An interventional study of Paula Exercises and Tibial Nerve Stimulation in Urinary Incontinence, sponsored by Riphah International University. Recruiting at 1 site in Pakistan. Open to female participants aged 30 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
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
This study will be randomized controlled trial and will be conducted in Arshian Hussnain Medical Clinic and at Marie Stopes Society. Non probability convenience sampling technique will be used and 56 participants will be recruited in study after randomization. Inclusion criteria will be females aged 30-45 years, multiparous women (≥2 full-term vaginal delivery). Exclusion criteria will be Neurological disorders, pregnancy and dermatological conditions .The subjects will be divided into two groups. Group A will receive Paula exercise and Tibial nerve stimulation. Group B will receive only Paula exercises. Both groups will receive baseline treatment which will include pelvic floor muscle contractions. The total duration of treatment will be 8 weeks and there will be 2 sessions each week. Outcomes assessed will be urinary function, pelvic floor muscles strength, sexual function \& quality of life. Outcomes will be assessed using validated tools such as the IIQ-7, Modified Oxford Scale, FSFI, and SF-36. After data collection, it will be analyzed by using SPSS version 21.
Exclusion Criteria:
Paula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly and for tibial stimulation Transcutaneous (TTNS) approach will be used
Other: Paula Exercises · Other: Tibial Nerve Stimulation
Paula exercises involve contracting circular muscles of the body (especially facial muscles like the orbicularis oris and orbicularis oculi) to stimulate pelvic floor activity indirectly
Other: Paula Exercises
* 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
* 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
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.
Time frame: 8th week
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
Time frame: 8th week
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
Time frame: 8th week
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).
Time frame: 8th week
Plan to share: No
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Riphah International University