RecruitingNot ApplicableNCT06783374

Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence

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)


Sponsor

Fundación Universidad Católica de Valencia San Vicente Mártir

Enrollment

63 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 45 Years

Inclusion Criteria5

  • 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 Criteria8

  • 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

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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.


Locations(1)

Catholic Univerity of Valencia

Valencia, Valencia, Spain

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NCT06783374


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