uterine fibroids ( leiomyomas ) are the most widespread reproductive tract tumors in women during their childbearing years . a variety of symptoms are associated with fibroids including pelvic pain , heavy and prolonged menstrual flow , abdominal pressure , urinary frequency , and infertility , thereby significantly affecting quality of life.[13 ] the standard for surgical treatment of fibroids is myomectomy or hysterectomy , with less invasive treatments being hormonal therapy , uterine artery embolization ( uae ) , and magnetic resonance - guided focused ultrasound surgery ( mrgfus).[47 ] the benefits of these minimally invasive strategies are that they spare the uterus , require minimal or no hospitalization , reduce complication rates , treatment costs , and recovery time . however , myomectomy and uae are preferable to hysterectomy as they minimize recovery time . the use of myomectomy can be limited by the location and size of the fibroid . while uae is often associated with complications such as post - embolization syndrome . in 2004 , the exablate 2000 mrgfus system was approved by the us food and drug association ( fda ) for the treatment of uterine fibroid by thermal ablation . mrgfus is a non - invasive treatment that utilizes high intensity focused ultrasound to target multiple focal spots , under real - time guidance and monitoring using magnetic resonance imaging ( mri ) , thereby providing anatomical and thermal feedback . the temperature of the tissue within the focal zone is raised and ablation of the targeted tissue is achieved through protein denaturation , cell death , and coagulative necrosis . for the past several years , mrgfus has been in clinical use for the treatment of symptomatic fibroids.[71216 ] for the treatment of uterine fibroids , mrgfus has shown to be safe and efficacious , according to studies of several groups worldwide.[71417 ] the duration of the procedure is approximately 3 - 4 hours . a reduction in symptoms for a period of up to 2 years following treatment without any major complications has been reported . advantages of this procedure are that it can be performed as an outpatient treatment and only targeted areas are ablated , leaving surrounding tissue intact . this article is the first to report the use of mrgfus treatment for uterine fibroids in a large cohort of patients in india , with a 6-month follow - up evaluation . we describe here our initial experience with the mrgfus system and report on the safety and short - term efficacy of the treatment on this specific patient population . between july 2010 and december 2010 , 50 women underwent uterine fibroid treatment in jaslok hospital and research center using the exablate 2000 mrgfus system ( insightec ltd . , tirat carmel , israel ) . necessary approval from ethics committee from jaslok hospital and research center was obtained before starting the study . to ensure patient safety and enhance efficacy , women who had bowel segment in the path of the ultrasound beam , between the transducer and the targeted fibroids , fibroids appearing hypointense and isointense on t2-weighted images and homogeneously enhancing on post - contrast studyfibroids having a maximum diameter of 12 cmpedunculated fibroids with more than 50% attachment 
  fibroids appearing hypointense and isointense on t2-weighted images and homogeneously enhancing on post - contrast study fibroids having a maximum diameter of 12 cm pedunculated fibroids with more than 50% attachment 
 t2 hyperintense and post - contrast non - enhancing fibroidspedunculated fibroids with less than 50% attachmentuterine posterior wall fibroidspatients with contraindications to mri such as patients with pacemakers , metallic implants , patients who were claustrophobic , and others 
  t2 hyperintense and post - contrast non - enhancing fibroids pedunculated fibroids with less than 50% attachment uterine posterior wall fibroids patients with contraindications to mri such as patients with pacemakers , metallic implants , patients who were claustrophobic , and others all patients were treated on the exablate 2000 mrgfus system , which is integrated with a 1.5-t mri scanner ( ge healthcare , milwaukee , wi , usa ) to produce real - time thermal images throughout the treatment stage of the procedure . prior to initiation of treatment , patients abdomen was shaved and cleaned , a urinary catheter was inserted , and conscious sedation ( inj . each patient lay prone on the exablate treatment table with their abdomen positioned over the ultrasound transducer bath and a button in their hands , which when pressed would