The Effects of PFMT and MPE in Elderly Women With SUI.
Primary Purpose
Stress Urinary Incontinence, Pelvic Floor Disorders, Aging
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pelvic Floor Muscle Training
Modified Pilates Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence focused on measuring aging, exercise, pelvic floor, urinary incontinence, women
Eligibility Criteria
Inclusion Criteria:
- being volunteer to participate in a study;
- being a woman over the age of 65;
- having the diagnosis of SUI;
- participants who scored at least 24 on the Mini Mental State Exam (MMSE).
Exclusion Criteria:
- having a neurological disease;
- having PFM which cannot contract;
- having a urinary tract infection;
- having the stage two or higher pelvic organ prolapse; and
- participants who received a SUI treatment in the recent year.
Sites / Locations
- Darulaceze Directorate of Istanbul
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1: Pelvic Floor Muscle Training
Group 2: Modified Pilates Exercises
Arm Description
volunteer elderly women with SUI
volunteer elderly women with SUI
Outcomes
Primary Outcome Measures
SUI frequency change - Incontinence Severity Index (ISI)
Incontinence Severity Index (ISI) was used to determine the UI frequency of the participants. This test consisted of two questions, regarding frequency and amount of leakage. Incontinence severity was determined by multiplying assigned values of two questions' responses. By taking into account the results, urine leakage was identified according to the following scale; 1-2 as 'slight', 3-4 as 'moderate', 8-9 as 'severe', 12 as 'very severe'.
SUI frequency and explosure from symptoms change - Urogenital Distress Inventory-Short Form (UDI-6)
Urogenital Distress Inventory-Short Form (UDI-6) questionnaire was used to measure the participants' exposure to incontinence symptoms. In this form consisting of 6 questions, each question takes values in the range of 0-4. Then, the total value is converted to values ranging from 0-100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely disturbed by this symptom.
SUI frequency and explosure from symptoms change - Incontinence Impact Questionnaire-Short Form (IIQ-7)
Incontinence Impact Questionnaire-Short Form (IIQ-7) was used to determine the extent to which urinary symptoms affect the participants' activities of daily living, social relationships and psychological states. This form included 7 questions and each question was assigned a value from 0 to 3. Then, the total value is converted to values ranging from 0-100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely disturbed by this symptom.
PFM activation change - MyoPlus4Puro-EMG device
MyoPlus4Puro-EMG device was used to determined the participants' PFM activation. The measurement was performed while subjects' knees were positioned at 140° of flexion with soles in the bed and there was a 30 cm gap between the feet. Active electrodes were placed on the right and left side of the perineal body. Passive electrode was located in front of the femoral. The length of contraction lasted five seconds and resting lasted five seconds, too. Five repeated contractions with a five second pause between each contraction were performed in total and the measurement lasted 50 seconds. However, in order for the contraction to be only in the pelvic floor muscles, before the measurement, the subjects were told how to perform the correct pelvic floor contraction without contracting the abdominal, hip and thigh muscles and without holding the breath.
Strength of lumbar stabilizing muscle change - Stabilizer Pressure Biofeedback
Stabilizer Pressure Biofeedback device was used to determine the strength of lumbar stabilizing muscle. Subjects were asked to be in the face-down position and the pillow was located in the abdominal region. The bottom edge of the pillow was placed in paralel with crista iliaca. Meanwhile, subjects' knees were in flat position, arms were by their side and their head was in a relaxed position. After the manometric pressure was adjusted to 70 mmHg, participant was asked to slowly contract his/her transversus abdominis (TrA) muscle. That's why, subject was instructed by saying 'suck your belly in'. The decrease of pressure value increases in direct proportion to the to the magnitude of the stabilization force. Three tests were completed in total and the average value was calculated.
Secondary Outcome Measures
Full Information
NCT ID
NCT05390008
First Posted
May 18, 2022
Last Updated
May 21, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05390008
Brief Title
The Effects of PFMT and MPE in Elderly Women With SUI.
Official Title
The Effects of Pelvic Floor Muscle Training and Modified Pilates Exercises in Elderly Women With Stress Urinary Incontinence
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
October 20, 2020 (Actual)
Study Completion Date
January 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
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 aim of the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI.
