Clinical trial NCT06783374: Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urge Urinary Incontinence
Overactive Bladder (OAB)
Keywords: Menopause
exercise
Neuromodulation
Posterior tibial nerve
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 63
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Overactive Bladder Questionnaire-Short Form
timeFrame: At baseline, Post1month, Post3months, Post6months
Secondary outcomes:
measure: Mapping of Incontinence Quality of Life (I-QOL)
timeFrame: at baseline, Post1month, Post3months, Post6months
measure: Bladder Diary
timeFrame: at baseline, Post1month, Post3months, Post6months
measure: Urinary Incontinence Short Form (ICIQ-UI-SF)
timeFrame: at baseline, Post1month, Post3months, Post6months
measure: Electromyography (EMG)
timeFrame: at baseline, Post1month, Post3months, Post6months
measure: Oxford Scale
timeFrame: at baseline, Post1month, Post3months, Post6months
measure: Tampa Scale-11 (TSK-11)
timeFrame: at baseline, Post1month, Post3months, Post6months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: at baseline, Post1month, Post3months, Post6months
measure: Sport Injury Rehabilitation Adherence Scales (SIRAS)
timeFrame: at baseline, Post1month, Post3months, Post6months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Catholic Univerity of Valencia
Study officials:
References:
citation: Fuentes-Aparicio L, Arranz-Martin B, Navarro-Brazalez B, Bailon-Cerezo J, Sanchez-Sanchez B, Torres-Lacomba M. Postural Sensorimotor Control on Anorectal Pressures and Pelvic Floor Muscle Tone and Strength: Effects of a Single 5P(R) LOGSURF Session. A Cross-Sectional Preliminary Study. Int J Environ Res Public Health. 2021 Apr 2;18(7):3708. doi: 10.3390/ijerph18073708.
citation: Sonmez R, Yildiz N, Alkan H. Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101486. doi: 10.1016/j.rehab.2021.101486. Epub 2021 Nov 11.
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citation: Fernandez-Cuadros ME, Martin-Martin LM, Albaladejo-Florin MJ, Perez-Moro OS, Alava-Rabasa S, Goizueta-San-Martin G. [Transcutaneous stimulation of the posterior tibial nerve modifies the sympathetic skin response and improves overactive bladder syndrome: Case series and possible diagnostic test]. Rehabilitacion (Madr). 2022 Oct-Dec;56(4):255-263. doi: 10.1016/j.rh.2021.04.005. Epub 2021 Sep 24. Spanish.
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citation: Abrams P. Describing bladder storage function: overactive bladder syndrome and detrusor overactivity. Urology. 2003 Nov;62(5 Suppl 2):28-37; discussion 40-2. doi: 10.1016/j.urology.2003.09.050.
citation: Carcelen-Fraile MDC, Aibar-Almazan A, Martinez-Amat A, Cruz-Diaz D, Diaz-Mohedo E, Redecillas-Peiro MT, Hita-Contreras F. Effects of Physical Exercise on Sexual Function and Quality of Sexual Life Related to Menopausal Symptoms in Peri- and Postmenopausal Women: A Systematic Review. Int J Environ Res Public Health. 2020 Apr 14;17(8):2680. doi: 10.3390/ijerph17082680.