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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physiotherapy treatment
Sponsored by
Vastra Gotaland Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pelvic Floor Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Nu sjukvårdRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Intervention group

Control Group

Healthy controls

Arm Description

intervention group will receive a physiotherapy individualized treatment

No intervention in women with injury in the levator ani

A group of women without injury that will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum.

Outcomes

Primary Outcome Measures

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.
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.
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.
Morphometry with ultrasound Area
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Morphometry with ultrasound Area
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Morphometry with ultrasound Levator urethra GAP (LUG)
The distance between the center of the urethra and the levator insertion (LUG) in cm
Morphometry with ultrasound Levator urethra GAP (LUG)
The distance between the center of the urethra and the levator insertion (LUG) in cm
Morphometry with ultrasound muscle thickness
Right and left puborectal muscle thickness (mm) .
Morphometry with ultrasound muscle thickness
Right and left puborectal muscle thickness (mm) .
Urogynecological symptoms.
Pelvic Floor Impact Questionnaire (PFIQ-7)
Urogynecological symptoms.
Pelvic Floor Impact Questionnaire (PFIQ-7)
Urogynecological symptoms.
Pelvic Floor Impact Questionnaire (PFIQ-7)
Urogynecological symptoms.
Pelvic Floor Distress Inventory-20 (PFDI-20)
Urogynecological symptoms.
Pelvic Floor Distress Inventory-20 (PFDI-20)
Urogynecological symptoms.
Pelvic Floor Distress Inventory-20 (PFDI-20)
Physics activity level.
Open questions on Physics activity level.
Physics activity level.
Open questions on Physics activity level.
Physics activity level.
Open questions on Physics activity level.
Sexual Function.
Female Sexual Function Index FSFI-19 questionnaire
Sexual Function.
Female Sexual Function Index FSFI-19 questionnaire
Sexual Function.
Female Sexual Function Index FSFI-19 questionnaire
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Fear-Avoidance Beliefs Questionnaire
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Fear-Avoidance Beliefs Questionnaire
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Fear-Avoidance Beliefs Questionnaire

Secondary Outcome Measures

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
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
Age
Age in years
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
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
Weight gain during pregnancy
Weight gain during pregnancy in kilograms
Delivery mode
Delivery mode:vaginal delivery, forceps delivery or vacuum delivery
Baby's birth weight
Baby's birth weight in kilograms
Previous abdominal operation
Number of previous abdominal operation
Gastric bypass
Gastric bypass surgery
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.
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.
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.

Full Information

First Posted
November 1, 2022
Last Updated
April 26, 2023
Sponsor
Vastra Gotaland Region
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1. Study Identification

