Effectiveness of Yoga as an Adjuvant Therapy on Lower Urinary Tract Symptoms and Quality of Life among Older Adults with Benign Prostatic Hyperplasia: A Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- At the end of three months to see change in IPSS
Overview
Brief Summary
This study is a randomized controlled trial evaluating the effectiveness of yoga as an adjuvant therapy in older adults with Benign Prostatic Hyperplasia (BPH). The study aims to assess the impact of yoga on Lower Urinary Tract Symptoms (LUTS) and Quality of Life (QoL).
Participants aged 60 years and above, diagnosed with BPH and mild-to-moderate LUTS, will be randomly allocated into two groups using computer-generated randomization (1:1 ratio). The intervention group will receive standard medication along with yoga therapy, while the control group will receive only standard medication. Yoga sessions will be conducted for 90 days, and adherence will be monitored.
Primary outcomes include changes in IPSS scores and QoL measures, while secondary outcomes will assess adherence and any adverse events.
This study follows ethical guidelines, and informed consent will be obtained from all participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Investigator Blinded
Eligibility Criteria
- Ages
- 60.00 Year(s) to 90.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •Patients of age above 60 years
- •Patients with LUTS with Mild and Moderate scores as per International Prostate Symptom Score) IPSS.
- •Patients having Robust and Pre-frail scores as per Fried Frailty Scale
- •Patients must have a confirmed diagnosis of BPH, based on clinical evaluation, medical history, and/or diagnostic tests such as digital rectal examination, uroflowmetry, prostate-specific antigen levels, and ultrasonography.
- •Patients must be physically capable of participating in yoga sessions, including the ability to perform basic physical movements and tolerate moderate physical exertion
- •Patients willing to participate in the study by attending 75 percent of yoga sessions and comply with study assessments
- •Not practising any structured yoga for last 6 months.
Exclusion Criteria
- •Patients with severe medical conditions that may significantly impact their ability to participate in the yoga intervention such as uncontrolled cardiovascular disease, severe musculoskeletal disorders
- •Patients who have undergone recent surgical procedures related to BPH management, such as transurethral resection of the prostate prostatectomy
- •Patients with active urinary tract infections may influence urinary symptoms or require immediate medical treatment should be excluded until the infection is resolved
- •Patients with neurological illness like spinal cord injury, progressive neurodegenerative disease
- •Patients with cognitive impairment may impair their ability to understand and comply with the study
- •Patients with vesical calculi, recurrent UTI, obstructive uropathy, high post void residual urine volume, raised serum PSA.
Outcomes
Primary Outcomes
At the end of three months to see change in IPSS
Time Frame: 3 months
Secondary Outcomes
- 1.Improvement in quality of life after three months of yoga therapy(2.Assess changes in LUTS severity following a structured yoga intervention.)
Investigators
Arun Sankar M
ALL INDIA INSTITUTE OF MEDICAL SCIENCES