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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Catholic Univerity of Valencia
RECRUITING
Valencia
Contact Information
Primary
Jesica L-G Leal García, PhD Student
jesica.leal@ucv.es
+34 657390304
Backup
Juan V-M Vicente Mampel, PhD
juan.vicente@ucv.es
+34 674177877
Time Frame
Start Date: 2025-03-04
Estimated Completion Date: 2026-11-10
Participants
Target number of participants: 63
Treatments
Experimental: Exercise + neuromodulation
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).
Sham_comparator: Exercise+ ShamNeuromodulation
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.
Active_comparator: Control Group
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.
Related Therapeutic Areas
Sponsors
Leads: Fundación Universidad Católica de Valencia San Vicente Mártir

This content was sourced from clinicaltrials.gov