Overactive Bladder (OAB), Urge Urinary Incontinence
Conditions
Keywords
Menopause, exercise, Neuromodulation, Posterior tibial nerve
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.
Interventions
PROCEDURENeuromodulation
A 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.
PROCEDUREExercise
Participants 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.
PROCEDUREExercise control group
Exercise 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.
PROCEDURESham Neuromodulation
A 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.
Sponsors
Fundación Universidad Católica de Valencia San Vicente Mártir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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.
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactJesica L-G Leal García, PhD Student
Backup ContactJuan V-M Vicente Mampel, PhD
Outcome results
None listed