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IRCT20260907070961N1 IRCT 2026-10-23 Shahid Beheshti University of Medical Sciences Comparison of the Effects of Yoga and Transcutaneous Tibial Nerve Stimulation in the Treatment of Women with Urgency Urinary Incontinence Comparison of the Effects of Yoga and Transcutaneous Tibial Nerve Stimulation on Stress, Anxiety, and Depression Levels, Quality of Life, Pelvic Floor Muscle Function, and Urinary Incontinence Symptoms in Women with Urgency Urinary Incontinence 2026-10-12 anticipated 70 Recruiting https://irct.ir/trial/93119 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization sequence was generated by an individual independent of the research team, using the online tool randomization.com, applying block randomization with a block size of 6 and an equal 1:1:1 allocation ratio across the three groups (Yoga therapy, TTNS, Combined). The generated sequence was placed into opaque, sealed, and sequentially numbered envelopes, which were held by a person other than the principal investigator. After baseline assessments confirmed a participant's eligibility, the researcher contacted the envelope custodian, and the next envelope in sequence was opened to reveal the assigned group. In this way, the researcher remained unaware of a participant's group assignment until the moment of definitive enrollment, Blinding description: To minimize assessment bias, pre- and post-intervention measurements were conducted in a separate session from the treatment sessions, with assessment forms coded rather than labeled by group assignment. Participants were also asked to refrain from disclosing their intervention group during assessment. N/A urgency urinary incontinence. Intervention 1: Intervention Group 1:Personalized yoga protocol delivered by a yoga instructor with a physiotherapist present, comprising 5 poses: bridge, warrior, garland (malasana), seated forward bend, and leg raises; aimed at strengthening pelvic floor and lower-limb muscles, and teaching proper breathing and relaxation. Each session lasted 1 hour, 3 times/week, for 12 sessions total, in 25 participants. Intervention 2: Intervention Group 2: Transcutaneous tibial nerve stimulation using an SDZ III stimulator (manufactured 2016) with Nahal adhesive electrodes. The first electrode was placed 3 cm above the medial malleolus and 2 cm posterior on the calf; the second electrode over the calcaneus. Device parameters: 20 Hz frequency, 200 μs pulse duration. Each session lasted 30 minutes, 3 times/week, for 12 sessions total, in 20 participants. Intervention 3: Intervention group 3: Intervention Group 3: Participants received both interventions concurrently — yoga therapy (1 hour) and transcutaneous tibial nerve stimulation (30 minutes), using the same protocols/equipment described above, 3 times/week, for 12 sessions total, in 20 participants. Yes - There is a plan to make this available What will be shared: Title: Raw pre- and post-intervention participant data Details: ICIQ-UI SF, I-QOL, DASS-21, and pelvic floor muscle strength scores for 60 participants across three groups, de-identified When: From publication of the final article, for 5 years To whom: Academic researchers, for research purposes only, with a stated proposal describing intended use Conditions: Research and academic purposes only (non-commercial) Conditions: Submission of a defined research proposal, approval by the corresponding author, and commitment to maintaining participant confidentiality/non-identification Where to obtain: Corresponding author (Dr. Hoda Niknam and PT zohreh rostam dokht effati) via email How to obtain: Email request outlining research purpose and data use plan → review and approval by corresponding author → de-identified data shared with requester Comments:
public Zohreh Rostam Dokht Effati
Mirdamad Blvd., just below Ketabi Square, Derna St., No. 18.
Tehran Iran (Islamic Republic of) 1616913111 +98 915 701 6453 Dpt.z2013@gmail.com Shahid Beheshti University of Medical Sciences scientific Zohreh Rostam Dokht Effati
No. 18, Derna St., just below Ketabi Square, Mirdamad Blvd.
Tehran Iran (Islamic Republic of) 1541754587 +98 915 701 6453 Dpt.z2013@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age range of 25 to 65 years History of urgency urinary incontinence for the past 6 months to 1 year, based on diagnosis by a specialist physician and confirmed with the Urinary Incontinence Symptom Questionnaire No history of regular pelvic floor exercises, pelvic floor physiotherapy, or yoga/yoga therapy during the past 6 months 25 years 65 years Female Pregnancy or intention to become pregnant during the study period Presence of pure stress urinary incontinence (without an urgency component) or predominance of the stress component in mixed incontinence Presence of pelvic organ prolapse of grade 2 or higher based on the POP-Q system A score of zero on pelvic floor muscle contraction strength assessment (inability to perform even a minimally detectable contraction) Cognitive impairments preventing proper understanding and execution of exercise instructions (yoga) or cooperation during TTNS sessions Presence of a cardiac pacemaker or other electrical implants (due to potential interference with the TTNS electrical stimulation device) Inability or unwillingness to attend yoga/TTNS sessions regularly according to the study schedule history of urinary tract infection in the past three months History of surgery in the pelvic, lumbar, or lower-limb region in the past year history of neurological disorders such as multiple sclerosis, stroke, Parkinson’s disease, or diabetic neuropathy, based on patient report history of sensory disorders in the lower limbs such as brain injuries, spinal cord injuries, peripheral nerve injuries, or nerve root involvement N39.41 بی‌اختیاری فوریتی ادراری (Urge incontinence) Treatment - Other Treatment - Other Treatment - Other Intervention Group 1:Personalized yoga protocol delivered by a yoga instructor with a physiotherapist present, comprising 5 poses: bridge, warrior, garland (malasana), seated forward bend, and leg raises; aimed at strengthening pelvic floor and lower-limb muscles, and teaching proper breathing and relaxation. Each session lasted 1 hour, 3 times/week, for 12 sessions total, in 25 participants. Intervention Group 2: Transcutaneous tibial nerve stimulation using an SDZ III stimulator (manufactured 2016) with Nahal adhesive electrodes. The first electrode was placed 3 cm above the medial malleolus and 2 cm posterior on the calf; the second electrode over the calcaneus. Device parameters: 20 Hz frequency, 200 μs pulse duration. Each session lasted 30 minutes, 3 times/week, for 12 sessions total, in 20 participants. Intervention group 3: Intervention Group 3: Participants received both interventions concurrently — yoga therapy (1 hour) and transcutaneous tibial nerve stimulation (30 minutes), using the same protocols/equipment described above, 3 times/week, for 12 sessions total, in 20 participants. Urinary incontinence symptoms (primary outcome). Timepoint: Before and after 12 intervention sessions. Method of measurement: ICIQ-UI SF questionnaire. Quality of life (secondary outcome). Timepoint: Before and after 12 intervention sessions. Method of measurement: I-QOL Questionnaire. Level of stress, anxiety, and depression (secondary outcome). Timepoint: Before and after 12 intervention sessions. Method of measurement: DASS-21 Questionnaire. Pelvic floor muscle contraction strength (secondary outcome). Timepoint: Before and after 12 intervention sessions. Method of measurement: Manual examination using the Modified Oxford scale. Shahid Beheshti University of Medical Sciences Approved 2026-08-29 deputy of research and technology, shahid beheshti university of medical sciences Building No. 2 (University Headquarters), 6th Floor, Arabi Street, Yemen Street, Shahid Chamran Highway, Shahid Beheshti University of Medical Sciences and Health Services, tehran Tehran Iran (Islamic Republic of)