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Not yet recruitingNCT07788560Updated Aug 26, 2026

Peroneal Neuromodulation vs Pelvic Floor Exercises in OAB

An interventional study of Transcutaneous Peroneal Electrical Neuromodulation and Pelvic Floor Exercise in Overactive Bladder (OAB) and Neuromodulation, sponsored by Marmara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by Marmara University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Overactive Bladder (OAB)
  • Neuromodulation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Transcutaneous peroneal electrical neuromodulation

    Participants assigned to this arm will receive transcutaneous peroneal electrical neuromodulation for 3 months. Neuromodulation will be administered in 30-minute sessions once weekly.

    Device: Transcutaneous Peroneal Electrical Neuromodulation

  • Active comparator
    Pelvic Floor Exercises

    Participants assigned to this arm will receive pelvic floor exercise therapy for 3 months. The exercises will be performed according to a standardized protocol under the guidance of the same physiotherapist.

    Behavioral: Pelvic Floor Exercise

Interventions

  • DeviceTranscutaneous Peroneal Electrical Neuromodulation

    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.

  • BehavioralPelvic Floor Exercise

    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.

05

What researchers measure

Primary outcomes

  1. Change in Overactive Bladder Symptom Score from 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.

    Time frame: Baseline to 3 months

06

Study locations

1 site
  • Marmara University School of Medicine Urology Department
    Istanbul, Pendik 34854, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07788560
Lead sponsor
Marmara University
Responsible party
Tarik Emre Sener (Associated Professor, Marmara University) — Principal investigator
First posted
Aug 26, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Apr 1, 2027 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Aug 26, 2026

Study contacts

Tarik Emre Sener
Contact
turkeraltuntas@hotmail.com
05344525700

Oversight

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

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