Introl bladder neck support prosthesis: international clinical experience.
The Introl bladder neck support prosthesis is a ring-shaped silastic device with two prongs located at one side such that when placed within the vaginal canal the bladder neck is suspended in a fashion similar to a surgical urethropexy. Since its initial description in 1988 the device has undergone clinical trials in the US and Japan, documenting its effectiveness in the treatment of stress and mixed incontinence in women. Introl is available for clinical use in the United States and has been well accepted by practicing clinicians. In Japan, exposure has occurred through clinical trials, which resulted in a high efficacy rate, i.e. 81% of the patients had either maximum benefit or benefit in the global usefulness rating, and 26% experienced minor adverse effects. This paper will summarize Introl clinical study findings and describe various clinical observations made during increased clinical usage.
Davila
G W
GW
Colorado Gynecology and Continence Center, Denver 80218, USA.
Kondo
A
A
D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D019736:Prostheses and Implants; D011475:Prosthesis Failure; D019919:Prosthesis Implantation / Q000295:instrumentation*; D012449:Safety; D001743:Urinary Bladder / Q000601:surgery*; D014550:Urinary Incontinence, Stress / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000601:surgery*; D014563:Urodynamics; D014567:Urography