Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence (UCV/INCONTINEN)

Fundación Universidad Católica de Valencia San Vicente Mártir

Status: Enrolling

Conditions: Overactive Bladder (OAB); Urge Urinary Incontinence

Treatments: Procedure: Exercise control group; Procedure: Exercise; Procedure: Neuromodulation; Procedure: Sham Neuromodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06783374

Ethical Commithe (Other Identifier)

UCV/2024-2025/020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 3 patient groups

Exercise + neuromodulation

Experimental group

Description:

The Intervention group will initially undergo posterior tibial nerve neuromodulation following a standardized protocol: 30 minutes per session, 2 sessions per week for 3 months. Sessions will have a duration of 60 minutes and will be structured into three distinct blocks. In the initial two treatment blocks, exercises will emphasize CORE stabilization and general strength training with forced exhalation to ensure appropriate activation of the transverse abdominal muscle, with the objective of preventing adverse effects associated with increased intra-abdominal pressure. The third work block will focus on addressing anticipatory postural adjustment control, given its established relationship with the pelvic floor muscles. This technique will be actively implemented in conjunction with the Proprioceptive Postural Reeducation Method (5P® LOGSURF).

Treatment:

Procedure: Exercise

Procedure: Neuromodulation

Exercise+ ShamNeuromodulation

Sham Comparator group

Description:

For the SHAM group, a non-penetrating needle with a retractable handle will be utilized, which is commonly employed in experimental research with Streitberger and Kleinhenz placebo needles. This method creates the appearance of insertion without penetrating the skin and allows the needles to remain in situ for the duration of the intervention. The SHAM group participants will adhere to the exercise protocol in the same manner as the intervention group.

Treatment:

Procedure: Sham Neuromodulation

Procedure: Exercise

Control Group

Active Comparator group

Description:

Conventional Physiotherapy. The control group engages in specific pelvic floor exercises, which are less complex in terms of neuromuscular processing (focusing on fundamental spinal stimuli), in contrast to the more comprehensive and intricate tasks of the intervention group. Additionally, manual therapy techniques are employed to inhibit trigger points in the musculature and ligamentous structures of the pelvic cavity, as well as intracavitary techniques aimed at alleviating mechanical pain.

Treatment:

Procedure: Exercise control group