immediately stop delivery of focused ultrasound energy . prior to initiation of treatment , a series of t2-weighted mr images in three orientations were acquired for identification of patients anatomy and procedure planning [ figure 1a ] . the treatment boundaries and sensitive areas such as nerves , bowels , and bone were marked using the exablate software . manual optimization of the sonication regions was performed by the attending physician using the pretreatment images and associated exablate software . during the treatment , a series of multiple sonications were applied over the course of approximately 3 - 4 h with a short cooling interval between each sonication . immediately following the procedure , t1-weighted contrast - enhanced images were acquired in order to calculate the non - perfused volume ( npv ) [ figure 1b ] . patients were given a dose of intravenous antibiotics ( injection augmentin 1.2 g ) kept overnight in the hospital before being discharged the next morning . most of the patients returned to their normal daily activities including working regular hours within 1 - 2 days after treatment . mri was used to measure the size of the fibroids and calculate the shrinkage [ figure 1c ] . axial , sagittal , and coronal t2-weighted magnetic resonance ( mri ) images of the pelvic region to plan treatment of the fibroids post - treatment post - contrast t1-weighted magnetic resonance ( mri ) images of the pelvic region shows the ablated fibroid ( approximate fibroid volume 271 cc six - month follow - up post - treatment post - contrast t1-weighted image shows 45 - 50% reduction in size of ablated fibroid ( approximate volume 140 cc ) the uterine fibroid symptom and quality of life ( ufsqol ) questionnaire was used to obtain an objective measure of the symptom level of the patients treated . the ufsqol is a validated symptom - specific questionnaire , with questions targeting classical uterine fibroid symptoms , such as frequent urination , pressure , and menorrhagia , which is used to calculate a symptom severity score ( sss ) . the most appropriate answer from a five - point scale is chosen by the patient and the final result is represented on a 100-point scale , with a lower score indicative of a lower severity of symptoms . localized and transient pain in the abdominal region , fever , vaginal discharge , leg and lower back pain , and localized skin burns were defined as non - significant , anticipated adverse events . statistical analysis was performed , using the student 's paired 2-sample t - test for mean value , to compare the mean sss values between pretreatment and 6-month follow - up . fibroids appearing hypointense and isointense on t2-weighted images and homogeneously enhancing on post - contrast studyfibroids having a maximum diameter of 12 cmpedunculated fibroids with more than 50% attachment 
  fibroids appearing hypointense and isointense on t2-weighted images and homogeneously enhancing on post - contrast study fibroids having a maximum diameter of 12 cm pedunculated fibroids with more than 50% attachment t2 hyperintense and post - contrast non - enhancing fibroidspedunculated fibroids with less than 50% attachmentuterine posterior wall fibroidspatients with contraindications to mri such as patients with pacemakers , metallic implants , patients who were claustrophobic , and others 
  t2 hyperintense and post - contrast non - enhancing fibroids pedunculated fibroids with less than 50% attachment uterine posterior wall fibroids patients with contraindications to mri such as patients with pacemakers , metallic implants , patients who were claustrophobic , and others all patients were treated on the exablate 2000 mrgfus system , which is integrated with a 1.5-t mri scanner ( ge healthcare , milwaukee , wi , usa ) to produce real - time thermal images throughout the treatment stage of the procedure . prior to initiation of treatment , patients abdomen was shaved and cleaned , a urinary catheter was inserted , and conscious sedation ( inj . each patient lay prone on the exablate treatment table with their abdomen positioned over the ultrasound transducer bath and a button in their hands , which when pressed would immediately stop delivery of focused ultrasound energy . prior to initiation of treatment , a series of t2-weighted mr images in three orientations were acquired for identification of patients anatomy and procedure planning [ figure 1a ] . the treatment boundaries and sensitive areas such as nerves , bowels , and bone were marked using the exablate software . manual optimization of the sonication regions was