Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence

NCT06783374 | Recruiting DMC

• 2 other identifiers: UCV/2024-2025/020Ethical Commithe
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Menopause; exercise; Neuromodulation; Posterior tibial nerve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mapping of Incontinence Quality of Life (I-QOL)

  at baseline, Post1month, Post3months, Post6months

• Bladder Diary

  at baseline, Post1month, Post3months, Post6months

• Urinary Incontinence Short Form (ICIQ-UI-SF)

  at baseline, Post1month, Post3months, Post6months

• Electromyography (EMG)

  at baseline, Post1month, Post3months, Post6months

• Oxford Scale

  at baseline, Post1month, Post3months, Post6months

Study Arms (3)

Exercise + neuromodulation

EXPERIMENTAL

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; Procedure: Exercise

Exercise+ ShamNeuromodulation

SHAM COMPARATOR

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; Procedure: Sham Neuromodulation

Control Group

ACTIVE COMPARATOR

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

Interventions

Neuromodulation PROCEDURE

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.

Exercise + neuromodulation

Exercise PROCEDURE

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.

Exercise + neuromodulation; Exercise+ ShamNeuromodulation

Exercise control group PROCEDURE

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.

Control Group

Sham Neuromodulation PROCEDURE

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.

Exercise+ ShamNeuromodulation

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Universidad Católica de Valencia San Vicente Mártir: lead

Study Sites (1)

Catholic Univerity of Valencia

Valencia, Valencia, 46001, Spain

RECRUITING

Related Publications (8)

• 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.

  PMID: 33918217 BACKGROUND

• 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.

  PMID: 33429090 BACKGROUND

• 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.

  PMID: 22741748 BACKGROUND

• 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.

  PMID: 34565565 BACKGROUND

• Bo K, Berghmans LC. Nonpharmacologic treatments for overactive bladder-pelvic floor exercises. Urology. 2000 May;55(5A Suppl):7-11; discussion 14-6.

  PMID: 10767443 BACKGROUND

• 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.

  PMID: 14662404 BACKGROUND

• 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.

  PMID: 32295114 BACKGROUND

• Leal-Garcia J, Blanco-Gimenez P, Jaenada-Carrillero E, Martinez-Soler M, Huertas-Ramirez B, Mahiques-Sanchis A, Vicente-Mampel J. 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. Healthcare (Basel). 2025 Jul 21;13(14):1759. doi: 10.3390/healthcare13141759.

  PMID: 40724784 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive; Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation; Exercise

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jesica L-G Leal García, PhD Student

CONTACT

+34 657390304; jesica.leal@ucv.es

Juan V-M Vicente Mampel, PhD

CONTACT

+34 674177877; juan.vicente@ucv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The groups will be arranged randomly, and the masking technique to be employed will be a double-blind procedure. The subjects will be randomly selected utilizing the EPIDAT 3.1 program. Both the participants and the investigator responsible for data collection remained unaware of the assigned intervention and the results obtained, respectively, until the study's conclusion. An independent researcher, employing an Excel formula, generated a table of random numbers to blind data collectors and outcome adjudicators, thereby ensuring unbiased outcome ascertainment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: April 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)