Perineal Physiotherapy in Postpartum

NCT03247660 | Completed DMC

• 1 other identifier: 21/2013
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Partum

Outcome Measures

Primary Outcomes (5)

• 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.

Study Arms (3)

PFMT&HE group

EXPERIMENTAL

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; Other: HE; Behavioral: Educational strategy

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 Educational strategy. The intervention will last 8 weeks, 2 sessions per week. Each session will last 40/50 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, 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

Interventions

PFM training OTHER

See information included in arm/group descriptions.

Also known as: Pelvic floor muscle training

PFMT&HE group

HE OTHER

See information included in arm/group descriptions.

Also known as: Hypopressive exercises

HE group; PFMT&HE group

Educational strategy BEHAVIORAL

See information included in arm/group descriptions.

Control group; HE group; PFMT&HE 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
• Postnatal women with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.

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: DOUBLE
• Who Masked: INVESTIGATOR, 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 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)