Idiopathic Overactive BladderNCT05387824
Tibial Nerve and Extracorporeal Magnetic Stimulation for Overactive Bladder
A study testing Magnetic stimulation -Armchair type MS • NovaMag NT-60, Electrical Stimulation- TTNS and Bladder Training in people with Idiopathic Overactive Bladder and Bladder Training, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Overactive bladder (OAB) syndrome is urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection. For the treatment of OAB; pharmacological and non-pharmacological methods are available. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Overactive Bladder, Bladder Training, Transcutaneous Tibial Nerve Stimulation
- What is being tested?
- Magnetic stimulation -Armchair type MS • NovaMag NT-60, Electrical Stimulation- TTNS and Bladder Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2022to 15 Nov 2022
- 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 90 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women over the age of 18 with clinical diagnosis of idiopathic OAB Urodynamically confirmed detrusor overactivity (the presence of detrusor contractions in the filling phase of saline cystometry)
- Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks Able to give written, informed consent Able to understand the precedures, 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
- History of BT, MS therapy
- Pregnancy or intention to become pregnant during the study Current vulvovaginitis or urinary tract infections or malignancy
- More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
- Cardiac pacemaker, implanted defibrillator, coronary artery stent
- Ongoing treatment for arrhythmia
- Lower abdominal pain or dysmenorrhea
Show all 11Show fewer
- yet to be diagnosed Electronic device or metallic implant applied to areas between the lumbar region and lower extremities
- Previous urogyneceological surgery within 3 months
- Ongoing surgical treatment or treatment with implantable devices for urinary incontinence or use of intrauterin copper devices
- 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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli, Kınıklı, 20100
Necmettin Yıldız, Professor MD, +905334147399, necmi74tr@hotmail.com
Saadet Nur Sena Öztekin, MD, +905434721066, senaoztekin@gmail.com
About this study
Official title: Comparison of the Efficacy of Transcutaneous Tibial Nerve Stimulation and Extracorporeal Magnetic Stimulation in Women With Idiopathic Overactive Bladder
Overactive bladder (OAB) syndrome is urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection. For the treatment of OAB; pharmacological and non-pharmacological methods are available. The availability and the continuation rate of pharmacological treatments are lower than non-pharmacological treatments due to side effects.
Non-pharmacologic treatment methods are evaluated in two groups as active and passive methods. Active methods which active participation of the patient is required during treatment are Pelvic floor muscle exercise (PFME), biofeedback assisted PFME, vaginal cones, while passive methods are Electrical Stimulation, extracorporeal Magnetic Stimulation (MStim) and Transcutaneous Tibial Nerve Stimulation (TTNS) techniques.
In this study, investigators aim to evaluate the effectiveness of TTNS and extracorporeal MStim, which are noninvasive methods, added to bladder training (BT) in women with OAB, with a prospective randomized controlled research method.
Read the detailed description
This study is a prospectively randomized, controlled trial. The trial will be held at Urogynecological Rehabilitation Unit of Pamukkale University, Physical Medicine and Rehabilitation Department between Nisan 2022 and October 2022. The local ethics committee approved the study (approvel no: 60116787-020/59365).
Participants will be informed about the purpose and contents of the study and all women give written consent to participate. By using a random number generator, all participants who include the study will be randomized into three groups as follows: The Group 1 will receive BT program alone, the Group 2 will be applied to BT plus TTNS, The Group 3 was applied to BT plus MStim.
Group 1: BT - Control group:
All women will be informed about BT for 30 minutes. Then it will be given as a written brochure to be implemented as a home program.
BT, consisting of four stages, will not contain any PFMT programs in anyone of three groups.
Group 2: BT plus TTNS:
Two self-adhesive surface electrodes will be positioned according to the protocol previously used with the negative electrode 2 cm behind the medial malleolus and positive electrode 10 cm proximal. Correct positioning will be determined by noting a hallux reaction (plantar flexion of great toe or fanning of all toes). The stimulation protocol will be delivered at fixed 20 Hz and pulse width 200 ms in continous mode in accordance with the PTNS stimulation protocol. The intensity of the stimulation current (range 0-50 mA) will be determined once correct positioning was established, according to the comfort level of the person. TTNS sessions will be performed twice a week for 6 weeks. Every session will be lasted 30 min. Treatment will consist of 12 sessions of stimulation.
