NCT07740668

Brief 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."

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2026

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 31, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 31, 2026

Status Verified

May 1, 2026

Enrollment Period

1 year

First QC Date

February 4, 2026

Last Update Submit

July 28, 2026

Conditions

StrokeOveractive Bladder (OAB)Tibial Nerve

Outcome Measures

Primary Outcomes (1)

  • Change in daily frequency of urgency episodes

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

    Baseline and at 12 weeks.

Secondary Outcomes (1)

  • Change in micturition frequency

    Baseline and at 12 weeks.

Study Arms (2)

posterior tibial nerve stimulation, PTNS

EXPERIMENTAL

50 patient who assessed after 12 weeks of treatment

Device: posterior tibial nerve stimulation, PTNS

standart treatment

NO INTERVENTION

standart treatment group, wil folllow 12 months

Interventions

posterior tibial nerve stimulation, PTNSDEVICE

posterior tibial nerve stimulation, PTNS

posterior tibial nerve stimulation, PTNS

Eligibility Criteria

Age40 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 informed consent

You may not qualify if:

  • 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 informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Kütahya, 43000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

StrokeUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Halil i ivelik, Assistant Professor, MD

CONTACT

+905423618713halib_ive@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

July 31, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 31, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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
More information

Locations

TU(1)