Gustavo Leibaschoff1, Pablo Gonzalez Izasa2, Jose Luis Cardona3, John R Miklos4, Robert D Moore5. 1. ynecology and Obstetrics Department, University of Buenos Aires School of Medicine, Buenos Aires, Argentina. 2. Gynecology and Obstetrics Department, Military University of Colombia,Urogynecology Department, Hospital Universitario San Jorge, Pereira, Colombia. 3. Pathology Department, Universidad Tecnologica, Pereira, Colombia. 4. Female Pelvic Medicine and Reconstructive Surgery Department, International Urogynecology Associates of Atlanta, Beverly Hills, California and Dubai, United Arab Emirates, Obstetrics and Gynecology Department, Emory University, Atlanta, Georgia. 5. Female Pelvic Medicine and Reconstructive Surgery, International Urogynecology Associates of Atlanta, Beverly Hills, California and Dubai, United Arab Emirates, Obstetrics and Gynecology Department, Emory University, Atlanta, Georgia.
Abstract
OBJECTIVE: The aim of this study was to evaluate the effects of non-ablative, monopolar transcutaneous temperature controlled radiofrequency (TTCRF) technology in the treatment of postmenopausal women suffering from genuine stress urinary incontinence (SUI) related to menopause and to evaluate histological changes vaginally associated with the treatment. MATERIALS AND METHODS: Subjective and objective symptoms of SUI were assessed in study subjects before and after TTCRF, (1 treatment every 30 days, for 3 months; n=10) and compared with the effects of a placebo treatment on a control group of demographically similar women (n =10). SUI was subjectively evaluated with subjective Urogenital Distress Inventory (UDI-6) and with the International Consultation on IncontinenceQuestionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after TTCRF treatments and objectively with cough stress test. Vaginal health was evaluated with the Vaginal Health Index (VHI) score and visual analogue score (VAS) for dyspareunia and dryness. Punch biopsies were obtained at the urethra-vesical junction in the anterior compartment, before and at the end of the treatment protocol. Basic and histochemical staining methods were used. RESULTS: In subjects suffering SUI, TTCRF treatment was associated with a significant (p<0.01) improvement of ICIQ-SF and UDI-6 scores. Seven of 10 patients (70%) had a negative cough stress test after the treatment protocol. Improvements were maintained up to the 12th week of follow-up. The results were supported by the positive histologic changes seen vaginally in women suffering from postmenopausal vaginal atrophy. TTCRF was well tolerated with no complications reported in study patients. CONCLUSION:TTCRF treatment in postmenopausal women suffering from SUI showed significant improvement in both objective and subjective symptoms. Vaginal health scores also improved as did VAS for dryness and dyspareunia. We feel these improvements were related to histological changes related to improvement in vaginal atrophy that were not observed in placebo patients.
RCT Entities:
OBJECTIVE: The aim of this study was to evaluate the effects of non-ablative, monopolar transcutaneous temperature controlled radiofrequency (TTCRF) technology in the treatment of postmenopausal women suffering from genuine stress urinary incontinence (SUI) related to menopause and to evaluate histological changes vaginally associated with the treatment. MATERIALS AND METHODS: Subjective and objective symptoms of SUI were assessed in study subjects before and after TTCRF, (1 treatment every 30 days, for 3 months; n=10) and compared with the effects of a placebo treatment on a control group of demographically similar women (n =10). SUI was subjectively evaluated with subjective Urogenital Distress Inventory (UDI-6) and with the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) before and after TTCRF treatments and objectively with cough stress test. Vaginal health was evaluated with the Vaginal Health Index (VHI) score and visual analogue score (VAS) for dyspareunia and dryness. Punch biopsies were obtained at the urethra-vesical junction in the anterior compartment, before and at the end of the treatment protocol. Basic and histochemical staining methods were used. RESULTS: In subjects suffering SUI, TTCRF treatment was associated with a significant (p<0.01) improvement of ICIQ-SF and UDI-6 scores. Seven of 10 patients (70%) had a negative cough stress test after the treatment protocol. Improvements were maintained up to the 12th week of follow-up. The results were supported by the positive histologic changes seen vaginally in women suffering from postmenopausal vaginal atrophy. TTCRF was well tolerated with no complications reported in study patients. CONCLUSION: TTCRF treatment in postmenopausal women suffering from SUI showed significant improvement in both objective and subjective symptoms. Vaginal health scores also improved as did VAS for dryness and dyspareunia. We feel these improvements were related to histological changes related to improvement in vaginal atrophy that were not observed in placebo patients.
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