Is NCT05685433 recruiting in Hialeah, FL?

Yes, NCT05685433 is currently recruiting participants at its Hialeah, FL location. This overactive bladder clinical trial is actively enrolling qualified participants.

How do I join the overactive bladder clinical trial in Hialeah?

To join this clinical trial in Hialeah, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Hialeah clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Overactive Bladder Clinical Trial in Hialeah, FL

Who Can Participate

Inclusion Criteria

Women and men above 18 years old with gender percentages reflective of disease prevalence in the U.S. population

Individual with diagnosis of overactive bladder with urgency urinary incontinence.

Individual has at least one urgency urinary incontinence episode on each of three days as determined on a 3-day voiding diary.

Individual gives written informed consent.

Individual is mentally competent and able to understand all study requirements.

Individual is willing and able to complete a 3-day voiding diary and quality of life questionnaire.

Individual is without pharmacological treatment of overactive bladder (anticholinergic and β3-adrenoceptor agonists) for 2 weeks prior to baseline or longer if the physician judges that the therapeutic effect is still present.

Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or who have undergone percutaneous tibial nerve stimulation (PTNS).

Individual is determined to be a suitable surgical candidate by physician.

Individual is appropriate for eCoin treatment based on the US FDA-approved IFU requirements.

Exclusion Criteria

Individual is not appropriate for eCoin therapy based upon the US FDA-approved IFU requirements.

Individual has clinically significant bladder outlet obstruction. (Suspected bladder outlet obstruction will be initially assessed by uroflow study with those having a maximum flow rate \< 15mL/s requiring additional evaluation.)

Individual has predominantly stress urinary incontinence (greater than 1/3 of leaks on baseline diary are stress).

Individual has an active urinary tract infection at time of enrollment.

Individual has known polyuria.

Individual has significant lower urinary tract pain or has been diagnosed with interstitial cystitis or bladder pain syndrome.

Individual has abnormal post void residual (i.e. greater than 200 cc initially and on repeat testing after double voiding)

Individual has clinically significant urethral stricture disease or bladder neck contracture. (Suspected disease or contracture will be initially assessed by uroflow study with those having a maximum flow rate \< 15mL/s requiring additional evaluation.)

Individual has chronic venous insufficiency with a history of skin change (hyperpigmentation, lipodermatosclerosis, ulceration) in the ankle region.

Individual has morbid obesity and in the opinion of the investigator is not a good candidate for the study.

Individual has had diagnosis of bladder, urethral, or prostate cancer.

Individual has had a prior anti-stress incontinence sling surgery within the last year.

Individual is pregnant or intends to become pregnant during the study.

Individual has the presence of urinary fistula, bladder stone, or interstitial cystitis.

Individual has uncontrolled diabetes mellitus (Hemoglobin A1C\>7) or diabetes with significant peripheral complications. (Uncontrolled diabetes will be ruled out by blood test excluding those with Hemoglobin A1C\>7).

Individual has an implantable neurostimulator, pacemaker, or implantable cardiac defibrillator (ICD).

Individual has been treated with onabotulinumtoxinA in the previous 9 months prior to enrollment, or more time if the principal investigator judges that the therapeutic effect is present.

Individual has been treated with percutaneous tibial nerve stimulation (PTNS) within the previous 4 weeks prior to enrollment or more time if the principal investigator judges that the therapeutic effect is present.

Individual is currently using transcutaneous electrical nerve stimulation (TENS) in the pelvic region, back, or legs.

Individual is aware that he or she will need an MRI scan other than a head/neck/shoulder MRI during the study period.

Individual has a clotting or bleeding disorder or is using anticoagulant therapies and in the opinion of the investigator is not a good candidate for the study (antiplatelet and anticoagulant therapy may be continued or held at the discretion of the investigator).

Individual is neutropenic or immune-compromised.

Individual has had previous surgery and/or significant scarring at the implant location.

Individual has ongoing dermatologic condition at the implant site, including but not limited to dermatitis and autoimmune disorders.

Individual has a clinically significant peripheral neuropathy in the lower extremities.

Individual has neurogenic bladder dysfunction.

Individual has pitting edema at implant location (≥ 2+ is excluded).

Individual has inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.

Individual has varicose veins and is symptomatic.

Individual has open wounds, trauma, or prior surgery in the lower extremities.

Individual has arterial disease in the lower extremities.

Individual has vasculitis in the lower extremities.

Individual has bladder stones or neoplasia. (Suspected bladder stones or neoplasia will be ruled out with a urine dipstick showing no more than trace blood, and microscopic analysis (which should be done in that case) shows ≥3 PBC's /HPF unless that subject has been worked up and found negative for clinically significant disease such as malignant neoplasm or stones.)

In the opinion of the investigator, Individual is not a good candidate for participation in the study.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Hialeah?

Yes, this clinical trial (NCT05685433) has an active research site in Hialeah, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Overactive Bladder Treatment Options in Hialeah, FL

If you're searching for overactive bladder treatment options in Hialeah, FL, this clinical trial (NCT05685433) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Hialeah research site is actively enrolling participants for this clinical trial. You'll receive care from experienced overactive bladder specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all overactive bladder clinical trials near you to find additional studies recruiting in your area.

Overactive Bladder Clinical Trial in Hialeah, FL

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