Radiofrequency Thermal Therapy Research Articles

Comparison of Low-Energy Radiofrequency Thermal Vaginal Therapy with Sham Treatment for Stress Urinary Incontinence in Postmenopausal Women: A Randomized Controlled Trial.

Low-energy radiofrequency (RF) thermal vaginal therapy for vaginal laxity and the genitourinary syndrome of menopause denatures collagen fibrils in the endopelvic fascia; fiber tightening during healing may stabilize the urethra and bladder neck, thereby resolving female stress urinary incontinence (SUI), especially in postmenopausal women. This study compared RF vaginal therapy with sham treatment for mild to moderate SUI. This double-blinded, randomized controlled trial, conducted at a tertiary center from September 2018 to April 2021, recruited postmenopausal women with mild to moderate degree of SUI who had never undergone surgery, energy-based therapy, or vaginal estrogen treatment. The intervention group received vaginal RF laser treatment; the sham group did not. The primary outcome was the 1-hour pad-weight test (PWT) result. Secondary outcomes were Incontinence Quality of Life (I-QOL), Urogenital Distress Inventory (UDI-6), Incontinence Impact Questionnaire (IIQ-7), Patient Global Impression of Improvement (PGI-I), percentage of improvement among all participants, and adverse events. Data were analyzed using STATA 17.0. Forty-nine participants randomized to RF (n = 23) and sham (n = 26) groups were eligible for analysis. PWT decreased during follow-up in the RF group but remained stable in the sham group; PWT did not significantly differ between groups. The 1-year post-treatment success rate was higher in the RF group (69.6%) than in the sham group (38.5%). At 1 year post-treatment, there were no statistically significant differences in any secondary outcomes. Low-energy RF vaginal therapy is an alternative treatment for mild to moderate SUI in postmenopausal women without serious adverse events. Larger randomized controlled trials should be conducted.

Pilot study of radiofrequency thermal therapy performed twice on the entire vaginal wall for vaginal laxity

ObjectiveRadiofrequency thermal (RFT) therapy is commonly performed to treat vaginal laxity (VL), but the optimal technique of RFT therapy is unclear. We aimed to evaluate the efficacy and safety of RFT therapy performed twice on the whole vaginal wall in women with VL. MethodsThis was a single-arm, open-label clinical trial conducted in a tertiary hospital in the Republic of Korea from July 2018 to January 2019. Non-pregnant, adult women with VL, defined as a score ≤3 on a vaginal laxity questionnaire (VLQ), were recruited. RFT therapy consisted of 2 office procedures performed 3 weeks apart. Starting from the upper vaginal wall at the 12 o’clock position, the whole vaginal wall was slowly rubbed with a heated vaginal probe for 20 minutes. After the 2nd RFT therapy session, patients had follow-up visits at 4 and 12 weeks, and changes in the VLQ score, Female Sexual Function Index (FSFI) score, Female Sexual Distress Scale (FSDS) score, and vaginal pressure at rest and during the Valsalva maneuver and treatment-emergent adverse events (TEAEs) were examined. ResultsThirty subjects were enrolled, but 28 were evaluated for efficacy measurements. RFT therapy improved the VLQ score (means at baseline, 4 weeks, and 12 weeks were 2.5, 4.9, and 4.8, respectively; p < 0.0001), FSFI score (means at baseline, 4 weeks, and 12 weeks were 21.9, 27.0, and 27.2, respectively; p < 0.0001), and FSDS score (means at baseline, 4 weeks, and 12 weeks were 33.8, 21.1, and 18.6, respectively; p < 0.0001); however, vaginal pressure did not increase. The effect of RFT therapy peaked at the 4-week follow-up and plateaued at week 12. No TEAE was observed, except transient grade 1 vaginal pain. ConclusionRFT therapy performed twice on the whole vaginal wall showed promising efficacy and safety profiles and has merit for further investigation.

Convective Radio Frequency Thermal Therapy for Treatment of Benign Prostatic Hyperplasia: Single Office Experience with 255 Patients over 4 Years.

