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NCT Number: NCT07788560

Peroneal Neuromodulation vs Pelvic Floor Exercises in OAB

Overactive bladder (OAB) is a common condition characterized by urinary urgency, usually accompanied by increased urinary frequency and nocturia, with or without urgency urinary incontinence. Several non-invasive treatment options are available, including pelvic floor exercises and neuromodulation.

This prospective, randomized study aims to compare the effectiveness and safety of transcutaneous peroneal electrical neuromodulation and pelvic floor exercises in adults with idiopathic OAB. Participants will be randomly assigned in a 1:1 ratio to receive either transcutaneous peroneal neuromodulation or pelvic floor exercise therapy for 3 months.

Treatment outcomes will be assessed using bladder diary parameters and OAB symptom scores at baseline and at 1 and 3 months after treatment initiation. Treatment adherence and treatment-related adverse events will also be evaluated. The study aims to determine whether transcutaneous peroneal neuromodulation provides comparable or improved clinical outcomes compared with pelvic floor exercises in patients with idiopathic OAB.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University School of Medicine Urology Department

Istanbul, Pendik, 34854, Turkey (Türkiye)

Location contact

Tarik Emre Sener

CONTACT

[email protected]

05344525700

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 years or older.
  • Diagnosis of idiopathic overactive bladder (OAB) based on clinical evaluation.
  • Presence of urinary urgency, with or without urgency urinary incontinence, usually accompanied by increased urinary frequency and/or nocturia.
  • OAB symptoms present for at least 3 months.
  • Ability to complete bladder diaries and symptom questionnaires.
  • Willingness to participate in the study and provide written informed consent.
  • Ability to comply with the assigned treatment protocol and scheduled follow-up visits.

Exclusion criteria

  • Neurogenic lower urinary tract dysfunction or a known neurological disease affecting bladder function.
  • Active urinary tract infection at the time of enrollment.
  • Significant pelvic organ prolapse.
  • Predominant stress urinary incontinence or mixed urinary incontinence with predominant stress symptoms.
  • Clinically significant bladder outlet obstruction or urinary retention.
  • History of major pelvic surgery or pelvic radiotherapy that may affect lower urinary tract function.
  • Previous treatment with botulinum toxin injection or neuromodulation within the predefined washout period.
  • Current use of OAB medications that cannot be discontinued or appropriately washed out before enrollment.
  • Pregnancy.
  • Presence of a cardiac pacemaker, implanted defibrillator, or another implanted electrical device incompatible with electrical stimulation.
  • Any condition that, in the investigator's judgment, would prevent safe participation or adherence to the study protocol.

Treatment and study plan

Transcutaneous Peroneal Electrical Neuromodulation

Device

Transcutaneous peroneal electrical neuromodulation will be administered once weekly for 3 months. Each treatment session will last 30 minutes. Electrical stimulation will be delivered transcutaneously over the peroneal nerve using surface electrodes.

pelvic floor exercise

Behavioral

Participants will undergo pelvic floor muscle training for 3 months according to a standardized exercise protocol. The exercises will be taught and supervised by the same trained physiotherapist to ensure standardized treatment across participants.

Primary outcomes

  1. Change in Overactive Bladder Symptom Score from baseline to 3 months

    Time frame: Baseline to 3 months

    The change in overactive bladder symptom severity will be assessed using the validated Overactive Bladder Questionnaire (OAB-V8). Scores will be recorded at baseline and at 3 months after initiation of treatment. A greater reduction in score indicates greater improvement in overactive bladder symptoms.

Study contacts

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

Tarik Emre Sener

CONTACT

[email protected]

05344525700

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Comparison of the Efficacy of Transcutaneous Peroneal Electrical Neuromodulation and Pelvic Floor Exercises in the Treatment of Idiopathic Overactive Bladder

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 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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