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Implantable Device
Tibial Nerve Stimulation for Urinary Incontinence
N/A
Recruiting
Led By Catherine Matthews, MD
Research Sponsored by Coloplast A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptoms of overactive bladder with urgency urinary incontinence (UUI) demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, and at least one leaking episode each 24-hour period
Ambulatory and able to use the toilet independently and without difficulty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, and 12 months
Awards & highlights
Study Summary
This trial is testing a new tibial nerve stimulator to see if it is safe and effective in treating people with urgency urinary incontinence.
Who is the study for?
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.Check my eligibility
What is being tested?
The INTIBIA study tests an implantable tibial nerve stimulator's safety and effectiveness for UUI. It's a double-blind study, meaning neither the researchers nor participants know who gets the therapeutic device versus a non-therapeutic version.See study design
What are the potential side effects?
Potential side effects may include local reactions at the implant site such as pain or infection, allergic responses to materials in the device, and possible interference with lower leg MRI procedures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have overactive bladder with leaks due to urgency, noted daily for 3 days.
Select...
I can walk and use the bathroom by myself without help.
Select...
I have been diagnosed with urge incontinence for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3, 6, and 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Other outcome measures
Daily Voids
Dry
EQ-5D-5L Questionnaire
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: INTIBIA TherapeuticExperimental Treatment1 Intervention
Implanted with INTIBIA device and programmed to therapeutic stimulation for the duration of the study.
Group II: INTIBIA Non-TherapeuticExperimental Treatment1 Intervention
Implanted with INTIBIA device and programmed to non-therapeutic stimulation for the first 3 months, then to therapeutic stimulation for the duration of the study.
Find a Location
Who is running the clinical trial?
Coloplast A/SLead Sponsor
152 Previous Clinical Trials
14,444 Total Patients Enrolled
1 Trials studying Lower Urinary Tract Symptoms
30 Patients Enrolled for Lower Urinary Tract Symptoms
Dale KlousStudy DirectorColoplast Corp
Catherine Matthews, MDPrincipal InvestigatorWake Forest University
6 Previous Clinical Trials
448 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to numbing medicine or adhesive materials.I have not had botulinum toxin therapy for urinary issues in the last year.I have overactive bladder with leaks due to urgency, noted daily for 3 days.I currently have a UTI or have had more than 3 UTIs in the last year.I am willing and able to agree to participate in the study.I have a blockage in my urinary tract.I have tried and not benefited from non-medical treatments for bladder control.I can walk and use the bathroom by myself without help.I agree to not change my bladder-related medications for 4 weeks before starting the study.I am willing and able to follow all study procedures and attend all visits.You have a medical condition that requires diathermy treatment.I have an ongoing or chronic infection.I have a long-term pain condition like fibromyalgia or chronic back pain.I have diabetes with nerve damage or my diabetes is not well-controlled.I do not have any neurological conditions affecting my bladder or leg nerves.My kidney function is very low or I am on dialysis.You are allergic to certain materials like plastic, rubber, or metals used in the study.I have been considered unsuitable for this trial by a doctor due to my medical history or current condition.I have tried nerve stimulation therapy for urinary issues.I need an MRI scan of my lower leg.I do not have infections, swelling, or inflammation in my legs.I do not have body structures that could make placing a medical device risky.I have been diagnosed with stress or mixed urinary incontinence.I have been diagnosed with urge incontinence for at least 6 months.I am between 22 and 80 years old.I have had pelvic cancer in the last two years.I have problems with my urinary system not related to cancer.My pelvic organs have dropped to or past the vaginal opening.I have been diagnosed with interstitial cystitis or bladder pain syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: INTIBIA Non-Therapeutic
- Group 2: INTIBIA Therapeutic
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Lower Urinary Tract Symptoms Patient Testimony for trial: Trial Name: NCT05250908 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are elderly individuals being welcomed in this clinical investigation?
"This research is seeking out individuals between the ages of 22 and 80."
Answered by AI
Are participants currently being accepted for this experiment?
"Per clinicaltrials.gov, this medical study is searching for participants as of the current time. The trial was initially posted on March 7th 2022 and underwent its most recent revision on September 30th 2022."
Answered by AI
Do I fit the criteria to enter into this medical experiment?
"This clinical trial is enrolling 225 patients aged 22 to 80 who suffer from urologic conditions. Notably, all applicants must satisfy the following requirements: 6 months of UUI diagnosis documentation; unrestricted mobility when it comes to toileting activities; consent for study participation freely given; 72-hour voiding diary with min 4 leaking episodes that correspond with urgency and at least one per 24 hours period; inefficacy/nonresponse to conservative or behavioural therapies (e.g., bladder diet, timed voiding); no OAB medications during the length of study; stable dose of other medications affecting bladder function over a span of four weeks prior baseline"
Answered by AI
In which locales can participants access this trial?
"11 facilities are serving as operating centres for this study, including the Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health in Allentown, The Female Pelvic Health Center in Newtown, and MedStar Washington Hospital Centre."
Answered by AI
How many participants has the clinical trial recruited thus far?
"This clinical trial, led by Coloplast A/S, requires 225 participants who meet the set inclusion criteria. The study is being conducted out of multiple sites including The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health in Allentown, Pennsylvania as well as The Female Pelvic Health Center in Newtown District of Columbia."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Other
Pennsylvania
Ohio
What site did they apply to?
Houston Metro Urology
MetroHealth System
Southeastern Urogynecology & Pelvic Surgery
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
0
1
Why did patients apply to this trial?
Have been incontinence for 10 years because of a spinal cord injury. I have tried diet restrictions, exercise and intentionally urinating during the day but the issue remains….
PatientReceived no prior treatments
Because I have overactive bladder I was diagnosed with that. I also leak and hate doing that 2-3 times a daily. I've been doing Pelvic Floor therapy for a while and just want something to help strengthen my pelvic floor more permanently. I see Dr. Darlene Gaynor Krupnick at the Lankenau Hospital location Midlantic Urology. And am hoping she will agree with this.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How much are the payments? How many trips to Los Angeles or how often would I have to be there?
PatientReceived no prior treatments
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