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Urinary IncontinenceNCT06003894

360 Degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence

A study testing kegel exercises and 360 degree expanded diaphragmatic breathing training in people with Urinary Incontinence, run by Uskudar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 65 years
Conditions the study is for
Urinary Incontinence
What is being tested?
kegel exercises and 360 degree expanded diaphragmatic breathing training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2023to 10 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Getting a score of 3 and above in the incontinence severity index.
  • Be in the age range of 12-65 years.
  • No neurological problems.

Who cannot join

  • Having a history of surgery or childbirth in the last 3 months.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Üsküdar Unıversıty

    Üsküdar, Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of the Effectiveness of Kegel Exercises and 360-degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence

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.

Read the detailed description

66 people with a score of 3 or higher on the Incontinence Severity Index will be included in the study. All participants will complete the King Health Questionnaire and Incontinence Quality of Life Questionnaires. The control group will consist of 33 people and will apply only Kegel exercises 2 sets a day, 3 days a week for 8 weeks. The experimental group will consist of 33 people and the participants will apply Kegel exercises for 8 weeks, 3 days a week, 2 sets a day. In addition to this, 360 degree expanded diaphragm breathing training will be given to the experimental group. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes. At the end of 8 weeks, all 3 questionnaires will be asked to be filled again. The variation between the initial results and the final results, as well as the differences between the final changes, will also be compared.

Being tested
kegel exercises, 360 degree expanded diaphragmatic breathing training
Keywords
kegel exercises, urinary incontinence, diaphragmatic breathing
Medical subject headings
Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • kegel exercisesOther

    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 diaphragmatic breathing trainingOther

    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.

Study groups in NCT06003894
Study groupRoleWhat they receive
kegel groupActive comparatorParticipants will only practice kegel exercises.
Receives: Other: kegel exercises
diaphragm groupExperimentalIn addition to kegel exercises, 360 degree expanded diaphragm breathing training will be given to the participants.
Receives: Other: kegel exercises; Other: 360 degree expanded diaphragmatic breathing training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 weeks

  2. 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).

    Measured: 10 weeks

  3. 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.

    Measured: 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completion20 Nov 2023
  4. Study completion10 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
360 degree expanded diaphragm breathing
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06003894
Sponsor's protocol ID
Uskudar64
Status last verified
Dec 2023
First submitted
15 Aug 2023
Last updated
22 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang YC, Chang KV. Kegel Exercises. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK555898/

    PubMed 32310358

  • Cho 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.

    PubMed 35036386

  • Singla 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.

    PubMed 28267602

  • Snodgrass 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.

    PubMed 20728128

  • Abu 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.

    PubMed 36553882

Questions about this trial

What is this clinical trial studying?

A study testing kegel exercises and 360 degree expanded diaphragmatic breathing training in people with Urinary Incontinence, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incontinence severity index (ISI) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06003894, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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