Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT07081412

Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

Led by Ege University · Updated on 2025-07-23

50

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

Sponsors

E

Ege University

Lead Sponsor

H

Health Institutes of Turkey

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who are 18 years or older and female with a diagnosis of Overactive Bladder (OAB) from urology or urogynecology clinics
  • Able and willing to continue T-PTNS treatment at home using the mobile application
  • Have a compatible smartphone and can use the T-PTNS mobile application
  • Agree to be followed up for one year after treatment
  • Have stopped all antimuscarinic medications for at least two weeks
  • Able to stand and use the toilet independently without difficulty
  • Willing to participate, informed about the study, and have signed informed consent agreeing to study requirements and restrictions
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnant, planning pregnancy during the study, or breastfeeding
  • Diagnosed with neurogenic bladder
  • Have uncontrolled Diabetes Mellitus
  • History of allergic skin reactions
  • Pelvic organ prolapse greater than Stage-2 extending beyond the hymen
  • Post-void residual urine of 100 ml or more by ultrasound
  • Contraindications for T-PTNS such as pacemakers, implantable defibrillators, or metal prostheses
  • Current urinary tract infection
  • Botox treatment to bladder or pelvic floor muscles within the past year
  • Previous pelvic floor surgery
  • Current use of TENS on pelvic region, back, or legs
  • Previous PTNS treatment
  • Use of Interstim or Bion devices
  • Do not accept treatment or follow-up
  • Unable to comply with study requirements
  • Investigator determines negative benefit/risk ratio
  • Participation in another clinical trial or use of investigational drug/device within 30 days before study visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

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

Izmir, İzmir, Turkey (Türkiye), 35100

Actively Recruiting

Loading map...

Research Team

A

Ahmet Ozgur Yeniel, Professor

CONTACT

G

Gokay Ozceltik, Associate Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here