Effects of Paula Exercises and Tibial Nerve Stimulation in Stress Urinary Incontinence
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Paula Exercises, Tibial Nerve Stimulation.
- Who it may be relevant to
- Registry conditions: Urinary Incontinence. Basic parameters: 30 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Combine Effects of Paula Exercises and Tibial Nerve Stimulation on Incontinence, Pelvic Floor Muscles Strength, Sexual Function and Quality of Life in Stress Urinary Incontinence
Overview
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
- 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 - Other Tibial Nerve Stimulation
* 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
Primary outcome measures
- Incontinence Impact Questionnaire IIQ 7: [Time frame: 8th week]
- Modified Oxford Scale [Time frame: 8th week]
- Female Sexual Function Index FSFI [Time frame: 8th week]
- SF 36 [Time frame: 8th week]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Arshian Hussnain Medical Clinic — Lahore
Publications
- 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. PMID 36676629
- 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.
- 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. PMID 33750376
- 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. PMID 38748331
- 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. PMID 35400016
Identifiers
NCT: NCT07576205 · REC/RCR & AHS/25/0502