Effects of Iyengar Yoga Therapy in the Management of Stress Urinary Incontinence Among Young Females

Stress Urinary Incontinence Clinical Trial

Official title:

Effects of Iyengar Yoga Therapy in the Management of Stress Urinary Incontinence Among

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04428853
• Other study ID #: SadiaS
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2020
• Source: Ziauddin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 30, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Behavioral:
• iyengar yoga
different yoga postures including warm up, cool down and meditation that incorporate 75 minutes of training

Locations

Country	Name	City	State
Pakistan	Ziauddin university	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Ziauddin University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pelvic muscle strength (Pre treatment)	Perineometer is used to to assess pelvic muscle strength	baseline
Primary	pelvic muscle strength (Post treatment)	Perineometer is used to to assess pelvic muscle strength	4th week after intervention
Primary	pelvic muscle strength (Post treatment)	Perineometer is used to to assess pelvic muscle strength	8th week after intervention
Primary	quantity of urine leakage (Pre treatment)	1-hour pad test is used to measure the quantity of urine leakage	baseline
Primary	quantity of urine leakage (Post treatment)	1-hour pad test is used to measure the quantity of urine leakage	4th week after intervention
Primary	quantity of urine leakage (Post treatment)	1-hour pad test is used to measure the quantity of urine leakage	8th week after intervention
Primary	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	baseline
Primary	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	4th week after intervention
Primary	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	8th week after intervention