Multiple SclerosisNCT06263556
Effectiveness of TTNS in MS Patients With Lower Urinary Track Symptoms
A study testing Pelvic floor exercises and Transcutaneous posterior tibial nerve stimulation in people with Multiple Sclerosis and Lower Urinary Tract Symptoms, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis, Lower Urinary Tract Symptoms
- What is being tested?
- Pelvic floor exercises and Transcutaneous posterior tibial nerve stimulation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jan 2024to 5 Dec 2024
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteer Adults (Age 18-50)
- Diagnosis of Multiple Sclerosis
- Expanded Disability Status Scale (EDSS) 0-6,5
- Lower urinary track symptoms (Urinary incontinence, urgency, nocturia and/or urinary frequency)
- Diagnosis of bladder disfunction with Urodynamic study within 1 months
Who cannot join
- Age less then 18
- Pacemaker or implantable defibrillator usage
- Diabetic polyuria
- Bleeding diathesis or severe bleeding tendency
- Pelvic floor disfunction or nerve damage effecting tibial nerve
- Currently pregnant or planning pregnancy
Show all 17Show fewer
- Active urinary infection
- Active malignancy
- Severe mental disability
- Cognitive deficit
- Expanded Disability Status Scale (EDSS) greater than or equal to 7
- Unable to attend to TPTNS treatment 2 times a week
- Urodynamic findings of bladder outlet obstruction
- Surgical history because of urinary incontinence
- Urologic surgical history because of lower urinary track disfunction or symptoms
- Diagnosis of prostatic enlargement
- Diagnosis of pelvic organ prolapse
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul
Sibel CAGLAR, +905333365651, dr.sibelcaglar@gmail.com
Arda Can KASAP, +905384590119, drardakasap@gmail.com
About this study
Official title: Effectiveness of Transcutaneous Posterior Tibial Nerve Stimulation in Multiple Sclerosis Patients With Lower Urinary Track Symptoms: A Sham Controlled Prospective Randomized Controlled Study
Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.
Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS.
Read the detailed description
This is a single-centered, prospective, single blind, randomized controlled study of patients with MS who suffer lower urinary track symptoms. All patients will be informed of the details of all the procedures and of the details of the study. After the written informed consent is obtained, patients will be distributed to two equal groups using randomized number table.
At the beginning and end of the study, post-void residue (PVR) will be calculated with ultrasonography, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life( I-QOL), 3 day bladder diary (number of urination, urge, incontinence, nocturia) forms will be administered.
Patients will be evaluated via PVR, urodynamic measurements, ICIQ-SF, I-QOL and bladder diary.
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms
- Being tested
- Pelvic floor exercises, Transcutaneous posterior tibial nerve stimulation, Sham stimulation
- Keywords
- Multiple Sclerosis, Lower Urinary Track Symptoms, LUTS, Posterior tibial nerve stimulation, TPTNS, TTNS
- Medical subject headings
- Multiple Sclerosis, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor exercisesBehavioural
Patients will be informed about pelvic floor muscles functions and written material will be given for home training.
Exercise program will be planned as 1 set, 3 times per day. Each set will include 10 pelvic floor contractions. Patient will be instructed to squeeze their pelvic muscles and keep them contracted for 8 seconds. Due to fatigue and spasticity patients may experience, patients will set their own resting periods between contractions. Patients will be told to avoid contracting abdominal and gluteal muscles and avoid holding their breathe during the exercise.
Patients will be instructed to perform exercise as following:
- Lie on your back. Take a deep breathe. Relax your abdominal muscles as you breathe out.
- Focus on your pelvic floor muscles. Squeeze your muscles as you are trying to stop the flow of your urine and stay contracted for 8 seconds, then relax.
- Repeat when you feel ready. You need to repeat this 10 times.
- Repeat this exercise 3 times per day
Transcutaneous posterior tibial nerve stimulationDevice
Patients in TTSN group will receive posterior tibial nerve stimulation based on the protocol explained before.
Sham stimulationDevice
Patients in sham stimulation group will receive sham stimulation based on the protocol explained before.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor exercises and Transcutaneous tibial nerve stimulation | Experimental | Patients in this group will receive pelvic floor exercise program as described before and transcutaneous tibial nerve stimulation (TTNS).