Convective radio frequency thermal therapy with the Rezūm® system is a relatively new treatment for benign prostatic hyperplasia with proven short-term durability. We report an update of previously published data from a single center showing durability through 4 years. A retrospective review of 255 patients who underwent the Rezūm procedure from a single surgeon was performed, including 25 patients from the Rezūm II study, from March 2014 to April 2018. Maximum urinary flow rate, I-PSS (International Prostate Symptom Score), I-PSS-QOL (quality of life), post-void residual, medication use and adverse events were monitored. Data were analyzed at baseline, and 3, 6, 12, 24, 36 and 48 months after treatment. Statistically significant improvement in maximum urinary flow rate (57.2%), I-PSS (54.7%) and I-PSS-QOL (59.2%) appear to be durable through 48 months, with improvement greater than 50% at most recent followup. We report a similarly low reoperation rate compared to the most recent data from the Rezūm II study (3.1% vs 4.4%), but with higher rates of urinary tract infection (18.8% vs 3.7%) and urinary retention (15.7% vs 3.7%). Overall satisfaction with the procedure experience (93.9%) and the outcome (90.9%) was high, with 97% of men interviewed recommending the procedure to a friend. In addition, 80% of men were able to stop all medication. Our experience provides the largest published cohort of patients undergoing this procedure and shows durable improvements in maximum urinary flow rate, I-PSS and I-PSS-QOL through 4 years. Patients outside of the inclusion criteria of Rezūm II appear to benefit from the procedure.

PD10-11 CONVECTIVE RADIOFREQUENCY THERMAL THERAPY FOR TREATMENT OF BPH: 4 YEAR FOLLOW UP FROM A SINGLE OFFICE EXPERIENCE

INTRODUCTION AND OBJECTIVES:Convective radiofrequency thermal therapy with the Rezum system is a relatively new treatment for benign prostatic hyperplasia (BPH) that has been shown to be durable th...

629 Comparison of lower urinary tract symptoms and sexual function response to convective radiofrequency thermal therapy of prostate (Rezûm®) to MTOPS study cohort

629 Comparison of lower urinary tract symptoms and sexual function response to convective radiofrequency thermal therapy of prostate (Rezûm®) to MTOPS study cohort

634 Convective radiofrequency thermal therapy (Rezum®) effectively treats lower urinary tract symptoms due to benign prostatic hyperplasia regardless of obesity while preserving erectile and ejaculatory function

634 Convective radiofrequency thermal therapy (Rezum®) effectively treats lower urinary tract symptoms due to benign prostatic hyperplasia regardless of obesity while preserving erectile and ejaculatory function

PD64-02 REAL LIFE EXPERIENCE WITH THE REZUM SYSTEM FOR BENIGN PROSTATIC HYPERPLASIA

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Surgical Therapy & New Technology III1 Apr 2018PD64-02 REAL LIFE EXPERIENCE WITH THE REZUM SYSTEM FOR BENIGN PROSTATIC HYPERPLASIA Daniel Mollengarden, Kenneth Goldberg, Daniel Wong, and Claus Goerg Roehrborn Daniel MollengardenDaniel Mollengarden More articles by this author , Kenneth GoldbergKenneth Goldberg More articles by this author , Daniel WongDaniel Wong More articles by this author , and Claus Goerg RoehrbornClaus Goerg Roehrborn More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.2974AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Convective radiofrequency water vapor thermal therapy with the Rezum system is a relatively new treatment for benign prostatic hyperplasia (BPH). We present results from a single surgeon in an office setting, including efficacy by prostate volume and patient satisfaction data. METHODS A retrospective review was performed on 129 patients who underwent the Rezum procedure by a single surgeon. All patients were at least four months out from treatment. International prostate symptom scores (IPSS), maximum flow rates (Qmax), residual urine volumes, medication usage, and adverse events were monitored. A scripted patient questionnaire was administered over the phone to obtain quality of life and satisfaction data. RESULTS Mean IPSS improved from a baseline of 18.3 to 6.9 and Qmax from 10.5 to 16.8 mL/sec at 3-6 months out (figure 1a). Improvements were independent of starting IPSS, treatment of a median lobe, and prostate size which measured up to 86 cc (figure 1b). There was a 17% prostate volume reduction on TRUS and 14% based on PSA levels. The most common adverse events were urinary tract infections (17%) and transient urinary retention (14%) (table 1). Ninety percent of patients stopped all BPH medications. Questionnaires revealed 86% of patients would recommend the procedure to a friend, and 77% and 74% were either satisfied or very satisfied with the procedure and its results, respectively (figure 2). CONCLUSIONS Rezum radiofrequency thermal therapy offers a minimally invasive option for BPH management with moderate improvement in symptoms and flow rate. The results appear to be independent of prostate size or presence of a median lobe, and patients are largely satisfied. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1219-e1220 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Daniel Mollengarden More articles by this author Kenneth Goldberg More articles by this author Daniel Wong More articles by this author Claus Goerg Roehrborn More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

