Overactive Bladder SyndromeNCT07171424

Moving Beyond p-Values: MCID for OAB-V8 8 and ICIQ-SF in Patients With OAB

A study testing Behavioral therapy and transcutaneous posterior tibial nerve stimulation in people with Overactive Bladder Syndrome, run by Artvin Coruh University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this study was to determine the Minimal Clinically Important Difference (MCID) for the Overactive Bladder Questionnaire-Version 8 (OAB-V8) and the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) in people with Overactive Bladder Syndrome (OAB). Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Overactive Bladder Syndrome
What is being tested?: Behavioral therapy and transcutaneous posterior tibial nerve stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2026to 30 Jun 2026
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

individuals diagnosed with urge and mixed urinary incontinence symptoms or with OAB symptoms only (no history of urinary incontinence),
women over 18 years of age.

Who cannot join

patients who did not give consent to participate in the study,
not understanding the instructions given by the researcher,
pregnancy or planning a pregnancy in the near future,
urinary tract infection or kidney stones,
pelvic organ prolapse of grade II or higher,
stress-type urinary incontinence,

Show all 10Show fewer

neurogenic bladder,
use of a pacemaker,
epilepsy,
peripheral neuropathy.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Prof. Dr. Cemil Taşçıoğlu City Hospital
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Moving Beyond p-Values: Minimal Clinically Important Difference for Overactive Bladder Questionnaire - Version 8 and International Consultation on Incontinence Questionnaire - Short Form in Patients With Overactive Bladder Syndrome

Read the detailed description

104 patients with OAB will receive common behavioral therapy and transcutaneous posterior tibial nerve stimulation (TPTNS) for 12 weeks. OAB-related symptoms and quality of life (QoL) will be assessed with the OAB-V8 and ICIQ-SF baseline and post-intervention. The receiver operating characteristic (ROC) analysis and the Gamma coefficient will be employed to determine sensitivity.

Conditions: Overactive Bladder Syndrome
Being tested: Behavioral therapy and transcutaneous posterior tibial nerve stimulation
Keywords: overactive bladder, minimal clinically important difference, urinary incontinence, quality of life, ROC curve
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.

Behavioral therapy and transcutaneous posterior tibial nerve stimulationOther
Behavioral therapy included appropriate fluid intake, bladder training, habit training, pelvic floor muscle exercises (Kegel exercises), prompted voiding, and scheduled voiding. TPTNS will be applied in a biphasic square waveform with a frequency of 20 Hz and 200 cycles/sec in 30-minute sessions. The current intensity will be varied between 0.5-20 mA according to the patient's pain threshold.

Study groups in NCT07171424
Study group	Role	What they receive
Experimental: Behavioral therapy and transcutaneous posterior tibial nerve stimulation	Experimental	Patients with OAB will receive behavioral therapy and TPTNS one day a week for 12 weeks as previously recommended. Receives: Other: Behavioral therapy and transcutaneous posterior tibial nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Overactive Bladder Questionnaire-Version 8 (OAB-V8)
On this scale, which ranges from 0 to 40 points, higher scores are associated with greater symptom severity.
Measured: Baseline
Overactive Bladder Questionnaire-Version 8 (OAB-V8)
On this scale, which ranges from 0 to 40 points, higher scores are associated with greater symptom severity.
Measured: After the 12-week intervention

Secondary outcomes (2)

International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)
The total score of the scale ranges from 0 to 21, with higher scores indicating more severe symptoms. It measures the frequency, severity, and impact of OAB through three main questions. An additional open-ended question allows patients to describe their symptoms.
Measured: Baseline
International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)
The total score of the scale ranges from 0 to 21, with higher scores indicating more severe symptoms. It measures the frequency, severity, and impact of OAB through three main questions. An additional open-ended question allows patients to describe their symptoms.
Measured: After the 12-week intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202630 Jun 2026

