Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence

Official title

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)

Overview

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.

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.

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, enhancin
• 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.

Primary outcome measures

• The Overactive Bladder Questionnaire-Short Form [Time frame: At baseline, Post1month, Post3months, Post6months]

Secondary outcome measures (8)

• Mapping of Incontinence Quality of Life (I-QOL) [Time frame: at baseline, Post1month, Post3months, Post6months]
• Bladder Diary [Time frame: at baseline, Post1month, Post3months, Post6months]
• Urinary Incontinence Short Form (ICIQ-UI-SF) [Time frame: at baseline, Post1month, Post3months, Post6months]
• Electromyography (EMG) [Time frame: at baseline, Post1month, Post3months, Post6months]
• Oxford Scale [Time frame: at baseline, Post1month, Post3months, Post6months]
• Tampa Scale-11 (TSK-11) [Time frame: at baseline, Post1month, Post3months, Post6months]
• Pain Catastrophizing Scale (PCS) [Time frame: at baseline, Post1month, Post3months, Post6months]
• Sport Injury Rehabilitation Adherence Scales (SIRAS) [Time frame: at baseline, Post1month, Post3months, Post6months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Spain · 1 center

• Catholic Univerity of Valencia — Valencia

Publications

• 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
• 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
• 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
• 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. Sp PMID 34565565
• 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
• 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
• 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
• 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/healthcare PMID 40724784

Identifiers

NCT: NCT06783374 · UCV/2024-2025/020 · Ethical Commithe

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