193 Comparison of Lower Urinary Tract Symptoms and Sexual Function Response to Convective Radiofrequency Thermal Therapy of Prostate (Rezűm®) to MTOPS Study Cohort

193 Comparison of Lower Urinary Tract Symptoms and Sexual Function Response to Convective Radiofrequency Thermal Therapy of Prostate (Rezűm®) to MTOPS Study Cohort

004 Convective Radiofrequency Thermal Therapy (Rezum®) Effectively Treats Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia Regardless of Obesity while Preserving Erectile and Ejaculatory Function

004 Convective Radiofrequency Thermal Therapy (Rezum®) Effectively Treats Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia Regardless of Obesity while Preserving Erectile and Ejaculatory Function

Three-Year Outcomes of the Prospective, Randomized Controlled Rezūm System Study: Convective Radiofrequency Thermal Therapy for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

To report 3-year outcomes of a prospective, multicenter, randomized, blinded control trial after treatment with convective radiofrequency (RF) water vapor thermal therapy for moderate to severe lower urinary tract symptoms due to benign prostatic hyperplasia (BPH). Fifteen centers enrolled and randomized 197 men ≥50 years old with International Prostate Symptom Score (IPSS) ≥13, maximum flow rate (Qmax) ≤15 mL/s, and prostate volume 30 to 80 cc to thermal therapy with Rezūm System or control (2:1). Rigid cystoscopy with simulated active treatment sound effects served as the control procedure. Convective RF thermal energy was delivered into obstructive prostate tissue including the median lobe as needed. After randomized comparison at 3 months, thermal therapy subjects were followed annually for 3 years. Convective RF thermal therapy yielded IPSS improvement of 160% compared with control subjects at 3 months (P <.0001). Maximal symptom relief of at least 50% improvement in IPSS, quality of life, Qmax, and BPH Impact Index remained durable throughout 3 years (P <.0001). Subjects with a treated median lobe had similar responses. No late-related adverse events occurred, and no de novo erectile dysfunction was reported. The surgical retreatment rate was 4.4% over 3 years. The minimally invasive convective RF thermal therapy is an office or ambulatory outpatient procedure with minimal transient perioperative side effects. It provides early effective and durable relief of BPH symptoms with preservation of sexual function in subjects followed up for 3 years and is applicable to treatment of the median lobe and hyperplastic central zone tissue.

Procedural techniques and multicenter postmarket experience using minimally invasive convective radiofrequency thermal therapy with Rezūm system for treatment of lower urinary tract symptoms due to benign prostatic hyperplasia.

ObjectiveThis report evaluates clinical experience with the Rezūm system after US Food and Drug Administration clearance in consecutive cases accrued by multiple community urologists for the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Treatment techniques for transurethral convective radiofrequency water-vapor thermal therapy and outcomes with up to 12 months’ follow-up are presented.Materials and methodsA total of 131 patients with moderate–severe LUTS were included in a retrospective analysis of BPH procedures with the Rezūm system. Pre- and postprocedure assessments included International Prostate Symptom Score (IPSS), quality of life, peak urinary flow rate, voided volume, and postvoid residual urine volume. Urologists used their own discretion for patient selection, with variable prostate sizes, LUTS severity, urinary retention, or presence of an obstructing median lobe. Safety signals and surgical retreatment rates were monitored prospectively.ResultsMen aged 47–96 years with prostates 13–183 cm3 showed significant improvement in IPSS, quality of life, and postvoid residual volume durable through 12 months after thermal therapy. Patients with either moderate (IPSS 8–19) or severe (IPSS 20–35) symptoms achieved significantly improved scores. Postprocedure adverse events normally anticipated and related to endoscopic instrumentation were transient and mild–moderate in nature. No de novo erectile or ejaculatory dysfunction was reported.ConclusionThis study corroborates prior published pilot and randomized controlled trial results indicating significant relief of urinary symptoms and reproducibility of responses to thermal therapy. Convective radiofrequency thermal therapy with the Rezūm system warrants consideration as a first-line treatment for LUTS/BPH as an alternative to the use of pharmaceutical agents.

