Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1

NCT03019094 | Withdrawn

• 1 other identifier: G01-CLP-0001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Interventional, Prospective, Open Label study

Conditions

Overactive Bladder

Keywords

overactive bladder; urge urinary incontinence; urgency frequency

Outcome Measures

Primary Outcomes (4)

• Incidence of serious adverse events

  Incidence of serious adverse events (system and/or procedure related events)

  6 and 12 months post-activation

• Clinical improvement in urge urinary incontinence

  Change from baseline in number of leaking episodes per day

  3 months post-activation

• Clinical improvement urinary frequency

  Change from baseline in number of voids per day

  3 months post-activation

• Clinical improvement in degree of urgency

  Change from baseline in degree of urgency prior to void

  3 months post-activation

Secondary Outcomes (9)

• Change in number of leaking episodes

  6- and 12 months post activation

• Change in number of voids

  6- and 12 months post activation

• Change in degree of urgency prior to void

  6- and 12 months post activation

• Change in number of absorbent pads

  3, 6, and 12 months post activation

• Change in volume voided per void

  3, 6, and 12 months post activation

Study Arms (1)

Treatment

EXPERIMENTAL

Implantation of the RENOVA tibial nerve stimulation system

Device: The RENOVA tibial nerve stimulation system

Interventions

The RENOVA tibial nerve stimulation system DEVICE

Study participants will be implanted with the RENOVA tibial nerve stimulation system

Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent.
• Patient who is mentally competent with the ability to understand and comply with the requirements of the study.
• Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
• Patients with overactive bladder symptoms including:
• Urinary frequency greater than or equal to 8 voids/24 hours and less than 16 voids/24 hours AND/OR
• Urinary urge incontinence of at least 2 incontinence episodes on a 3-Day voiding diary
• If used, patients should be on stable dose of antimuscarinics and/or beta-3 adrenergic agonists for at least 6 weeks prior to enrollment and agree not to change their dose until the 3-month follow-up visit.
• If used, patients should be on a stable dose of tricyclic antidepressants and Flomax for at least 6 weeks prior to enrollment and agree not to change their dose until the 3-month follow-up visit.
• Patient who has failed conservative treatments after at least 6 months of treatment (i.e. lifestyle modification-fluid consumption, behavioral modification, and pharmacological therapy).
• Patients with no clinical evidence of a tibial motor sensory deficit.
• Patients with competent sphincter mechanism.
• Patients with normally functioning upper urinary tract and no renal failure.
• Leg circumference in the range of 20-30 cm at implantation site.
• Patients with a standard 3-Day voiding diary at baseline.

You may not qualify if:

• Previous participation in another study with any investigational drug or device within the past 90 days.
• Any metal or other implant in the area of BlueWind RENOVA implantation site.
• Patients who have not had stable OAB medications for at least 6 weeks.
• Patients with neurogenic bladder.
• Patients who are taking diuretics.
• Patients who have received botulinum toxin injections within the past 12 months.
• Patients who have received or are receiving nerve stimulation therapies for OAB treatment, including Sacral Nerve Stimulation (and are still implanted) or Posterior Tibial Nerve Stimulation (during the last 3 months).
• Current pregnancy or attempting to get pregnant.
• Previous urinary incontinence surgery or implantation of artificial graft material.
• Any spinal or genitourinary surgery within the last 6 months.
• Previous abdominoperineal resection of the rectum or radical hysterectomy (female)/ prostatectomy (male).
• Skin, orthopedic or neurologic anatomical limitations that preclude implantation or/and use of the device.
• Pelvic pain disorders.
• Obvious clinically demonstrated genuine stress incontinence including mixed incontinence.
• Any neurological disease or disorder including Alzheimer's, Parkinson, Multiple Sclerosis, neuropathy or injury resulting in neuropathy.

Sponsors & Collaborators

• BlueWind Medical: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 12, 2017
• Study Start: April 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 16, 2017

Record last verified: 2017-05