Perineal Physiotherapy in Postpartum

Post Partum Clinical Trial

— PT-POSTPARTO  

Official title:

Effectiveness of the Perineal Physiotherapy in the Prevention and Treatment of Pelvic Floor Dysfunction in Postpartum

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03247660
• Other study ID #: 21/2013
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2023

Study information

• Verified date: January 2024
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: To find out the effectiveness of pelvic-perineal physiotherapy in prevention and treatment of postpartum pelvic floor dysfunction caused by vaginal delivery.

Description:

Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned to one of these groups: Experimental group: pelvic-perineal physical therapy plus hypopressive exercises plus training in lifestyle advice; Experimental group II: hypopressive exercises plus training in lifestyle advice; Control group: just training in lifestyle advice. In the 3 groups several physical therapy assessments will be undertaken: 1st before intervention, 2nd immediately after completing intervention; 3th, 4th, 5th and 6th after 3, 6, 12 and 24 months. Study subjects: Postnatal women (6 and 8 weeks after vaginal delivery), primiparous, whose vaginal delivery has occurred in the "PrÍncipe de Asturias" Hospital, which have not been already treated for pelvic floor dysfunction, and after reading, understanding and freely signing an informed consent form. Sample size: 240 subjects will be included (80 subjects per group). Allowing for 15% of drop-outs and taking into account that 17% of women in the intervention group may develop pelvic floor dysfunction (urinary incontinence) versus 40% in the control group, with an alpha risk of 0.05, a beta risk of 0.1 in a bilateral contrast using the arcsine approximation. Data analysis: A descriptive analysis will be done of all 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: 240
• Est. completion date: December 2023
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Postnatal women (6 and 8 weeks after vaginal delivery)

• Primiparous

• Whose vaginal delivery has occurred in the "Príncipe de Asturias" Hospital

• Women have not been already treated for pelvic floor dysfunction

• Women reading, understanding and freely signing an informed consent form

Exclusion Criteria:

• Postnatal women with medical diagnosis of pelvic floor dysfunction (PFD) prior to pregnancy and delivery

• Women with a history of conservative treatment or PFD surgery

• Women with concomitant or systemic disease that may affect the treatment (neurological, gynecological, urological or connective tissue), or with active or recurrent urinary infection without treatment at the time of the intervention proposed in this study, or hematuria

• Postnatal women with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.

Related Conditions & MeSH terms

• Post Partum

Intervention

Other:
• PFM training
See information included in arm/group descriptions.
• HE
See information included in arm/group descriptions.

Behavioral:
• Educational strategy
See information included in arm/group descriptions.

Locations

Country	Name	City	State
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 in life impact of pelvic floor dysfunction	It 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).	5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Primary	Change in symptoms and quality of life	It will be assessed by PFDI-20 that is both a symptom inventory and a measure of the degree of bother and distress 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 quality of life. 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.	5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.
Primary	Change in pelvic floor muscle strength	It will be measured with manometry (cm2O2)	5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), , 3 months, 6 months and 12 months after the intervention.
Primary	Change in pelvic floor muscle characteristics	Vaginal palpation will qualify PFM condition using the Levator any test (LAT) ranging from 0 to 5, according to the muscles strength and endurance.	5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.
Primary	Change in pelvic floor muscle strength	It will be measured with dynamometry (gr)	5 assessments to evaluate change from baseline: at baseline, after the intervention period (2 months from baseline), 3 months, 6 months and 12 months after the intervention.