Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence

Last updated: April 10, 2025
Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Overall Status: Active - Recruiting

Phase

N/A

Condition

Enuresis

Urinary Incontinence

Treatment

Exercise control group

Exercise

Neuromodulation

Clinical Study ID

NCT06783374
UCV/2024-2025/020
Ethical Commithe
  • Ages > 45
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 63
Treatment Group(s): 4
Primary Treatment: Exercise control group
Phase:
Study Start date:
March 04, 2025
Estimated Completion Date:
November 10, 2026

Study Description

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.

Connect with a study center

  • Catholic Univerity of Valencia

    Valencia, 46001
    Spain

    Active - Recruiting

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