The Effects of PFMT and MPE in Elderly Women With SUI.

Not Applicable

Completed

• Conditions: Pelvic Floor Disorders; Aging; Stress Urinary Incontinence
• Interventions: Other: Pelvic Floor Muscle Training; Other: Modified Pilates Exercise

• Registration Number: NCT05390008
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Study Timeline

• Study Start: 2020-07-20
• Primary Completion: 2020-10-20
• Study Completion: 2021-01-20
• Status Verified: 2022-05
• Study First Submitted: 2022-05-18
• Study First Submitted QC: 2022-05-21
• Last Update Submitted: 2022-05-21
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. being volunteer to participate in a study;
2. being a woman over the age of 65;
3. having the diagnosis of SUI;
4. participants who scored at least 24 on the Mini Mental State Exam (MMSE).

Exclusion Criteria

1. having a neurological disease;
2. having PFM which cannot contract;
3. having a urinary tract infection;
4. having the stage two or higher pelvic organ prolapse; and
5. participants who received a SUI treatment in the recent year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Pelvic Floor Muscle Training	Pelvic Floor Muscle Training	volunteer elderly women with SUI
Group 2: Modified Pilates Exercises	Modified Pilates Exercise	volunteer elderly women with SUI

Primary Outcome Measures

Name	Time	Method
SUI frequency change - Incontinence Severity Index (ISI)	SUI frequency was assessed by Incontinence Severity Index (ISI) at before and after 12 weeks of treatment	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)	SUI frequency and explosure from symptoms was assessed by Urogenital Distress Inventory-Short Form (UDI-6) at before and after 12 weeks of treatment	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)	SUI frequency and explosure from symptoms was assessed by Incontinence Impact Questionnaire-Short Form (IIQ-7) at before and after 12 weeks of treatment	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	PFM activation was assessed by MyoPlus4Puro-EMG device at before and after 12 weeks of treatment	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	Strength of lumbar stabilizing muscle was assessed by stabilizer at before and after 12 weeks of treatment	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.

Trial Locations

Locations (1)

Darulaceze Directorate of Istanbul; 🇹🇷 Istanbul, Kayisdagi, Turkey