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Clinical Feasibility Study, Implantable Tibial Nerve Stimulator (ITNS)

2019-10-10 09:39:45 | BioPortfolio

Summary

Study objectives: To report feasibility data for safety and effectiveness of the study device.

Study device: Nine Continents Medical implantable tibial nerve stimulator (ITNS) model 9C-680 with programmer model 9C-580.

Intended use: The study device is intended for treatment of the symptoms of overactive bladder (OAB), including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

Type of design: Single-arm longitudinal design.

Study sites: Single site, in the United States.

Study duration: One year total, comprising six months for enrolling and implanting 10 subjects, and 26 weeks for follow-up.

Study Design

Conditions

Overactive Bladder

Intervention

Implantation and neuromodulation therapy

Location

Pacific Urology
San Ramon
California
United States
94583

Status

Recruiting

Source

Nine Continents Medical, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-10T09:39:45-0400

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Medical and Biotech [MESH] Definitions

Symptom of overactive detrusor muscle of the URINARY BLADDER that contracts with abnormally high frequency and urgency. Overactive bladder is characterized by the frequent feeling of needing to urinate during the day, during the night, or both. URINARY INCONTINENCE may or may not be present.

Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.

A HERNIA-like condition in which the weakened pelvic muscles cause the URINARY BLADDER to drop from its normal position. Fallen urinary bladder is more common in females with the bladder dropping into the VAGINA and less common in males with the bladder dropping into the SCROTUM.

Involuntary discharge of URINE as a result of physical activities that increase abdominal pressure on the URINARY BLADDER without detrusor contraction or overdistended bladder. The subtypes are classified by the degree of leakage, descent and opening of the bladder neck and URETHRA without bladder contraction, and sphincter deficiency.

Historically, tissue transplantation, especially of refrigerated tissue (after Filatov). It was theorized that nonspecific substances, capable of initiating restorative processes, formed in tissues when refrigerated. Cell therapy (after Niehans) refers to implantation of tissue by injection. Originally this involved fresh cells but later frozen or lyophilized cells.

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