Pelviperineal Physiotherapy in Postpartum

NCT03247660 | Completed DMC

• 2 other identifiers: 21/2013PI17/01449
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Partum

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in life impact of pelvic floor dysfunction

  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

  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

  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

  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.

Study Arms (3)

Pelviperineal physiotherapy (PP) group

EXPERIMENTAL

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; Other: HE; Behavioral: Educational strategy

Hypopressive exercices (HE) group

EXPERIMENTAL

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; Behavioral: Educational strategy

Control group

ACTIVE COMPARATOR

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

Interventions

PFM training OTHER

See information included in arm/group descriptions.

Also known as: Pelvic floor muscle training

Pelviperineal physiotherapy (PP) group

HE OTHER

See information included in arm/group descriptions.

Also known as: Hypopressive exercises

Hypopressive exercices (HE) group; Pelviperineal physiotherapy (PP) group

Educational strategy BEHAVIORAL

See information included in arm/group descriptions.

Control group; Hypopressive exercices (HE) group; Pelviperineal physiotherapy (PP) group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

University of Alcalá. FPSM research group. HUPA

Alcalá de Henares, Madrid, 28805, Spain

Location

Related Publications (1)

• 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.

  PMID: 32378735 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 3 groups: 2 experimental groups and 1 control group

Study Record Dates

• First Submitted: August 5, 2017
• First Posted: August 14, 2017
• Study Start: October 10, 2017
• Primary Completion: December 20, 2023
• Study Completion: December 10, 2024
• Last Updated: August 25, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)