Effects of Paula Exercises and Tibial Nerve Stimulation in Stress Urinary Incontinence

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-45
SponsorRiphah International University

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 volunteers

Qualifiers

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

Design model

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

52 Participants
are divided into 2 treatment groups
Group A: Paula Exercises & Tibial Nerve StimulationExperimental treatment 2 interventions
Group B: Paula ExercisesActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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