Tibial Nerve Stimulation for Urinary Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and effectiveness of a new implantable tibial nerve stimulator for individuals with urgency urinary incontinence (UUI), a condition characterized by a sudden, strong need to urinate that leads to leaks. Participants will receive either therapeutic or non-therapeutic stimulation from the INTIBIA device. The trial suits those who have experienced UUI for over six months, have at least four leaking episodes with urgency over a three-day period, and have tried but not succeeded with other treatments like bladder training. As an unphased trial, this study offers participants the chance to contribute to pioneering research in managing UUI.
Will I have to stop taking my current medications?
You will need to stop taking overactive bladder (OAB) medications for the duration of the study. However, you must maintain a stable dose of any other medications that affect bladder function for at least four weeks before starting the study.
What prior data suggests that this implantable tibial nerve stimulator is safe for treating urgency urinary incontinence?
Research shows that the INTIBIA Therapeutic device, used to stimulate the tibial nerve, has promising safety results. One study tested this device on people with overactive bladder, similar to urgency urinary incontinence. The study found that most participants tolerated the device well, with no serious side effects directly linked to it.
Another study examined a similar device for urgency urinary incontinence and found it safe over two years. Participants reported improvements without major side effects. This suggests that the INTIBIA device is likely safe, though individual experiences can vary.
Overall, past research supports the safety of this type of tibial nerve stimulator. However, deciding to join a clinical trial is personal. Discuss any concerns with healthcare professionals before participating.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the INTIBIA device for urinary incontinence because it offers a new approach by using tibial nerve stimulation, which is different from traditional treatments like pelvic floor exercises, medications, or surgeries. Unlike these standard methods, the INTIBIA device is implanted and delivers targeted stimulation to the tibial nerve, potentially reducing symptoms by modulating nerve activity directly related to bladder control. This technique could provide a less invasive alternative with fewer side effects and the convenience of continuous therapy, making it a promising option for those who haven’t found relief with existing treatments.
What evidence suggests that this device is effective for urinary incontinence?
Research shows that stimulating the tibial nerve can help with urinary incontinence. In this trial, participants will receive the INTIBIA device implant. One group will undergo non-therapeutic stimulation for the first 3 months before switching to therapeutic stimulation, while another group will receive therapeutic stimulation throughout the study. Previous studies have shown that similar devices improved symptoms and quality of life for people with an overactive bladder, including those experiencing sudden urges to urinate. One study found that a similar device reduced daily incontinence episodes by 71% in participants. Additionally, percutaneous tibial nerve stimulation (PTNS) improved symptoms in about 60% of patients, with success rates for reducing urgency and incontinence ranging from 77% to 100%. These findings suggest that tibial nerve stimulation could significantly lessen urinary incontinence symptoms.12678
Who Is on the Research Team?
Catherine Matthews, MD
Principal Investigator
Wake Forest University
Are You a Good Fit for This Trial?
This trial is for adults aged 22-80 with a history of urgency urinary incontinence (UUI) who've tried other therapies without success. Participants must not be pregnant, planning pregnancy, or have certain health conditions like end-stage renal failure or neurological disorders that affect bladder function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Treatment
All eligible subjects are implanted with the INTIBIA device and randomized to either therapeutic or non-therapeutic stimulation for the first 3 months.
Therapeutic Treatment
All subjects receive therapeutic stimulation after the initial 3 months.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments including voiding diaries and questionnaires.
Device Retention or Removal
Participants are offered the option to keep the device or have it explanted at the end of the study.
What Are the Treatments Tested in This Trial?
Interventions
- INTIBIA Non-Therapeutic
- INTIBIA Therapeutic
Find a Clinic Near You
Who Is Running the Clinical Trial?
Coloplast A/S
Lead Sponsor
Kristian Villumsen
Coloplast A/S
Chief Executive Officer since 2018
Master's degree in Political Science from Aarhus University
Preeti Jain
Coloplast A/S
Chief Medical Officer since 2023
MD from University of Copenhagen