Physical Therapy on Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

— PT-POP  

Official title:

Effectiveness of Physical Therapy on Pelvic Organ Prolapse Stages I & II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244397
• Other study ID #: 21/2012
• Status: Completed
• Phase: N/A
• Start date: August 8, 2017
• Est. completion date: February 28, 2020

Study information

• Verified date: April 2020
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 28, 2020
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• Physical therapy + educational strategy
See arm/group descriptions

Behavioral:
• Educational strategy
See arm/group descriptions

Locations

Country	Name	City	State
Spain	Physiotherapy in women´s health research group. University of Alcalà	Alcalà de Henares	Madrid
Spain	University of Alcalá. FPSM research group. HUPA	Alcalá de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Life impact of Pelvic Floor Dysfunction (PFD) will be assessed by the PFIQ-7 Spanish version.	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).	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.
Primary	Change of Symptoms and Quality of life (QoL) will be assessed by P-QOL & PFDI-20 Spanish versions	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.	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.
Primary	Change of Pelvic Floor Muscle (PFM) strength will be measured by manometry	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)	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.
Primary	Change of pelvis floor muscles (PFM) condition by vaginal palpation using Oxford Test	Oxford test range from 0 to 5, according to the muscles strength	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.
Primary	Change of Pelvic Floor Muscle (PFM) strength will be measured by dynamometry	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.	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.
Primary	Change of pelvis floor muscles (PFM) condition by vaginal palpation Levator Any Test (LAT)	LAT range from 0 to 5, according to the muscles strength and endurance	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.