Urinary Incontinence
Conditions
Keywords
Tibial Nerve, Incontinence, Pelvic Floor, Quality of life, Female, Stress Urinary Incontinence
Brief summary
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
Detailed description
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.
Interventions
OTHERPaula 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
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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)
Exclusion criteria
* 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 * Pelvic organ prolapse beyond stage II (POP-Q system) * Current use of other incontinence therapies (e.g., medication, PTNS, PFMT) * Diagnosed malignancy * Diagnosed psychiatric disorder * Pregnancy * Diagnosed dermatological condition * Participants who are currently enrolled in other clinical trials to avoid potential confounding factors.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Impact Questionnaire IIQ 7: | 8th week | 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 | 8th week | 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 | 8th week | 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 | 8th week | 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). |
Countries
Pakistan
Contacts
CONTACTimran amjad
PRINCIPAL_INVESTIGATORsobia ghafoor, MSPT-OM
Riphah International University
Outcome results
None listed