Aims of Study:
To evaluate the safety and effectiveness of a new method to treat female stress urinary incontinence (SUI).  This easily performed procedure shrinks the endopelvic fascia EPF and lifts the urethrovesical junction to a more anatomically correct position thereby restoring continence.  This treatment does not use implantable materials such as mesh or sutures. 

 

Methods:
It is well documented in other medical specialities such as orthopaedics, vascular surgery, and neurology that heating collagenous tissue from 60°C to 100°C causes the collagen to denature and the tissue to shrink.  It is postulated that shrinking the previously stretched EPF lifts the area around the urethra and bladder neck in a way similar to conventional sling and suspension procedures.  A prospective IDE study was conducted on 26 women with genuine SUI confirmed by urodynamics. All patients had positive valsalva leak point pressures.  Symptom duration was 10.4 ± 8.9 years.  Over 80% of the subjects used one or more pads per day; all of the subjects averaged one or more episodes per day.  Using transvaginal paraurethral or “U” shaped incisions, and reflection of the vaginal epithelial surface, the EPF was directly visualized.  Precisely controlled radio frequency energy was applied with an instrument (SURx, Inc., Pleasanton, CA) to the EPF causing it to heat and shrink.  The incisions were closed using conventional techniques.  Initial safety, tolerability and short-term efficacy data were collected using standardized methods. 

 

Results:
All patients were treated on an outpatient basis and discharged 2-4 hours following the procedure. RF treatment time did not cumulatively exceed five minutes.  Operative time ranged from 30-45 minutes.  There were no operative complications. One patient had a urinary tract infection that resolved with antibiotic treatment.  All patients returned to normal ambulatory activities (excluding strenuous exercise) on the first post-operative day.  Success was defined as negative valsalva, reduction in daily SUI episodes, reduction in pad use, improved quality of life score, and patient satisfaction.

 

Success Rates (%)    3 month           6 month           12 month

                                    14/18               9/10                 7/8

                                    (77.8%)           (90.0%)           (87.5%)

 

Conclusions:
Lifting the urethrovesical junction and urethra by shrinking the endopelvic fascia without the use of implantable sutures or mesh appears to be safe and well tolerated by patients.  The early efficacy data are promising.  Data collected on a larger number of patients and for a longer follow-up period is ongoing. 

 

This study was sponsored by SURx, Inc.