Detailed Description
Stress Urinary Incontinence (SUI) is associated with situations which bladder pressure exceeds the pressure at which the urethra has the capacity to remain closed, such as physical exertion, coughing, and sneezing. SUI is more predominant in women worldwide, with a prevalence ranging from 10% in young women to 45% in the elderly. Physiotherapy interventions in SUI include patient education including recommendations for bladder and/or bowel training, fluid management, and diet modification; modalities for decrease pain; pelvic floor muscle training (PFMT) with or without biofeedback and/or electrical stimulation to improve strength and coordination of the pelvic floor muscle (PFM) and stabilization exercises to improve strength of abdominal and/or lumbar stabilizer muscles.
PFMT includes repetitive contraction of the PFM, which increases perineal support and improves the muscle tone of the PFM. Modified pilates exercises (MPE) is a mind-body approach that includes slow, controlled movements that focus on posture and breathing.
The aim of the study was to compare the effects of PFMT and MPE on SUI frequency and explosure from symptoms, PFM activation response and strength of lumbar stabilizing muscle in elderly women with SUI. In this study, thirty-four elderly women who were diagnosed with SUI were randomized into Group 1: PFMT (n=17) or Group 2: MPE (n=17). Both groups performed their exercises twice a week for 12 weeks and accompanied by a physiotherapist. Incontinence Severity Index (ISI), Urogenital Distress Inventory-Short Form (UDI-6) and Incontinence Impact Questionnaire-Short Form (IIQ-7) were used to assess SUI frequency and explosure from symptoms, electromyography (EMG) device was used to assess PFM activation response and a stabilizer was used to assess strength of lumbar stabilizing muscle. The assessments were performed at baseline and after 12 week treatment. The effect size was calculated for the assessments used in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Pelvic Floor Disorders, Aging
Keywords
aging, exercise, pelvic floor, urinary incontinence, women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Pelvic Floor Muscle Training
Arm Type
Experimental
Arm Description
volunteer elderly women with SUI
Arm Title
Group 2: Modified Pilates Exercises
Arm Type
Experimental
Arm Description
volunteer elderly women with SUI
Intervention Type
Other
Intervention Name(s)
Pelvic Floor Muscle Training
Intervention Description
In order to increase participants' PFM strength and endurance , PFMT was taught two days a week for 12 weeks. This training included two type of exercises that consisted of fast and slow PFM contractions.
Fast Contractions: This exercise was done in sitting position, While participants' arms were on thighs with their feet resting on the floor and sitting unsupported on the back of their seat. They were taught how to quickly contract and relax their PFM.
Slow Contractions: The practice position of this exercise was in sitting position as it happened in fast contraction. This training lasted for 12 weeks and it was divided into periods as 1-3 week, 4-6 week, 7-9 week, 10-12 week. In the forth coming weeks of this period, the number of exercise repetitions and the number of sets were increased.
Intervention Type
Other
Intervention Name(s)
Modified Pilates Exercise
Intervention Description
Before starting the 12-week practice protocol, the concept of stabilization was explained to the participants. Participants were taught how to control the core region by using the stabilizer device and the basic principles of pilates. The exercise program was planned that would last 50 minutes. This program was carried out as three-stage and these stages were warm-up phase, main exercise program and cool down phase. The allocated times for the warm-up phase was 10 minutes. The allocated time for the main exercise program was 30 minutes and active resting was done by performing breathing exercises in the 15th minute of the main exercise program. The allocated time for the cool down phase was 10 minutes. Each exercise was done as 10 repetitions then the next exercise was started.
The exercises of the second 6 weeks were performed by adding a red elastic exercise band at the beginner-intermediate level, which released 1.7 kg force with 100% stretching.
Primary Outcome Measure Information:
Title
SUI frequency change - Incontinence Severity Index (ISI)
Description
Incontinence Severity Index (ISI) was used to determine the UI frequency of the participants. This test consisted of two questions, regarding frequency and amount of leakage. Incontinence severity was determined by multiplying assigned values of two questions' responses. By taking into account the results, urine leakage was identified according to the following scale; 1-2 as 'slight', 3-4 as 'moderate', 8-9 as 'severe', 12 as 'very severe'.
Time Frame
SUI frequency was assessed by Incontinence Severity Index (ISI) at before and after 12 weeks of treatment
Title
SUI frequency and explosure from symptoms change - Urogenital Distress Inventory-Short Form (UDI-6)
Description
Urogenital Distress Inventory-Short Form (UDI-6) questionnaire was used to measure the participants' exposure to incontinence symptoms. In this form consisting of 6 questions, each question takes values in the range of 0-4. Then, the total value is converted to values ranging from 0-100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely disturbed by this symptom.
