The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.

Pelvic Floor Disorders Clinical Trial

Official title:

The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury. A Pilot Randomized Controlled Trial Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05617092
• Other study ID #: 278806
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Vastra Gotaland Region
• Contact: Rocio Montejo, PhD
• Phone: +46104352244
• Email: rocio.montejo.rodriguez[@]vgregion.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot randomized pilot controlled trial (RTC)is to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator injury that is intended to be used in a larger scale multicenter randomized controlled trial (RTC) in the future. The main questions it aims to answer are if a physiotherapy program in women with a levator injury:

1. Can improve the pelvic floor morphometry (PFM).

2. Can improve urogynecological symptoms

3. The effect of a physiotherapy program in the sexual function

4. The effect of a physiotherapy program in the patient's fear avoidance beliefs about physical activity and work Type of study: randomized pilot controlled trial (RTC) The design of this trial will be a pilot randomized controlled trial with 3 arms. Participants will be randomized in 2 arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Researchers will compare the 3 groups to see if a physiotherapy program have benefits in morphometry of the pelvic floor, urogynecological symptoms, sexual function and to avoid fear avoidance beliefs about physical activity and work.

Description:

The levator ani is a broad, thin muscle group, situated on either side of the pelvis. It supports the viscera in the pelvic cavity, and surrounds the various structures that pass through it. The levator ani muscles are of central importance in pelvic organ support and the maintenance of urinary and fecal continence. Vaginal delivery was associated with a higher number of pelvic floors injury at different levels (10% to 30% of women with vaginal deliveries). One of these specific types of pelvic floor injury include levator avulsion muscle (LAM) and levator ballooning. International clinical guidelines in agreement with meta-analysis recommend pelvic floor muscle (PFM) physiotherapy as a first line treatment for symptoms related to postpartum injuries. However, it is unclear whether women with levator ani injury lesions could respond to physiotherapy. There have been no randomized studies on this matter and the pilot studies have focused on anatomy rather than symptoms.

Trial Design A randomized pilot-controlled trial is designed to collect acceptability and feasibility outcomes of a physiotherapy individualized program in women with levator ani injury that is intended to be used in a larger scale multicenter randomized controlled trial in the future.

Methods The design of this trial will be a pilot randomized controlled trial with 3 arms:2 randomized arm of women with levator ani injury to either physiotherapy or standard care and an arm of woman without levator injury Participants Assessed for eligibility will be primiparous with a simplex vaginal delivery, aged ≥18 years, that understands the Swedish language, who approve vaginal examinations and with known risk factors for avulsion (instrumental delivery, maternal age >35 years, prolonged or precipitous second stage, and fetal occipito-posterior position).

10-12 weeks after the delivery a clinical 3 D ultrasound of pelvic floor will be perform.

Women with an injury in the levator ani will be randomized into two groups, one for intervention and the other for control.

Interventions The intervention group will receive a physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms with the information provided by the employed questionnaires and clinic exploration.

Physiotherapy treatment will start from 3 months postpartum to about 1 year after The control group will receive general information according to the postpartum care guidelines of the region ( Västrä Gotaland Regionen).

Objective

The main objectives of this pilot study will be to evaluate the effect of a physiotherapy program in women with a levator ani injury:

1. To demonstrate the feasibility of conducting a trial to evaluate the intervention, including the feasibility and acceptability of randomising the intervention and the feasibility of outcome measure collection.

2. To improve the pelvic floor muscle morphometry.

3. To improve the urogynecological symptoms.

4. To improve the sexual function.

5. To improve the patient's fear avoidance beliefs about physical activity. Outcome Morphometrics variables as Pelvic Organ Prolapse Quantification Examination (POP-Q) Modified Oxford Grading System and Ultrasound variables: External an external sphincter, Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2) LAM area (cm2), Right and left puborectal muscle thickness (mm) will be collect.

The followed questionnaires will be use: Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory-20 (PFDI-20), Fear Avoidance Beliefs Questionnaire (Physical Activity/PA) and Female Sexual Function Index FSFI-19.

Feasibility of recruitment will be assessed by exploring: the number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period,the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial after 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.

Randomization Women with an injury in the levator found in the ultrasound will be randomized with a computer program into two groups, one for intervention and the other for control A group of women without injury will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum.

Blinding Ultrasound diagnosis of levator ani muscle injury will be determined by 2 gynecologists blinded to delivery outcomes, using validated protocols. Women with levator ani injury will be randomly assigned to one of two groups: one (Intervention), and the other (the comparison group) receiving conventional recommendations.

