Urinary Bladder, OveractiveNCT06349694
Comparison of the Efficacy of Transcutaneos Nerve Stimulations in Women With Idiopathic Overactive Bladder
A study testing Transcutaneous MPN stimulation (T-MPNS) and Transcutaneous tibial nerve stimulation (TTNS) in people with Urinary Bladder, Overactive, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (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 MPN stimulation (T-MPNS) and Transcutaneous tibial nerve stimulation (TTNS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Apr 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 complate the voiding diary and QoL questionnaire
- The strength of PFM 3/5 and more
Who cannot join
- Women with stress urinary incontinence
- History of conservative therapy (BT, T-MPNS and TTNS/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/tibial nerve region on inner foot/ankle 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 urogyneceological surgery within 3 months
- Neurogenic bladder, signs of neurologic abnormalities at objective examination; history of the peripheral or central neurologic pathology
- Ultrasonographic evidence of PVR volume more than 100 ml
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Transcutaneos Medial Plantar Nerve and Tibial Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Controlled Trial
Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.
The main questions we aim to answer are:
Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
Read the detailed description
The main questions we aim to answer are:
Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Transcutaneous MPN stimulation (T-MPNS), Transcutaneous tibial nerve stimulation (TTNS), BT (Control group)
- Keywords
- Idiopatic overactive bladder, Transcutaneous medial plantar nerve stimulation, Transcutaneous tibial nerve stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous MPN stimulation (T-MPNS)Other
Transcutaneous MPN stimulation (T-MPNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.
Transcutaneous tibial nerve stimulation (TTNS)Other
Transcutaneous tibial nerve stimulation (TTNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control.
BT (Control group)Other
Conventional bladder training
| Study group | Role | What they receive |
|---|---|---|
| BT plus T-MPNS | Experimental | T-MPNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus T-MPNS treatment program Receives: Other: Transcutaneous MPN stimulation (T-MPNS) |
| BT plus TTNS | Experimental | TTNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus TTNS treatment program Receives: Other: Transcutaneous tibial nerve stimulation (TTNS) |
| BT (Control group) | Active comparator | Information about BT will be explained to patients for 30 min. Then written form about BT will be given to be implemented as a home program. Receives: Other: BT (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in incontinence episodes (positive response rate)
Reduction in incontinence episodes will be collected from the 3-day bladder diary. Woman with ≥50% reduction in incontinence episodes were considered positive responders
Measured: Change from baseline positive response rate at the 6th week after the treatment
Secondary outcomes (8)
The severity of incontinence
The 24-hour pad test will be carried out to evaluate the severity of incontinence
Measured: Change from baseline the 24-hour pad test at the 6th week after the treatment
Symptom severity
Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in women with OAB
Measured: Change from baseline Overactive Bladder Questionnaire (OAB-V8) 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 voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary at the 6th week after the treatment
Quality of life (IIQ7)
The Quality of Life-Incontinence Impact Questionnaire (IIQ7)
Measured: Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment
The Hospital Anxiety and Depression Scale (HAD)
The Hospital Anxiety and Depression Scale (HAD), developed by Zigmond and Snaith in 1983, with its validity and reliability study conducted in Turkey by Aydemir et al. in 1987, assesses anxiety and depression levels. It consists of 14 questions, seven for anxiety and seven for depression, scored on a four-point Likert scale. Scores are summed for each subscale: 1, 3, 5, 7, 9, 11, and 13 for anxiety, and 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 point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment
FSFI
In the evaluation of sexual function, the FSFI 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 FSFI score below 26.55 is indicative of sexual dysfunction
Measured: Change from baseline point of FSFI at the 6th week after the treatment
Cure-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 improvements at the 6th week after the treatment
Treatment satisfaction
The change of their urinary incontinence on a 5-point Likert scale (5, very satisfied; 1, very unsatisfied)
Measured: Change from baseline of their urinary incontinence on a 5-point Likert scale 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 posted5 Apr 2024
- Study start22 Apr 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 (19)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
- 60 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
- NCT06349694
- Sponsor's protocol ID
- PamukkaleU.ftr-NYıldız-001
- Status last verified
- Mar 2024
- First submitted
- 1 Apr 2024
- Last updated
- 5 Apr 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. Neurourol Urodyn. 2017 Feb;36(2):221-244. doi: 10.1002/nau.23107. Epub 2016 Dec 5.
PubMed 279181222. C.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 25623739Subak LL, Quesenberry CP, Posner SF, Cattolica E, Soghikian K. The effect of behavioral therapy on urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2002 Jul;100(1):72-8. doi: 10.1016/s0029-7844(02)01993-2.
PubMed 12100806Burgio 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 12425706de 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 37417565Lee HE, Cho SY, Lee S, Kim M, Oh SJ. Short-term Effects of a Systematized Bladder Training Program for Idiopathic Overactive Bladder: A Prospective Study. Int Neurourol J. 2013 Mar;17(1):11-7. doi: 10.5213/inj.2013.17.1.11. Epub 2013 Mar 31.
PubMed 23610706Schreiner L, dos Santos TG, Knorst MR, da Silva Filho IG. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J. 2010 Sep;21(9):1065-70. doi: 10.1007/s00192-010-1165-6. Epub 2010 May 11.
PubMed 20458465Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.
PubMed 23206722Tezer 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 32960999
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Transcutaneos Medial Plantar Nerve and Tibial Nerve Stimulation in Women With Idiopathic Overactive Bladder: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06349694
- Acronym / sponsor ID
- PamukkaleU.ftr-NYıldız-001
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Idiopatic overactive bladder, Transcutaneous medial plantar nerve stimulation, Transcutaneous tibial nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 5 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.