The intervention will comprise 12 session of transcutaneous tibial nerve stimulation (Twice a week, for 6 continuous weeks). Each session will last 30 minutes. Two self adhesive surface electrodes will be positioned according to the protocol used by Booth et al and Sonmez et al, with the negative electrode 2 cm behind the medial malleolus, and positive electrode 10 cm proximal to it. Correct positioning will be determined by noting a hallux reaction (plantar flexion of great toe). Stimulation will be delivered at fixed frequency of 20 Hz and pulse width of 200 ms. The intensity level of the stimulation current (range 0-50 mA) will be determined once hallux reaction is observed, according to patient's tolerance. Receives: Behavioral: Pelvic floor exercises; Device: Transcutaneous posterior tibial nerve stimulation |
| Pelvic floor exercises and Sham Stimulation | Sham comparator | Patients in this group will receive pelvic floor exercise program as described before and Sham stimulation.
The intervention will comprise 12 session of sham stimulation. (Twice a week, for 6 continuous weeks) Each session will last 30 minutes. Two self adhesive surface electrodes will be positioned According to the protocol used by Booth et al, with the negative electrode 2 cm behind the lateral malleolus, and positive electrode 10 cm proximal to it, therefore avoiding the posterior tibial nerve. The stimulation current will be reduced to 2 mA once the tingling sensation is obtained and patients will be informed that they may not feel electrical sensation during the session. Stimulation will be delivered at fixed frequency of 20 Hz and pulse width of 200 ms.
If willing, patients in this group will receive TTNS treatment after the study is completed. Receives: Behavioral: Pelvic floor exercises; Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence Quality of Life (I-QOL)
I-QOL is used for evaluation of quality of life in patients with incontinence. It comprises 22 questions presented under three subscales: limiting behavior, psychosocial impact, and social embarrassment. All the questions are based on a five-point Likert scale (1 = a lot, 2 = quite a bit, 3 = moderate, 4 = a little, and 5 = not at all). Points obtained by each question are added together which results in a total point of 0 to 110. This total point is then recalculated to take a value between 0-100 for better understand. Higher scores indicate a better quality of life. Validation of turkish version is available.
Measured: 6 weeks (Before and after the treatment)
Secondary outcomes (3)
Post-void residue (PVR)
Post-void residue (PVR) will be calculated with ultrasonography. Evaluation will be made by same person in all patients after urination, in supine position transabdominally with 2-5 Mhz convex probe using E-Saote Mylab Seven (Italy) device.
Measured: 6 weeks (Before and after the treatment)
Bladder diary
2 or 3 day bladder diary is recommended by European Association of Urology in patients with lower urinary track symptoms. Urination frequency, urgency, incontinence and nocturia will be evaluated using 3 day bladder diary.
Measured: 6 weeks (Before and after the treatment)
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
ICIQ-SF allows the assessment of incontinence's severity, frequency and its impact on quality of life. ICIQ-SF scoring is also a practical and reliable method for baseline and post-treatment evaluation of patients with urge incontinence. It contains six questions. First and second questions are about demographics and the sixth question is about conditions that lead to incontinence. First, second and sixth questions have no point value. Total score varies between 0 and 21 and is obtained by adding third, fourth and fifth question's points. Higher scores indicate greater problems with incontinence. Validation of turkish version is available.
Measured: 6 weeks (Before and 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 posted16 Feb 2024
- Study start17 Jan 2024
- Primary completion5 Nov 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Model description
- Patients will be randomized and assigned to either group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sibel Caglar Okur, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Sibel CAGLAR, Principal investigator, Bakirkoy Dr. Sadi Konuk Research and Training HospitalArda can Kasap, Study chair, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263556
- Sponsor's protocol ID
- 2023/389
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kabay SC, Yucel M, Kabay S. Acute effect of posterior tibial nerve stimulation on neurogenic detrusor overactivity in patients with multiple sclerosis: urodynamic study. Urology. 2008 Apr;71(4):641-5. doi: 10.1016/j.urology.2007.11.135.
PubMed 18387393Perez DC, Chao CW, Jimenez LL, Fernandez IM, de la Llave Rincon AI. Pelvic floor muscle training adapted for urinary incontinence in multiple sclerosis: a randomized clinical trial. Int Urogynecol J. 2020 Feb;31(2):267-275. doi: 10.1007/s00192-019-03993-y. Epub 2019 Jun 10.
