NCT06054724

Brief Summary

The aim of the study is to examine and compare the effects of yoga-based and pilates-based respiratory training on incontinence severity, pelvic floor muscle function and quality of life in the rehabilitation of individuals with urinary incontinence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

August 7, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

October 10, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

September 19, 2023

Last Update Submit

October 8, 2024

Conditions

Keywords

urinary incontinenceyogapilatesrespiratory training

Outcome Measures

Primary Outcomes (5)

  • International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)

    International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is used to measure the severity of incontinence. This form includes questions about the frequency and amount of urinary incontinence, its effect on daily life and the causes of urinary incontinence, and an evaluation is made for the last 4 weeks. It is calculated by summing the scores of the 3 dimensions in the test, and a result in the range of 0-21 points is obtained.

    baseline and post-intervention (7th week)

  • 24-Hour Pad Test

    24-hour pad test The 24-Hour Pad Test is an objective evaluation method used to determine the severity of urinary incontinence. Patients are asked to start the test with an empty bladder. It is requested that the used pad should be changed every 4-6 hours and kept in a locked bag until it is taken to the hospital. Patients use the same type of pad throughout the test and are asked to bring an unused pad of the same type when coming to the hospital. The amount of urinary incontinence is calculated by subtracting the weight of the clean pad from the weight of the pads accumulated within 24 hours. It is classified as 4-20 g mild, 21-74 g moderate, \>75 g severe urinary incontinence.

    baseline and post-intervention (7th week)

  • PFM Function- MyoPlusPro EMG Device

    Pelvic floor muscle function will be evaluated with electromyographic measurement (EMG). Before the test, participants will be asked to empty their bladders and will be taught to contract and relax the isolated pelvic floor muscle. Surface active electrodes will be placed to the right and left of the perineal body, and they will be asked to make 5 maximal contractions and 5 relaxations, and the obtained values will be recorded in μV.

    baseline and post-intervention (7th week)

  • Incontinence Quality of Life Questionnaire (I-QOL)

    Incontinence Quality of Life Questionnaire (I-QOL) includes questions that examine limitation of behavior, psychosocial influence and social isolation. Questions are scored between 1 and 5, and high scores indicate good quality of life.

    baseline and post-intervention (7th week)

  • Incontinence Impact Questionnaire Short Form (IIQ-7)

    The Incontinence Impact Questionnaire (IIQ-7) is used to measure the impact of urinary incontinence on individuals' daily and social lives and participation. The survey contains 7 questions, each question is scored between 1 and 4. High scores indicate negative impact.

    baseline and post-intervention (7th week)

Secondary Outcomes (2)

  • Core Muscle Endurance Assessment

    baseline and post-intervention (7th week)

  • Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) assessment

    baseline and post-intervention (7th week)

Study Arms (2)

Yoga-based Respiration Group

EXPERIMENTAL

This group will be given yoga-based breathing exercises

Other: Yoga-Based Respiration Training

Pilates-based Respiration Group

EXPERIMENTAL

This group will be given pilates-based breathing exercises

Other: Pilates-Based Respiration Training

Interventions

The selected asanas, believed to be beneficial for urinary incontinence, will be practiced with a focus on breath. After the assessment session, participants will engage in three days of face-to-face yoga sessions. On the days when face-to-face sessions are held, participants will perform the second session on their own at home. The exercises will be progressively intensified during the 3rd and 5th weeks to ensure progression. The exercise program will be conducted at home, with approximately 20-minute sessions, twice a day, five days a week, for a total of 6 weeks.

Yoga-based Respiration Group

Before starting the 6-week practice protocol, participants will be taught the transversus abdominis muscle activation and centering, pilates-specific lateral costal breathing and other key elements of pilates. Pilates exercises chosen as beneficial for urinary incontinence will be performed with a focus on breath. After the assessment session, participants will engage in three days of face-to-face pilates sessions. On the days when face-to-face sessions are held, participants will perform the second session on their own at home. The exercises will be progressively intensified during the 3rd and 5th weeks to ensure progression. The exercise program will be conducted at home, with approximately 20-minute sessions, twice a day, five days a week, for a total of 6 weeks.

Pilates-based Respiration Group

Eligibility Criteria

Age25 Years - 65 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having the diagnosis of stress or mixed urinary incontinence.
  • Being volunteer to participate in the study.
  • Having planned routine treatment program and being compliant with treatment
  • Having no obstacles for the planned assessments.
  • People who capable of written, verbal and visual communication

You may not qualify if:

  • Having received treatment for urinary incontinence in the last 3 months.
  • Using medication for vaginal or urinary tract infections.
  • Pregnancy.
  • Being within the first 3 years postpartum.
  • Presence of concurrent pulmonary, neurological, rheumatological, or musculoskeletal disorders affecting spinal alignment.
  • History of surgery that may impede the exercise planned within the scope of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Basaksehir, Turkey (Türkiye)

Location

Istanbul University-Cerrahpasa

Istanbul, Buyukcekmece, 34500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sevval Z Girit

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR
  • Ipek Yeldan, Prof.

    Istanbul University - Cerrahpasa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

September 19, 2023

First Posted

September 26, 2023

Study Start

August 7, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

October 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations