Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence

Not Applicable

Recruiting

• Conditions: Urge Urinary Incontinence; Overactive Bladder (OAB)

• Registration Number: NCT06783374
• Lead Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2025-01-14
• Study First Submitted QC: 2025-01-14
• Study First Posted: 2025-01-20
• Study Start: 2025-03-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2026-11-10
• Study Completion: 2026-11-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Overactive Bladder Questionnaire-Short Form	At baseline, Post1month, Post3months, Post6months	The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a concise, self-administered patient-reported outcomes instrument comprising two scales that assess symptom bother and health-related quality of life (HR-QOL) in patients with OAB. This self-administered, disease-specific questionnaire evaluates symptomatic discomfort (6 items) and health-related quality of life (HRQoL, 13 items) using a 6-point Likert scale. Scores are transformed to a 0-100 scale, where higher symptom scores indicate greater severity, and higher HRQoL scores reflect better quality of life

Secondary Outcome Measures

Name	Time	Method
Mapping of Incontinence Quality of Life (I-QOL)	at baseline, Post1month, Post3months, Post6months	Mapping of Incontinence Quality of Life (I-QOL) is a widely utilized self-reported health-related quality of life instrument for individuals with urinary incontinence (UI). It comprises 22 items, each employing a 5-point ordinal response scale where 1 = extremely, 2 = quite a lot, 3 = moderately, 4 = a little, and 5 = not at all.
Bladder Diary	at baseline, Post1month, Post3months, Post6months	Bladder Diary is a non-invasive assessment tool that provides insights into bladder function. It is utilized to measure the frequency and severity of urinary dysfunction symptoms, such as overactive bladder.
Urinary Incontinence Short Form (ICIQ-UI-SF)	at baseline, Post1month, Post3months, Post6months	Urinary Incontinence Short Form (ICIQ-UI-SF) comprises three components that assess subjective frequency, subjective severity, and quality of life through a self-administered questionnaire. Questions 3 to 5 are scored items, with responses totaled to achieve a minimum score of 0 and maximum of 21.
Electromyography (EMG)	at baseline, Post1month, Post3months, Post6months	Electromyography (EMG) is a reliable, non-invasive method to assess pelvic floor muscle (PFM) tone, strength, endurance, and function. Electrical activity is recorded using a vaginal probe to monitor deep and superficial PFM layers. Measurements are obtained in supine and standing positions.
Oxford Scale	at baseline, Post1month, Post3months, Post6months	Oxford Scale is a subjective classification system utilized to evaluate the strength and quality of pelvic floor muscle (PFM) contractions through intracavitary palpation with one or two fingers. The modified scale comprises 5 grades: 0 = no contraction; 1 = flickering muscle movements; 2 = weak contraction; 3 = increased pressure with slight muscle elevation; 4 = firm contraction with moderate elevation of the vaginal posterior wall; 5 = strong contraction with finger resistance against the abdominal wall.
Tampa Scale-11 (TSK-11)	at baseline, Post1month, Post3months, Post6months	Tampa Scale-11 (TSK-11) is a validated instrument for assessing kinesiophobia, or fear of movement, in individuals with chronic pain. It identifies fear-avoidance beliefs with scores ranging from 11 to 44, where higher scores indicate greater fear of reinjury. The TSK-11 demonstrates reliability (α = 0.84) and is widely employed in musculoskeletal pain populations.
Pain Catastrophizing Scale (PCS)	at baseline, Post1month, Post3months, Post6months	Pain Catastrophizing Scale (PCS) is a 13-item self-administered instrument assessing pain magnification, rumination, and helplessness. Scores range from 13 to 62, with higher scores indicating greater catastrophizing. The validated Spanish version exhibits high reliability (α = 0.95; test-retest r = 0.70-0.75).
Sport Injury Rehabilitation Adherence Scales (SIRAS)	at baseline, Post1month, Post3months, Post6months	Sport Injury Rehabilitation Adherence Scales (SIRAS) evaluates patient adherence during rehabilitation sessions, as rated by healthcare professionals. It assesses the intensity with which patients complete exercises, their consistency in following instructions, and their receptiveness to program adjustments. The scale comprises three items scored to produce a total between 0 and 15, with higher scores indicating greater adherence.

Trial Locations

Locations (1)

Catholic Univerity of Valencia; 🇪🇸 Valencia, Spain