PubMed 31183535Celiker Tosun O, Kaya Mutlu E, Ergenoglu AM, Yeniel AO, Tosun G, Malkoc M, Askar N, Itil IM. Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):525-37. doi: 10.1177/0269215514546768. Epub 2014 Aug 20.
PubMed 25142280Booth 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 23206722Sonmez 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 33429090Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
PubMed 15227649Cetinel B, Ozkan B, Can G. The validation study of ICIQ-SF Turkish version. Turkish J Urol 2004;30(3):332-338.
Seckiner I, Yesilli C, Mungan NA, Aykanat A, Akduman B. Correlations between the ICIQ-SF score and urodynamic findings. Neurourol Urodyn. 2007;26(4):492-494. doi: 10.1002/nau.20389.
PubMed 17304520Wagner TH, Patrick DL, Bavendam TG, Martin ML, Buesching DP. Quality of life of persons with urinary incontinence: development of a new measure. Urology. 1996 Jan;47(1):67-71; discussion 71-2. doi: 10.1016/s0090-4295(99)80384-7.
PubMed 8560665Patrick DL, Martin ML, Bushnell DM, Yalcin I, Wagner TH, Buesching DP. Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology. 1999 Jan;53(1):71-6. doi: 10.1016/s0090-4295(98)00454-3.
PubMed 9886591Ozerdogan N, Beji NK, Yalcin O. Urinary incontinence: its prevalence, risk factors and effects on the quality of life of women living in a region of Turkey. Gynecol Obstet Invest. 2004;58(3):145-50. doi: 10.1159/000079422. Epub 2004 Jun 29.
PubMed 15237249Eyigor S, Karapolat H, Akkoc Y, Yesil H, Ekmekci O. Quality of life in patients with multiple sclerosis and urinary disorders: reliability and validity of Turkish-language version of Incontinence Quality of Life Scale. J Rehabil Res Dev. 2010;47(1):67-71. doi: 10.1682/jrrd.2009.08.0132.
PubMed 20437328Groen J, Pannek J, Castro Diaz D, Del Popolo G, Gross T, Hamid R, Karsenty G, Kessler TM, Schneider M, 't Hoen L, Blok B. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2016 Feb;69(2):324-33. doi: 10.1016/j.eururo.2015.07.071. Epub 2015 Aug 22.
PubMed 26304502Nambiar AK, Bosch R, Cruz F, Lemack GE, Thiruchelvam N, Tubaro A, Bedretdinova DA, Ambuhl D, Farag F, Lombardo R, Schneider MP, Burkhard FC. EAU Guidelines on Assessment and Nonsurgical Management of Urinary Incontinence. Eur Urol. 2018 Apr;73(4):596-609. doi: 10.1016/j.eururo.2017.12.031. Epub 2018 Feb 3.
PubMed 29398262Roehrborn CG, Peters PC. Can transabdominal ultrasound estimation of postvoiding residual (PVR) replace catheterization? Urology. 1988 May;31(5):445-9. doi: 10.1016/0090-4295(88)90746-7.
PubMed 3284155
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcutaneous Posterior Tibial Nerve Stimulation in Multiple Sclerosis Patients With Lower Urinary Track Symptoms: A Sham Controlled Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06263556
- Acronym / sponsor ID
- 2023/389
- Conditions
- Multiple Sclerosis, Lower Urinary Tract Symptoms
- Keywords
- Multiple Sclerosis, Lower Urinary Track Symptoms, LUTS, Posterior tibial nerve stimulation, TPTNS, TTNS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 5 Nov 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 16 Feb 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.
Multiple sclerosis (MS) is the most common inflammatory disease of the central nervous system. It is characterized with demyelinated plaques affecting subcortical, brain stem, and spinal cord nerve fibers. During the course of the disease, with the affection myelinated nerve tracks, lower urinary track symptoms may occur. 50-90% of the MS patients experience lower urinary track symptoms (LUTS) such as urinary incontinence, urgency, nocturia and/or urinary frequency during the at one point of their life.
Aim of this study is to determine the effects of transcutaneous tibial nerve stimulation (TTNS) on symptoms and quality of life in MS patients with LUTS.
Detailed description
This is a single-centered, prospective, single blind, randomized controlled study of patients with MS who suffer lower urinary track symptoms. All patients will be informed of the details of all the procedures and of the details of the study. After the written informed consent is obtained, patients will be distributed to two equal groups using randomized number table.
At the beginning and end of the study, post-void residue (PVR) will be calculated with ultrasonography, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Quality of Life( I-QOL), 3 day bladder diary (number of urination, urge, incontinence, nocturia) forms will be administered.
Patients will be evaluated via PVR, urodynamic measurements, ICIQ-SF, I-QOL and bladder diary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized and assigned to either group.
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor exercises and Transcutaneous tibial nerve stimulation | Experimental | Behavioral: Pelvic floor exercises, Device: Transcutaneous posterior tibial nerve stimulationPatients in this group will receive pelvic floor exercise program as described before and transcutaneous tibial nerve stimulation (TTNS). The intervention will comprise 12 session of transcutaneous tibial nerve stimulation (Twice a week, for 6 continuous weeks). Each session will last 30 minutes. Two self adhesive surface electrodes will be positioned according to the protocol used by Booth et al and Sonmez et al, with the negative electrode 2 cm behind the medial malleolus, and positive electrode 10 cm proximal to it. Correct positioning will be determined by noting a hallux reaction (plantar flexion of great toe). Stimulation will be delivered at fixed frequency of 20 Hz and pulse width of 200 ms. The intensity level of the stimulation current (range 0-50 mA) will be determined once hallux reaction is observed, according to patient's tolerance. |
| Pelvic floor exercises and Sham Stimulation | Sham comparator | Behavioral: Pelvic floor exercises, Device: Sham stimulationPatients in this group will receive pelvic floor exercise program as described before and Sham stimulation. The intervention will comprise 12 session of sham stimulation. (Twice a week, for 6 continuous weeks) Each session will last 30 minutes. Two self adhesive surface electrodes will be positioned According to the protocol used by Booth et al, with the negative electrode 2 cm behind the lateral malleolus, and positive electrode 10 cm proximal to it, therefore avoiding the posterior tibial nerve. The stimulation current will be reduced to 2 mA once the tingling sensation is obtained and patients will be informed that they may not feel electrical sensation during the session. Stimulation will be delivered at fixed frequency of 20 Hz and pulse width of 200 ms. If willing, patients in this group will receive TTNS treatment after the study is completed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Volunteer Adults (Age 18-50)
- Diagnosis of Multiple Sclerosis
- Expanded Disability Status Scale (EDSS) 0-6,5
- Lower urinary track symptoms (Urinary incontinence, urgency, nocturia and/or urinary frequency)
- Diagnosis of bladder disfunction with Urodynamic study within 1 months
Key exclusion criteria (17 listed)
- Age less then 18
- Pacemaker or implantable defibrillator usage
- Diabetic polyuria
- Bleeding diathesis or severe bleeding tendency
- Pelvic floor disfunction or nerve damage effecting tibial nerve
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 |
|---|---|---|
| Pelvic floor exercisesPatients will be informed about pelvic floor muscles functions and written material will be given for home training. Exercise program will be planned as 1 set, 3 times per day. Each set will include 10 pelvic floor contractions. Patient will be instructed to squeeze their pelvic muscles and keep them contracted for 8 seconds. Due to fatigue and spasticity patients may experience, patients will set their own resting periods between contractions. Patients will be told to avoid contracting abdominal and gluteal muscles and avoid holding their breathe during the exercise. Patients will be instructed to perform exercise as following: 1. Lie on your back. Take a deep breathe. Relax your abdominal muscles as you breathe out. 2. Focus on your pelvic floor muscles. Squeeze your muscles as you are trying to stop the flow of your urine and stay contracted for 8 seconds, then relax. 3. Repeat when you feel ready. You need to repeat this 10 times. 4. Repeat this exercise 3 times per day | Behavioural | Pelvic floor exercises and Sham Stimulation, Pelvic floor exercises and Transcutaneous tibial nerve stimulation |
| Transcutaneous posterior tibial nerve stimulationPatients in TTSN group will receive posterior tibial nerve stimulation based on the protocol explained before. | Device | Pelvic floor exercises and Transcutaneous tibial nerve stimulation |
| Sham stimulationPatients in sham stimulation group will receive sham stimulation based on the protocol explained before. | Device | Pelvic floor exercises and Sham Stimulation |
Primary outcome
Incontinence Quality of Life (I-QOL)
Time frame: 6 weeks (Before and after the treatment)
I-QOL is used for evaluation of quality of life in patients with incontinence. It comprises 22 questions presented under three subscales: limiting behavior, psychosocial impact, and social embarrassment. All the questions are based on a five-point Likert scale (1 = a lot, 2 = quite a bit, 3 = moderate, 4 = a little, and 5 = not at all). Points obtained by each question are added together which results in a total point of 0 to 110. This total point is then recalculated to take a value between 0-100 for better understand. Higher scores indicate a better quality of life. Validation of turkish version is available.
