Tensi+ for Overactive Bladder
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called Tensi+ to determine its safety and effectiveness for people with overactive bladder (OAB). OAB can cause frequent urges to urinate, sometimes leading to accidental leaks. The trial includes two groups: one using the real Tensi+ device and another using a look-alike device with no effect. Suitable participants have experienced OAB symptoms, such as frequent urination and urgency, for at least three months. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance OAB treatment options.
Will I have to stop taking my current medications?
The trial requires that you stop taking any overactive bladder medications at least 30 days before joining the study.
What prior data suggests that the Tensi+ device is safe for treating overactive bladder?
Research has shown that the Tensi+ device is generally safe for treating symptoms of an overactive bladder, such as frequent urination and urgency. Studies indicate that most patients tolerate Tensi+ well. Specifically, one study found that 67% of patients noticed a positive effect after using the device for three months. Another study highlighted its safety for managing bladder symptoms, with many people continuing to use it as recommended. While every treatment can have some side effects, the available evidence suggests Tensi+ is a safe option for many people dealing with these bladder issues.12345
Why are researchers excited about this trial?
Unlike the standard treatments for overactive bladder, which often include medications like anticholinergics or beta-3 agonists, Tensi+ is a device-based therapy. This new approach is exciting because it offers a non-drug solution, potentially reducing the side effects associated with medications. Tensi+ targets the bladder's neural pathways through gentle electrical stimulation, which might provide more direct symptom relief. Researchers are eager to see if this innovative method can offer a quicker and more comfortable option for patients.
What evidence suggests that the Tensi+ device is effective for treating overactive bladder?
Research has shown that the Tensi+ device, which employs Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS), may help treat overactive bladder (OAB). In studies, 67% of patients noticed symptom improvement after using the device. Specifically, out of 65 patients, 44 reported success, and 25 of those were very satisfied with their treatment. This trial will compare the Tensi+ device with an identical Tensi+ sham device to evaluate its effectiveness. The Tensi+ device could help reduce frequent urination, sudden urges, and leaks for many people. Used at home, the device offers a convenient option for managing OAB symptoms.45678
Are You a Good Fit for This Trial?
This trial is for adults 22 or older with overactive bladder (OAB), experiencing urgency and frequent urination, documented by bladder diaries. Participants must have had symptoms for at least 3 months, be able to give informed consent, and commit to all testing in the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Tensi+ device or a sham device for 12 weeks to evaluate its effectiveness in treating overactive bladder symptoms
Follow-up
Participants are monitored for sustained treatment effects and safety from Week 12 to Week 24
What Are the Treatments Tested in This Trial?
Interventions
- Tensi+
Trial Overview
The Tensi+ device is being tested for its safety and effectiveness in treating OAB. It uses Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) to alleviate symptoms like urinary frequency, urgency, and urge urinary incontinence.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stimuli Technology
Lead Sponsor
Citations
New TENSI+ Device for Transcutaneous Posterior Tibial ...
Treatment was successful in 44/65 patients (67%), with 25/65 (38%) reporting both an objective improvement and high satisfaction. All OAB- ...
Evaluation of the Tensi+ Device for the Treatment ...
The main objective is to assess the efficacy (actual clinical benefit) of TC-pTNS with Tensi+ device for management of overactive bladder in an adult population ...
Efficacy and safety of the TENSI+ device for posterior tibial ...
Patients use the device at home every day. In our short-term trial, TENSI+ use improved symptoms in 67% of patients.
New TENSI+ Device for Transcutaneous Posterior Tibial ...
Treatment was successful in 44/65 patients (67%), with 25/65 (38%) reporting both an objective improvement and high satisfaction. All OAB- ...
New TENSI+ Device for Transcutaneous Posterior Tibial ...
The primary outcome was efficacy at 3 mo, according to objective improvements and patient satisfaction.
Tensi+ for Treating Overactive Bladder: A Randomized ...
Study Overview. The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial ...
Tensi+ For Clinicians | CliniMed
There are also recent multicentre studies confirm Tensi+ is effective and safe in the management of OAB. 67% patient efficacy after 3 months1.
Transcutaneous tibial nerve stimulation TENSI+ system
Prospective multicentric data highlights TENSI+ to be an effective and safe treatment for lower urinary tract symptoms with high treatment adherence at 3 months ...
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