First posted12 Sep 2025
Study start1 Jan 2026
Primary completion30 May 2026
Study completion30 Jun 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Overactive Bladder SyndromeStudies 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: Not applicable
Intervention model: Single group
Model description: In this prospective study, one treatment group was formed to receive behavioral therapy and transcutaneous posterior tibial nerve stimulation (TPTNS).
Masking: None (open label)
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07171424
Sponsor's protocol ID: MCID-2
Status last verified: Aug 2026
First submitted: 6 Sep 2025
Last updated: 28 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Chiengthong K, Bunyavejchevin S. Efficacy of Erbium YAG laser treatment in overactive bladder syndrome: a randomized controlled trial. Menopause. 2023 Apr 1;30(4):414-420. doi: 10.1097/GME.0000000000002159. Epub 2023 Feb 27.
PubMed 36854167
Reynolds WS, Fowke J, Dmochowski R. The Burden of Overactive Bladder on US Public Health. Curr Bladder Dysfunct Rep. 2016 Mar;11(1):8-13. doi: 10.1007/s11884-016-0344-9. Epub 2016 Jan 23.
PubMed 27057265
Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
PubMed 31039103
Yang DY, Zhao LN, Qiu MX. Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation. Medicine (Baltimore). 2021 May 21;100(20):e25941. doi: 10.1097/MD.0000000000025941.
PubMed 34011072
Abrams P, Smith AP, Cotterill N. The impact of urinary incontinence on health-related quality of life (HRQoL) in a real-world population of women aged 45-60 years: results from a survey in France, Germany, the UK and the USA. BJU Int. 2015 Jan;115(1):143-52. doi: 10.1111/bju.12852. Epub 2014 Aug 16.
PubMed 24958472
Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94. doi: 10.1007/BF02850085.
PubMed 16418145
Avery 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 15227649
Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 2000 May;53(5):459-68. doi: 10.1016/s0895-4356(99)00206-1.
PubMed 10812317
Frawley H, Shelly B, Morin M, Bernard S, Bo K, Digesu GA, Dickinson T, Goonewardene S, McClurg D, Rahnama'i MS, Schizas A, Slieker-Ten Hove M, Takahashi S, Voelkl Guevara J. An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment. Neurourol Urodyn. 2021 Jun;40(5):1217-1260. doi: 10.1002/nau.24658. Epub 2021 Apr 12.
PubMed 33844342
Hu JS, Pierre EF. Urinary Incontinence in Women: Evaluation and Management. Am Fam Physician. 2019 Sep 15;100(6):339-348.
PubMed 31524367
Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.
PubMed 30311692
Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. doi: 10.1177/0363546509354163. Epub 2009 Dec 31.
PubMed 20044494
Lehman LA, Velozo CA. Ability to detect change in patient function: responsiveness designs and methods of calculation. J Hand Ther. 2010 Oct-Dec;23(4):361-70; quiz 371. doi: 10.1016/j.jht.2010.05.003. Epub 2010 Jul 17.
PubMed 20638823

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
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All Overactive Bladder Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Moving Beyond p-Values: Minimal Clinically Important Difference for Overactive Bladder Questionnaire - Version 8 and International Consultation on Incontinence Questionnaire - Short Form in Patients With Overactive Bladder Syndrome
ClinicalTrials.gov ID: NCT07171424
Acronym / sponsor ID: MCID-2
Conditions: Overactive Bladder Syndrome
Keywords: overactive bladder, minimal clinically important difference, urinary incontinence, quality of life, ROC curve
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Artvin Coruh UniversityUniversity, hospital or other
Study start: 1 Jan 2026 (actual)
Primary completion: 30 May 2026 (actual)
Study completion: 30 Jun 2026 (actual)
First posted: 12 Sep 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: In this prospective study, one treatment group was formed to receive behavioral therapy and transcutaneous posterior tibial nerve stimulation (TPTNS).

Arm	Type	Receives
Experimental: Behavioral therapy and transcutaneous posterior tibial nerve stimulation	Experimental	Other: Behavioral therapy and transcutaneous posterior tibial nerve stimulationPatients with OAB will receive behavioral therapy and TPTNS one day a week for 12 weeks as previously recommended.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

individuals diagnosed with urge and mixed urinary incontinence symptoms or with OAB symptoms only (no history of urinary incontinence),
women over 18 years of age.

Key exclusion criteria (10 listed)

patients who did not give consent to participate in the study,
not understanding the instructions given by the researcher,
pregnancy or planning a pregnancy in the near future,
urinary tract infection or kidney stones,
pelvic organ prolapse of grade II or higher,

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
Behavioral therapy and transcutaneous posterior tibial nerve stimulationBehavioral therapy included appropriate fluid intake, bladder training, habit training, pelvic floor muscle exercises (Kegel exercises), prompted voiding, and scheduled voiding. TPTNS will be applied in a biphasic square waveform with a frequency of 20 Hz and 200 cycles/sec in 30-minute sessions. The current intensity will be varied between 0.5-20 mA according to the patient's pain threshold.	Other	Experimental: Behavioral therapy and transcutaneous posterior tibial nerve stimulation

Primary outcome

Overactive Bladder Questionnaire-Version 8 (OAB-V8)
Time frame: Baseline
On this scale, which ranges from 0 to 40 points, higher scores are associated with greater symptom severity.
Overactive Bladder Questionnaire-Version 8 (OAB-V8)
Time frame: After the 12-week intervention
On this scale, which ranges from 0 to 40 points, higher scores are associated with greater symptom severity.

2 secondary outcomes

International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)
Time frame: Baseline
International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF)
Time frame: After the 12-week intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
Background: PubMed 36854167Chiengthong K, Bunyavejchevin S. Efficacy of Erbium YAG laser treatment in overactive bladder syndrome: a randomized controlled trial. Menopause. 2023 Apr 1;30(4):414-420. doi: 10.1097/GME.0000000000002159. Epub 2023 Feb 27.
Background: PubMed 27057265Reynolds WS, Fowke J, Dmochowski R. The Burden of Overactive Bladder on US Public Health. Curr Bladder Dysfunct Rep. 2016 Mar;11(1):8-13. doi: 10.1007/s11884-016-0344-9. Epub 2016 Jan 23.
Background: PubMed 31039103Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019 Sep;202(3):558-563. doi: 10.1097/JU.0000000000000309. Epub 2019 Aug 8.
Background: PubMed 34011072Yang DY, Zhao LN, Qiu MX. Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation. Medicine (Baltimore). 2021 May 21;100(20):e25941. doi: 10.1097/MD.0000000000025941.
Background: PubMed 24958472Abrams P, Smith AP, Cotterill N. The impact of urinary incontinence on health-related quality of life (HRQoL) in a real-world population of women aged 45-60 years: results from a survey in France, Germany, the UK and the USA. BJU Int. 2015 Jan;115(1):143-52. doi: 10.1111/bju.12852. Epub 2014 Aug 16.
Background: PubMed 16418145Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94. doi: 10.1007/BF02850085.
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.
Background: PubMed 10812317Husted JA, Cook RJ, Farewell VT, Gladman DD. Methods for assessing responsiveness: a critical review and recommendations. J Clin Epidemiol. 2000 May;53(5):459-68. doi: 10.1016/s0895-4356(99)00206-1.
Background: PubMed 33844342Frawley H, Shelly B, Morin M, Bernard S, Bo K, Digesu GA, Dickinson T, Goonewardene S, McClurg D, Rahnama'i MS, Schizas A, Slieker-Ten Hove M, Takahashi S, Voelkl Guevara J. An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment. Neurourol Urodyn. 2021 Jun;40(5):1217-1260. doi: 10.1002/nau.24658. Epub 2021 Apr 12.
Background: PubMed 31524367Hu JS, Pierre EF. Urinary Incontinence in Women: Evaluation and Management. Am Fam Physician. 2019 Sep 15;100(6):339-348.
Background: PubMed 30311692Ramirez-Garcia I, Blanco-Ratto L, Kauffmann S, Carralero-Martinez A, Sanchez E. Efficacy of transcutaneous stimulation of the posterior tibial nerve compared to percutaneous stimulation in idiopathic overactive bladder syndrome: Randomized control trial. Neurourol Urodyn. 2019 Jan;38(1):261-268. doi: 10.1002/nau.23843. Epub 2018 Oct 12.
Background: PubMed 20044494Greco NJ, Anderson AF, Mann BJ, Cole BJ, Farr J, Nissen CW, Irrgang JJ. Responsiveness of the International Knee Documentation Committee Subjective Knee Form in comparison to the Western Ontario and McMaster Universities Osteoarthritis Index, modified Cincinnati Knee Rating System, and Short Form 36 in patients with focal articular cartilage defects. Am J Sports Med. 2010 May;38(5):891-902. doi: 10.1177/0363546509354163. Epub 2009 Dec 31.
Individual participant dataSharing planned: No

Related trials for Overactive Bladder Syndrome

Enrolling by invitationObservational study
Migraine Medication Effects on Urinary Symptoms
Overactive Bladder, Bladder Pain Syndrome
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
Tensi+ for Treating Overactive Bladder
Overactive Bladder (OAB)
Not yet recruitingObservational study
Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
Overactive Bladder Syndrome
Recruiting
Improving Overactive Bladder Treatment Access and Adherence
Overactive Bladder Syndrome, Urinary Incontinence

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.

Zeynep Yıldız Kızkın principal investigator

Artvin Coruh 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 Behavioral therapy and transcutaneous posterior tibial nerve stimulation in people with Overactive Bladder Syndrome, run by Artvin Coruh 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 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: finished, as of the sponsor's last update on 28 Aug 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overactive Bladder Questionnaire-Version 8 (OAB-V8) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 NCT07171424, which also lists 13 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 28 Aug 2026.