Combining neuromodulation and exercise for treating urinary incontinence
Effect of a Peripheral and Central Neuromodulation Protocol Combined With the Application of Therapeutic Exercise in Patients Diagnosed With Urinary Incontinence. A Randomized Control Trial (RCT)
This study is testing if combining special exercises with nerve stimulation can help menopausal women with urge urinary incontinence and overactive bladder feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Fundación Universidad Católica de Valencia San Vicente Mártir Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06783374 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of combining therapeutic exercise with neuromodulation techniques to treat urge urinary incontinence (UUI) and overactive bladder (OAB) in menopausal women. The approach focuses on modulating the neurophysiology of bladder functionality through pelvic floor strength training and peripheral neuromodulation. Participants will be assessed for their response to these interventions over a specified duration, with a control group receiving sham neuromodulation. The goal is to improve quality of life by reducing the symptoms associated with UUI.
Who should consider this trial
Good fit: Ideal candidates are women over 45 years old who have been diagnosed with urinary incontinence or overactive bladder for at least three months.
Not a fit: Patients with stress urinary incontinence or those with neurological or psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of urinary incontinence and enhance the quality of life for affected patients.
How similar studies have performed: While the combination of neuromodulation and exercise is a novel approach, similar studies have shown promise in treating overactive bladder symptoms.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Present with a diagnosis of urinary incontinence or overactive bladder * Women of menopausal age (\>45 years) * ≥3 months of duration * Fulfill the established criteria for patient selection for neuromodulation treatment (urge urinary incontinence) * Speak native Spanish or English Exclusion Criteria: * Prior or scheduled surgical procedures in the lumbar or abdominal region * Presence of fractures or severe pathological conditions * Current pregnancy or potential for pregnancy during the study period * Neurological or psychiatric disorders * Presence of stress urinary incontinence * Female subjects with autoimmune diseases or malignancies * Belonephobia * Subjects who have undergone previous neuromodulation
Where this trial is running
Valencia, Valencia
- Catholic Univerity of Valencia — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Jesica L-G Leal García, PhD Student
- Email: jesica.leal@ucv.es
- Phone: +34 657390304
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.