Study ObjectiveTo assess the safety and efficacy of a new nonsurgical transvaginal device (The Solarant System, Solarant Medical, Livermore, CA) that delivers RF energy transvaginally to the endopelvic fascia (EPF) without incisions to treat GSI in women.DesignProspective single arm feasibility trial of 20 patients receiving treatment with the Solarant System.SettingMajor academic hospital in Guadalajara, Mexico.Patients20 women with GSI due to urethral hypermobility confirmed by urodynamic evaluation. Preoperatively all 20 patients had >1 urinary incontinence episode per day (average 3.8 episodes/day) and a positive cough Valsalva. Detrusor instability was excluded by cystometry.InterventionAll women underwent a procedure with the Solarant System. During this procedure, the system delivered precisely controlled RF energy bilaterally to the anterior vaginal wall, lateral to the urethra and proximal to the bladder neck causing the EPF to heat and shrink. Concomitantly, the system cooled the surface tissue layer of the vaginal mucosa.Measurements and Main ResultsProcedure time was less than an hour. All patients voided spontaneously within 2-5 hours and were discharged within 3-5 hours. No patient developed urge, frequency or retention. Several patients had vaginal mucosal tissue changes at treatment sites—most were asymptomatic and resolved with conservative management. At 3 month follow-up, 85% (17/20) were dry or <1 incontinence episode/day and 75% (15/20) had a negative cough Valsalva.ConclusionThis new nonsurgical RF system and procedure appears to be a safe and effective minimally invasive approach to treatment of GSI in women. Further follow-up is ongoing and additional clinical studies are planned.(NOTE: This is an investigational device; this study was sponsored by Solarant Medical, Inc., Livermore, CA.) Study ObjectiveTo assess the safety and efficacy of a new nonsurgical transvaginal device (The Solarant System, Solarant Medical, Livermore, CA) that delivers RF energy transvaginally to the endopelvic fascia (EPF) without incisions to treat GSI in women. To assess the safety and efficacy of a new nonsurgical transvaginal device (The Solarant System, Solarant Medical, Livermore, CA) that delivers RF energy transvaginally to the endopelvic fascia (EPF) without incisions to treat GSI in women. DesignProspective single arm feasibility trial of 20 patients receiving treatment with the Solarant System. Prospective single arm feasibility trial of 20 patients receiving treatment with the Solarant System. SettingMajor academic hospital in Guadalajara, Mexico. Major academic hospital in Guadalajara, Mexico. Patients20 women with GSI due to urethral hypermobility confirmed by urodynamic evaluation. Preoperatively all 20 patients had >1 urinary incontinence episode per day (average 3.8 episodes/day) and a positive cough Valsalva. Detrusor instability was excluded by cystometry. 20 women with GSI due to urethral hypermobility confirmed by urodynamic evaluation. Preoperatively all 20 patients had >1 urinary incontinence episode per day (average 3.8 episodes/day) and a positive cough Valsalva. Detrusor instability was excluded by cystometry. InterventionAll women underwent a procedure with the Solarant System. During this procedure, the system delivered precisely controlled RF energy bilaterally to the anterior vaginal wall, lateral to the urethra and proximal to the bladder neck causing the EPF to heat and shrink. Concomitantly, the system cooled the surface tissue layer of the vaginal mucosa. All women underwent a procedure with the Solarant System. During this procedure, the system delivered precisely controlled RF energy bilaterally to the anterior vaginal wall, lateral to the urethra and proximal to the bladder neck causing the EPF to heat and shrink. Concomitantly, the system cooled the surface tissue layer of the vaginal mucosa. Measurements and Main ResultsProcedure time was less than an hour. All patients voided spontaneously within 2-5 hours and were discharged within 3-5 hours. No patient developed urge, frequency or retention. Several patients had vaginal mucosal tissue changes at treatment sites—most were asymptomatic and resolved with conservative management. At 3 month follow-up, 85% (17/20) were dry or <1 incontinence episode/day and 75% (15/20) had a negative cough Valsalva. Procedure time was less than an hour. All patients voided spontaneously within 2-5 hours and were discharged within 3-5 hours. No patient developed urge, frequency or retention. Several patients had vaginal mucosal tissue changes at treatment sites—most were asymptomatic and resolved with conservative management. At 3 month follow-up, 85% (17/20) were dry or <1 incontinence episode/day and 75% (15/20) had a negative cough Valsalva. ConclusionThis new nonsurgical RF system and procedure appears to be a safe and effective minimally invasive approach to treatment of GSI in women. Further follow-up is ongoing and additional clinical studies are planned.(NOTE: This is an investigational device; this study was sponsored by Solarant Medical, Inc., Livermore, CA.) This new nonsurgical RF system and procedure appears to be a safe and effective minimally invasive approach to treatment of GSI in women. Further follow-up is ongoing and additional clinical studies are planned.
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