360 Degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence
Comparison of the Effectiveness of Kegel Exercises and 360-degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence
1 other identifier
interventional
66
1 country
1
Brief Summary
The aim of this study is to investigate the effect of transferring the healthy intra-abdominal pressure created by 360 degree expanded diaphragm breathing taught to the patient to the pelvic cavity on incontinence problems.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2023
CompletedFirst Posted
Study publicly available on registry
August 22, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2023
CompletedDecember 22, 2023
December 1, 2023
3 months
August 15, 2023
December 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The incontinence severity index (ISI)
It was developed in epidemiological and clinical studies to identify women with urinary incontinence of varying severity. The questionnaire score is obtained by multiplying the value given to the frequency of urinary incontinence by the value given to the amount of urinary incontinence. The result obtained; classified as mild, moderate, severe, very severe.
10 weeks
Understanding King's Health Questionnaire (KHQ)
The King's Health questionnaire is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. It includes 7 sub-headings consisting of multiple items in addition to two single-item questions such as general health status and impact on quality of life. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). For other areas, scores range from 0 (best) to -100 (worst).
10 weeks
Incontinence Quality of Life Questionnaire (I-QOL)
In the Incontinence Quality of Life Scale (I-QOL), which consists of 22 items, all items are evaluated on a five-category Likert-type scale (1= a lot, 2= a lot, 3= moderately, 4= a little, 5= not at all). The scores of the questionnaire and its subscales are obtained by adding the scores of each item and dividing this total by the number of items. For easier explanation of the scores, the calculated total score is converted to a scale value from 0 (lowest quality of life) to 100 (highest quality of life). High scores indicate better quality of life than low scores.
10 weeks
Study Arms (2)
kegel group
ACTIVE COMPARATORParticipants will only practice kegel exercises.
diaphragm group
EXPERIMENTALIn addition to kegel exercises, 360 degree expanded diaphragm breathing training will be given to the participants.
Interventions
Kegel exercises; It is done by squeezing your pelvic floor muscles for 3 to 5 seconds and relaxing them. Participants are expected to do this exercise in the form of hold-relax 10-15 times each set. Participants are expected to practice Kegel exercises, 2 sets a day, 3 days a week for 8 weeks.
360-degree expanded diaphragm breathing is the delivery of air taken during inspiration to the postero-lateral wall of the abdomen. Breathing in this way ensures that the pressure in the abdomen is distributed equally in all directions. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes.
Eligibility Criteria
You may qualify if:
- Getting a score of 3 and above in the incontinence severity index.
- Be in the age range of 12-65 years.
- No neurological problems.
You may not qualify if:
- Having a history of surgery or childbirth in the last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Üsküdar Unıversıty
Üsküdar, Istanbul, Turkey (Türkiye)
Related Publications (5)
Huang YC, Chang KV. Kegel Exercises. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555898/
PMID: 32310358BACKGROUNDCho ST, Kim KH. Pelvic floor muscle exercise and training for coping with urinary incontinence. J Exerc Rehabil. 2021 Dec 27;17(6):379-387. doi: 10.12965/jer.2142666.333. eCollection 2021 Dec.
PMID: 35036386BACKGROUNDSingla N, Aggarwal H, Foster J, Alhalabi F, Lemack GE, Zimmern PE. Management of Urinary Incontinence Following Suburethral Sling Removal. J Urol. 2017 Sep;198(3):644-649. doi: 10.1016/j.juro.2017.02.3341. Epub 2017 Mar 4.
PMID: 28267602BACKGROUNDSnodgrass W, Barber T. Comparison of bladder outlet procedures without augmentation in children with neurogenic incontinence. J Urol. 2010 Oct;184(4 Suppl):1775-80. doi: 10.1016/j.juro.2010.04.017. Epub 2010 Aug 21.
PMID: 20728128BACKGROUNDAbu Raddaha AH, Nasr EH. Kegel Exercise Training Program among Women with Urinary Incontinence. Healthcare (Basel). 2022 Nov 24;10(12):2359. doi: 10.3390/healthcare10122359.
PMID: 36553882BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Elif AKAR
Uskudar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asst. Prof. Dr.
Study Record Dates
First Submitted
August 15, 2023
First Posted
August 22, 2023
Study Start
September 1, 2023
Primary Completion
November 20, 2023
Study Completion
December 10, 2023
Last Updated
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share