Effects of Iyengar Yoga Therapy in the Management of Stress Urinary Incontinence Among Young Females
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
iyengar yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Married Females of age 17-40 year
- Diagnosed Cases of Stress Urinary Incontinence due to pelvic floor muscle weakness
Exclusion Criteria:
- Current Urinary Tract Infection (UTI) or hematuria
- Pregnancy
- On pharmacological treatment of SUI
- Any red flags
Sites / Locations
- Ziauddin university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
exercise
Arm Description
A schedule has designed by the researcher for group yoga therapy of the participant twice a week, each session lasting for 75- minutes for the duration of 8 weeks
Outcomes
Primary Outcome Measures
pelvic muscle strength (Pre treatment)
Perineometer is used to to assess pelvic muscle strength
pelvic muscle strength (Post treatment)
Perineometer is used to to assess pelvic muscle strength
pelvic muscle strength (Post treatment)
Perineometer is used to to assess pelvic muscle strength
quantity of urine leakage (Pre treatment)
1-hour pad test is used to measure the quantity of urine leakage
quantity of urine leakage (Post treatment)
1-hour pad test is used to measure the quantity of urine leakage
quantity of urine leakage (Post treatment)
1-hour pad test is used to measure the quantity of urine leakage
Quality of life (Pre treatment)
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
Quality of life (Post treatment)
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
Quality of life (Post treatment)
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04428853
Brief Title
Effects of Iyengar Yoga Therapy in the Management of Stress Urinary Incontinence Among Young Females
Official Title
Effects of Iyengar Yoga Therapy in the Management of Stress Urinary Incontinence Among
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziauddin University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
the study is aimed to identify the feasibility, safety, and efficacy of iyengar Yoga therapy in the management of stress urinary incontinence among young female
Detailed Description
A total of 44 young female participants will be recruited in this study after signing a written consent. Participants will be attending a 1 hour orientation session prior to yoga therapy providing a general introduction that includes principles, effectiveness and use of props in Iyengar yoga. A schedule will be design by the researcher for group yoga therapy of the participant twice a week, each session lasting for 75- minutes for the duration of 8 weeks by a certified yoga instructor and an assistant. Participants will also instruct to practice yoga at home for 1 additional day per week and to record the dates and duration of practice at home. A manual will be given to the participants with written descriptions in both English and Urdu with pictures portraying each of the key yoga postures performed in the classes. Tips on how to practice each posture safely and comfortably and how to adapt each posture to improve incontinence and pelvic floor function will also be provided in the manual.
Protocols for Yoga Group:
The protocols for Iyengar yoga Therapy will be based on 2 days supervised group yoga classes with an additional 1 day of home yoga performed per week for 8-weeks. Each session will be performed for 75 minutes. This protocol will include 5 phases 1) warm up 2) Pranayamas 3) Active Phase 4) Restorative Phase 5) Meditation.
Warm up:
Warm up will be performed with slow movement combined with breathing for 10 minutes in order to increase core body temperature, lubrication of joint, make connection of mind body spirit and improve blood circulation. Four different postures that will be performed by the participants under the supervision of certified yoga therapist includes cat/cow, wag the tail, thoracic rotation and rock backs. Each posture will be repeated with 5-10 breaths (Miller, 2017).
Pranayamas:
This phase will be consisted of 2 kinds of breathing patterns including Bhramari breathing. This will be performed 5 times with the hold of 10 seconds and Nadi Shodhana breathing. This will be repeated 10 times with the hold of 10 seconds.
Active Phase:
Active phase will be focused on 12 Asanas that are performed in Standing, Sitting and supine positions, directly addressing pelvic floor muscles. In standing postures, Trikonasana, Parsvokonasana, Tadasana, Parsvottasana, Virabhadrasana II, Utkatasana whereas, In Sitting postures, Bharadvajasana, Malasana, Baddha Konasana, and In Supine postures participants will instruct to perform Supta Padagushthasana, Supta Baddha Konasana, Salamba Set Bandhasana.
All of the Asanas will be performed with 5 repetitions. Participants will be maintaining each position for the duration of 15 seconds whereas; intermittent rest of 30 seconds will be given between each yoga posture.
Restorative Phase:
This phase will be focused on postures that rejuvenate the body, mind and spirit while reducing stress and tension of the body. It consists of two postures Viparita Karani Variation and Savasana. Participants must stay in each posture for 4-5 minutes. Meditation:
Meditation guided by breath and mind awareness of the whole body for 10 minutes with calm music.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
exercise
Arm Type
Experimental
Arm Description
A schedule has designed by the researcher for group yoga therapy of the participant twice a week, each session lasting for 75- minutes for the duration of 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
iyengar yoga
Intervention Description
different yoga postures including warm up, cool down and meditation that incorporate 75 minutes of training
Primary Outcome Measure Information:
Title
pelvic muscle strength (Pre treatment)
Description
Perineometer is used to to assess pelvic muscle strength
Time Frame
baseline
Title
pelvic muscle strength (Post treatment)
Description
Perineometer is used to to assess pelvic muscle strength
Time Frame
4th week after intervention
Title
pelvic muscle strength (Post treatment)
Description
Perineometer is used to to assess pelvic muscle strength
Time Frame
8th week after intervention
Title
quantity of urine leakage (Pre treatment)
Description
1-hour pad test is used to measure the quantity of urine leakage
Time Frame
baseline
Title
quantity of urine leakage (Post treatment)
Description
1-hour pad test is used to measure the quantity of urine leakage
Time Frame
4th week after intervention
Title
quantity of urine leakage (Post treatment)
Description
1-hour pad test is used to measure the quantity of urine leakage
Time Frame
8th week after intervention
Title
Quality of life (Pre treatment)
Description
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
Time Frame
baseline
Title
Quality of life (Post treatment)
Description
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
Time Frame
4th week after intervention
Title
Quality of life (Post treatment)
Description
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
Time Frame
8th week after intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Married Females of age 17-40 year
Diagnosed Cases of Stress Urinary Incontinence due to pelvic floor muscle weakness
Exclusion Criteria:
Current Urinary Tract Infection (UTI) or hematuria
Pregnancy
On pharmacological treatment of SUI
Any red flags
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sadia shafaq
Organizational Affiliation
Ziauddin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ziauddin university
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Iyengar Yoga Therapy in the Management of Stress Urinary Incontinence Among Young Females
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