ClinicalTrials.gg
Not yet recruitingNCT07740668Updated Jul 31, 2026

Efficacy of Transcutaneous Electrical Stimulation Therapy in the Treatment of Overactive Bladder Developing After Stroke

An interventional study of posterior tibial nerve stimulation, PTNS in Stroke, Overactive Bladder (OAB) and Tibial Nerve, sponsored by Kutahya Health Sciences University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Kutahya Health Sciences University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
Female
01

Study summary

This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke.

Primary Hypothesis: PTNS therapy will significantly improve OAB symptoms in post-stroke patients compared to standard care/sham stimulation.

Primary Outcome Measure: Change from baseline in Overactive Bladder Symptom Score (OABSS) and/or frequency of urgency episodes as assessed after 12 weeks of treatment."

Read the detailed description

controlled clinical trial designed to evaluate the efficacy of transcutaneous electrical stimulation (posterior tibial nerve stimulation, PTNS) in the treatment of overactive bladder (OAB) developing after stroke.

02

Conditions studied

  • Stroke
  • Overactive Bladder (OAB)
  • Tibial Nerve
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 50 is close to the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Kutahya Health Sciences University is the lead sponsor of 219 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female
  • Age 40 to 70 years
  • History of ischemic or hemorrhagic stroke at least 6 months before enrollment
  • Presence of overactive bladder symptoms
  • Ability to provide written

Exclusion criteria

Exclusion Criteria:

  • Age outside the study range
  • Pregnancy or breastfeeding
  • Active urinary tract infection
  • Neurogenic conditions other than stroke affecting bladder function
  • Inability to comply with study procedures
  • Refusal or inability to provide
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    posterior tibial nerve stimulation, PTNS

    50 patient who assessed after 12 weeks of treatment

    Device: posterior tibial nerve stimulation, PTNS

  • No intervention
    standart treatment

    standart treatment group, wil folllow 12 months

Interventions

  • Deviceposterior tibial nerve stimulation, PTNS

    posterior tibial nerve stimulation, PTNS

06

What researchers measure

Primary outcomes

  1. Change in daily frequency of urgency episodes

    Number of urgency episodes per 24 hours recorded in patient bladder diary.

    Time frame: Baseline and at 12 weeks.

Secondary outcomes

  1. Change in micturition frequency

    Average number of micturitions per 24 hours.

    Time frame: Baseline and at 12 weeks.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data (IPD) underlying the results (including demographic data, primary and secondary outcome measures) may be shared with qualified researchers upon reasonable request. Data will be available after publication of the study results for a period of 5 years. Access will be granted following approval of a data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: De-identified individual participant data (IPD), along with the study protocol, SAP, and informed consent form, will be available upon reasonable request to the corresponding investigator. Data will be shared starting 6 months after publication of the study results and will be available for up to 5 years

Access criteria: De-identified individual participant data (IPD), including baseline demographics, primary and secondary outcome measures, and supporting documents (protocol, SAP, ICF), will be available to qualified researchers conducting scientific research in related fields. Data will be shared upon reasonable request to the corresponding investigator and access will be granted following approval of a data sharing agreement to ensure confidentiality and ethical use. For additional information, please contact: halib_ive@hotmail.com

Data sharing details ↗ · ksbu.edu.tr

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 12 months is below that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2026
First posted
Jul 31, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2027
CompletionEst.
Oct 1, 2027
Last update
Jul 31, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07740668
Responsible party
Sponsor
First posted
Jul 31, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Oct 1, 2027 (estimated)
Last update
Jul 31, 2026

Study contacts

Halil i ivelik, Assistant Professor, MD
Contact
halib_ive@hotmail.com
+905423618713

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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