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Introl bladder neck support prosthesis: international clinical experience
1Colorado Gynecology and Continence Center, Denver 80218, USA.
International Urogynecology Journal and Pelvic Floor Dysfunction
|January 1, 1997
Summary
The Introl bladder neck support prosthesis effectively treats stress and mixed incontinence in women. Clinical trials show high efficacy rates with minimal adverse effects, making it a well-accepted treatment option.
Area of Science:
- Urology
- Gynecology
- Medical Devices
Background:
- Stress and mixed urinary incontinence affect many women.
- Surgical urethropexy is a common treatment, but non-surgical options are sought.
- The Introl bladder neck support prosthesis offers a novel approach.
Purpose of the Study:
- To summarize clinical findings on the Introl prosthesis.
- To document the effectiveness of Introl in treating female incontinence.
- To describe clinical observations from its use.
Main Methods:
- Review of clinical trials conducted in the US and Japan.
- Analysis of patient outcomes and global usefulness ratings.
- Documentation of adverse effects during clinical usage.
Main Results:
- High efficacy rates reported in Japanese clinical trials (81% benefit).
- Introl prosthesis is available and well-accepted in the US.
- Minor adverse effects were experienced by 26% of patients in Japan.
Conclusions:
- The Introl prosthesis is an effective treatment for stress and mixed incontinence.
- The device has demonstrated a favorable efficacy and safety profile.
- Increased clinical usage provides valuable insights into its application.