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

Official title

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

Overview

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.

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.

Interventions

• 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 o
• 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).

Primary outcome measures

• Pain in the perineal space [Time frame: Change from baseline to 14-18 weeks and 12-14 months]
• Complications of healing of birth trauma [Time frame: Change from baseline to 14-18 weeks and 12-14 months]
• Pain in the perineum in relation to bodily and motor functions [Time frame: Change from baseline to 14-18 weeks and 12-14 months]

Secondary outcome measures (11)

• The quality of sexual functions [Time frame: Change from baseline to 14-18 weeks and 12-14 months]
• Quality of life of people with urinary incontinence [Time frame: Change from baseline to 14-18 weeks and 12-14 months]
• Health related quality of life [Time frame: 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 [Time frame: 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 [Time frame: Change from baseline to 10-14 weeks]
• The presence of possible motion synkinesis [Time frame: Change from baseline to 10-14 weeks]
• The condition of the wound [Time frame: Change from baseline to 10-14 weeks]
• The condition of the scar [Time frame: Change from baseline to 10-14 weeks]
• The presence of the abdominal separation [Time frame: Change from baseline to 10-14 weeks]
• Hypermobility [Time frame: Change from baseline to 10-14 weeks]
• Satisfaction with physiotherapy [Time frame: Change from baseline to 10-14 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Czechia · 1 center

• University Hospital — Brno

Identifiers

NCT: NCT06568406 · Epi-Fyzio

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