BridgeMD
New treatment option for Overactive Bladder Syndrome
Official title Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation
ClinicalTrials.gov ID: NCT07081412
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients who are ≥18 years old and female patients diagnosed with OAB\ in Urology or Urogynecology outpatient clinics and who meet the 2. Being able...
- 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,
You likely can't join 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...
- 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
See the full eligibility criteria
- Patients who are ≥18 years old and female patients diagnosed with OAB\ in Urology or Urogynecology outpatient clinics and who meet the 2. Being able to continue their T-PTNS\ \ treatment at home with the mobile...
- 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...
- 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
- Those who may have problems complying with the requirements of the study plan
- Negative benefit/risk ratio determined by the investigator
- Those who have been included in any other clinical trial or use of investigational drug/device therapy within 30 days before the study visit
The study team makes the final eligibility decision.
Where it's taking place
- Izmir, İzmir, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Izmir, İzmir, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.