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Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence

NCT06783374 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2025-04-13

No results posted yet for this study

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.

Conditions

  • Urge Urinary Incontinence
  • Overactive Bladder (OAB)

Interventions

PROCEDURE

Neuromodulation

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.

PROCEDURE

Exercise

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.

PROCEDURE

Exercise 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.

PROCEDURE

Sham 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 & Collaborators

  • Fundación Universidad Católica de Valencia San Vicente Mártir

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-04
Primary Completion
2026-11-10
Completion
2026-11-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06783374 on ClinicalTrials.gov