A new intraurethral sphincter prosthesis with a self contained urinary pump

Area of Science:

• Urology
• Biomedical Engineering
• Medical Devices

Background:

• Atonic bladder in women presents significant challenges for urinary management.
• Existing treatments for atonic bladder may have limitations in efficacy and patient tolerance.

Purpose of the Study:

• To develop and evaluate a novel intraurethral sphincter prosthesis with an integrated urinary pump for women with atonic bladder.
• To assess the safety, efficacy, and usability of this new device in a clinical setting.

Main Methods:

• A self-contained intraurethral sphincter prosthesis with a silicone catheter, valve, pump, and novel fixation method was designed.
• The device is activated externally via a hand-held control, utilizing magnetic coupling to power the pump.
• Clinical evaluation involved 17 women with atonic bladder, assessing continence and bladder emptying.

Main Results:

• Fifteen of 17 patients achieved dryness and complete bladder emptying during usage periods ranging from 2 weeks to 16 months.
• The device facilitated urine flow of 10-12 cc/sec, restoring continence after bladder evacuation.
• Two patients discontinued use due to uninhibited detrusor contractions, with device removal occurring without complications.

Conclusions:

• The intraurethral sphincter prosthesis with a self-contained pump demonstrates promising results for managing atonic bladder in women.
• The device offers a potential solution for restoring continence and improving quality of life for affected individuals.
• Further investigation may be warranted for patients with specific bladder dynamics like uninhibited detrusor contractions.