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NCT Number: NCT07740668

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

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."

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Overactive Bladder (OAB) Pathological Conditions, Signs and Symptoms Signs and Symptoms Tibial Nerve Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations Vascular Diseases

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kutahya Health Sciences University

Kütahya, 43000, Turkey (Türkiye)

Location contact

KSBU Evliya Celebi Research Hospital KSBU Evliya Celebi Research Hospital, Hospital Chief

CONTACT

[email protected]

+902743000081

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent

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 informed consent

Treatment and study plan

posterior tibial nerve stimulation, PTNS

Device

posterior tibial nerve stimulation, PTNS

Primary outcomes

  1. Change in daily frequency of urgency episodes

    Time frame: Baseline and at 12 weeks.

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

Secondary outcomes

  1. Change in micturition frequency

    Time frame: Baseline and at 12 weeks.

    Average number of micturitions per 24 hours.

Study contacts

Contact information is provided by the study sponsor or research team.

Halil i ivelik, Assistant Professor, MD

CONTACT

[email protected]

+905423618713

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2026
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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