Clinical trial NCT03244397: Physical Therapy on Pelvic Organ Prolapse
Official title: Effectiveness of Physical Therapy on Pelvic Organ Prolapse Stages I & II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: Experimental group and Control group
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Life impact of Pelvic Floor Dysfunction (PFD) will be assessed by the PFIQ-7 Spanish version.
timeFrame: 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.
measure: Change of Symptoms and Quality of life (QoL) will be assessed by P-QOL & PFDI-20 Spanish versions
timeFrame: 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.
measure: Change of Pelvic Floor Muscle (PFM) strength will be measured by manometry
timeFrame: 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.
measure: Change of pelvis floor muscles (PFM) condition by vaginal palpation using Oxford Test
timeFrame: 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.
measure: Change of Pelvic Floor Muscle (PFM) strength will be measured by dynamometry
timeFrame: 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.
measure: Change of pelvis floor muscles (PFM) condition by vaginal palpation Levator Any Test (LAT)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Alcalà de Henares
country: Spain
facility: Physiotherapy in women´s health research group. University of Alcalà
state: Madrid
city: Alcalá de Henares
country: Spain
facility: University of Alcalá. FPSM research group. HUPA
state: Madrid
Study officials:
References: