Combined Paula exercises and tibial nerve stimulation for stress urinary incontinence
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
This trial will test whether adding tibial nerve stimulation to Paula exercises helps women aged 30–45 with stress urinary incontinence reduce leakage and improve pelvic floor strength, sexual function, and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 30 Years to 45 Years |
| Sex | Female |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07576205 on ClinicalTrials.gov |
What this trial studies
This is a randomized controlled trial enrolling 56 multiparous women with clinically confirmed stress urinary incontinence at a clinic in Lahore. Participants are randomized to two groups: one receives Paula exercises plus tibial nerve stimulation, and the other receives Paula exercises alone; both groups also receive baseline pelvic floor muscle contraction training. Treatments occur twice weekly for eight weeks, and outcomes include urinary function, pelvic floor muscle strength, sexual function, and quality of life measured with IIQ-7, the Modified Oxford Scale, FSFI, and SF-36. Data will be analyzed using SPSS to compare changes between groups.
Who should consider this trial
Good fit: Ideal candidates are multiparous women aged 30–45 with clinically confirmed stress urinary incontinence of at least 3 months' duration who can correctly perform pelvic floor contractions and are not pregnant.
Not a fit: Women with predominant urge or mixed incontinence, neurological disease, recent pelvic surgery, significant pelvic organ prolapse, pregnancy, dermatological conditions at the stimulation site, or other listed exclusions are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combined approach could reduce leakage, strengthen pelvic floor muscles, and improve sexual function and overall quality of life for affected women.
How similar studies have performed: Tibial nerve stimulation and pelvic floor muscle training have each shown benefit for urinary incontinence in prior studies, but the specific combination with the Paula method is less well studied.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lahore, Punjab Province
- Arshian Hussnain Medical Clinic — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: sobia ghafoor, MSPT-OM — Riphah International University
- Study coordinator: imran amjad
- Email: imran.amjad@riphah.edu.pk
- Phone: 03324390125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.