Group 3: BT plus MStim:
Pariticipants will be told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MStim, the device will be set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature (10,13-15). When setting the device at each treatment session, participants will be interviewed so that they'll receive stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity). MStim will be applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MStim sessions will be performed by other physician.
- Conditions
- Idiopathic Overactive Bladder, Bladder Training, Transcutaneous Tibial Nerve Stimulation, Magnetic Stimulation
- Being tested
- Magnetic stimulation -Armchair type MS • NovaMag NT-60, Electrical Stimulation- TTNS, Bladder Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic stimulation -Armchair type MS • NovaMag NT-60Device
MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.
Electrical Stimulation- TTNSDevice
TTNS were performed 2 days a week, for 30 min a day, for a total of 12 sessions for 6 weeks.
Bladder TrainingBehavioural
Control group All women were informed about BT for 30 minutes. Then it was given as a written brochure to be implemented as a home program.
BT, consisting of four stages, did not contain any PFMT programs in two groups.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Bladder Training - Control group | Active comparator | BT, consisting of four stages, won't contain any PFMT programs in all groups. In these stages, including urgency supression strategies, it was aimed to delay urination, to inhibit detrusor contraction and to prevent urgency; by squeezing the PFM several times in a row (women will be encouraged to pause/ stop their work, sit down if possible, relax the entire body and squeeze PFM repeatedly), breathing deeply, giving their attention to another job for a while and self-motivating (I can do it, I can check the urination, etc.). Receives: Behavioral: Bladder Training |
| Group 2: Bladder Training + TTNS | Experimental | Two self-adhesive surface electrodes will be positioned according to the protocol which previously explained, with the negative electrode 2 cm behind the medial malleolus and positive electrode 10 cm proximal. Correct positioning wil be determined by noting a hallux reaction (plantar flexion of great toe or fanning of all toes). The stimulation protocol will be delivered at fixed 20 Hz and pulse width 200 ms in continous mode in accordance with the PTNS stimulation protocol. The intensity of the stimulation current (range 0-50 mA) will be determined once correct positioning are established, according to the comfort level of the person. TTNS sessions will be performed twice a week for 6 weeks. Every session will be lasted 30 min. Treatment will consist of 12 sessions of stimulation. Receives: Device: Electrical Stimulation- TTNS; Behavioral: Bladder Training |
| Group 3: Bladder Training + MStim | Experimental | Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MS, the device will be set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature. When setting the device at each treatment session, patients will be interviewed so that they receive the stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) . Receives: Device: Magnetic stimulation -Armchair type MS • NovaMag NT-60; Behavioral: Bladder Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence episodes
Patients with a 50% or greater reduction in incontinence episodes were consider positive responders
Measured: 6 weeks
Secondary outcomes (8)
Severity of incontinence
The 24-hour pad test was carried out to evaluate urinary loss.
Measured: 6 weeks
Nocturia
It was used "nocturia" from data collected with a 3-day bladder diary.
Measured: 6 weeks
Frequency
It was used "frequency" from data collected with a 3-day bladder diary.
Measured: 6 weeks
Number of pads
It was used "number of pads" from data collected with a 3-day bladder diary.
Measured: 6 weeks
Symptom severity
Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in patients with in the study. Minimum score is 0, maximum score is 40 and high scores mention worse outcome.
Measured: 6 weeks
QoL
The Incontinence Impact Questionnaire (IIQ-7) scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem. Minimum score is 0, maximum score is 21 and high scores mention worse outcome.
Measured: 6 weeks
improvement rate
The improvement was assessed in terms of 50% and more reduction in wet weight compared to baseline measurements in the 24-hour pad test.
