Uterine fibroids, also called uterine leiomyomas or myomas, are the most common type of pelvic tumor in women. They are common in women of reproductive age, usually are not malignant, rarely interfere with pregnancy, and often shrink after menopause. Some are asymptomatic, but others can cause pain, pressure, infertility, and/or bleeding. Individuals may have a single fibroid or multiple fibroids. The fibroids may be located in the submucosal, subserosal, or intramural tissue layers. Confirmation of their presence can be obtained by ultrasound (US)/sonogram, magnetic resonance imaging (MRI), or hysteroscopy. If the fibroids are causing no, or mild, symptoms, then they are usually not treated, but are monitored. If the fibroids are causing symptoms, often medical management is the first intervention used. Non-hormonal medications that can be used include non-steroidal anti-inflammatory drugs (NSAIDs) and tranexamic acid (Lysteda). Some examples of hormonal medications that can be prescribed to treat symptomatic fibroids include estrogen-progestin contraceptives, gonadotropin-releasing hormone (GnRH) agonists (Lupron Depot, Eligard, Zoladex, Trelstar), or progestin-releasing intrauterine devices (IUD). If medical management is inappropriate for the individual, has failed to control the symptoms, or is not desired by the individual, there are a number of treatments that are available. Historically, the options were uterine artery embolization (UAE), myomectomy, or hysterectomy. Uterine artery embolizations are associated with significant pain and decreased post-procedure fertility rates. A myomectomy can be performed laparoscopically, but is associated with extended recovery time, significant cost, a risk of inadequate uterine closure, a decreased post-procedure fertility rate, requires a high degree of skill to perform, and has a high probability of adhesion formation after the procedure. A hysterectomy is an open surgical procedure that includes the risks normally associated with open surgery, requires an extended recovery time, and removes the option for future childbearing. The choice of which of these treatments is used should be based on a discussion of the individual's preferences, presence of malignancy or other co-morbid conditions, desire to preserve the uterus, desire for childbearing, and the number, size, and location of the fibroids. A summary of uterine-preserving treatments is presented here. RADIOFREQUENCY ABLATION (RFA)During RFA, a scope is advanced to the fibroid, either through the vagina or cervix (hysteroscopic), or through a small incision in the abdomen (laparoscopic). Once the fibroid has been identified, several needles are threaded through the scope into the fibroid. An energy source is applied to the fibroid tissue, which heats and destroys the tissue. Over the course of the following months to one year, the fibroid will shrink as the individual's body processes and breaks down the necrotic tissue.The Canadian Agency for Drugs and Technologies in Health (CADTH, 2017) published a systematic review of the efficacy and cost effectiveness of uterine-preserving procedures, including RFA. They were only able to identify one published randomized controlled trial (RCT) comparing RFA with myomectomy that fit their criteria for inclusion in the report. The published results of the study demonstrated a greater reduction in bleeding in the myomectomy cohort, but the difference, compared to the RFA cohort, was not statistically significant. There were no statistically significant differences between the two cohorts in pelvic pressure improvements or health-related quality of life (HRQOL) scores. Although the blood loss in the myomectomy cohort was statistically greater than the RFA cohort, the volume was small (51 ml versus 16 ml, p<0.001). No individuals in the myomectomy cohort required further interventions, but three individuals in the RFA cohort underwent additional interventions (two hysterectomies and one myomectomy). At one-year follow-up, more individuals in the myomectomy cohort expressed satisfaction with the treatment outcome than in the RFA cohort (86.5 percent versus 42.9 percent, p=0.004). The length of the hospital stay after the procedure was significantly longer in the myomectomy cohort as compared to the RFA cohort (29.9 hours versus 10.0 hours, p<0.001). Per the CADTH report on the study, evidence of the treatment effect of RFA was not discussed in the study findings despite that being an area of interest stated in the trial protocol. In the summary of their findings in the CADTH report, it was stated that per review of the literature, uterine-preserving treatments decrease fibroid-related symptoms and improve HRQOL. Although RFA had a lower risk of peri-procedural complications