3 secondary outcomes
Post-void residue (PVR)
Time frame: 6 weeks (Before and after the treatment)
Bladder diary
Time frame: 6 weeks (Before and after the treatment)
International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time frame: 6 weeks (Before and 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 16 Feb 2024.
- Background: PubMed 18387393Kabay SC, Yucel M, Kabay S. Acute effect of posterior tibial nerve stimulation on neurogenic detrusor overactivity in patients with multiple sclerosis: urodynamic study. Urology. 2008 Apr;71(4):641-5. doi: 10.1016/j.urology.2007.11.135.
- Background: PubMed 31183535Perez DC, Chao CW, Jimenez LL, Fernandez IM, de la Llave Rincon AI. Pelvic floor muscle training adapted for urinary incontinence in multiple sclerosis: a randomized clinical trial. Int Urogynecol J. 2020 Feb;31(2):267-275. doi: 10.1007/s00192-019-03993-y. Epub 2019 Jun 10.
- Background: PubMed 25142280Celiker Tosun O, Kaya Mutlu E, Ergenoglu AM, Yeniel AO, Tosun G, Malkoc M, Askar N, Itil IM. Does pelvic floor muscle training abolish symptoms of urinary incontinence? A randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):525-37. doi: 10.1177/0269215514546768. Epub 2014 Aug 20.
- 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.
- 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 15227649Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
- BackgroundCetinel B, Ozkan B, Can G. The validation study of ICIQ-SF Turkish version. Turkish J Urol 2004;30(3):332-338.
- Background: PubMed 17304520Seckiner I, Yesilli C, Mungan NA, Aykanat A, Akduman B. Correlations between the ICIQ-SF score and urodynamic findings. Neurourol Urodyn. 2007;26(4):492-494. doi: 10.1002/nau.20389.
- Background: PubMed 8560665Wagner TH, Patrick DL, Bavendam TG, Martin ML, Buesching DP. Quality of life of persons with urinary incontinence: development of a new measure. Urology. 1996 Jan;47(1):67-71; discussion 71-2. doi: 10.1016/s0090-4295(99)80384-7.
- Background: PubMed 9886591Patrick DL, Martin ML, Bushnell DM, Yalcin I, Wagner TH, Buesching DP. Quality of life of women with urinary incontinence: further development of the incontinence quality of life instrument (I-QOL). Urology. 1999 Jan;53(1):71-6. doi: 10.1016/s0090-4295(98)00454-3.
- Background: PubMed 15237249Ozerdogan N, Beji NK, Yalcin O. Urinary incontinence: its prevalence, risk factors and effects on the quality of life of women living in a region of Turkey. Gynecol Obstet Invest. 2004;58(3):145-50. doi: 10.1159/000079422. Epub 2004 Jun 29.
- Background: PubMed 20437328Eyigor S, Karapolat H, Akkoc Y, Yesil H, Ekmekci O. Quality of life in patients with multiple sclerosis and urinary disorders: reliability and validity of Turkish-language version of Incontinence Quality of Life Scale. J Rehabil Res Dev. 2010;47(1):67-71. doi: 10.1682/jrrd.2009.08.0132.
- 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.
Sibel CAGLAR principal investigator
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Arda can Kasap study chair
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor exercises and Transcutaneous posterior tibial nerve stimulation in people with Multiple Sclerosis and Lower Urinary Tract Symptoms, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital 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 17 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 16 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sibel CAGLAR (+905333365651, dr.sibelcaglar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Quality of Life (I-QOL) (time frame: 6 weeks (Before and 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 NCT06263556, which also lists 15 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 16 Feb 2024.