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

Definition of the Effect of Early Individual Physiotherapy on Evaluation of Pain, Quality of Life, Function of the Pelvic Floor Muscles, and on the Sexual Functions in Women Following an Episiotomy During a Delivery

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.

Study Overview

• Status: Recruiting
• Conditions: Gynecological; Surgery (Previous), Causing Obstructed Labor
• Intervention / Treatment: Procedure: Physiotherapy; Diagnostic test: Urogynaecology

Detailed Description

Project Objectives Evaluate the benefits, advantages, and disadvantages of early individual physiotherapy on the selected parameters in women following a performed uncomplicated episiotomy during a vaginal delivery.

Primary objective: Specification of the differences between two groups of expectant mothers following an uncomplicated episiotomy based on the results of a survey. The comparison is carried out between a group of mothers who underwent individual postnatal physiotherapy treatment and another group of mothers that were treated in a standard way.

Secondary objective: Evaluation of the functional changes in mothers that underwent individual physiotherapeutic treatment following an uncomplicated episiotomy.

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lukáš Hruban, PhD; Phone Number: 00420532238306; Email: hruban.lukas@fnbrno.cz
• Study Contact Backup: Name: Marika Bajerová, MSc; Phone Number: 00420532238359; Email: bajerova.marika@fnbrno.cz

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • University Hospital
    • Contact: Marika Bajerová, MSc.; Email: Bajerova.Marika@fnbrno.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• paravaginal haematoma immediately after birth and before inclusion in the study
• multiple sclerosis
• serious neurological disorders
• connective tissue diseases
• chronic inflammatory bowel diseases
• congenital developmental disorders of the external genitalia

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scheduled Physiotherapy (Intervention); 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; 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.; Diagnostic test: Urogynaecology; 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).
Active Comparator: Standard Care (Control); 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quality of sexual functions	The Female Sexual Function Index (FSFI) is a standardized 19-item questionnaire used to assess various aspects of female sexual function, including desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored separately, with higher scores indicating better sexual function, and the total score ranging from 2 to 36. The FSFI is widely used in clinical and research settings to diagnose female sexual dysfunction and monitor treatment outcomes, offering a comprehensive and validated tool for evaluating sexual health in women.	Change from baseline to 14-18 weeks and 12-14 months
Quality of life of people with urinary incontinence	The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is a standardized tool used to assess the severity and impact of urinary incontinence on quality of life. It consists of a few questions that evaluate the frequency, amount of leakage, and the overall impact of urinary incontinence on daily activities. Additionally, it includes a self-diagnostic item to help identify the type of incontinence. The ICIQ-UI SF is widely used in both clinical practice and research to quickly and effectively assess urinary incontinence and guide treatment decisions.	Change from baseline to 14-18 weeks and 12-14 months
Health related quality of life	The Euro Quality of Life Five Dimensions (EQ-5D-5L) is a standardized questionnaire used to measure health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is assessed on a five-level scale, ranging from no problems to extreme problems, allowing for a detailed evaluation of a person's health status. The questionnaire also includes a Visual Analog Scale (VAS) where respondents rate their overall health on a scale from 0 to 100. The EQ-5D-5L is commonly used in clinical and research settings to assess health outcomes, inform healthcare decisions, and evaluate the effectiveness of interventions.	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	The Oxford Scale, also known as the Medical Research Council (MRC) scale, is a tool used to assess muscle strength. It ranges from 0 to 5, with 0 indicating no muscle contraction and 5 representing normal strength with full resistance. This scale is widely used in clinical settings, particularly in neurology and rehabilitation, to evaluate and monitor muscle strength.	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	The PERFECT Scheme is a method for assessing pelvic floor muscle function. It stands for Power, Endurance, Repetitions, Fast contractions, Every contraction, Coordination, and Timing. This comprehensive approach is used to evaluate and treat pelvic floor disorders, such as incontinence, allowing for tailored rehabilitation and progress tracking.	Change from baseline to 10-14 weeks
The presence of possible motion synkinesis	The physiotherapist investigates the presence of possible motion synkinesis in an attempt to activate the pelvic floor muscles - short adductors of the hips and gluteal muscles. Presence of motion synkinesis.	Change from baseline to 10-14 weeks
The condition of the wound	The physiotherapist examines the condition of the wound and its surroundings by palpation per vaginam. They assess the presence of any swelling and haematoma of the pubic region (presence YES x NO). They assess the sensitivity (the skin sensitivity and the vaginal sensitivity: increased x decreased x no sensitivity).	Change from baseline to 10-14 weeks
The condition of the scar	The physiotherapist checks the condition of the scar and the surrounding soft tissues of the pelvic floor by palpation per vaginam. They assess the sensitivity per vaginam using palpation (record: decreased x increased x no sensitivity), painfulness (presence YES x NO), displacement of the scar in relation to the bottom (presence YES x NO), and elastici-ty of the scars (presence YES x NO).	Change from baseline to 10-14 weeks
The presence of the abdominal separation	The physiotherapist examines the presence of the abdominal separation (DRA). The DRA is examined using palpation. The prevalence of DRA is analyzed and recorded as YES/NO.	Change from baseline to 10-14 weeks
Hypermobility	The physiotherapist examines hypermobility. The hypermobility is measured using the Beighton score. The Beighton Score is a quick assessment tool used to evaluate joint hypermobility, commonly in the context of conditions like Ehlers-Danlos Syndrome. It involves scoring five specific movements, with a total score ranging from 0 to 9. Points are awarded for hyperextension of the little fingers, thumbs, elbows, knees, and the ability to place palms flat on the floor with straight knees. A score of 4 or more suggests generalized hypermobility, while a lower score is typically considered within the normal range. This simple test helps identify individuals with hypermobility and is often part of a broader diagnostic evaluation.	Change from baseline to 10-14 weeks
Satisfaction with physiotherapy	The physiotherapist hands the expectant woman the Likert scale to measure the satisfaction with the early physiotherapy care. A Likert scale is a widely used rating scale that measures attitudes, opinions, or perceptions by asking respondents to indicate their level of agreement or disagreement with a series of statements. It typically consists of 5 or 7 points, ranging from one extreme to another, such as "Strongly Disagree" to "Strongly Agree," with a neutral option in the middle (e.g., "Neither Agree nor Disagree"). The Likert scale is commonly used in surveys and questionnaires to quantify subjective data, making it easier to analyze and interpret responses in a standardized manner.	Change from baseline to 10-14 weeks

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Investigators: Principal Investigator: Lukáš Hruban, PhD, University Hospital Brno, Czechia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: pain; quality of life; scar; physiotherapy; Episiotomy; sexual dysfunction; dyspareunia; pelvic floor
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Dystocia
• Other Study ID Numbers: Epi-Fyzio

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