and shorter hospital stays, there were more re-interventions needed as compared to individuals who had undergone a myomectomy secondary to recurrence of the fibroids or inadequate symptom control. The studies identified for uterine-preserving procedures, including RFA, had low quality due to small cohort sizes, poor study design, and an imbalance in the baseline between-group characteristics of the studied individuals. The observational results across the studies were inconsistent. There was limited evidence pertaining to which individuals would be suitable for which procedures. As an example, the review discussed that laparoscopic RFA is not appropriate to use with submucosal fibroids, but hysteroscopic RFA is indicated for this situation. Individuals treated with a hysterectomy reported higher HRQOL improvements when compared to the less-invasive uterine-preserving treatments. The CADTH report did not discuss the economic impact of RFA.The Agency for Healthcare Research and Quality (AHRQ) published a comparative effectiveness review in 2017 for the management of uterine fibroids. They determined that there were two RCTs that were published on RFA that met their criteria for the review, but the studies were both of poor quality. The reported evidence on outcomes for the individuals in the studies was insufficient. The two studies did publish limited results on the effects of the RFA on bleeding, HRQOL, and successful pregnancies after the procedure, but did not report on major complications or outcomes related to pain. Their assessment of the literature was that the strength of evidence for RFA was insufficient to inform care.Havryliuk et al., (2017) undertook a systematic review of the literature for symptomatic fibroid management. The review focused on hysterectomy, myomectomy, UAE, MRI-guided focused US (MRg-FUS), and laparoscopic RFA. In the section discussing RFA, one of the advantages identified concerning RFA was that the procedure is US guided so needle placement can be visualized within the fibroid, thus eliminating the need for extensive dissection of tissue, which could lead to scar tissue or blood loss. Another benefit of RFA is that other gynecologic conditions can be identified via the US at the time of the procedure and be treated also. Based on the review of the literature, lap RFA has low rates of complications, minimal loss of blood, low rates of re-interventions, major improvements in HRQOL, major improvements in symptoms as compared to other interventions for fibroids (hysterectomy, myomectomy, UAE), lack of a requirement for hospital admission, and minimal disruption of the uterine tissue, which may be advantageous to individuals who desire future childbearing. Some of the limitations of the published studies include lack of consistency in describing complications, lack of treating larger fibroids, lack of large RCTs or good-quality studies comparing RFA to other uterine-sparing procedures, and lack of adequate data on post-procedure pregnancy rates. The authors recommended the undertaking of additional comprehensive well-powered (RCTs) to validate the results of these studies.Bradley et al., (2019) undertook a systematic review and meta-analysis on RFA used in the treatment of uterine fibroids to assess for the effectiveness of the procedure. The authors reviewed prospective randomized trial, non-comparative trials, and comparative trials but included only the results from the RFA arm. In total, they reviewed 20 studies in 32 articles with 1283 individuals treated. Data of interest included length of procedures, length of hospital stays, length of time until normal activities were resumed, length of time until returning to work, change in fibroid volumes, change in symptom severity, change in HRQOL, and the need for re-interventions. The data were observed at pre-procedure, three months, six months, one year, and any time after one year. The RFA procedures were performed via a laparoscopic route, via a transcervical route, or via a transvaginal route. Median follow-up time was 12 months but ranged from immediately post-procedure to 5.3 years. The mean procedure time for the laparoscopic route was 73 minutes, 44 minutes for the transcervical route, and 24 minutes for the transvaginal route. The mean time to discharge after the procedure was 10.7 hours for the laparoscopic route and 2.5 hours for both the transvaginal and transcervical routes. The mean time to resumption of normal activities after the procedure was 9 days for the laparoscopic route and 3.3 days for the transcervical route. There was no reporting for the transvaginal route. The mean time to returning to work after the procedure was 6.5 days for the laparoscopic route and 3.6 days for the transcervical route. There