Peroneal Neuromodulation vs Pelvic Floor Exercises in OAB

NCT07788560 | Not Yet Recruiting

• 1 other identifier: MAR.UAD.0036
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder (OAB); Neuromodulation

Outcome Measures

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.

  Baseline to 3 months

Study Arms (2)

Transcutaneous peroneal electrical neuromodulation

ACTIVE COMPARATOR

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

Pelvic Floor Exercises

ACTIVE COMPARATOR

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

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.

Transcutaneous peroneal electrical neuromodulation

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.

Pelvic Floor Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine Urology Department

Istanbul, Pendik, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tarik Emre Sener

CONTACT

05344525700; turkeraltuntas@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

TU (1)