The Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method in the Postpartum Period

April 21, 2024 updated by: Damla Korkmaz Dayican, Izmir Tinaztepe University

Comparison of the Effects of Pelvic Floor Muscle Training Applied With the Telerehabilitation Method and Supervised in the Postpartum Period on Pelvic Floor Muscle Function, Pelvic Floor Symptoms and Quality of Life

Pelvic floor muscle training (PFMT) is routinely recommended to treat and prevent pelvic floor symptoms in the postpartum period. However, due to the high cost, remoteness of the location, and responsibilities of the baby, women cannot participate in PFMT whenever and wherever they want. Telerehabilitation (TR) may be an effective method to facilitate women's access to PFMT. Therefore, our study aims to compare the short and medium-term effects of PFMT applied with the TR method on pelvic floor symptoms, symptom-related quality of life and pelvic floor muscle function with supervised PFMT. This randomized controlled study was conducted at Yeditepe University Hospital Bağdat Street Polyclinic Pelvic Floor Center and online synchronous platform on women aged 18-35 and between the 6th and 8th weeks postpartum. Participants were randomly assigned to the synchronized PFMT performed with the telerehabilitation method (TR-PFMT) group and the supervised PFMT (S-PFMT) group. The same PFMT program was carried out in both groups for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program was carried out via a synchronous online platform (Skype™ program) in the TR-PFMT group, and as a face-to-face session in the S-PFMT group. Participants' pelvic floor symptoms were evaluated with the Pelvic Floor Distress Inventory-20 (PFDI-20), symptom-related quality of life was evaluated with the Pelvic Floor Impact Questionnaire-7 (PFIQ-7), and pelvic floor muscle function was evaluated with superficial electromyography. Evaluations were made 3 times in total: before the exercise program, after the exercise program and at the 8th week after the exercise program (6th month postpartum).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34010
        • Yeditepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a woman between 18-35 years old
  • Between the 6th and 8th weeks postpartum
  • Native Turkish
  • Having the appropriate technological infrastructure to participate in an exercise session via the Internet (for the TR-PFMT group)

Exclusion Criteria:

  • Number of births >2
  • The week of pregnancy <32
  • Having a history of 3rd and 4th-degree perineal tears
  • Cesarean birth
  • Inability to contract the pelvic floor muscle (pelvic floor muscle strength ≤2 according to the Modified Oxford Scale)
  • The electromyography values of the abdominal muscles or hip adductors during contraction of the pelvic floor muscles are more than 10 microvolts
  • The presence of neurological, orthopedic, psychiatric, hematological or cardiovascular disease that would prevent PFMT as questioned by the gynecologist
  • Body mass index ≥ 25 kg/m²
  • The presence of active urinary tract or vaginal infection in the last week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TR-PFMT group
In the TR-PFMT group, the PFMT program was carried out via a synchronous online platform (Skype™ program). Participants were asked to install Skype™ software on their personal computers or phones and create a personal account. In the first evaluation session, participants were taught how to use the hardware and software. Additionally, they were asked to place their cameras at an average distance of 1-1.5 meters so that their entire body could be seen. At the beginning of each session, they were informed that their information was kept confidential and their audio and video images would not be shared with another person.
Other: Pelvic floor muscle training
The PFMT program was carried out for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program consisted of education, diaphragm breathing exercises, pelvic mobility exercises, exercises to strengthen and stretch the pelvic floor muscles and other muscles related to the pelvis. In addition, the participants were expected to do the same exercises at home 2 days a week.
Active Comparator: S-PFMT group
In the S-PFMT group, the PFMT program was conducted as a face-to-face session in groups of 4 people.
Other: Pelvic floor muscle training
The PFMT program was carried out for 45-50 minutes, 2 days a week for 8 weeks, by two physiotherapists specialized experienced in the pelvic floor. The program consisted of education, diaphragm breathing exercises, pelvic mobility exercises, exercises to strengthen and stretch the pelvic floor muscles and other muscles related to the pelvis. In addition, the participants were expected to do the same exercises at home 2 days a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pelvic Floor Distress Inventory-20 to measure the total pelvic floor symptoms
Time Frame: pre-intervention; immediately after the intervention
It was used to assess the severity of the pelvic floor symptoms such as pelvic organ prolapse, colorectal-anal, and urinary symptoms. It consists of 20 questions and three subdimensions: Pelvic Organ Prolapse Distress Inventory-6, Colorectal-Anal Distress Inventory-8, and Urinary Distress Inventory-6. Each subdimension is averaged and multiplied by 25 to convert the score of the scale to a number out of 100. The score of the subdimension ranges from 0 to 100 and the total score ranges from 0 to 300. A higher score on the scale indicates greater severity of the complaints.
pre-intervention; immediately after the intervention
Pelvic Floor Distress Inventory-20 to measure the pelvic organ prolapse symptoms
Time Frame: pre-intervention; immediately after the intervention
It was used to assess the severity of the pelvic floor symptoms such as pelvic organ prolapse, colorectal-anal, and urinary symptoms. It consists of 20 questions and three subdimensions: Pelvic Organ Prolapse Distress Inventory-6, Colorectal-Anal Distress Inventory-8, and Urinary Distress Inventory-6. Each subdimension is averaged and multiplied by 25 to convert the score of the scale to a number out of 100. The score of the subdimension ranges from 0 to 100 and the total score ranges from 0 to 300. A higher score on the scale indicates greater severity of the complaints.
pre-intervention; immediately after the intervention
Pelvic Floor Distress Inventory-20 to measure the colorectal-anal symptoms
Time Frame: pre-intervention; immediately after the intervention
It was used to assess the severity of the pelvic floor symptoms such as pelvic organ prolapse, colorectal-anal, and urinary symptoms. It consists of 20 questions and three subdimensions: Pelvic Organ Prolapse Distress Inventory-6, Colorectal-Anal Distress Inventory-8, and Urinary Distress Inventory-6. Each subdimension is averaged and multiplied by 25 to convert the score of the scale to a number out of 100. The score of the subdimension ranges from 0 to 100 and the total score ranges from 0 to 300. A higher score on the scale indicates greater severity of the complaints.
pre-intervention; immediately after the intervention
Pelvic Floor Distress Inventory-20 to measure the urinary symptoms
Time Frame: pre-intervention; immediately after the intervention
It was used to assess the severity of the pelvic floor symptoms such as pelvic organ prolapse, colorectal-anal, and urinary symptoms. It consists of 20 questions and three subdimensions: Pelvic Organ Prolapse Distress Inventory-6, Colorectal-Anal Distress Inventory-8, and Urinary Distress Inventory-6. Each subdimension is averaged and multiplied by 25 to convert the score of the scale to a number out of 100. The score of the subdimension ranges from 0 to 100 and the total score ranges from 0 to 300. A higher score on the scale indicates greater severity of the complaints.
pre-intervention; immediately after the intervention
Pelvic Floor Impact Questionnaire-7 to measure the total pelvic floor symptoms related quality of life
Time Frame: pre-intervention; immediately after the intervention
It was used to evaluate the impact of pelvic floor symptoms on quality of life. It consists of 21 questions and three subdimensions: Urinary Impact Questionnaire-7, Colorectal-Anal Impact Questionnaire-7, and Pelvic Organ Prolapse Impact Questionnaire-7. It is calculated by taking the average of each subdimension and multiplying it by 100/3 to convert the score of the scale into a 100-point system. The score of the subdimension ranges from 0 to 100 and the total score ranges from 0 to 300. A high score indicates that the pelvic floor symptoms negatively affect quality of life.
pre-intervention; immediately after the intervention
Pelvic Floor Impact Questionnaire-7 to measure the pelvic organ prolapse symptoms related quality of life
Time Frame: pre-intervention; immediately after the intervention
It was used to evaluate the impact of pelvic floor symptoms on quality of life. It consists of 21 questions and three subdimensions: Urinary Impact Questionnaire-7, Colorectal-Anal Impact Questionnaire-7, and Pelvic Organ Prolapse Impact Questionnaire-7. It is calculated by taking the average of each subdimension and multiplying it by 100/3 to convert the score of the scale into a 100-point system. The score of the subdimension ranges from 0 to 100 and the total score ranges from 0 to 300. A high score indicates that the pelvic floor symptoms negatively affect quality of life.
pre-intervention; immediately after the intervention
Pelvic Floor Impact Questionnaire-7 to measure the colorectal-anal symptoms related quality of life
Time Frame: pre-intervention; immediately after the intervention
It was used to evaluate the impact of pelvic floor symptoms on quality of life. It consists of 21 questions and three subdimensions: Urinary Impact Questionnaire-7, Colorectal-Anal Impact Questionnaire-7, and Pelvic Organ Prolapse Impact Questionnaire-7. It is calculated by taking the average of each subdimension and multiplying it by 100/3 to convert the score of the scale into a 100-point system. The score of the subdimension ranges from 0 to 100 and the total score ranges from 0 to 300. A high score indicates that the pelvic floor symptoms negatively affect quality of life.
pre-intervention; immediately after the intervention
Pelvic Floor Impact Questionnaire-7 to measure the urinary symptoms related quality of life
Time Frame: pre-intervention; immediately after the intervention
It was used to evaluate the impact of pelvic floor symptoms on quality of life. It consists of 21 questions and three subdimensions: Urinary Impact Questionnaire-7, Colorectal-Anal Impact Questionnaire-7, and Pelvic Organ Prolapse Impact Questionnaire-7. It is calculated by taking the average of each subdimension and multiplying it by 100/3 to convert the score of the scale into a 100-point system. The score of the subdimension ranges from 0 to 100 and the total score ranges from 0 to 300. A high score indicates that the pelvic floor symptoms negatively affect quality of life.
pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the pre-basal activity of the pelvic floor muscles
Time Frame: pre-intervention; immediately after the intervention
The NeuroTract Myoplus 2 PRO (Verity Medical LTD., UK) brand EMG device was used to evaluate pelvic floor muscle function. EMG activities of the pelvic floor muscles were recorded with disposable 3.2 x 3.2 cm superficial electrodes. Bipolar electrodes were placed on the right and left sides of the perineal body (3-9 o'clock), and the monopolar reference electrode was placed on the right spina iliac anterior superior. Measurements were performed in the supine position during voluntary relaxation and voluntary contraction of the pelvic floor muscles. The Glazer Protocol, which is a valid and reliable method to evaluate pelvic floor muscle function, was used. According to this protocol, Pre-baseline rest activity, phasic activity, tonic activity, endurance activity and post-baseline rest activity of the pelvic floor muscles were evaluated. EMG activities were automatically recorded by the device.
pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the phasic activity of the pelvic floor muscles
Time Frame: pre-intervention; immediately after the intervention
The NeuroTract Myoplus 2 PRO (Verity Medical LTD., UK) brand EMG device was used to evaluate pelvic floor muscle function. EMG activities of the pelvic floor muscles were recorded with disposable 3.2 x 3.2 cm superficial electrodes. Bipolar electrodes were placed on the right and left sides of the perineal body (3-9 o'clock), and the monopolar reference electrode was placed on the right spina iliac anterior superior. Measurements were performed in the supine position during voluntary relaxation and voluntary contraction of the pelvic floor muscles. The Glazer Protocol, which is a valid and reliable method to evaluate pelvic floor muscle function, was used. According to this protocol, Pre-baseline rest activity, phasic activity, tonic activity, endurance activity and post-baseline rest activity of the pelvic floor muscles were evaluated. EMG activities were automatically recorded by the device.
pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the tonic activity of the pelvic floor muscles
Time Frame: pre-intervention; immediately after the intervention
The NeuroTract Myoplus 2 PRO (Verity Medical LTD., UK) brand EMG device was used to evaluate pelvic floor muscle function. EMG activities of the pelvic floor muscles were recorded with disposable 3.2 x 3.2 cm superficial electrodes. Bipolar electrodes were placed on the right and left sides of the perineal body (3-9 o'clock), and the monopolar reference electrode was placed on the right spina iliac anterior superior. Measurements were performed in the supine position during voluntary relaxation and voluntary contraction of the pelvic floor muscles. The Glazer Protocol, which is a valid and reliable method to evaluate pelvic floor muscle function, was used. According to this protocol, Pre-baseline rest activity, phasic activity, tonic activity, endurance activity and post-baseline rest activity of the pelvic floor muscles were evaluated. EMG activities were automatically recorded by the device.
pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the endurance activity of the pelvic floor muscles
Time Frame: pre-intervention; immediately after the intervention
The NeuroTract Myoplus 2 PRO (Verity Medical LTD., UK) brand EMG device was used to evaluate pelvic floor muscle function. EMG activities of the pelvic floor muscles were recorded with disposable 3.2 x 3.2 cm superficial electrodes. Bipolar electrodes were placed on the right and left sides of the perineal body (3-9 o'clock), and the monopolar reference electrode was placed on the right spina iliac anterior superior. Measurements were performed in the supine position during voluntary relaxation and voluntary contraction of the pelvic floor muscles. The Glazer Protocol, which is a valid and reliable method to evaluate pelvic floor muscle function, was used. According to this protocol, Pre-baseline rest activity, phasic activity, tonic activity, endurance activity and post-baseline rest activity of the pelvic floor muscles were evaluated. EMG activities were automatically recorded by the device.
pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the post-baseline rest activity of the pelvic floor muscles
Time Frame: pre-intervention; immediately after the intervention
The NeuroTract Myoplus 2 PRO (Verity Medical LTD., UK) brand EMG device was used to evaluate pelvic floor muscle function. EMG activities of the pelvic floor muscles were recorded with disposable 3.2 x 3.2 cm superficial electrodes. Bipolar electrodes were placed on the right and left sides of the perineal body (3-9 o'clock), and the monopolar reference electrode was placed on the right spina iliac anterior superior. Measurements were performed in the supine position during voluntary relaxation and voluntary contraction of the pelvic floor muscles. The Glazer Protocol, which is a valid and reliable method to evaluate pelvic floor muscle function, was used. According to this protocol, Pre-baseline rest activity, phasic activity, tonic activity, endurance activity and post-baseline rest activity of the pelvic floor muscles were evaluated. EMG activities were automatically recorded by the device.
pre-intervention; immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Tinaztepe University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yeditepe University
Biruni University
Fenerbahce University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Arzu Razak Özdinçler, PT, PhD, Prof., Fenerbahce University
  • Principal Investigator: Damla Korkmaz Dayıcan, PT, PhD (c), İzmir Tınaztepe University
  • Principal Investigator: Burçin Özyürek, PT, PhD (c), Yeditepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T-DAYICAN-002

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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