was no reporting for the transvaginal route. The mean fibroid volume loss was 47 percent at three months, 55 percent at six months, 66 percent at one year, and 71 percent after one year. Using the laparoscopic route as a comparator, the fibroid volume loss was four percent greater with the transcervical route and the transvaginal route was 10 percent greater at the one-year timeframe. Compared to preprocedural scores, HRQOL scores improved by 30 points at three months, by 37 points at six months, 39 points at one year, and by 31 points after one year. Compared to preprocedural scores, symptoms scores improved by 29 points by three months, by 35 points at six months, by 42 points at one year, and by 40 points after one year. The annual rate of re-intervention was 4.2 percent at one year (2.7 percent for the laparoscopic route, 3.8 percent for the transcervical route, and 5.3 percent for the transvaginal route), 8.2 percent at two years, and 11.5 percent at three years. The reported rate of re-intervention at three years for uterine artery embolization is 17 percent, for hysteroscopic myomectomy is 21 percent, for endometrial ablation is 24 percent, and for laparoscopic myomectomy is 11 percent. Limitations of the studies were that none were blinded, 19 of 20 studies failed to adjust for attrition, fewer studies reported on follow-up data beyond one year so there is limited long-term data available for the procedures, and there was no justification for the sample size used in 15 of 20 studies. Not all of the studies reported long-term follow-up data. There was insufficient data in the reviewed studies to allow statistical comparisons to be performed between the three procedural routes, so the superiority or inferiority of one route over the others was not able to be determined. Because fibroid volumes in each of the studies were reported as mean volumes, it was not possible to determine if the decrease in fibroid volume had an association with pre-procedural fibroid size. Complication reporting was inconsistent in the reviewed studies so was unable to be reported upon in this systematic review although none of the studies reported any serious complications.Taheri et al., (2019) undertook a systematic review of non-resective uterine and fibroid volume reduction therapies looking at UAE, focused US (FUS), and RFA. Information from eight studies reporting results from RFA on uterine fibroids were reviewed. The laparoscopic RFA system (Acessa) was associated with a 45.1 percent decrease in fibroid volume at 12 months while the transcervical RFA system (Sonata) was associated with a 66.6 percent decrease in fibroid volume at 12 months. The pooled data on fibroid volume decrease at 12 months for UAE was 66 percent. This data was obtained by reviewing 52 studies on UAE. The pooled data on fibroid volume decrease at 12 months for FUS was 28 percent. This data was obtained by reviewing 18 studies on FUS. Based on the reviewed studies, a greater number of larger fibroids are able to be treated with UAE as compared to RFA. This is consistent with clinical practice where RFA is used to treat smaller individual fibroids whereas UAE is used to treat more global disease. One of the reviewed studies on FUS reported that there was an increased trend of greater re-intervention rates in individuals with lower fibroid volume decreases at six months (21.6 percent). Three studies on UAE also reported this trend however a fourth study was unable to find any association between volume reduction and re-intervention rates, and a fifth study was unable to find any association between volume reductions of <45 percent and an increased risk of re-intervention. No studies on RFA reported on any trends comparing fibroid reduction to the risk of re-intervention. Re-intervention rates for UAE at five years are reported to be 20-30 percent. Re-intervention rates at 12 months for Sonata are reported to be 8 percent. Re-intervention rates at 36 months for Acessa are reported to be 11 percent. One of the limitations in the published literature mentioned in this systematic review is the lack of fertility and pregnancy data after RFA treatment although small case series have demonstrated that pregnancy did occur after some individuals had undergone the procedure. FUS is approved for individuals who desire future pregnancy. There are mixed results with UAE's effects on future pregnancy. Undergoing UAE can alter the blood supply to the ovaries. The authors recommended the need for RCTs with head-to-head comparisons of these three procedures to compare efficacy and to determine which groupings of individuals would be best suited for which procedure.The American College of Obstetricians and Gynecologists (ACOG, 2021) released a practice bulletin