Our study is the first prospective randomized controlled trial that compares the effectiveness of transcutaneous medial plantar nerve stimulation (T-MPNS) and transcutaneous tibial nerve stimulation (TTNS) added to bladder training (BT) in women with idiopathic overactive bladder (OAB). İn this study, we aimed to assess the efficacy of T-MPNS and TTNS added to BT on quality of life (QoL) and clinical parameters asssociated with idiopathic OAB. In addition, preparation time for stimulation, treatment satisfaction and discomfort levels of the patients were evaluated.
The main questions we aim to answer are:
Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
Detailed description
The main questions we aim to answer are:
Is T-MPNS as effective as TTNS in the treatment of idiopathic OAB? For this purpose, we planned to compare transcutaneous applications of the tibial and plantar medial nerve in women with idiopathic OAB. 60 women with OAB will be randomized to 3 groups by using random number generator: BT program alone to Group 1 (n=20), BT plus T-MPNS to Group 2 (n=20), BT plus TTNS to Group 3 (n=20) will be applied.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BT plus T-MPNS | Experimental | Other: Transcutaneous MPN stimulation (T-MPNS)T-MPNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus T-MPNS treatment program |
| BT plus TTNS | Experimental | Other: Transcutaneous tibial nerve stimulation (TTNS)TTNS sessions will be performed twice a week for 6 weeks. Each session will be lasted 30 minutes. The intervention will be included a 12-session BT plus TTNS treatment program |
| BT (Control group) | Active comparator | Other: BT (Control group)Information about BT will be explained to patients for 30 min. Then written form about BT will be given to be implemented as a home program. |
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 complate the voiding diary and QoL questionnaire
- The strength of PFM 3/5 and more
Key exclusion criteria (10 listed)
- Women with stress urinary incontinence
- History of conservative therapy (BT, T-MPNS and TTNS/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/tibial nerve region on inner foot/ankle 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 MPN stimulation (T-MPNS)Transcutaneous MPN stimulation (T-MPNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control. | Other | BT plus T-MPNS |
| Transcutaneous tibial nerve stimulation (TTNS)Transcutaneous tibial nerve stimulation (TTNS) is the electrostimulation of the lumbosacral roots that produce an activation of the lumbosacral plexus that controls the visceral organs and the pelvic floor muscles, thereby improving bladder control. | Other | BT plus TTNS |
| BT (Control group)Conventional bladder training | Other | BT (Control group) |
Primary outcome
Improvement in incontinence episodes (positive response rate)
Time frame: Change from baseline positive response rate at the 6th week after the treatment
Reduction in incontinence episodes will be collected from the 3-day bladder diary. Woman with ≥50% reduction in incontinence episodes were considered positive responders
8 secondary outcomes
The severity of incontinence
Time frame: Change from baseline the 24-hour pad test at the 6th week after the treatment
Symptom severity
Time frame: Change from baseline Overactive Bladder Questionnaire (OAB-V8) at the 6th week after the treatment
Frequency of voiding, nocturia, number of pads
Time frame: Change from baseline voiding, nocturia, and the number of pads used will be collected from the 3-day bladder diary at the 6th week after the treatment
Quality of life (IIQ7)
Time frame: Change from baseline point of The Quality of Life-Incontinence Impact Questionnaire at the 6th week after the treatment
The Hospital Anxiety and Depression Scale (HAD)
Time frame: Change from baseline point of The Hospital Anxiety and Depression Scale (HAD) at the 6th week after the treatment
FSFI
Time frame: Change from baseline point of FSFI at the 6th week after the treatment
Cure-improvement rates
Time frame: Change from baseline cure and improvements at the 6th week after the treatment
Treatment satisfaction
Time frame: Change from baseline of their urinary incontinence on a 5-point Likert scale at the 6th week after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Background: PubMed 27918122Bo 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. Neurourol Urodyn. 2017 Feb;36(2):221-244. doi: 10.1002/nau.23107. Epub 2016 Dec 5.
- Background2. C.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 12100806Subak LL, Quesenberry CP, Posner SF, Cattolica E, Soghikian K. The effect of behavioral therapy on urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2002 Jul;100(1):72-8. doi: 10.1016/s0029-7844(02)01993-2.
- 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 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 23610706Lee HE, Cho SY, Lee S, Kim M, Oh SJ. Short-term Effects of a Systematized Bladder Training Program for Idiopathic Overactive Bladder: A Prospective Study. Int Neurourol J. 2013 Mar;17(1):11-7. doi: 10.5213/inj.2013.17.1.11. Epub 2013 Mar 31.
- Background: PubMed 20458465Schreiner L, dos Santos TG, Knorst MR, da Silva Filho IG. Randomized trial of transcutaneous tibial nerve stimulation to treat urge urinary incontinence in older women. Int Urogynecol J. 2010 Sep;21(9):1065-70. doi: 10.1007/s00192-010-1165-6. Epub 2010 May 11.
- Background: PubMed 23206722Booth J, Hagen S, McClurg D, Norton C, MacInnes C, Collins B, Donaldson C, Tolson D. A feasibility study of transcutaneous posterior tibial nerve stimulation for bladder and bowel dysfunction in elderly adults in residential care. J Am Med Dir Assoc. 2013 Apr;14(4):270-4. doi: 10.1016/j.jamda.2012.10.021. Epub 2012 Nov 30.
- 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. This study is not recruiting at the moment.
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 MPN stimulation (T-MPNS) and Transcutaneous tibial nerve stimulation (TTNS) 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: status not confirmed, as of the sponsor's last update on 5 Apr 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rabia Melis Gündoğan, M.d (+905544730153, r.gundogan@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 (positive response rate) (time frame: Change from baseline positive response rate 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 NCT06349694, which also lists 19 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 5 Apr 2024.