Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45+
SponsorFundación Universidad Católica de Valencia San Vicente Mártir
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Neuromodulation
Procedure/SurgeryA protocol of posterior tibial nerve electrostimulation will be implemented, inducing retrograde electrostimulation through the pelvic nerves, which are connected to the spinal cord via the sacral plexus at segments S2 and S3. It is recommended to conduct an average of 10 sessions to evaluate the efficacy of the treatment, within a range of 6 to 16 sessions, each lasting 30 minutes, completing a treatment period of 3 months.
Exercise
Procedure/SurgeryParticipants will engage in a 60-minute exercise session, divided into two blocks: Block 1 will comprise 10 to 12 repetitions per set, aiming to achieve a perceived exertion level of 7 to 10 on the rating of perceived exertion (RPE). Block 2 will utilize the 5P® LOGSURF Method, termed Proprioceptive Perineal Postural Reeducation, which employs unstable positions to promote postural adjustment and continuous balance. This approach facilitates the activation of the abdominopelvic muscles, enhancing control and strengthening of the pelvic-perineal region.
Exercise control group
Procedure/SurgeryExercise The control group engages in specific pelvic floor exercises, which are less complex in terms of neuromuscular processing, such as Kegel's exercise. The protocol for these exercises is standardized and conducted individually, comprising 8 to 12 sessions of 20-40 minutes each, performed twice weekly.
Sham Neuromodulation
Procedure/SurgeryA needle with a retractable handle will be used, commonly employed in experimental research with Streitberger and Kleinhenz placebo needles. This creates the appearance of insertion without penetrating the skin and allows the needles to remain in place for the duration of the intervention.
Treatment groups
63 Participants
are divided into 3 treatment groupsGroup A: Exercise + neuromodulationExperimental treatment 2 interventions
Group B: Exercise+ ShamNeuromodulationSham comparator 2 interventions
Group C: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Overactive Bladder Questionnaire-Short Form
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
Time frame
At baseline, Post1month, Post3months, Post6monthsSecondary outcomes
1
Mapping of Incontinence Quality of Life (I-QOL)
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.
Time frame
at baseline, Post1month, Post3months, Post6months2
Bladder Diary
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.
Time frame
at baseline, Post1month, Post3months, Post6months3
Urinary Incontinence Short Form (ICIQ-UI-SF)
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.
Time frame
at baseline, Post1month, Post3months, Post6months4
Electromyography (EMG)
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.
Time frame
at baseline, Post1month, Post3months, Post6monthsSponsors and contacts
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Source ClinicalTrials.gov