Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2020-07-20
2021-01-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Two Different Pelvic Floor Muscle Training Programs in Stress Urinary Incontinence
NCT05293886
Dynamic Neuromuscular Stabilization vs Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
NCT07075900
Comparison of Stabilization Exercises and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence
NCT05193435
360 Degree Expanded Diaphragm Exercises in Women With Stress Urinary Incontinence
NCT06120699
The Effects of Vaginal Tampon Training Added to Pelvic Floor Muscle Training in Stress Urinary Incontinence
NCT02924740
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1: Pelvic Floor Muscle Training
volunteer elderly women with SUI
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.
Group 2: Modified Pilates Exercises
volunteer elderly women with SUI
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Istanbul University - Cerrahpasa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ebru Kaya Mutlu, PT
Assoc. Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ebru Kaya Mutlu
Role: PRINCIPAL_INVESTIGATOR
Istanbul University - Cerrahpasa
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Darulaceze Directorate of Istanbul
Istanbul, Kayisdagi, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06/05/2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.