Pelviperineal Physiotherapy in Postpartum (PT-POSTPARTO)

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

Objective: To compare the effectiveness of pelviperineal physiotherapy hypopressive exercise, and pelvic health education for the prevention and treatment of postpartum pelvic floor dysfunction in primiparous women after 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: pelviperineal physical therapy plus pelvic health education and training in the Knack manoeuvre; Experimental group II: hypopressive exercises plus pelvic health education and training in the Knack manoeuvre; Control group: pelvic health education, training in the Knack manoeuvre, and general recommendations for pelvic floor muscle exercises at home. 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 and12 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: The sample size was calculated a priori using the PFDI-20 as the primary outcome. Based on a clinically meaningful between-group difference of 20 points and an SD of change of 31.2 points, 55 participants per group were required. A total of 165 participants were randomized (55 per group). Data analysis: A descriptive analysis will be performed for all variables. Intervention effects will be assessed using linear mixed-effects models for change from baseline, including group, time, and group-by-time interaction as fixed effects, with adjustment for the centered baseline value of the outcome and a participant-specific random intercept. A two-sided significance level of 0.05 will be used.

• Study Type: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

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.
• Women with perineal pain preventing vaginal dynamometry.
• Postnatal women with cognitive impairment or insufficient Spanish-language proficiency preventing adequate understanding of study procedures.
• Women with severe maternal complications or serious neonatal conditions.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pelviperineal physiotherapy (PP) group; An individualised pelvic floor muscle training (PFMT) programme 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. Active intravaginal electrical stimulation will also be applied when PFM strength was <3 on the Modified Oxford Scale. Participants also received pelvic health education, standardised instruction in the Knack manoeuvre, and an individualised home exercise programme. Educational strategy will also be applied. The intervention will last 8 weeks, 2 sessions per week. Each session will last 60 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: Hypopressive exercices (HE) group; Women will be instructed in thirty-three Hypopressives exercises (HE) described by the developer of the Hypopressive Abdominal Gymnastics, Dr. Caufriez plus pelvic health education, standardised instruction in the Knack manoeuvre, and individualised home practice were also provided. The intervention will last 8 weeks, 2 sessions per week. Each session will last 60 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, standardised instruction in the Knack manoeuvre, and general recommendations for PFM exercise at home. No supervised or individualised PFMT or hypopressive exercise was provided. The intervention will last 8 weeks, 1 session per week. Each session will last 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 symptoms and quality of life	It will be assessed by PFDI-20 Spanish version 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.

Secondary 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.
Pelvic floor muscle contraction and strenght	Vaginal palpation will qualify PFM contraction and strength. using the Modified Oxford Score ranging from 0 to 5, according to the muscles contraction and strength.	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.
Changes in sexual function	It will be assessed using the Spanish version of the Female Sexual Function Index (FSFI). The FSFI consists of 19 items assessing six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain, with higher scores indicating better sexual function.	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 and tone	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 10, 2017
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): December 10, 2024

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): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 21, 2026
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 21/2013; PI17/01449 (Other Grant/Funding Number: Instituto de Salud Carlos III (ISCIII), SPAIN)

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