Impact of Early Physiotherapy on Pain, Quality of Life, Pelvic Floor Function, and Sexual Health Post-Episiotomy

NCT06568406 | Recruiting

• 1 other identifier: Epi-Fyzio
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical incision of the perineum and the posterior vaginal wall during a vaginal delivery (episiotomy) is among the most common surgical procedures performed in obstetrics. On the condition of having been performed correctly and in certain situations, episiotomy can be beneficial for a mother in decreasing the risk of a serious perineum injury. The benefit for a foetus can lie in acceleration of the final stage of delivery in the event of acute foetal distress. Many adverse effects are however connected to episiotomy. The morbidity connected to episiotomy can affect physical, mental, and social well-being of women during immediate as well as long-term post-partum periods. Currently, there are no universal standards that would describe and recommend physiotherapy for women following episiotomy during the first days, weeks, and months after a delivery. Care about the wound and the resulting scar after giving birth with episiotomy is an important topic because clinical experience shows that scars in the perineal area can have negative effects on the function of the pelvic floor muscles, on perineum pains, sexual health, and on mental well-being of a woman. Treatment of women with perineal wounds therefore requires a multidisciplinary approach, in which doctors, physiotherapists, and other medical professionals should be aware of the impact of a perineal scar on the quality of woman's life. Treatment or perineal scars, external genitalia, and the pelvic floor together with a targeted education of women in individual care after their scars should be part of evidence-based practice.

Conditions

Gynecological; Surgery (Previous), Causing Obstructed Labor

Keywords

Episiotomy; physiotherapy; pelvic floor; scar; pain; dyspareunia; sexual dysfunction; quality of life

Outcome Measures

Primary Outcomes (3)

• Pain in the perineal space

  The Short-Form McGill Pain Questionnaire (SF-MPQ) is a concise tool for assessing pain, derived from the original McGill Pain Questionnaire. It consists of three components: the Pain Rating Index (PRI), which includes 15 descriptors (11 sensory and 4 affective) rated on a scale from 0 to 3; the Present Pain Intensity (PPI), where pain is rated on a 6-point scale; and, in some versions, a Visual Analog Scale (VAS), where pain intensity is marked on a 10 cm line.

  Change from baseline to 14-18 weeks and 12-14 months

• Complications of healing of birth trauma

  The description refers to the observation of wound complications by a physician, including the appearance of dehiscences (wound separations), secondary healing (delayed healing process), hematomas (localized collections of blood), infections in the wound, and the need for resuturing of the perineum. These complications are typically monitored post-surgery or after childbirth to ensure proper wound healing and to manage any issues that arise.

  Change from baseline to 14-18 weeks and 12-14 months

• Pain in the perineum in relation to bodily and motor functions

  A Visual Analog Scale (VAS) related to Activities of Daily Living (ADL) is a tool used to assess the impact of pain or other symptoms on a person's ability to perform daily tasks. The VAS typically consists of a horizontal line, usually 10 cm in length, with endpoints labeled to represent the extremes of the symptom's effect-such as "No impact on ADL" at one end and "Completely unable to perform ADL" at the other. Patients are asked to mark a point on the line that represents the extent to which their condition affects their daily activities. The distance from the "No impact" end to the patient's mark is measured in centimeters or millimeters, providing a quantifiable score that reflects the severity of the impact on their ability to carry out ADL. This tool is widely used in clinical settings to monitor changes over time and to evaluate the effectiveness of treatments aimed at improving functional independence.

  Change from baseline to 14-18 weeks and 12-14 months

Secondary Outcomes (11)

• The quality of sexual functions

  Change from baseline to 14-18 weeks and 12-14 months

• Quality of life of people with urinary incontinence

  Change from baseline to 14-18 weeks and 12-14 months

• Health related quality of life

  Change from baseline to 14-18 weeks and 12-14 months

• The functions of the pelvic floor muscles by palpation per vaginam and records them using the OXFORD SCALE

  Change from baseline to 10-14 weeks

• The functions of the pelvic floor muscles by palpation per vaginam and records them using the PERFECT SCHEME

  Change from baseline to 10-14 weeks

Study Arms (2)

Scheduled Physiotherapy (Intervention)

EXPERIMENTAL

The mothers in the group A will be referred to the physiotherapist's office at predetermined intervals (intervention group) compared to the current care system.

Procedure: Physiotherapy; Diagnostic Test: Urogynaecology

Standard Care (Control)

ACTIVE COMPARATOR

The mothers included in the group B will undergo standard care in the established manner at the Department of Obstetrics and Gynecology of the Faculty Hospital in Brno, which consists of routine treatment of the perineum and inspection of the perineum by a doctor that by rule occurs the 3rd day after delivery and by the end of the hospitalization

Diagnostic Test: Urogynaecology

Interventions

Physiotherapy PROCEDURE

Examination by a physiotherapist: the first check-up with an examination and a therapeutic intervention with the patient is performed within 24-72 hours after delivery. This is followed by two regular outpatient check-ups by a physiotherapist for the purpose of therapy and education. The second check takes place after 6-8 weeks. And the third check occurs after 10-14 weeks after childbirth. In these three checks, data collection is carried out simultaneously (in order to complete the secondary objective). The patients are examined and monitored by the same physiotherapist.

Scheduled Physiotherapy (Intervention)

Urogynaecology DIAGNOSTIC_TEST

Examination by a urogynaecologist this is carried out in the period of 14-18 weeks after childbirth in order to complete the primary objective. Data collection in order to complete the primary objective is done in the period of 14-18 weeks and 12-14 months after delivery (the online method without the need for a physical visit is preferred).

Scheduled Physiotherapy (Intervention); Standard Care (Control)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female aged 18 to 40
• following an uncomplicated mediolateral episiotomy
• primipara at term with the cephalic occiput anterior position of the foetus
• signature of the informed consent and understanding of the study protocol

You may not qualify if:

• premature birth prior to 37+0
• other presentation than the cephalic occiput anterior position
• a performed vaginal extraction
• an associated vaginal rupture
• an injury of the anal sphincter
• multiple sclerosis
• serious neurological disorders
• connective tissue diseases
• chronic inflammatory bowel diseases
• congenital developmental disorders of the external genitalia

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital

Brno, 62500, Czechia

RECRUITING

MeSH Terms

Conditions

Cicatrix; Pain; Dyspareunia; Sexual Dysfunction, Physiological

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Lukáš Hruban, PhD

  University Hospital Brno, Czechia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukáš Hruban, PhD

CONTACT

00420532238306; hruban.lukas@fnbrno.cz

Marika Bajerová, MSc

CONTACT

00420532238359; bajerova.marika@fnbrno.cz

Study Design

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

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)