Unique Protocol Identification Number
NCT05617092
Brief Title
The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury.
Official Title
The Effect of a Postpartum Training Program on Women Who Have Suffered a Levator Ani Injury. A Pilot Randomized Controlled Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vastra Gotaland Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: Can improve the pelvic floor morphometry (PFM). Can improve urogynecological symptoms The effect of a physiotherapy program in the sexual function 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.
Detailed 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: 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. To improve the pelvic floor muscle morphometry. To improve the urogynecological symptoms. To improve the sexual function. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Floor Disorders, Pelvic Floor; Perineal Rupture, Obstetric, Physiotherapy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
intervention group will receive a physiotherapy individualized treatment
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No intervention in women with injury in the levator ani
Arm Title
Healthy controls
Arm Type
No Intervention
Arm Description
A group of women without injury that will be invited to filling in the questionnaires that will be carried out in the study three, six months and one year postpartum.
Intervention Type
Other
Intervention Name(s)
Physiotherapy treatment
Intervention Description
physiotherapy individualized treatment according to the needs of the patient and clinical findings and symptoms
Primary Outcome Measure Information:
Title
Feasibility of the trial.
Description
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.
Time Frame
4 months after delivery
Title
Feasibility of the trial.
Description
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.
Time Frame
6 months after delivery
Title
Feasibility of the trial.
Description
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.
Time Frame
12 months after delivery
Title
Morphometry with ultrasound Area
Description
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Time Frame
10-12 weeks after delivery
Title
Morphometry with ultrasound Area
Description
3-D Ultrasound examination., Levator hiatus area at rest (cm2),during Valsalva (cm2) and at maximum contraction (cm2)
Time Frame
12 months after delivery
Title
Morphometry with ultrasound Levator urethra GAP (LUG)
Description
The distance between the center of the urethra and the levator insertion (LUG) in cm
Time Frame
10-12 weeks after delivery
Title
Morphometry with ultrasound Levator urethra GAP (LUG)
Description
The distance between the center of the urethra and the levator insertion (LUG) in cm
Time Frame
12 months after delivery
Title
Morphometry with ultrasound muscle thickness
Description
Right and left puborectal muscle thickness (mm) .
Time Frame
10-12 weeks after delivery
Title
Morphometry with ultrasound muscle thickness
Description
Right and left puborectal muscle thickness (mm) .
Time Frame
12 months after delivery
Title
Urogynecological symptoms.
Description
Pelvic Floor Impact Questionnaire (PFIQ-7)
Time Frame
3 months after delivery
Title
Urogynecological symptoms.
Description
Pelvic Floor Impact Questionnaire (PFIQ-7)
Time Frame
6 months after delivery
Title
Urogynecological symptoms.
Description
Pelvic Floor Impact Questionnaire (PFIQ-7)
Time Frame
12 months after delivery
Title
Urogynecological symptoms.
Description
Pelvic Floor Distress Inventory-20 (PFDI-20)
Time Frame
3 months after delivery
Title
Urogynecological symptoms.
Description
Pelvic Floor Distress Inventory-20 (PFDI-20)
Time Frame
6 months after delivery
Title
Urogynecological symptoms.
Description
Pelvic Floor Distress Inventory-20 (PFDI-20)
Time Frame
12 months after delivery
Title
Physics activity level.
Description
Open questions on Physics activity level.
Time Frame
3 months after delivery
Title
Physics activity level.
Description
Open questions on Physics activity level.
Time Frame
6 months after delivery
Title
Physics activity level.
Description
Open questions on Physics activity level.
Time Frame
12 months after delivery
Title
Sexual Function.
Description
Female Sexual Function Index FSFI-19 questionnaire
Time Frame
3 months after delivery
Title
Sexual Function.
Description
Female Sexual Function Index FSFI-19 questionnaire
Time Frame
6 months after delivery
Title
Sexual Function.
Description
Female Sexual Function Index FSFI-19 questionnaire
Time Frame
12 months after delivery
Title
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Description
Fear-Avoidance Beliefs Questionnaire
Time Frame
3 months after delivery
Title
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Description
Fear-Avoidance Beliefs Questionnaire
Time Frame
6 months after delivery
Title
Fear Avoidance Beliefs Questionnaire (Physical Activity/PA)
Description
Fear-Avoidance Beliefs Questionnaire
Time Frame
12 months after delivery
Secondary Outcome Measure Information:
Title
Pelvic Organ Prolapse Quantification Examination (POP-Q)
Description
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
Time Frame
10-12 weeks after delivery
Title
Pelvic Organ Prolapse Quantification Examination (POP-Q)
Description
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
Time Frame
12 months after delivery
Title
Age
Description
Age in years
Time Frame
10-12 weeks after delivery
Title
Body mass index (BMI)
Description
BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2
Time Frame
10-12 weeks after delivery
Title
Body mass index (BMI)
Description
BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2
Time Frame
12 months after delivery
Title
Weight gain during pregnancy
Description
Weight gain during pregnancy in kilograms
Time Frame
10-12 weeks after delivery
Title
Delivery mode
Description
Delivery mode:vaginal delivery, forceps delivery or vacuum delivery
Time Frame
10-12 weeks after delivery
Title
Baby's birth weight
Description
Baby's birth weight in kilograms
Time Frame
10-12 weeks after delivery
Title
Previous abdominal operation
Description
Number of previous abdominal operation
Time Frame
10-12 weeks after delivery
Title
Gastric bypass
Description
Gastric bypass surgery
Time Frame
10-12 weeks after delivery
Title
Modified Oxford Grading Scale
Description
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.
Time Frame
10-12 weeks after delivery
Title
Modified Oxford Grading Scale
Description
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.
Time Frame
6 months after delivery
Title
Modified Oxford Grading Scale
Description
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.
Time Frame
12 months after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rocio Montejo, PhD
Phone
+46104352244
Email
rocio.montejo.rodriguez@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rocio Montejo, PhD
Organizational Affiliation
Vastra Gotaland Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nu sjukvård
City
Trollhättan
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocio Montejo

12. IPD Sharing Statement

Plan to Share IPD
No

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

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