Urge Urinary IncontinenceUCV/INCONTINENNCT06783374
Effect of Neuromodulation and Therapeutic Exercise in Urinary Incontinence
A study testing Neuromodulation and Exercise in people with Urge Urinary Incontinence and Overactive Bladder (OAB), run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Urge Urinary Incontinence, Overactive Bladder (OAB)
- What is being tested?
- Neuromodulation and Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 4 Mar 2025to 10 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Catholic Univerity of Valencia
Valencia, Valencia, 46001
Jesica L-G Leal García, PhD Student, +34 657390304, jesica.leal@ucv.es
Juan V-M Vicente Mampel, PhD, +34 674177877, juan.vicente@ucv.es
About this study
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)
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.
Read the 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.
- Being tested
- Neuromodulation, Exercise, Exercise control group, Sham Neuromodulation
- Keywords
- Menopause, exercise, Neuromodulation, Posterior tibial nerve
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuromodulationProcedure or surgery
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.
ExerciseProcedure or surgery
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 control groupProcedure or surgery
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.
Sham NeuromodulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: 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. Receives: Procedure: Exercise control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At baseline, Post1month, Post3months, Post6months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: at baseline, Post1month, Post3months, Post6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start4 Mar 2025
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Urge Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783374
- Sponsor's protocol ID
- UCV/2024-2025/020
- Other IDs
- Ethical Commithe
- Acronym
- UCV/INCONTINEN
- Status last verified
- Dec 2024
- First submitted
- 14 Jan 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33918217Sonmez 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.
PubMed 33429090Arlandis 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.
PubMed 22741748Fernandez-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.
PubMed 34565565Bo K, Berghmans LC. Nonpharmacologic treatments for overactive bladder-pelvic floor exercises. Urology. 2000 May;55(5A Suppl):7-11; discussion 14-6.
PubMed 10767443Abrams 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.
PubMed 14662404Carcelen-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.
PubMed 32295114Leal-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.
PubMed 40724784
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06783374
- Acronym / sponsor ID
- UCV/INCONTINEN / UCV/2024-2025/020
- Keywords
- Menopause, exercise, Neuromodulation, Posterior tibial nerve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise + neuromodulation | Experimental | Procedure: Neuromodulation, Procedure: ExerciseThe 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). |
| Exercise+ ShamNeuromodulation | Sham comparator | Procedure: Exercise, Procedure: Sham NeuromodulationFor 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. |
| Control Group | Active comparator | Procedure: Exercise control groupConventional 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuromodulationA 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 or surgery | Exercise + neuromodulation |
| ExerciseParticipants 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 or surgery | Exercise + neuromodulation, Exercise+ ShamNeuromodulation |
| Exercise control groupExercise 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 or surgery | Control Group |
| Sham NeuromodulationA 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. | Procedure or surgery | Exercise+ ShamNeuromodulation |
Primary outcome
The Overactive Bladder Questionnaire-Short Form
Time frame: At baseline, Post1month, Post3months, Post6months
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
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Results publication: PubMed 33918217Fuentes-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.
- Results publication: PubMed 33429090Sonmez 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.
- Results publication: PubMed 22741748Arlandis 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.
- Results publication: PubMed 34565565Fernandez-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.
- Results publication: PubMed 10767443Bo K, Berghmans LC. Nonpharmacologic treatments for overactive bladder-pelvic floor exercises. Urology. 2000 May;55(5A Suppl):7-11; discussion 14-6.
- Results publication: PubMed 14662404Abrams 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.
- Results publication: PubMed 32295114Carcelen-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.
- Derived from this study: PubMed 40724784Leal-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromodulation and Exercise in people with Urge Urinary Incontinence and Overactive Bladder (OAB), run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jesica L-G Leal García, PhD Student (+34 657390304, jesica.leal@ucv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Overactive Bladder Questionnaire-Short Form (time frame: At baseline, Post1month, Post3months, Post6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06783374, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.