The investigator assessing outcome will be blinded to treatment allocation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• simplex vaginal first delivery with a elevator ani injury

• aged =18 years

• understands the Swedish language in speech and writing

• approves vaginal examination

Exclusion Criteria:

• diagnosed sphincter injury grade 3-4

• serious postpartum disease (heart failure, thrombophlebitis, recent pulmonary embolism, acute infectious disease, genital haemorrhage, severe hypertension, dyspnoea, severe anemia or severe mental illness)

Related Conditions & MeSH terms

• Pelvic Floor Disorders
• Pelvic Floor; Perineal Rupture, Obstetric
• Physiotherapy
• Rupture

Intervention

Other:
• Physiotherapy treatment
physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms

Locations

Country	Name	City	State
Sweden	Nu sjukvård	Trollhättan

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the trial.	The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.	4 months after delivery
Primary	Feasibility of the trial.	The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.	6 months after delivery
Primary	Feasibility of the trial.	The number of those referred to the trial over the study period, who meet the eligibility criteria, the number of eligible patients who consent to participate in the trial over the study period, and the number of patients who decline to participate, the number of participants who consent to participate that remain in the trial by 4-month follow-up, the number/proportion of participants with complete baseline data over the study period, the number/proportion of participants with complete follow-up data at 4 months follow-up, the number/proportion of participants retained at the end of each module of treatment.	12 months after delivery
Primary	Morphometry with ultrasound Area	3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)	10-12 weeks after delivery
Primary	Morphometry with ultrasound Area	3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)	12 months after delivery
Primary	Morphometry with ultrasound Levator urethra GAP (LUG)	The distance between the center of the urethra and the levator insertion (LUG) in cm	10-12 weeks after delivery
Primary	Morphometry with ultrasound Levator urethra GAP (LUG)	The distance between the center of the urethra and the levator insertion (LUG) in cm	12 months after delivery
Primary	Morphometry with ultrasound muscle thickness	Right and left puborectal muscle thickness (mm) .	10-12 weeks after delivery
Primary	Morphometry with ultrasound muscle thickness	Right and left puborectal muscle thickness (mm) .	12 months after delivery
Primary	Urogynecological symptoms.	Pelvic Floor Impact Questionnaire (PFIQ-7)	3 months after delivery
Primary	Urogynecological symptoms.	Pelvic Floor Impact Questionnaire (PFIQ-7)	6 months after delivery
Primary	Urogynecological symptoms.	Pelvic Floor Impact Questionnaire (PFIQ-7)	12 months after delivery
Primary	Urogynecological symptoms.	Pelvic Floor Distress Inventory-20 (PFDI-20)	3 months after delivery
Primary	Urogynecological symptoms.	Pelvic Floor Distress Inventory-20 (PFDI-20)	6 months after delivery
Primary	Urogynecological symptoms.	Pelvic Floor Distress Inventory-20 (PFDI-20)	12 months after delivery
Primary	Physics activity level.	Open questions on Physics activity level.	3 months after delivery
Primary	Physics activity level.	Open questions on Physics activity level.	6 months after delivery
Primary	Physics activity level.	Open questions on Physics activity level.	12 months after delivery
Primary	Sexual Function.	Female Sexual Function Index FSFI-19 questionnaire	3 months after delivery
Primary	Sexual Function.	Female Sexual Function Index FSFI-19 questionnaire	6 months after delivery
Primary	Sexual Function.	Female Sexual Function Index FSFI-19 questionnaire	12 months after delivery
Primary	Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)	Fear-Avoidance Beliefs Questionnaire	3 months after delivery
Primary	Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)	Fear-Avoidance Beliefs Questionnaire	6 months after delivery
Primary	Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)	Fear-Avoidance Beliefs Questionnaire	12 months after delivery
Secondary	Pelvic Organ Prolapse Quantification Examination (POP-Q)	assessing the degree of prolapse of pelvic organs to help standardize diagnosing, comparing, documenting, and sharing of clinical findingsThe prolapsed organs will be measured in centimeters to the hymen	10-12 weeks after delivery
Secondary	Pelvic Organ Prolapse Quantification Examination (POP-Q)	assessing the degree of prolapse of pelvic organs to help standardize diagnosing, comparing, documenting, and sharing of clinical findingsThe prolapsed organs will be measured in centimeters to the hymen	12 months after delivery
Secondary	Age	Age in years	10-12 weeks after delivery
Secondary	Body mass index (BMI)	BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2	10-12 weeks after delivery
Secondary	Body mass index (BMI)	BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2	12 months after delivery
Secondary	Weight gain during pregnancy	Weight gain during pregnancy in kilograms	10-12 weeks after delivery
Secondary	Delivery mode	Delivery mode:vaginal delivery, forceps delivery or vacuum delivery	10-12 weeks after delivery
Secondary	Baby's birth weight	Baby's birth weight in kilograms	10-12 weeks after delivery
Secondary	Previous abdominal operation	Number of previous abdominal operation	10-12 weeks after delivery
Secondary	Gastric bypass	Gastric bypass surgery	10-12 weeks after delivery
Secondary	Modified Oxford Grading Scale	The modified Oxford Grading Scale [4] quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.	10-12 weeks after delivery
Secondary	Modified Oxford Grading Scale	The modified Oxford Grading Scale [4] quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.	6 months after delivery
Secondary	Modified Oxford Grading Scale	The modified Oxford Grading Scale [4] quantifies pelvic floor muscle strength as: 0, no contraction; 1, flicker; 2, weak; 3, moderate; 4, good; and 5, strong.	12 months after delivery