Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

NCT07081412 | Recruiting DMC

• 1 other identifier: TRIP-HOME
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To record the T-PTNS device (SmartUric) treatment performed by the patient at home via a mobile application in a remotely monitorable, secure and interactive manner with registration notes and a sham control group.

Conditions

Overactive Bladder Syndrome; Overactive Bladder (OAB); Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)

Keywords

overactive bladder; neuromodulation; Posterior Tibial Nerve Stimulation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 3-Day Bladder Diary

  The 3-Day Bladder Diary is a structured patient-reported record used to evaluate urinary frequency, volume, fluid intake, urgency episodes, incontinence events, and nocturia across 3 consecutive days. Parameters recorded: * Time of each void * Voided volume (mL) * Fluid intake (time and volume) * Incontinence episodes (yes/no, with type if known) * Urgency (optional, often rated 0-3 or described qualitatively) * Nocturia episodes. At least 30% reduction in 24-hour urinary frequency or defined as at least a 50% reduction in the number of urgency sensations with or without incontinence and/or at least a 30% reduction in 24-hour urinary frequency via a urinary diary filled by the patient for three days.

  Baseline, 12th week, and 12th month

Secondary Outcomes (5)

• Overactive Bladder Questionnaire (OAB-V8)

  Baseline, 12th week, and 12th month

• International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

  Baseline, 12th week, and 12th month

• The Overactive Bladder Quality of Life Short-Form (OAB-q SF)

  Baseline, 12th week, and 12th month

• Female Sexual Function Index (FSFI)

  Baseline, 12th week, and 12th month

• Female Lower Urinary Tract Symptoms Long Form Module (ICIQ-FLUTS Long Form)

  Baseline, 12th week, and 12th month

Study Arms (2)

Test Device

EXPERIMENTAL

T-PTNS treatment will be performed at home with an external generator and two surface electrode testers. Each T-PTNS session will consist of a test and treatment section. The treatment will be planned and carried out by the researchers. Treatment dose is 1 day/week, 30 minutes/session, totaling 12 sessions. Treatment Pulse Frequency: 20 Hz, Treatment Pulse Width: 200us (microsecond).

Device: Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month

Sham Device

PLACEBO COMPARATOR

These are devices that have the same physical appearance, interface and feedback features, but are prepared in a way that they will not provide electrical stimulation during the treatment session. They are delivered to the CRO by the project manager and are randomized through the CRO and given to the researchers with a code. The duration and frequency of treatment will be the same as the treatment group.

Device: Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week

Interventions

Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a test device at 12 week and 12 month DEVICE

T-PTNS treatment will be performed at home with an external generator and two surface electrodes SmartUric medical device. Each T-PTNS session will consist of test and treatment sections. The treatment will be planned and carried out by researchers. The treatment dose is 1 day/week, 30 minutes/session, totaling 12 sessions. Treatment Pulse Frequency: 20 Hz, Treatment Pulse Width: 200us (microsecond).

Test Device

Efficacy of remotely monitored transcutaneous posterior tibial nerve neuromodulation via a placebo device at 12 week DEVICE

These are devices that have the same physical appearance, interface and feedback features, but are prepared in a way that they will not provide electrical stimulation during the treatment session. They are delivered to the Contract Research Organization (CRO) by the project manager and are randomized through the CRO and given to the researchers with a code. The duration and frequency of treatment will be the same as the treatment group.

Sham Device

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: born female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being able to continue their T-PTNS\*\* treatment at home with the mobile application and accepting this,
• Having a smartphone compatible with the application for T-PTNS and being able to use the application
• Agreeing to be followed up for one year after treatment,
• Having stopped all antimuscarinics for at least two weeks,
• Being able to stand and use the toilet independently without difficulty,
• Volunteers who are willing to participate, have been informed about the study and have given signed informed consent, stating that they can comply with the requirements and restrictions listed in the informed consent form (ICP) and this protocol.

You may not qualify if:

• Patients under the age of 18
• Patients who are pregnant according to the results of a pregnancy test with urine or blood test, or who are planning a pregnancy during the study period, or who are breastfeeding
• Patients diagnosed with neurogenic bladder
• Patients with Dabetes Mellitus whose blood sugar cannot be controlled
• Patients with a history of allergic reactions on the skin
• Cases with prolapse greater than Stage-2 according to the POP-Q staging system and extending beyond the hymen
• Cases with a PVR evaluation of 100 ml and above with USG
• Contraindications for T-PTNS treatment (patients with pacemakers, implantable defibrillators or metal prostheses
• Patients with urinary tract infection\*
• Having had botox applied to the bladder or pelvic floor muscles within the last year
• Having had a previous surgery related to the pelvic floor
• Current TENS use in the pelvic region, back or legs
• Having received PTNS treatment before
• Use of Interstim or Bion
• Those who do not accept the treatment or follow-up to be performed

Sponsors & Collaborators

• Ege University: lead
• Health Institutes of Turkey: collaborator

Study Sites (1)

EGE UNIVERSITY, FACULTY OF MEDICINE, Department of Obstetrics and Gynecology

Izmir, İzmir, 35100, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• • Cardozo, L., Rovner, E., Wagg, A., Wein, A., Abrams, P. 2023. Incontinence (7th Edition). Bristol UK: ICI-ICS. International Continence Society.

  BACKGROUND

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

Study Officials

• Gokay Ozceltik, Associate Professor

  Ege University, Faculty of Medicine, Department of Obstetrics and Gynaecology

  PRINCIPAL INVESTIGATOR

• Fuat Kızılay, Associate Professor

  Ege University, Faculty of Medicine, Department of Urology

  STUDY CHAIR

• Sevtap Gunay Ucurum, Associate Professor

  Izmir Katip Celebi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  STUDY CHAIR

Central Study Contacts

Ahmet Ozgur Yeniel, Professor

CONTACT

+90 232 343 4 343; drayeniel@hotmail.com

Gokay Ozceltik, Associate Professor

CONTACT

+90 232 343 4 343; gokayozceltik@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: July 12, 2025
• First Posted: July 23, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

TU (1)