Perspective on the Rezūm® System: a minimally invasive treatment strategy for benign prostatic hyperplasia using convective radiofrequency water vapor thermal therapy.

Convective radiofrequency (RF) water vapor thermal therapy is a minimally invasive office or outpatient procedure for the treatment of bothersome moderate-to-severe lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). It provides an option for patients seeking rapid and durable relief of urinary symptoms, improved quality of life, and preservation of sexual function as an alternative to long-term use of drugs and avoidance of the potential side effects of pharmaceuticals or invasive BPH surgery. The procedure is also applicable for the treatment of the median lobe or elevated bladder neck from central zone hyperplasia. This perspective presents a comprehensive overview of the Rezūm® System convective RF thermal therapy device, the principles upon which it is based, the operative procedure, and the clinical evidence accrued to this point in time.

Convective Thermal Therapy: Durable 2-Year Results of Randomized Controlled and Prospective Crossover Studies for Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

We report 2-year outcomes of a multicenter randomized controlled trial plus 1-year results of a crossover trial after treatment with convective radiofrequency water vapor thermal energy for lower urinary tract symptoms due to benign prostatic hyperplasia. A total of 197 men at least 50 years old with I-PSS (International Prostate Symptom Score) 13 or greater, maximum flow rate 15 ml per second or less and prostate size 30 to 80 cc were randomized 2:1 to thermal therapy with the Rezūm® System or a control group. Rigid cystoscopy with simulated active treatment sounds served as the control procedure. After unblinding at 3 months control subjects could requalify for crossover study. Convectively delivered radiofrequency thermal energy was delivered into obstructive prostate tissue, including the median lobe as needed. The primary efficacy end point was a change in severity of symptom scores. Convective radiofrequency thermal therapy improved urinary symptoms significantly over controls at 3 months and provided a sustained 51% reduction from baseline at 24 months (p <0.0001). This produced a 5 and 8-point or greater score decrease in 84% and 74% of subjects, respectively, at24months. Crossover subject symptoms, flow rate and quality of life measures were markedly improved after thermal therapy compared to after the control procedure (p= 0.024 to <0.0001). No de novo erectile dysfunction was reported. Convective radiofrequency water vapor thermal therapy is a minimally invasive office or outpatient procedure that provides early effective symptom relief that remains durable for 2 years and is applicable to the median lobe.

Chemoradiotherapy and concurrent radiofrequency thermal therapy to treat primary rectal cancer and prediction of treatment responses.

The present study aimed to evaluate a previously reported predictive formula of output-limiting symptoms induced by radiofrequency (RF) to determine the efficacy of this neoadjuvant chemoradiation (NACR) and concurrent RF thermal therapy. The present study included 81 consecutive patients with confirmed diagnoses of rectal adenocarcinoma that was localized in the mid-low rectum (up to 12 cm from the anal verge) who received NACR [intensity-modulated radiotherapy (IMRT), 50 Gy/25 fractions, capecitabine 1,700 mg/m2/day for 5 days/week)] with concurrent thermal therapy (Thermotron-RF8, once a week for 5 weeks with 50 min irradiation). Patients with progressive disease (PD) did not receive RF outputs higher than the predicted value. Some patients who were predicted to receive more output in fact received more than the predicted output. In patients who were predicted to receive moderately higher outputs, 37.5% of the patients experienced pathological complete responses, which was the highest rate, while in those who did not receive more than the predicted output, 66.7% of the patients experienced PD, which was the highest rate in the present study. We speculate that RF thermal therapy may offset the chemoradiation effects in some patients. Adding thermal therapy as a multimodality therapy to NACR potentially affects patients with lower predicted outputs and actual observed outputs slightly higher than the predictive value. Our predictive equation for initial energy output, in which output-limiting symptoms can be used to predict treatment efficacy, consequently, can be used to decide whether to continue this treatment modality.

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia.

ObjectiveThe objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations.Patients and methodsMen aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20–120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months.ResultsLUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen.ConclusionThe Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.

A pilot study comparing the efficacy of radiofrequency and microwave diathermy in combination with intra-articular injection of hyaluronic acid in knee osteoarthritis.