Time Frame
SUI frequency and explosure from symptoms was assessed by Urogenital Distress Inventory-Short Form (UDI-6) at before and after 12 weeks of treatment
Title
SUI frequency and explosure from symptoms change - Incontinence Impact Questionnaire-Short Form (IIQ-7)
Description
Incontinence Impact Questionnaire-Short Form (IIQ-7) was used to determine the extent to which urinary symptoms affect the participants' activities of daily living, social relationships and psychological states. This form included 7 questions and each question was assigned a value from 0 to 3. Then, the total value is converted to values ranging from 0-100. A score of 0 indicates that the patient is not bothered at all, while a score of 100 indicates that the patient is extremely disturbed by this symptom.
Time Frame
SUI frequency and explosure from symptoms was assessed by Incontinence Impact Questionnaire-Short Form (IIQ-7) at before and after 12 weeks of treatment
Title
PFM activation change - MyoPlus4Puro-EMG device
Description
MyoPlus4Puro-EMG device was used to determined the participants' PFM activation. The measurement was performed while subjects' knees were positioned at 140° of flexion with soles in the bed and there was a 30 cm gap between the feet. Active electrodes were placed on the right and left side of the perineal body. Passive electrode was located in front of the femoral. The length of contraction lasted five seconds and resting lasted five seconds, too. Five repeated contractions with a five second pause between each contraction were performed in total and the measurement lasted 50 seconds. However, in order for the contraction to be only in the pelvic floor muscles, before the measurement, the subjects were told how to perform the correct pelvic floor contraction without contracting the abdominal, hip and thigh muscles and without holding the breath.
Time Frame
PFM activation was assessed by MyoPlus4Puro-EMG device at before and after 12 weeks of treatment
Title
Strength of lumbar stabilizing muscle change - Stabilizer Pressure Biofeedback
Description
Stabilizer Pressure Biofeedback device was used to determine the strength of lumbar stabilizing muscle. Subjects were asked to be in the face-down position and the pillow was located in the abdominal region. The bottom edge of the pillow was placed in paralel with crista iliaca. Meanwhile, subjects' knees were in flat position, arms were by their side and their head was in a relaxed position. After the manometric pressure was adjusted to 70 mmHg, participant was asked to slowly contract his/her transversus abdominis (TrA) muscle. That's why, subject was instructed by saying 'suck your belly in'. The decrease of pressure value increases in direct proportion to the to the magnitude of the stabilization force. Three tests were completed in total and the average value was calculated.
Time Frame
Strength of lumbar stabilizing muscle was assessed by stabilizer at before and after 12 weeks of treatment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Elderly women
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
being volunteer to participate in a study;
being a woman over the age of 65;
having the diagnosis of SUI;
participants who scored at least 24 on the Mini Mental State Exam (MMSE).
Exclusion Criteria:
having a neurological disease;
having PFM which cannot contract;
having a urinary tract infection;
having the stage two or higher pelvic organ prolapse; and
participants who received a SUI treatment in the recent year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ebru Kaya Mutlu
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Darulaceze Directorate of Istanbul
City
Istanbul
State/Province
Kayisdagi
ZIP/Postal Code
34755
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33416968
Citation
Falah-Hassani K, Reeves J, Shiri R, Hickling D, McLean L. The pathophysiology of stress urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2021 Mar;32(3):501-552. doi: 10.1007/s00192-020-04622-9. Epub 2021 Jan 8. Erratum In: Int Urogynecol J. 2021 Jun;32(6):1607.
Results Reference
background
PubMed Identifier
28977091
Citation
Oliveira M, Ferreira M, Azevedo MJ, Firmino-Machado J, Santos PC. Pelvic floor muscle training protocol for stress urinary incontinence in women: A systematic review. Rev Assoc Med Bras (1992). 2017 Jul;63(7):642-650. doi: 10.1590/1806-9282.63.07.642.
Results Reference
background
PubMed Identifier
25142280
Citation
Celiker Tosun O, Kaya Mutlu E, Ergenoglu AM, Yeniel AO, Tosun G, Malkoc M, Askar N, Itil IM. Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):525-37. doi: 10.1177/0269215514546768. Epub 2014 Aug 20.
Results Reference
background
PubMed Identifier
29329567
Citation
Lausen A, Marsland L, Head S, Jackson J, Lausen B. Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a mixed methods pilot for a randomised controlled trial. BMC Womens Health. 2018 Jan 12;18(1):16. doi: 10.1186/s12905-017-0503-y.
Results Reference
background
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The Effects of PFMT and MPE in Elderly Women With SUI.
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