Ensayos clínicos

 Inclusion Criteria:

• Subjects 18 years of age or older.
• A 3-day voiding diary demonstrating a minimum of 3 episodes of urinary urge incontinence in 72 hours.
• Have a diagnosis of UUI for at least 6 months.
• No OAB pharmacotherapy for 2 weeks prior to completion of the baseline voiding diary and Overactive Bladder Quality of Life (OAB-q) questionnaire.
• Failed, or are not a candidate for, conservative non-pharmacologic treatment (e.g., pelvic floor training, biofeedback, behavioral modification)
• In the opinion of the Investigator, subject has failed and/or is intolerant to at least 1 overactive bladder medication or Investigator has determined that medication use is not appropriate based on the subject’s profile and medical history.
• Willing and able to accurately complete study diaries, questionnaires, attend visits, operate the system, and comply with the study protocol.
• Willing and able to provide signed and dated informed consent.

Exclusion Criteria:

• Have neurological conditions such as multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury (e.g., paraplegia).
• Severe uncontrolled diabetes.
• History of urinary retention within the previous 6 months.
• Current symptomatic urinary tract infection.
• Have primary stress incontinence or mixed incontinence where the stress component overrides the urge component [see enrollment/baseline requirements for use of the Medical, Epidemiological, and Social Aspects of Aging urinary incontinence questionnaire (MESA) questionnaire].
• Diagnosis of bladder pain syndrome, pelvic pain, or interstitial cystitis.
• Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture).
• History of a prior implantable tibial neuromodulation system.
• Knowledge of planned diathermy procedures.
• Have had treatment of urinary symptoms with sacral neuromodulation in the past 6 months, botulinum toxin therapy in the past 9 months or percutaneous tibial nerve stimulation (PTNS)/percutaneous tibial neuromodulation (PTNM) in the past 3 months.
• Skin lesions or compromised skin integrity (e.g., skin atrophy, thinning, fragility, etc.) which may affect incision healing at the implant site.  Current or a recent history (within the past 6 months) of a medical condition such as venous insufficiency and/or venous stasis ulcers, clinically significant malnutrition, immunocompromised state, or other relevant chronic disease which may indicate a higher risk for delayed or poor wound healing.
• Anatomical defects, clinically significant edema or previous surgeries which precludes use of the device (including any metal implant that is within 20 cm of the intended neurostimulator location).
• Previous pelvic floor surgery in the last 6 months.
• Women who are pregnant or planning to become pregnant during the course of the study.
• Any subject who is considered to be part of a vulnerable patient population.**
• Characteristics indicating a poor understanding of the study or characteristics that indicate the subject may have poor compliance with the study protocol requirements.
• Concurrent participation in another clinical study that may add additional safety risks and/or confound study results.***