performed by the attending physician using the pretreatment images and associated exablate software . during the treatment , a series of multiple sonications were applied over the course of approximately 3 - 4 h with a short cooling interval between each sonication . immediately following the procedure , t1-weighted contrast - enhanced images were acquired in order to calculate the non - perfused volume ( npv ) [ figure 1b ] . patients were given a dose of intravenous antibiotics ( injection augmentin 1.2 g ) kept overnight in the hospital before being discharged the next morning . most of the patients returned to their normal daily activities including working regular hours within 1 - 2 days after treatment . mri was used to measure the size of the fibroids and calculate the shrinkage [ figure 1c ] . axial , sagittal , and coronal t2-weighted magnetic resonance ( mri ) images of the pelvic region to plan treatment of the fibroids post - treatment post - contrast t1-weighted magnetic resonance ( mri ) images of the pelvic region shows the ablated fibroid ( approximate fibroid volume 271 cc six - month follow - up post - treatment post - contrast t1-weighted image shows 45 - 50% reduction in size of ablated fibroid ( approximate volume 140 cc ) the uterine fibroid symptom and quality of life ( ufsqol ) questionnaire was used to obtain an objective measure of the symptom level of the patients treated . the ufsqol is a validated symptom - specific questionnaire , with questions targeting classical uterine fibroid symptoms , such as frequent urination , pressure , and menorrhagia , which is used to calculate a symptom severity score ( sss ) . the most appropriate answer from a five - point scale is chosen by the patient and the final result is represented on a 100-point scale , with a lower score indicative of a lower severity of symptoms . localized and transient pain in the abdominal region , fever , vaginal discharge , leg and lower back pain , and localized skin burns were defined as non - significant , anticipated adverse events . statistical analysis was performed , using the student 's paired 2-sample t - test for mean value , to compare the mean sss values between pretreatment and 6-month follow - up . the mean body mass index ( bmi ) and age of the 50 indian women treated with mrgfus in the current study were 25.2  1.6 ( range : 21 ~ 28 kg / m ) and 36.2  8.3 years ( mean  sd ; range : 21 - 53 ) , respectively . the total mean fibroid volume was 119.5  76.0 cc ( range : 4.7 ~ 411.1 cc ) . sixty - eight percent of the patients had a single fibroid , 26% of the patient had between two and four fibroids , and 6% had more than five fibroids . twenty patients ( 40% ) had a second treatment and one patient ( 2% ) had three treatments . an average of 84 sonications was performed per treatment , with average treatment duration ( from first to last sonications ) was 2:42  0:48 h ( n = 71 treatments ) . non - enhancing regions on t1-weighted contrast - enhanced images acquired immediately following the procedure showed an average npv of 88%  6% of the fibroid volume . at 6-month follow - up , fibroid shrinkage was measured at 30%  11% decrease in fibroid volume ( n = 61 fibroids ) . prior to treatment , the mean sss was 56.9  4.8 ( n = 50 ) , which is indicative of highly symptomatic patients . six months following treatment , there was a significant decrease in the mean sss score to 28.6  6.0 ( n = 50 ) ( p < 0.001 ) . there was no report of severe or unexpected adverse events from any of the 50 patients at any point during treatment or during the follow - up period . 10 incidences of leg pain were reported ( 20% of patients ) , nine of them resolved in 6 months after treatment , and one patient reported mild leg pain at the 6-month follow - up . in addition , one incidence each of urinary tract infection ( 2% ) , urine retention ( 2% ) , skin blister ( 2% ) , and abdominal pain ( 2% ) were recorded following treatment , all resolved in 6 months after treatment . the quality of life for women with uterine fibroids is severely impacted due to associated symptoms such as pelvic pain , abdominal pressure , urinary frequency , menstrual abnormalities , and even infertility . the available treatment options for uterine fibroids include invasive procedures such as hysterectomy and less invasive therapies such as uae , myomectomy , myolysis , and most recently mrgfus . patients with symptomatic uterine fibroids who wish to preserve their fertility and reduce their recovery time prefer such noninvasive therapies . the advantages of mrgfus treatment over other