Clinical trial NCT04428853: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Ziauddin University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 44
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: pelvic muscle strength (Pre treatment)
timeFrame: baseline
measure: pelvic muscle strength (Post treatment)
timeFrame: 4th week after intervention
measure: pelvic muscle strength (Post treatment)
timeFrame: 8th week after intervention
measure: quantity of urine leakage (Pre treatment)
timeFrame: baseline
measure: quantity of urine leakage (Post treatment)
timeFrame: 4th week after intervention
measure: quantity of urine leakage (Post treatment)
timeFrame: 8th week after intervention
measure: Quality of life (Pre treatment)
timeFrame: baseline
measure: Quality of life (Post treatment)
timeFrame: 4th week after intervention
measure: Quality of life (Post treatment)
timeFrame: 8th week after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ziauddin university
state: Sindh
Study officials:
affiliation: Ziauddin University
name: sadia shafaq
role: PRINCIPAL_INVESTIGATOR
References: