Clinical trial NCT05390008: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Pelvic Floor Disorders
Aging
Keywords: aging
exercise
pelvic floor
urinary incontinence
women
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SUI frequency change - Incontinence Severity Index (ISI)
timeFrame: SUI frequency was assessed by Incontinence Severity Index (ISI) at before and after 12 weeks of treatment
measure: SUI frequency and explosure from symptoms change - Urogenital Distress Inventory-Short Form (UDI-6)
timeFrame: SUI frequency and explosure from symptoms was assessed by Urogenital Distress Inventory-Short Form (UDI-6) at before and after 12 weeks of treatment
measure: SUI frequency and explosure from symptoms change - Incontinence Impact Questionnaire-Short Form (IIQ-7)
timeFrame: SUI frequency and explosure from symptoms was assessed by Incontinence Impact Questionnaire-Short Form (IIQ-7) at before and after 12 weeks of treatment
measure: PFM activation change - MyoPlus4Puro-EMG device
timeFrame: PFM activation was assessed by MyoPlus4Puro-EMG device at before and after 12 weeks of treatment
measure: Strength of lumbar stabilizing muscle change - Stabilizer Pressure Biofeedback
timeFrame: Strength of lumbar stabilizing muscle was assessed by stabilizer at before and after 12 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Darulaceze Directorate of Istanbul
state: Kayisdagi
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ebru Kaya Mutlu
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.