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

NCT ID: NCT05390008

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-01-20

Brief Summary

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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

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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.

Conditions

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Stress Urinary Incontinence Pelvic Floor Disorders Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1: Pelvic Floor Muscle Training

volunteer elderly women with SUI

Group Type EXPERIMENTAL

Pelvic Floor Muscle Training

Intervention Type OTHER

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.

Group 2: Modified Pilates Exercises

volunteer elderly women with SUI

Group Type EXPERIMENTAL

Modified Pilates Exercise

Intervention Type OTHER

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.

Interventions

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Pelvic Floor Muscle Training

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

Modified Pilates Exercise

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Ebru Kaya Mutlu, PT

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ebru Kaya Mutlu

Role: PRINCIPAL_INVESTIGATOR

Istanbul University - Cerrahpasa

Locations

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Darulaceze Directorate of Istanbul

Istanbul, Kayisdagi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33416968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28977091 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25142280 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29329567 (View on PubMed)

Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

Reference Type DERIVED
PMID: 39704322 (View on PubMed)

Other Identifiers

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06/05/2022

Identifier Type: -

Identifier Source: org_study_id

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