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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paula Exercises & Tibial Nerve Stimulation | Experimental | 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 |
|
| Paula Exercises | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paula Exercises | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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 | 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). | 8th week |
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Inclusion Criteria:
Exclusion Criteria:
postpartum Stress Urinary Incontinence
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| imran amjad | Contact | 03324390125 | imran.amjad@riphah.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| sobia ghafoor, MSPT-OM | Riphah International University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arshian Hussnain Medical Clinic | Recruiting | Lahore | Punjab Province | 6400 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36676629 | Background | Yang X, Wang X, Gao Z, Li L, Lin H, Wang H, Zhou H, Tian D, Zhang Q, Shen J. The Anatomical Pathogenesis of Stress Urinary Incontinence in Women. Medicina (Kaunas). 2022 Dec 20;59(1):5. doi: 10.3390/medicina59010005. | |
| Background | Mushtaq S. EFFICACY OF EXERCISE-BASED TECHNIQUES TO TREAT STRESS URINARY INCONTINENCE IN FEMALES EXCEPT FOR KEGELS TECHNIQUE: A NARRATIVE REVIEW OF THE LATEST EVIDENCE. Pakistan Journal of Rehabilitation. 2024;13(1):17-29. | ||
| 33750376 |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Tibial Nerve Stimulation | Other |
|
|
| Background |
| Aliyu SU, Hanif SM, Lawal IU. Effect of Paula exercise method on functional outcomes of women with post fistula repair incontinence: a protocol for randomized controlled trial. BMC Womens Health. 2021 Mar 9;21(1):101. doi: 10.1186/s12905-021-01249-w. |
| 38748331 | Background | Lee UJ, MacDiarmid S, Matthews CA, Gillespie E, Peters KM. Tibial Nerve Stimulation for Urge Urinary Incontinence and Overactive Bladder: Narrative Review of Randomized Controlled Trials and Applicability to Implantable Devices. Adv Ther. 2024 Jul;41(7):2635-2654. doi: 10.1007/s12325-024-02864-3. Epub 2024 May 15. |
| 35400016 | Background | Al-Danakh A, Safi M, Alradhi M, Almoiliqy M, Chen Q, Al-Nusaif M, Yang X, Al-Dherasi A, Zhu X, Yang D. Posterior Tibial Nerve Stimulation for Overactive Bladder: Mechanism, Classification, and Management Outlines. Parkinsons Dis. 2022 Mar 16;2022:2700227. doi: 10.1155/2022/2700227. eCollection 2022. |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |