Urinary Bladder, OveractiveNCT06390488
Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder
A study testing Transcutaneous medial plantar nerve stimulation (T-MPNS) in people with Urinary Bladder, Overactive, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of T-MPNS vs placebo in women with idiopathic OAB. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Transcutaneous medial plantar nerve stimulation (T-MPNS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2024to 28 Feb 2025
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over the age of 18 with clinical diagnosis of idiopathic OAB
- Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
- Able to understand the procedures, advantages and possible side effects
- Willing and able to complete the voiding diary and QoL questionnaire
- The strength of pelvic floor muscles 3/5 and more
Who cannot join
- Women with stress urinary incontinence
- History of conservative therapy (T-MPNS and Transcutaneous Tibial Nerve Stimulation/PTNS) within 6 months
- Pregnancy or intention to become pregnant during the study
- Current vulvovaginitis or urinary tract infections or malignancy
- Anatomic or posttraumatic malformations/skin disorders of medial plantar nerve region on inner foot that cannot allow to apply the electrodes
- More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
Show all 10Show fewer
- Cardiac pacemaker, implanted defibrillator
- Previous urogynecological surgery within 3 months
- Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- Ultrasonographic evidence of post-void residual volume more than 100 ml
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Double-blind Placebo Controlled Trial
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of T-MPNS vs placebo in women with idiopathic OAB.
The main questions aimed to be answered are:
What are the effects of Transcutaneous Medial Plantar Nerve Stimulation (T-MPSS) on clinical parameters related to incontinence and quality of life compared to the placebo group in women with idiopathic overactive bladder (OAB)? Participants (n:40) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive T-MPSS (n:20) and the second group will receive placebo T-MPSS (n:20). Measurements will be performed twice in total, before and at the end of treatment (6th week).
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Transcutaneous medial plantar nerve stimulation (T-MPNS), Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)
- Keywords
- Idiopathic overactive bladder, Transcutaneous medial plantar nerve stimulation, Urinary incontinence
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous medial plantar nerve stimulation (T-MPNS)Other
T-MPNS will be conducted unilaterally in the supine position using the electrotherapy device with surface electrodes. Two round self-adhesive electrodes will be positioned, with the negative electrode near the metatarsal-phalangeal joint of the great toe on the medial aspect of the foot and the positive electrode approximately 2 cm inferior-posterior to the medial malleolus (in front of the Medio-Malleolar-Calcaneal axis). Channel 1 will provide active stimulation, while channel 2 will remain inactive.
Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)Other
Sham T-MPNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the T-MPNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation.
| Study group | Role | What they receive |
|---|---|---|
| T-MPNS | Experimental | In this study, the stimulation device will be connected to the patient via channel 1, and active stimulation will be performed. Channel 2 will not be connected to the patient, thus no stimulation will be given through this channel. Both channels will utilize a stimulation protocol set to continuous mode with a frequency of 20 Hz and a pulse width of 200 ms. The intensity of the current for channel 1 (ranging from 0 to 50 mA) will be determined based on the comfort level of the patient after ensuring correct positioning. Correct positioning will be confirmed by observing a hallux reaction (plantar flexion of the big toe or, rarely, fanning of the fingers). T-MPNS sessions will be conducted twice a week for 6 weeks, with each session lasting 30 minutes. The intervention will consist of a 12-session T-MPNS treatment program. Receives: Other: Transcutaneous medial plantar nerve stimulation (T-MPNS) |
| Sham T-MPNS | Sham comparator | In the Sham T-MPNS group, patients will receive stimulation with the same electrotherapy device, same patient and electrode positioning, and identical current characteristics as the T-MPNS group. Channel 2 of the device will be connected to the patient without delivering stimulation, while channel 1 will not be connected but will display current intensity and treatment duration on the device screen. The current intensity on channel 1 will only be able to be increased up to 2-3 mA to prevent patients from exceeding this level. Patients will be advised that higher stimulations might negatively affect treatment outcomes. All patients, including those in the placebo group, will be informed that the absence of motor or sensory responses during treatment does not imply ineffectiveness, alleviating concerns about lack of sensation. Sham T-MPNS sessions will be conducted twice weekly for 6 weeks, with each session lasting 30 minutes, totaling 12 sessions. Receives: Other: Sham Transcutaneous medial plantar nerve stimulation (T-MPNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in incontinence episodes
Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders
Measured: Change from baseline Improvement in incontinence episodes at the 6th week after the treatment
Secondary outcomes (8)
The severity of incontinence
The 24-hour pad test was carried out to evaluate the severity of incontinence
Measured: Change from baseline the severity of incontinence at the 6th week after the treatment
Symptom severity
Overactive Bladder Questionnaire (OAB-V8) will be used to evaluate symptom severity in women with OAB in the study. The OAB-V8 consists of 8 questions in which patients can be classified as symptom severity: none (0), very little (1), a little (2), quite a few (3), very (4), and too many (5). The total score ranges from 0-40.
Measured: Change from baseline symptom severity at the 6th week after the treatment
Frequency of voiding, nocturia, number of pads
The frequency of voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary.
Measured: Change from baseline Frequency of voiding, nocturia, number of pads at the 6th week after the treatment
The Quality of Life
The Quality of Life-Incontinence Impact Questionnaire (IIQ7) will be used to assess specific QoL related to incontinence
Measured: Change from baseline the Quality of Life at the 6th week after the treatment
Anxiety and Depression level
The Hospital Anxiety and Depression Scale (HAD), validated and reliability tested in Turkey in 1987, assesses levels of anxiety and depression. It comprises 14 questions, seven for anxiety and seven for depression, scored on a four-point Likert scale. Scores are summed for each subscale: questions 1, 3, 5, 7, 9, 11, and 13 for anxiety, and questions 2, 4, 6, 8, 10, 12, and 14 for depression. In Turkey, cutoff scores are 10/11 for anxiety and 7/8 for depression, indicating risk.
Measured: Change from baseline anxiety and Depression level at the 6th week after the treatment
Assessment of sexual functions Assessment of sexual functions
In the evaluation of sexual function, the Female Sexual Function Index questionnaire is used, consisting of 19 questions assessing six main factors: sexual desire, arousal, lubrication, orgasm, satisfaction, and pain/discomfort. The highest possible total raw score is 95, while the lowest is 4. After multiplying the coefficients, the highest score is 36, and the lowest is 2. Impact coefficients used for scoring are: 0.6 for sexual desire, 0.3 for arousal and lubrication, and 0.4 for orgasm, satisfaction, and pain/discomfort. An Female Sexual Function Index score below 26.55 is indicative of sexual dysfunction
Measured: Change from baseline assessment of sexual functions at the 6th week after the treatment
Cure and improvement rates
Cure and improvement rates will be recorded in all groups at the end-of-treatment assessments. Values under 1.3 g in the 24-hour pad test will be considered as "cure", while a 50% or greater reduction in wet weight compared to baseline measurements at the end of treatment will be considered as "improvement".
Measured: Change from baseline cure and improvement rates at the 6th week after the treatment
Treatment Satisfaction Level
At the end of the treatment, participants will be asked to evaluate their satisfaction level with the administered treatment using a Likert scale ranging from 1 to 5 (5=very satisfied, 4=satisfied, 3=neither satisfied nor dissatisfied, 2=dissatisfied, 1=very dissatisfied).
Measured: Change from baseline Treatment Satisfaction Level at the 6th week after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start28 Nov 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmettin Yildiz, Pamukkale University
- Investigators
- Necmettin Yıldız, Prof., Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06390488
- Sponsor's protocol ID
- PamukkaleU.ftr-NYıldız-2
- Status last verified
- Nov 2024
- First submitted
- 1 Apr 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
PubMed 27921161C.K. Harding, M.C. Lapitan, S. Arlandis, K. Bø, H. Cobussen-Boekhorst, E. Costantini, et al. The European Association of Urology (EAU) Guidelines. EAU Guidelines on Management of Non-Neurogenic Female Lower Urinary Tract Symptoms. In: EAU Guidelines, 2023 (Internet). Available online at: https://uroweb.org/guidelines/non-neurogenic-female-luts
Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23.
PubMed 25623739de Groat WC, Yoshimura N. Anatomy and physiology of the lower urinary tract. Handb Clin Neurol. 2015;130:61-108. doi: 10.1016/B978-0-444-63247-0.00005-5.
PubMed 26003239de Groat WC, Griffiths D, Yoshimura N. Neural control of the lower urinary tract. Compr Physiol. 2015 Jan;5(1):327-96. doi: 10.1002/cphy.c130056.
PubMed 25589273Sonmez 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 33429090Yildiz N, Sonmez R. Transcutaneous medial plantar nerve stimulation in women with idiopathic overactive bladder. Investig Clin Urol. 2023 Jul;64(4):395-403. doi: 10.4111/icu.20230009.
PubMed 37417565Burgio KL, Goode PS, Locher JL, Umlauf MG, Roth DL, Richter HE, Varner RE, Lloyd LK. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2293-9. doi: 10.1001/jama.288.18.2293.
PubMed 12425706Tezer T, Yildiz N, Sarsan A, Alkan H. Short-term effect of magnetic stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial. Neurourol Urodyn. 2022 Aug;41(6):1380-1389. doi: 10.1002/nau.24957. Epub 2022 May 20.
PubMed 35593007Yamanishi T, Homma Y, Nishizawa O, Yasuda K, Yokoyama O; SMN-X Study Group. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol. 2014 Apr;21(4):395-400. doi: 10.1111/iju.12289. Epub 2013 Oct 14.
PubMed 24118165Firinci S, Yildiz N, Alkan H, Aybek Z. Which combination is most effective in women with idiopathic overactive bladder, including bladder training, biofeedback, and electrical stimulation? A prospective randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2498-2508. doi: 10.1002/nau.24522. Epub 2020 Sep 22.
PubMed 32960999O'Sullivan R, Karantanis E, Stevermuer TL, Allen W, Moore KH. Definition of mild, moderate and severe incontinence on the 24-hour pad test. BJOG. 2004 Aug;111(8):859-62. doi: 10.1111/j.1471-0528.2004.00211.x.
PubMed 15270937Tarcan T, Mangır N, Özgür MÖ, Akbal C. OAB-V8 Overactive Bladder Questionnaire Validation Study. (Turkish) Üroloji Bülteni 2012;21:113-116. http://www.kontinansdernegi.org/userfiles/media/kontinans.galenos.com.tr/oab-v8-asiri-aktif-mesane-sorgulama-formu.pdf
Acquadro C, Kopp Z, Coyne KS, Corcos J, Tubaro A, Choo MS, Oh SJ. Translating overactive bladder questionnaires in 14 languages. Urology. 2006 Mar;67(3):536-40. doi: 10.1016/j.urology.2005.09.035.
PubMed 16527574Cam C, Sakalli M, Ay P, Cam M, Karateke A. Validation of the short forms of the incontinence impact questionnaire (IIQ-7) and the urogenital distress inventory (UDI-6) in a Turkish population. Neurourol Urodyn. 2007;26(1):129-33. doi: 10.1002/nau.20292.
PubMed 17083117
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Medial Plantar Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Double-blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT06390488
- Acronym / sponsor ID
- PamukkaleU.ftr-NYıldız-2
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Idiopathic overactive bladder, Transcutaneous medial plantar nerve stimulation, Urinary incontinence
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 28 Nov 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 30 Apr 2024 (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.
The investigators conducted a prospective, randomized double-blind, placebo-controlled study based on a placebo technique to evaluate the efficacy of T-MPNS vs placebo in women with idiopathic OAB.
The main questions aimed to be answered are:
What are the effects of Transcutaneous Medial Plantar Nerve Stimulation (T-MPSS) on clinical parameters related to incontinence and quality of life compared to the placebo group in women with idiopathic overactive bladder (OAB)? Participants (n:40) with idiopathic OAB who meet the exclusion and inclusion criteria will be divided into 2 groups using a randomization table. The first group will receive T-MPSS (n:20) and the second group will receive placebo T-MPSS (n:20). Measurements will be performed twice in total, before and at the end of treatment (6th week).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-MPNS | Experimental | Other: Transcutaneous medial plantar nerve stimulation (T-MPNS)In this study, the stimulation device will be connected to the patient via channel 1, and active stimulation will be performed. Channel 2 will not be connected to the patient, thus no stimulation will be given through this channel. Both channels will utilize a stimulation protocol set to continuous mode with a frequency of 20 Hz and a pulse width of 200 ms. The intensity of the current for channel 1 (ranging from 0 to 50 mA) will be determined based on the comfort level of the patient after ensuring correct positioning. Correct positioning will be confirmed by observing a hallux reaction (plantar flexion of the big toe or, rarely, fanning of the fingers). T-MPNS sessions will be conducted twice a week for 6 weeks, with each session lasting 30 minutes. The intervention will consist of a 12-session T-MPNS treatment program. |
| Sham T-MPNS | Sham comparator | Other: Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)In the Sham T-MPNS group, patients will receive stimulation with the same electrotherapy device, same patient and electrode positioning, and identical current characteristics as the T-MPNS group. Channel 2 of the device will be connected to the patient without delivering stimulation, while channel 1 will not be connected but will display current intensity and treatment duration on the device screen. The current intensity on channel 1 will only be able to be increased up to 2-3 mA to prevent patients from exceeding this level. Patients will be advised that higher stimulations might negatively affect treatment outcomes. All patients, including those in the placebo group, will be informed that the absence of motor or sensory responses during treatment does not imply ineffectiveness, alleviating concerns about lack of sensation. Sham T-MPNS sessions will be conducted twice weekly for 6 weeks, with each session lasting 30 minutes, totaling 12 sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women over the age of 18 with clinical diagnosis of idiopathic OAB
- Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks
- Able to understand the procedures, advantages and possible side effects
- Willing and able to complete the voiding diary and QoL questionnaire
- The strength of pelvic floor muscles 3/5 and more
Key exclusion criteria (10 listed)
- Women with stress urinary incontinence
- History of conservative therapy (T-MPNS and Transcutaneous Tibial Nerve Stimulation/PTNS) within 6 months
- Pregnancy or intention to become pregnant during the study
- Current vulvovaginitis or urinary tract infections or malignancy
- Anatomic or posttraumatic malformations/skin disorders of medial plantar nerve region on inner foot that cannot allow to apply the electrodes
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 |
|---|---|---|
| Transcutaneous medial plantar nerve stimulation (T-MPNS)T-MPNS will be conducted unilaterally in the supine position using the electrotherapy device with surface electrodes. Two round self-adhesive electrodes will be positioned, with the negative electrode near the metatarsal-phalangeal joint of the great toe on the medial aspect of the foot and the positive electrode approximately 2 cm inferior-posterior to the medial malleolus (in front of the Medio-Malleolar-Calcaneal axis). Channel 1 will provide active stimulation, while channel 2 will remain inactive. | Other | T-MPNS |
| Sham Transcutaneous medial plantar nerve stimulation (T-MPNS)Sham T-MPNS group will be stimulated using the same electrotherapy device, with patients positioned identically and electrodes placed in the same positions as in the T-MPNS group. The current characteristics (pulse frequency 20 Hz and pulse width 200 ms) will also remain consistent across both channels. The second channel of the stimulation device will be designated as the channel connected to the patient but without delivering stimulation. | Other | Sham T-MPNS |
Primary outcome
Improvement in incontinence episodes
Time frame: Change from baseline Improvement in incontinence episodes at the 6th week after the treatment
Reduction in incontinence episodes will be collected. Women with ≥50% reduction in incontinence episodes will be considered positive responders
8 secondary outcomes
The severity of incontinence
Time frame: Change from baseline the severity of incontinence at the 6th week after the treatment
Symptom severity
Time frame: Change from baseline symptom severity at the 6th week after the treatment
Frequency of voiding, nocturia, number of pads
Time frame: Change from baseline Frequency of voiding, nocturia, number of pads at the 6th week after the treatment
The Quality of Life
Time frame: Change from baseline the Quality of Life at the 6th week after the treatment
Anxiety and Depression level
Time frame: Change from baseline anxiety and Depression level at the 6th week after the treatment
Assessment of sexual functions Assessment of sexual functions
Time frame: Change from baseline assessment of sexual functions at the 6th week after the treatment
Cure and improvement rates
Time frame: Change from baseline cure and improvement rates at the 6th week after the treatment
Treatment Satisfaction Level
Time frame: Change from baseline Treatment Satisfaction Level at the 6th week after the treatment
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 2 Dec 2024.
