Perineal Physiotherapy in Postpartum (PT-POSTPARTO)

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

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

Study Overview

• Status: Completed
• Conditions: Post Partum
• Intervention / Treatment: Other: PFM training; Other: HE; Behavioral: Educational strategy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Torres-Lacomba, PhD; Email: maria.torres@uah.es
• Study Contact Backup: Name: Beatriz Navarro-Brazález, PhD; Email: b.navarrobrazalez@gmail.com

Study Locations

• Spain
  • Madrid
    • Alcalá de Henares, Madrid, Spain, 28805
      • University of Alcalá. FPSM research group. HUPA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PFMT&HE group; A directly pelvic floor muscle (PFM) training protocol will be applied. Participants will performed PFM exercises in the way proposed by the PERFECT scheme. Biofeedback exercises will be also performed in lithotomy position. If the evolution of the women will allow it, the last two treatment biofeedback sessions will be conducted in standing position, to train PFM in more challenging and functional situation. In this group participants will be also trained hypopressive breathing and will perform five hypopressive exercises: two postures in supine, one on four-kneeling, and two in standing position. Educational strategy will also be applied. The intervention will last 8 weeks, 2 sessions per week. Each session will last 40/50 minutes.	Other: PFM training; See information included in arm/group descriptions.; Other Names: Pelvic floor muscle training; Other: HE; See information included in arm/group descriptions.; Other Names: Hypopressive exercises; Behavioral: Educational strategy; See information included in arm/group descriptions.
Experimental: HE group; Women will be instructed in thirty-three Hypopressives exercises (HE) described by the developer of the Hypopressive Abdominal Gymnastics, Dr. Caufriez plus Educational strategy. The intervention will last 8 weeks, 2 sessions per week. Each session will last 40/50 minutes.	Other: HE; See information included in arm/group descriptions.; Other Names: Hypopressive exercises; Behavioral: Educational strategy; See information included in arm/group descriptions.
Active Comparator: Control group; The educational strategy will consist of instruction of printed materials and dimensional anatomical models about the anatomy of the pelvic floor and the physiology of the pelvic organs. It will be recommended to avoid risk factors, such as gaining weight, weight lifting, high impact sports, constipation, smoking, or drinking too much caffeine. They will also instruct in toilet habits, and will be taught to use the knack maneuver before and during increases of intra-abdominal pressure. The intervention will last 8 weeks, 1 session per week. Each session will last 40/50 minutes.	Behavioral: Educational strategy; See information included in arm/group descriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: University of Alcala

Publications and helpful links

General Publications

• Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: August 5, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21/2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No