minimally invasive ones are that it is entirely non - invasive , can be performed as an outpatient treatment , has a low incidence of complications , and can be repeated , if necessary . mrgfus is favorable , compared to other thermal ablative techniques , in that it is a noninvasive technique in which the focused ultrasound energy penetrates the body , but is absorbed significantly only when the beam reaches the focal spot . as a result , only the targeted regions are heated to coagulation level , thereby minimizing or eliminating potential damage to nearby tissues or organs . since its approval by the fda in 2004 , mrgfus has been shown in several studies to be a feasible and safe nonsurgical alternative for fibroid therapy.[142123 ] the current report provides corroborative safety and short - term clinical efficacy data on mrgfus treatment for symptomatic uterine fibroids . it is the first report , however , to provide such data for a large cohort of indian women . the 6-month follow - up data showed a significant reduction in the sss and a large average npv ratio , indicative of successful fibroid ablation . there were no major adverse events reported , and only one incidence of moderate leg pain , 6 months after treatment , was reported . it is important to note that the ufsqol questionnaire is widely used as an objective tool to assess treatment efficacy especially in minimally invasive uterine fibroid therapies , such as uae and other noninvasive uterine fibroid therapies . this assessment technique was developed to suit an ethnically diverse population of individuals and has since been implemented in a range of studies with cohorts of patients from various ethnic backgrounds . given that the current treatments were performed on a patient population of an ethnic background never before studied ( indian women ) , it is of significance that these results corroborate those of previous findings , particularly with those of us clinical trials where patient cohorts were of differing ethnic background . although the study represents a short - term ( 6-month ) analysis , the initial symptomatic relief described here is sufficient to conclude that mrgfus can be effectively implemented as a treatment for women presenting with symptomatic uterine fibroids . the unique advantages of this treatment are that it is completely non - invasive , it can be performed on an outpatient basis , the recovery time is short , and the complication rate is low . additional studies should be performed to determine the long - term safety and efficacy profiles of mrgfus for the treatment of uterine fibroids in this and other population . mrgfus is a good and completely non - invasive treatment option for young patients . as per the data this can be of great advantage to patients with significant ssss at the beginning of treatment . also , the postoperative recovery being fast , patients can get back to their regular activities almost the next day .
objectives : to study the results of magnetic resonance - guided focused ultrasound surgery ( mrgfus ) treatment carried out on indian patients in our hospital.materials and methods : fifty indian women ( mean age = 36.2  8.3 years ) were treated for fibroids as outpatients using the exablate mrgfus system ( insightec ) . 
 non - perfused volumes ( npvs ) were measured immediately after treatment to calculate the treatment outcomes . a validated symptom - specific questionnaire to record their symptoms prior to treatment and six months following treatment 
 was completed by patients . 
 the size of the fibroids was measured on the day of the treatment and during the 6-month checkup to calculate shrinkage . 
 adverse events during and following treatment were recorded and monitored.results:the average npv ratio measured after the treatment was 88%  6% , indicative of high ablated fibroid tissue . 
 prior to treatment , the mean symptoms severity score was 56.9  4.8 ( n = 50 ) , which is indicative of highly symptomatic patients . 
 six months following treatment , there was an average fibroid shrinkage of 30%  11% , and a significant decrease in the mean score to 28.6  6.0 ( n = 50 ) ( p < 0.001 ) . 
 there were no reports of serious or unexpected adverse events at any point during treatment or during the follow - up period from any of the 50 women treated in the current study.conclusions:the current results obtained after 6 months of treatment corroborated previous data on the safety and efficacy of mrgfus for treating uterine fibroids . 
 this is the first publication that provides such data for a large cohort of indian women .