A prospective multisite study of radiofrequency bipolar energy for treatment of genuine stress incontinence.

STUDY

OBJECTIVE

To assess the efficacy of radiofrequency electrothermal energy to treat genuine stress incontinence (GSI).

DESIGN

Multicenter, prospective, single-arm, longitudinal study (Canadian Task Force classification II-1).

SETTING

Six North American university-affiliated and private clinic sites.

PATIENTS: Ninety-four women undergoing laparoscopic treatment for GSI.

INTERVENTION: Radiofrequency bipolar treatment of paravaginal tissue to induce tissue shrinkage causing bladder neck elevation.

MEASUREMENTS AND MAIN

RESULTS

Patients underwent complete urogynecologic evaluations, with urodynamic testing, including Valsalva leak point pressure, to confirm the diagnosis of GSI. Paravaginal tissue was treated lateral from the urethra and bladder neck out to the arcus white line, with bipolar electrothermal energy to shrink bladder-supporting connective tissue. Treatment resulted in 30% shrinkage in paravaginal endopelvic fascia surface area by direct measurement. At 1 year the objective cure rate was 79% by urodynamic testing, improvement in quality of life by questionnaire was 81%, decrease in leaking episodes and pad use was significant (p <0.001), and patient satisfaction was 83%. Complications (7%) were secondary to laparoscopy. There were no injuries from the radiofrequency probe.

CONCLUSION

Radiofrequency bipolar electrothermal energy appears to be a safe an efficient means of treating mild to moderate GSI. It results in shrinkage and elevation of paravaginal connective tissue, stabilizing the urethra and bladder neck, thereby restoring continence. Long-term follow-up is necessary.