Measured: 6 weeks
24-hour pad test (Cure)
In 24-hour pad test, 1.3 gr under of it was considered as a cure.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start2 Jun 2022
- Primary completion29 Oct 2022
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Overactive BladderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmettin Yildiz, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387824
- Sponsor's protocol ID
- sn 60116787-020/59365
- Status last verified
- Oct 2022
- First submitted
- 17 May 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildiz N, Oztekin SNS, Akkoc Y. Comparison of Magnetic and Transcutaenous Tibial Nerve Stimulation Added to Bladder Training for Overactive Bladder: A Randomized Controlled Trial. Int Urogynecol J. 2025 Dec;36(12):2379-2388. doi: 10.1007/s00192-025-06215-w. Epub 2025 Jul 7.
PubMed 40622410
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Transcutaneous Tibial Nerve Stimulation and Extracorporeal Magnetic Stimulation in Women With Idiopathic Overactive Bladder
- ClinicalTrials.gov ID
- NCT05387824
- Acronym / sponsor ID
- sn 60116787-020/59365
- Conditions
- Idiopathic Overactive Bladder, Bladder Training, Transcutaneous Tibial Nerve Stimulation, Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 29 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 24 May 2022 (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.
Overactive bladder (OAB) syndrome is urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection. For the treatment of OAB; pharmacological and non-pharmacological methods are available. The availability and the continuation rate of pharmacological treatments are lower than non-pharmacological treatments due to side effects.
Non-pharmacologic treatment methods are evaluated in two groups as active and passive methods. Active methods which active participation of the patient is required during treatment are Pelvic floor muscle exercise (PFME), biofeedback assisted PFME, vaginal cones, while passive methods are Electrical Stimulation, extracorporeal Magnetic Stimulation (MStim) and Transcutaneous Tibial Nerve Stimulation (TTNS) techniques.
In this study, investigators aim to evaluate the effectiveness of TTNS and extracorporeal MStim, which are noninvasive methods, added to bladder training (BT) in women with OAB, with a prospective randomized controlled research method.
Detailed description
This study is a prospectively randomized, controlled trial. The trial will be held at Urogynecological Rehabilitation Unit of Pamukkale University, Physical Medicine and Rehabilitation Department between Nisan 2022 and October 2022. The local ethics committee approved the study (approvel no: 60116787-020/59365).
Participants will be informed about the purpose and contents of the study and all women give written consent to participate. By using a random number generator, all participants who include the study will be randomized into three groups as follows: The Group 1 will receive BT program alone, the Group 2 will be applied to BT plus TTNS, The Group 3 was applied to BT plus MStim.
Group 1: BT - Control group:
All women will be informed about BT for 30 minutes. Then it will be given as a written brochure to be implemented as a home program.
BT, consisting of four stages, will not contain any PFMT programs in anyone of three groups.
Group 2: BT plus TTNS:
Two self-adhesive surface electrodes will be positioned according to the protocol previously used with the negative electrode 2 cm behind the medial malleolus and positive electrode 10 cm proximal. Correct positioning will be determined by noting a hallux reaction (plantar flexion of great toe or fanning of all toes). The stimulation protocol will be delivered at fixed 20 Hz and pulse width 200 ms in continous mode in accordance with the PTNS stimulation protocol. The intensity of the stimulation current (range 0-50 mA) will be determined once correct positioning was established, according to the comfort level of the person. TTNS sessions will be performed twice a week for 6 weeks. Every session will be lasted 30 min. Treatment will consist of 12 sessions of stimulation.
Group 3: BT plus MStim:
Pariticipants will be told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MStim, the device will be set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature (10,13-15). When setting the device at each treatment session, participants will be interviewed so that they'll receive stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity). MStim will be applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MStim sessions will be performed by other physician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Bladder Training - Control group | Active comparator | Behavioral: Bladder TrainingBT, consisting of four stages, won't contain any PFMT programs in all groups. In these stages, including urgency supression strategies, it was aimed to delay urination, to inhibit detrusor contraction and to prevent urgency; by squeezing the PFM several times in a row (women will be encouraged to pause/ stop their work, sit down if possible, relax the entire body and squeeze PFM repeatedly), breathing deeply, giving their attention to another job for a while and self-motivating (I can do it, I can check the urination, etc.). |
| Group 2: Bladder Training + TTNS | Experimental | Device: Electrical Stimulation- TTNS, Behavioral: Bladder TrainingTwo self-adhesive surface electrodes will be positioned according to the protocol which previously explained, with the negative electrode 2 cm behind the medial malleolus and positive electrode 10 cm proximal. Correct positioning wil be determined by noting a hallux reaction (plantar flexion of great toe or fanning of all toes). The stimulation protocol will be delivered at fixed 20 Hz and pulse width 200 ms in continous mode in accordance with the PTNS stimulation protocol. The intensity of the stimulation current (range 0-50 mA) will be determined once correct positioning are established, according to the comfort level of the person. TTNS sessions will be performed twice a week for 6 weeks. Every session will be lasted 30 min. Treatment will consist of 12 sessions of stimulation. |
| Group 3: Bladder Training + MStim | Experimental | Device: Magnetic stimulation -Armchair type MS • NovaMag NT-60, Behavioral: Bladder TrainingPatients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is in serted by this magnetic field, an eddy current flow is generated. This eddy current stimulates nerve or muscle of the pelvic floor. To apply MS, the device will be set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature. When setting the device at each treatment session, patients will be interviewed so that they receive the stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) . |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women over the age of 18 with clinical diagnosis of idiopathic OAB Urodynamically confirmed detrusor overactivity (the presence of detrusor contractions in the filling phase of saline cystometry)
- Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks Able to give written, informed consent Able to understand the precedures, 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 (11 listed)
- History of BT, MS therapy
- Pregnancy or intention to become pregnant during the study Current vulvovaginitis or urinary tract infections or malignancy
- More than stage 2 according to the pelvic organ prolapse quantification (POP-Q)
- Cardiac pacemaker, implanted defibrillator, coronary artery stent
- Ongoing treatment for arrhythmia
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 |
|---|---|---|
| Magnetic stimulation -Armchair type MS • NovaMag NT-60MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. | Device | Group 3: Bladder Training + MStim |
| Electrical Stimulation- TTNSTTNS were performed 2 days a week, for 30 min a day, for a total of 12 sessions for 6 weeks. | Device | Group 2: Bladder Training + TTNS |
| Bladder TrainingControl group All women were informed about BT for 30 minutes. Then it was given as a written brochure to be implemented as a home program. BT, consisting of four stages, did not contain any PFMT programs in two groups. | Behavioural | Group 1: Bladder Training - Control group, Group 2: Bladder Training + TTNS, Group 3: Bladder Training + MStim |
Primary outcome
Incontinence episodes
Time frame: 6 weeks
Patients with a 50% or greater reduction in incontinence episodes were consider positive responders
8 secondary outcomes
Severity of incontinence
Time frame: 6 weeks
Nocturia
Time frame: 6 weeks
Frequency
Time frame: 6 weeks
Number of pads
Time frame: 6 weeks
Symptom severity
Time frame: 6 weeks
QoL
Time frame: 6 weeks
improvement rate
Time frame: 6 weeks
24-hour pad test (Cure)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Derived from this study: PubMed 40622410Yildiz N, Oztekin SNS, Akkoc Y. Comparison of Magnetic and Transcutaenous Tibial Nerve Stimulation Added to Bladder Training for Overactive Bladder: A Randomized Controlled Trial. Int Urogynecol J. 2025 Dec;36(12):2379-2388. doi: 10.1007/s00192-025-06215-w. Epub 2025 Jul 7.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic stimulation -Armchair type MS • NovaMag NT-60, Electrical Stimulation- TTNS and Bladder Training in people with Idiopathic Overactive Bladder and Bladder Training, 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 2 inclusion and 11 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 1 Nov 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence episodes (time frame: 6 weeks). 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 NCT05387824, which also lists 1 linked publication.
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 1 Nov 2022.