Actively Recruiting

Phase Not Applicable
Age: 45Years +
FEMALE
ID06783374

Effect of Peripheral and Central Neuromodulation Combined With Therapeutic Exercise in Women With Urinary Incontinence A Randomized Controlled Trial

Led by Fundación Universidad Católica de Valencia San Vicente Mártir · Updated on 2025-04-13

63

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Urge urinary incontinence (UUI) is part of overactive bladder, a severe chronic condition that affects bladder function and quality of life, especially in menopausal women. This trial evaluates the effectiveness of combining therapeutic exercise with neuromodulation techniques to treat UUI by targeting the nerve activity involved in bladder control. Researchers aim to understand how these combined approaches may help improve symptoms and bladder function in affected women. The study includes three groups: one receiving posterior tibial nerve neuromodulation alongside a specialized exercise program focusing on core strength and postural control; a sham group receiving placebo neuromodulation with the same exercise protocol; and a control group performing pelvic floor exercises with manual therapy. Neuromodulation sessions last 30 minutes twice weekly for three months, while exercise sessions last 60 minutes divided into blocks emphasizing pelvic and postural muscle activation. Participants will be evaluated using questionnaires like the Overactive Bladder Questionnaire-Short Form and quality of life assessments at baseline, 1, 3, and 6 months post-treatment. Additional measures include bladder diaries, electromyography, and pain and adherence scales. The study monitors safety, symptom changes, and quality of life over six months to assess the combined treatment's impact in women with UUI.

CONDITIONS

Brief Title

Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence

Who Can Participate

Age: 45Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Present with a diagnosis of urinary incontinence or overactive bladder
  • Women of menopausal age (>45 years)
  • Symptoms lasting 3 months or more
  • Meet criteria for neuromodulation treatment for urge urinary incontinence
  • Speak native Spanish or English
Not Eligible

You will not qualify if you...

  • Prior or planned surgeries in lumbar or abdominal areas
  • Presence of fractures or severe pathological conditions
  • Current pregnancy or potential pregnancy during study
  • Neurological or psychiatric disorders
  • Stress urinary incontinence
  • Autoimmune diseases or malignancies in female subjects
  • Fear of needles (belonephobia)
  • Previous neuromodulation treatments

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive neuromodulation sessions twice weekly for 3 months combined with structured exercise sessions focusing on pelvic floor strength and postural reeducation, or participate in control exercise protocols with or without sham neuromodulation.

Approximately 24 sessions (2 sessions per week)

Follow-up

Duration - 3 months

Participants are monitored for treatment outcomes and quality of life improvements over a 3-month period following the end of treatment.

1 visit at 1 month, 1 visit at 3 months, and 1 visit at 6 months post-treatment

Trial Site Locations

Total: 1 location

1

Catholic Univerity of Valencia

Valencia, Valencia, Spain, 46001

Actively Recruiting

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Research Team

J

Jesica L-G Leal García, PhD Student

J

Juan V-M Vicente Mampel, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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Published Research Related To This Trial

Postural Sensorimotor Control on Anorectal Pressures and Pelvic Floor Muscle Tone and Strength: Effects of a Single 5P® LOGSURF Session. A Cross-Sectional Preliminary Study.

Laura Fuentes-Aparicio, Beatriz Arranz-Martín, Beatriz Navarro-Brazález...

https://pubmed.ncbi.nlm.nih.gov/33918217

Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial.

Rafet Sonmez, Necmettin Yildiz, Hakan Alkan

https://pubmed.ncbi.nlm.nih.gov/33429090

Quality of life in patients with overactive bladder: validation and psychometric properties of the Spanish Overactive Bladder Questionnaire-short Form.

Salvador Arlandis, Miguel A Ruiz, Carlos Errando...

https://pubmed.ncbi.nlm.nih.gov/22741748

[Transcutaneous stimulation of the posterior tibial nerve modifies the sympathetic skin response and improves overactive bladder syndrome: Case series and possible diagnostic test].

M E Fernández-Cuadros, L M Martín-Martín, M J Albaladejo-Florín...

https://pubmed.ncbi.nlm.nih.gov/34565565

Effects of Physical Exercise on Sexual Function and Quality of Sexual Life Related to Menopausal Symptoms in Peri- and Postmenopausal Women: A Systematic Review.

María Del Carmen Carcelén-Fraile, Agustín Aibar-Almazán, Antonio Martínez-Amat...

https://pubmed.ncbi.nlm.nih.gov/32295114

Effect of a Peripheral Neuromodulation Protocol Combined with the Application of Therapeutic Exercise in Patients Diagnosed with Urinary Incontinence-A Study Protocol for a Randomized Controlled Trial.

Jesica Leal-García, Paula Blanco-Giménez, Eloy Jaenada-Carrillero...

https://pubmed.ncbi.nlm.nih.gov/40724784