[Purpose] This study aimed to compare the efficacy of radiofrequency diathermy with that of microwave diathermy in combination with intra-articular injection of hyaluronic acid into the knee of patients with osteoarthritis (OA). [Subjects] A total of 17 patients with knee OA were enrolled. The participants were randomly divided into two groups: a radiofrequency diathermy group (RF group, 9 subjects), and a microwave diathermy group (MW group, 8 subjects). [Methods] Subjects received radiofrequency or microwave thermal therapy 3 times at 1-week intervals. Intra-articular injection of hyaluronic acid was administered 10 min before every thermal therapy session. The outcome was evaluated using the Japan Orthopaedic Association (JOA) and the Lequesne Index (LI) at baseline, at weeks 1 (1 week after the first thermal therapy) and 3 (1 week after the last thermal therapy). [Results] The JOA scale increased significantly after three sessions of thermal therapy in the RF group, while no significant increase was observed in the MW group. LI decreased significantly after 3 weeks in the RF group. In the MW group, there was no significant difference in LI between the two time points. [Conclusion] This study revealed that symptom relief in patients with knee OA was greater with radiofrequency diathermy than with microwave diathermy with concurrent use of hyaluronic acid injection, presumably due to the different heating characteristics of the two methods.

A tumor-specific cleavable nanosystem of PEG-modified C60@Au hybrid aggregates for radio frequency-controlled release, hyperthermia, photodynamic therapy and X-ray imaging

Taking advantages of fullerene (C60) and gold nanoparticles (AuNPs) for potentials in photodynamic therapy (PDT), drug delivery and radio frequency thermal therapy (RTT), a C60@Au hybrid nanocomposite was synthesized by chemical deposition of Au nanoparticles onto C60, and functionalized by PEG5000 via a pH cleavable hydrazone bond, making C60@Au-PEG keep the PEG on the surface of drug delivery system during circulation but dissociate PEG from the system after accumulation in tumor tissue, then doxorubicin (DOX) was loaded onto C60@Au-PEG with a very high drug loading efficiency. The release profiles of DOX from C60@Au-PEG/DOX showed strong dependences on radio frequency (RF). For the drug delivery, C60@Au-PEG/DOX afforded much higher antitumor efficacy owing to 8.6-fold higher DOX uptake of tumor than DOX. Besides, in this work, C60@Au-PEG/DOX not only served as a powerful RTT agent for RF-thermal ablation of tumor and a strong photosensitizer (PS) for PDT, but also as an X-ray contrast agent for tumor diagnosis. In the in vitro and in vivo studies, C60@Au-PEG/DOX showed excellent chemo-RF thermal-photodynamic therapeutic efficacy, RF-controlled drug releasing function, tumor targeting property, tumoral acid PEG dissociating character and X-ray imaging ability, demonstrating that there is a great potential of C60@Au-PEG/DOX for simultaneous diagnosis and therapy in cancer treatment. Statement of significanceA significant challenge in cancer therapy is to maximize the therapeutic efficacy and minimize the side effects. In the past decade, a lot of nanoparticles have been used as the carriers for efficient drug delivery. However, the design of drug delivery system (DDS) with stimuli-responsive controlled-release property, simultaneous diagnosis and therapy functions is still a challenge. Herein, we developed a new drug delivery system (C60@Au-PEG/DOX), and explored its applications in tumor therapy. The in vitro and in vivo results showed C60@Au-PEG/DOX could significantly improve the therapeutic efficacy and reduce the systemic toxicity through X-ray imaging guided locatable DOX release, photodynamic and photothermal therapies. These results are of interest as they demonstrate a multi-functional DDS for tumor theranostic applications.

A fullerene-based multi-functional nanoplatform for cancer theranostic applications

Recently, nanomaterials with multiple functions, such as drug carrier, MRI and optical imaging, photothermal therapy etc, have become more and more popular in the domain of cancer research. In this study, a C60–IONP nanocomposite is synthesized via decorating iron oxide nanoparticles (IONP) onto fullerene (C60) and then functionalized by polyethylene glycol (PEG2000), giving C60–IONP–PEG with excellent stability in physiological solutions, finally folic acid (FA), a widely used tumor targeting molecule, was linked to C60–IONP–PEG in order to obtain an active tumor targeting effect to MCF-7 cells and malignant tumor in mice models. Herein, a hybrid nanoplatform with multi-functional characteristics for cancer diagnosis, photodynamic therapy (PDT), radiofrequency (RF) thermal therapy (RTT) and magnetic targeting applications was developed and explored its biofunctions in vitro and in vivo. C60–IONP–PEG–FA showed neglectable toxicity, not only served as a powerful tumor diagnostic magnetic resonance imaging (MRI) contrast agent, but also as a strong photosensitizer and powerful agent for photothermal ablation of tumor, furthermore a remarkable synergistic enhancement of PDT combination with RTT was also observed during the treatment both in vitro and in vivo. Moreover, the multi-functional nanoplatform also could selectively kill cancer cells in highly localized regions via the excellent active tumor targeting and magnetic targeted abilities. This work showed the multi-functional C60–IONP–PEG–FA nanoplatform had a great potential for cancer theranostic applications.

