About this trial
The aim of this study is to compare the combined effects of Paula method \& tibial nerve stimulation on incontinence, pelvic floor muscles strength, sexual function and quality of life in stress urinary incontinence
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Multiparous women (≥2 full-term vaginal deliveries)
Clinical diagnosis of stress urinary incontinence (confirmed by cough stress test)
Duration of symptoms ≥3 months
Ability to correctly perform pelvic floor contractions (confirmed by digital examination)
Disqualifiers
Neurological disorders (e.g., multiple sclerosis, spinal cord injury)
Mixed or urge urinary incontinence as the predominant type
Previous pelvic surgery or incontinence-related procedures within the past year
Current pregnancy or <6 months postpartum
Trial design
Parallel
Treatments tested in this trial
Paula Exercises
Other intervention* Frequency: 2 sessions per week * Session Duration: 20 minutes * Repeated voluntary contractions of eye muscles (e.g., squinting) and mouth muscles (e.g., puckering lips), abdominal contractions followed by pelvic contractions. * Controlled breathing and postural awareness * Each type of contraction repeated 10-15 times per session * 30-second rest between sets, total 20 sets * Duration:8 weeks
Tibial Nerve Stimulation
Other intervention* Frequency: 20 Hz * Pulse Width: 200 microseconds * Intensity: Adjusted to elicit mild toe flexion ,0 to 10 mA * Session Duration: 20 minutes * Frequency: 2 sessions per week * Total Duration:8 weeks
Treatment groups
Trial outcomes
Primary outcomes
Incontinence Impact Questionnaire IIQ 7:
The Incontinence Impact Questionnaire (IIQ-7) is a brief, 7-item instrument used to assess the impact of urinary incontinence on a woman's quality of life.
Modified Oxford Scale
The Modified Oxford Scale is a clinical tool used to assess the strength of pelvic floor muscles through vaginal or rectal examination. It uses a 6-point scale (0 to 5), where 0 indicates no contraction and 5 represents a strong contraction. A Cronbach's alpha is not typically reported for this scale because it is based on a single-item, ordinal rating by a clinician, rather than a multi-item questionnaire
Female Sexual Function Index FSFI
The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire designed to assess six domains of female sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. Each domain is scored individually and contributes to a total score that reflects overall sexual function, with higher scores indicating better function
SF 36
The Short Form-36 Health Survey (SF-36) is a widely used 36-item questionnaire designed to measure health-related quality of life across eight domainsThese domains contribute to two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Sponsors and contacts
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