Catholic University Foundation of Valencia San Vicente Mártir
Urge urinary incontinence (UUI) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder affecting healthcare systems worldwide. The efficacy of therapeutic exercise and neuromodulation in the treatment of UUI is evaluated, and these techniques are combined.
Urge Urinary Incontinence
Overactive Bladder (OAB)
Neuromodulation
Exercise
Exercise control group
Sham Neuromodulation
NA
Urge urinary incontinence (UUI) is a component of the condition known as overactive bladder, a severe and debilitating chronic disorder that affects the neurophysiology of micturition and bladder functionality, particularly in processes associated with menopause, leading to a deterioration in quality of life. Various therapeutic approaches are employed to treat overactive bladder. Among the most frequently implemented interventions are sacral or tibial nerve neurostimulation. This intervention targets the pathophysiological substrate by modulating the somatic afferent activity of the bladder and interfering with the activity of fibers responsible for pain modulation and neuromuscular system functionality. In essence, the described approach focuses on reducing peripheral input. Based on the aforementioned information, it was hypothesized that training through a pelvic floor strength protocol, performed adjunctively with peripheral neuromodulation prior to its implementation, may provide the ability to inhibit detrusor contractions via involuntary contractions of the perineal musculature.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 63 participants |
| Masking : | DOUBLE |
| Masking Description : | The groups will be arranged randomly, and the masking technique to be employed will be a double-blind procedure. The subjects will be randomly selected utilizing the EPIDAT 3.1 program. Both the participants and the investigator responsible for data collection remained unaware of the assigned intervention and the results obtained, respectively, until the study's conclusion. An independent researcher, employing an Excel formula, generated a table of random numbers to blind data collectors and outcome adjudicators, thereby ensuring unbiased outcome ascertainment. |
| Primary Purpose : | TREATMENT |
| Official Title : | 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) |
| Actual Study Start Date : | 2025-04-10 |
| Estimated Primary Completion Date : | 2026-11-10 |
| Estimated Study Completion Date : | 2026-11-10 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 45 Years |
| Sexes Eligible for Study: | FEMALE |
| Accepts Healthy Volunteers: |
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Catholic Univerity of Valencia
Valencia, Spain, 46001