- Background: PubMed 27921161Bo K, Frawley HC, Haylen BT, Abramov Y, Almeida FG, Berghmans B, Bortolini M, Dumoulin C, Gomes M, McClurg D, Meijlink J, Shelly E, Trabuco E, Walker C, Wells A. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for the conservative and nonpharmacological management of female pelvic floor dysfunction. Int Urogynecol J. 2017 Feb;28(2):191-213. doi: 10.1007/s00192-016-3123-4. Epub 2016 Dec 5.
- BackgroundC.K. Harding, M.C. Lapitan, S. Arlandis, K. Bø, H. Cobussen-Boekhorst, E. Costantini, et al. The European Association of Urology (EAU) Guidelines. EAU Guidelines on Management of Non-Neurogenic Female Lower Urinary Tract Symptoms. In: EAU Guidelines, 2023 (Internet). Available online at: https://uroweb.org/guidelines/non-neurogenic-female-luts
- Background: PubMed 25623739Gormley EA, Lightner DJ, Faraday M, Vasavada SP; American Urological Association; Society of Urodynamics, Female Pelvic Medicine. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol. 2015 May;193(5):1572-80. doi: 10.1016/j.juro.2015.01.087. Epub 2015 Jan 23.
- Background: PubMed 26003239de Groat WC, Yoshimura N. Anatomy and physiology of the lower urinary tract. Handb Clin Neurol. 2015;130:61-108. doi: 10.1016/B978-0-444-63247-0.00005-5.
- Background: PubMed 25589273de Groat WC, Griffiths D, Yoshimura N. Neural control of the lower urinary tract. Compr Physiol. 2015 Jan;5(1):327-96. doi: 10.1002/cphy.c130056.
- Background: 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.
- Background: PubMed 37417565Yildiz N, Sonmez R. Transcutaneous medial plantar nerve stimulation in women with idiopathic overactive bladder. Investig Clin Urol. 2023 Jul;64(4):395-403. doi: 10.4111/icu.20230009.
- Background: PubMed 12425706Burgio KL, Goode PS, Locher JL, Umlauf MG, Roth DL, Richter HE, Varner RE, Lloyd LK. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA. 2002 Nov 13;288(18):2293-9. doi: 10.1001/jama.288.18.2293.
- Background: PubMed 35593007Tezer T, Yildiz N, Sarsan A, Alkan H. Short-term effect of magnetic stimulation added to bladder training in women with idiopathic overactive bladder: A prospective randomized controlled trial. Neurourol Urodyn. 2022 Aug;41(6):1380-1389. doi: 10.1002/nau.24957. Epub 2022 May 20.
- Background: PubMed 24118165Yamanishi T, Homma Y, Nishizawa O, Yasuda K, Yokoyama O; SMN-X Study Group. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol. 2014 Apr;21(4):395-400. doi: 10.1111/iju.12289. Epub 2013 Oct 14.
- Background: PubMed 32960999Firinci S, Yildiz N, Alkan H, Aybek Z. Which combination is most effective in women with idiopathic overactive bladder, including bladder training, biofeedback, and electrical stimulation? A prospective randomized controlled trial. Neurourol Urodyn. 2020 Nov;39(8):2498-2508. doi: 10.1002/nau.24522. Epub 2020 Sep 22.
- Background: PubMed 15270937O'Sullivan R, Karantanis E, Stevermuer TL, Allen W, Moore KH. Definition of mild, moderate and severe incontinence on the 24-hour pad test. BJOG. 2004 Aug;111(8):859-62. doi: 10.1111/j.1471-0528.2004.00211.x.
- 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.
Necmettin Yıldız, Prof. study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous medial plantar nerve stimulation (T-MPNS) in people with Urinary Bladder, Overactive, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 10 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: opening soon, as of the sponsor's last update on 2 Dec 2024. 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 Turkey (Türkiye). 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 Emre Bezmez, M.D. (+902584444747, emrebezmez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in incontinence episodes (time frame: Change from baseline Improvement in incontinence episodes at the 6th week after the treatment). 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 NCT06390488, which also lists 20 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 2 Dec 2024.