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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder (OAB); Urge Urinary Incontinence
• Intervention / Treatment: Procedure: Neuromodulation; Procedure: Exercise; Procedure: Sham Neuromodulation; Procedure: Exercise control group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jesica L-G Leal García, PhD Student; Phone Number: +34 657390304; Email: jesica.leal@ucv.es
• Study Contact Backup: Name: Juan V-M Vicente Mampel, PhD; Phone Number: +34 674177877; Email: juan.vicente@ucv.es

Study Locations

• Spain
  • Valencia, Spain, 46001
    • Recruiting
    • Catholic Univerity of Valencia
    • Contact: Jesica L-G Leal García, PhD Student; Phone Number: +34 657390304; Email: jesica.leal@ucv.es
    • Contact: Juan V-M Vicente Mampel, PhD; Phone Number: +34 674177877; Email: juan.vicente@ucv.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	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.
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.	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: 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Overactive Bladder Questionnaire-Short Form	The Overactive Bladder Questionnaire-Short Form (OAB-q SF) is a concise, self-administered patient-reported outcomes instrument comprising two scales that assess symptom bother and health-related quality of life (HR-QOL) in patients with OAB. This self-administered, disease-specific questionnaire evaluates symptomatic discomfort (6 items) and health-related quality of life (HRQoL, 13 items) using a 6-point Likert scale. Scores are transformed to a 0-100 scale, where higher symptom scores indicate greater severity, and higher HRQoL scores reflect better quality of life	At baseline, Post1month, Post3months, Post6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mapping of Incontinence Quality of Life (I-QOL)	Mapping of Incontinence Quality of Life (I-QOL) is a widely utilized self-reported health-related quality of life instrument for individuals with urinary incontinence (UI). It comprises 22 items, each employing a 5-point ordinal response scale where 1 = extremely, 2 = quite a lot, 3 = moderately, 4 = a little, and 5 = not at all.	at baseline, Post1month, Post3months, Post6months
Bladder Diary	Bladder Diary is a non-invasive assessment tool that provides insights into bladder function. It is utilized to measure the frequency and severity of urinary dysfunction symptoms, such as overactive bladder.	at baseline, Post1month, Post3months, Post6months
Urinary Incontinence Short Form (ICIQ-UI-SF)	Urinary Incontinence Short Form (ICIQ-UI-SF) comprises three components that assess subjective frequency, subjective severity, and quality of life through a self-administered questionnaire. Questions 3 to 5 are scored items, with responses totaled to achieve a minimum score of 0 and maximum of 21.	at baseline, Post1month, Post3months, Post6months
Electromyography (EMG)	Electromyography (EMG) is a reliable, non-invasive method to assess pelvic floor muscle (PFM) tone, strength, endurance, and function. Electrical activity is recorded using a vaginal probe to monitor deep and superficial PFM layers. Measurements are obtained in supine and standing positions.	at baseline, Post1month, Post3months, Post6months
Oxford Scale	Oxford Scale is a subjective classification system utilized to evaluate the strength and quality of pelvic floor muscle (PFM) contractions through intracavitary palpation with one or two fingers. The modified scale comprises 5 grades: 0 = no contraction; 1 = flickering muscle movements; 2 = weak contraction; 3 = increased pressure with slight muscle elevation; 4 = firm contraction with moderate elevation of the vaginal posterior wall; 5 = strong contraction with finger resistance against the abdominal wall.	at baseline, Post1month, Post3months, Post6months
Tampa Scale-11 (TSK-11)	Tampa Scale-11 (TSK-11) is a validated instrument for assessing kinesiophobia, or fear of movement, in individuals with chronic pain. It identifies fear-avoidance beliefs with scores ranging from 11 to 44, where higher scores indicate greater fear of reinjury. The TSK-11 demonstrates reliability (α = 0.84) and is widely employed in musculoskeletal pain populations.	at baseline, Post1month, Post3months, Post6months
Pain Catastrophizing Scale (PCS)	Pain Catastrophizing Scale (PCS) is a 13-item self-administered instrument assessing pain magnification, rumination, and helplessness. Scores range from 13 to 62, with higher scores indicating greater catastrophizing. The validated Spanish version exhibits high reliability (α = 0.95; test-retest r = 0.70-0.75).	at baseline, Post1month, Post3months, Post6months
Sport Injury Rehabilitation Adherence Scales (SIRAS)	Sport Injury Rehabilitation Adherence Scales (SIRAS) evaluates patient adherence during rehabilitation sessions, as rated by healthcare professionals. It assesses the intensity with which patients complete exercises, their consistency in following instructions, and their receptiveness to program adjustments. The scale comprises three items scored to produce a total between 0 and 15, with higher scores indicating greater adherence.	at baseline, Post1month, Post3months, Post6months

