Pelvic Organ Prolapse
Conditions
Brief 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.
Interventions
OTHERPhysical therapy + educational strategy
See arm/group descriptions
BEHAVIORALEducational strategy
See arm/group descriptions
Sponsors
University of Alcala
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Two groups: Experimental group and Control group
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Women with POP of any stage I or II according to POP-Q system.
Exclusion criteria
* Women diagnosed with POP stage III or IV according to POP-Q system * Women with a history of conservative POP treatment or surgery * Women with concomitant disease that may affect treatment (neurological, gynecological or urological) or urinary tract infection or recurrent hematuria * Women who are pregnant or have had a vaginal birthing the last six months * Women with cognitive limitations in understanding the information, answer questionnaires, consent and / or participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Life impact of Pelvic Floor Dysfunction (PFD) will be assessed by the PFIQ-7 Spanish version. | 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention. | The PFIQ-7 consists of 3 scales of 7 questions each taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire. The 3 scales are scored from 0 (least impact) to 100 (greatest impact) and an overall summary score (0 to 300). |
| Change of Symptoms and Quality of life (QoL) will be assessed by P-QOL & PFDI-20 Spanish versions | 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention. | P-QOL assess the symptom severity and its impact on the quality of life in women with POP; and the PFDI-20 that is both a symptom inventory and a measure of the degree of bother and distress (QoL) caused by pelvic floor symptoms. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300 and the higher the score, the worse QoL. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions collecting data about UI, POP and colorectal and anal symptoms. |
| Change of Pelvic Floor Muscle (PFM) strength will be measured by manometry | 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention. | Three maximum PFM contractions will be requested and will be used the mean value. For the manometry (cm2O2), an air-filled probe will be used (Peritron, Melbourne, Australia) |
| Change of pelvis floor muscles (PFM) condition by vaginal palpation using Oxford Test | 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention. | Oxford test range from 0 to 5, according to the muscles strength |
| Change of Pelvic Floor Muscle (PFM) strength will be measured by dynamometry | 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention. | Three maximum PFM contractions will be requested and will be used the mean value. For the dynamometry (gr) a two-arms speculum (Pelvimeter Phenix, Montpellier, France) in mid-sagittal plane, and in close position will be utilized. |
| Change of pelvis floor muscles (PFM) condition by vaginal palpation Levator Any Test (LAT) | 6 assessments to evaluate the change from baseline: at baseline, after the intervention period, 3 months, 6 months, 12 months and 24 months after the intervention. | LAT range from 0 to 5, according to the muscles strength and endurance |
Countries
Spain
Outcome results
None listed