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

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

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

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Behavioral: iyengar yoga

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74000
      • Ziauddin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise; 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	Behavioral: iyengar yoga; different yoga postures including warm up, cool down and meditation that incorporate 75 minutes of training

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ziauddin University
• Investigators: Principal Investigator: sadia shafaq, Ziauddin University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SadiaS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No