Collaborators and Investigators

• Sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir

Publications and helpful links

General Publications

• Sonmez R, Yildiz N, Alkan H. Efficacy of percutaneous and transcutaneous tibial nerve stimulation in women with idiopathic overactive bladder: A prospective randomised controlled trial. Ann Phys Rehabil Med. 2022 Jan;65(1):101486. doi: 10.1016/j.rehab.2021.101486. Epub 2021 Nov 11.
• Bo K, Berghmans LC. Nonpharmacologic treatments for overactive bladder-pelvic floor exercises. Urology. 2000 May;55(5A Suppl):7-11; discussion 14-6.
• Fuentes-Aparicio L, Arranz-Martin B, Navarro-Brazalez B, Bailon-Cerezo J, Sanchez-Sanchez B, Torres-Lacomba M. Postural Sensorimotor Control on Anorectal Pressures and Pelvic Floor Muscle Tone and Strength: Effects of a Single 5P(R) LOGSURF Session. A Cross-Sectional Preliminary Study. Int J Environ Res Public Health. 2021 Apr 2;18(7):3708. doi: 10.3390/ijerph18073708.
• Arlandis S, Ruiz MA, Errando C, Villacampa F, Arumi D, Lizarraga I, Rejas J. Quality of life in patients with overactive bladder: validation and psychometric properties of the Spanish Overactive Bladder Questionnaire-short Form. Clin Drug Investig. 2012 Aug 1;32(8):523-32. doi: 10.2165/11633760-000000000-00000.
• Fernandez-Cuadros ME, Martin-Martin LM, Albaladejo-Florin MJ, Perez-Moro OS, Alava-Rabasa S, Goizueta-San-Martin G. [Transcutaneous stimulation of the posterior tibial nerve modifies the sympathetic skin response and improves overactive bladder syndrome: Case series and possible diagnostic test]. Rehabilitacion (Madr). 2022 Oct-Dec;56(4):255-263. doi: 10.1016/j.rh.2021.04.005. Epub 2021 Sep 24. Spanish.
• Abrams P. Describing bladder storage function: overactive bladder syndrome and detrusor overactivity. Urology. 2003 Nov;62(5 Suppl 2):28-37; discussion 40-2. doi: 10.1016/j.urology.2003.09.050.
• Carcelen-Fraile MDC, Aibar-Almazan A, Martinez-Amat A, Cruz-Diaz D, Diaz-Mohedo E, Redecillas-Peiro MT, Hita-Contreras F. Effects of Physical Exercise on Sexual Function and Quality of Sexual Life Related to Menopausal Symptoms in Peri- and Postmenopausal Women: A Systematic Review. Int J Environ Res Public Health. 2020 Apr 14;17(8):2680. doi: 10.3390/ijerph17082680.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2025
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026

Study Registration Dates

• First Submitted: January 14, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: exercise; Neuromodulation; Menopause; Posterior tibial nerve
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Bladder Diseases; Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: UCV/2024-2025/020; Ethical Commithe (Other Identifier: FundacionUCV)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No