsement.