An interventional study of Pelvic floor muscle training in Pelvic Floor Disorders, Postpartum Disorder and Quality of Life, sponsored by Izmir Tinaztepe University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by Izmir Tinaztepe University · Not applicable, Interventional, and Treatment
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).
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's enrollment of 58 is close to the median of 63 across 148 interventional studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Izmir Tinaztepe University is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Pelvic Floor Distress Inventory-20 to measure the total pelvic floor symptoms
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.
Time frame: pre-intervention; immediately after the intervention
Pelvic Floor Distress Inventory-20 to measure the pelvic organ prolapse symptoms
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.
Time frame: pre-intervention; immediately after the intervention
Pelvic Floor Distress Inventory-20 to measure the colorectal-anal symptoms
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.
Time frame: pre-intervention; immediately after the intervention
Pelvic Floor Distress Inventory-20 to measure the urinary symptoms
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.
Time frame: pre-intervention; immediately after the intervention
Pelvic Floor Impact Questionnaire-7 to measure the total pelvic floor symptoms related quality of life
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.
Time frame: pre-intervention; immediately after the intervention
Pelvic Floor Impact Questionnaire-7 to measure the pelvic organ prolapse symptoms related quality of life
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.
Time frame: pre-intervention; immediately after the intervention
Pelvic Floor Impact Questionnaire-7 to measure the colorectal-anal symptoms related quality of life
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.
Time frame: pre-intervention; immediately after the intervention
Pelvic Floor Impact Questionnaire-7 to measure the urinary symptoms related quality of life
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.
Time frame: pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the pre-basal activity of the pelvic floor muscles
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.
Time frame: pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the phasic activity of the pelvic floor muscles
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.
Time frame: pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the tonic activity of the pelvic floor muscles
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.
Time frame: pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the endurance activity of the pelvic floor muscles
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.
Time frame: pre-intervention; immediately after the intervention
Surface electromyography (EMG) to measure the post-baseline rest activity of the pelvic floor muscles
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.
Time frame: pre-intervention; immediately after the intervention
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Izmir Tinaztepe University