Laxity of the Vaginal Introitus After Childbirth: Nonsurgical Outpatient Procedure for Vaginal Tissue Restoration and Improved Sexual Satisfaction Using Low-Energy Radiofrequency Thermal Therapy

Vaginal childbirth may result in vaginal introital laxity, altered genital sensation during sexual intercourse, and reduced sexual satisfaction. We report the long-term effectiveness of a single nonsurgical procedure with radiofrequency (RF) energy for laxity at the vaginal introitus. Prospective single-arm study of 30 premenopausal women (21-52 year) with one 30-minute office procedure using RF applied to the vaginal introitus; 12-month outcome assessments included the linguistic validated Japanese versions of the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised (FSDS-R) and the Vaginal Laxity and Sexual Satisfaction Questionnaires. Sexual function improved significantly throughout 6 months (30 subjects); mean FSFI total score was 22.4±6.7 before treatment and then improved to mean 26.0±5.8 at month 6 (P=0.002), inclusive of improved scores in five of six FSFI domains except desire (P<0.001 -<0.01). In the 22 of 30 subjects remaining evaluable at 12 months, the mean was 26.0±5.2 (P=0.08). Distress related to sexual activity decreased significantly; baseline FSDS-R mean score of 15.8±11.7 improved to 9.8±8.0 at one month and was sustained throughout 12 months (P<0.001 - 0.002). Subjects reported decreased vaginal laxity within the first month after the procedure (P<0.001); responses peaked, and effectiveness was sustained through 12 months (P<0.001). A single nonsurgical office-based RF procedure for vaginal introital laxity achieved significant and sustainable 12-month effectiveness with respect to improved integrity at the vaginal introitus and improved sexual satisfaction. Treatment was well-tolerated with no adverse events.

Comparison of percutaneous radiofrequency thermal ablation and surgical resection for small hepatocellular carcinoma

BackgroundThe purpose of this investigation was to compare the outcome of percutaneous radiofrequency thermal ablation therapy (PRFA) with surgical resection (SR) in the treatment of single and small hepatocellular carcinoma (HCC).MethodsWe conducted a retrospective cohort study on 231 treatment naive patients with a single HCC ≤ 3 cm who had received either curative PRFA (162 patients) or curative SR (69 patients). All patients were regularly followed up after treatment at our department with blood and radiologic tests.ResultsThe 1-, 3- and 5-year overall survival rates after PRFA and SR were 95.4%, 79.6% and 63.1%, respectively in the PRFA group and 100%, 81.4% and 74.6%, respectively in the SR group. The corresponding recurrence free survival rates at 1, 3 and 5 years after PRFA and SR were 82.0%, 38.3% and 18.0%, respectively in the PRFA group and 86.0%, 47.2% and 26.0%, respectively in the SR group. In terms of overall survival and recurrence free survival, there were no significant differences between these two groups. In comparison of PRFA group patients with liver cirrhosis (LC) (n = 127) and SR group patients with LC (n = 50) and in comparison of PRFA group patients without LC (n = 35) and SR group patients without LC (n = 19), there were also no significant differences between two groups in terms of overall survival and recurrence free survival. In the multivariate analysis of the risk factors contributing to overall survival, serum albumin level was the sole significant factor. In the multivariate analysis of the risk factors contributing to recurrence free survival, presence of LC was the sole significant factor. The rate of serious adverse events in the SR group was significantly higher than that in the PRFA group (P = 0.023). Hospitalization length in the SR group was significantly longer than in the PRFA group (P = 0.013).ConclusionsPRFA is as effective as SR in the treatment of single and small HCC, and is less invasive than SR. Therefore, PRFA could be a first choice for the treatment of single and small HCC.