addressing the management of symptomatic uterine fibroids. In the section of the bulletin discussing RFA, it was stated that laparoscopic RFA could be considered as a minimally invasive procedure for fibroids in individuals who desired a uterine-sparing treatment and who are counselled concerning the limited available published literature on studies that focused on reproductive outcomes. The recommendation was rated with a Level B because it is based on limited or inconsistent scientific evidence. All three approaches were mentioned in the bulletin as having similar effectiveness in reducing uterine fibroid volume and improving quality of life scores but it was further specified that the laparoscopic approach had been studied more than the other approaches. While briefly addressing the transcervical approach in the bulletin, ACOG does not explicitly give recommendations for this approach. The current limited access to RFA was noted.Radiofrequency ablation is a uterine-sparing, minimally invasive procedure that can destroy fibroid tissue. The published evidence for the procedure includes prospective cohorts, RCTs, and systematic reviews. Relevant outcomes are symptoms, quality of life, and treatment-related morbidity. The meta-analysis found low rates of reintervention with RFA and quality of life outcomes that were similar to uterine artery embolization and myomectomy at 12 months. Data on reintervention rates at 36 months were limited to 1 RCT and 1 cohort study with high loss to follow-up. No studies reported reintervention rates at 60 months. Two RCTs found that RFA was noninferior to laparoscopic myomectomy on the primary outcome: length of hospitalization. A number of secondary outcomes were reported at 12 and 24 months in 1 RCT, including symptoms and quality of life. None of the secondary outcomes demonstrated significant between-group differences in a subgroup analysis of 43 patients. The procedure has faster recovery than myomectomy and provides a reduction in symptoms and improvement in quality of life in the short term. Recurrence and reintervention rates at longer follow-up are unknown. Well-designed comparative trials with longer follow-up are needed to determine the effect of RFA on health outcomes compared with other treatment options such as myomectomy. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.Despite the significant limitations in the reliable evidence for transcervical and laparoscopic RFA for the treatment of uterine fibroids, there appears to be some support among treating providers for the procedures. Among the professional providers that may use these treatment methodologies, the choice of laparoscopic versus transcervical RFA treatment is dependent on fibroid number, type, and location, and the preference of the individual being treated. For example, predominantly lower uterine segment or cervical leiomyomata, or those with a predominant submucosal location or intramural International Federation of Gynecology and Obstetrics (FIGO) type 2 or 3 fibroids may suggest a transcervical approach, whereas fibroids with largely fundal or extramural components may suggest a laparoscopic approach.
LASER OR BIPOLAR NEEDLES
During these procedures, either a laser or bipolar needle is introduced via a hysteroscope or a laparoscope into the fibroid. An energy source is then applied to the fibroid which causes coagulation and necrosis of the tissue. The laser or bipolar needle is repeatedly reintroduced into the fibroid in order to treat additional areas of the fibroid as only a small area is coagulated with each pass.
Goldfarb (1992) reported on the use of laser coagulation in a single-arm, prospective, open-label pilot study of 75 individuals with symptomatic myomas of moderate size. The individuals were separated into two groups. The first group had myomas that measured between three and five cm in size after medical treatment. The second group had myomas that measured between five and ten cm in size after medical treatment. All of the individuals underwent two to six months of treatment with GnRH agonist therapy to shrink the size of the fibroids and decrease the potential for post-procedure bleeding. The individuals were followed up at one-, three-, and six-months post procedure. Ultrasounds demonstrated a 50 to 70 percent reduction in myoma size after the procedure beyond the reduction in size from the medication given prior to the procedure. Complications included one individual who developed a pelvic abscess and required a hysterectomy. Another individual developed bacteremia but recovered after receiving antibiotics (Donnez et al., 2000).
Nisolle et al., (1993) and Donnez et al., (2000) reported on the use of laser coagulation in a single-arm, prospective, open-label pilot study of 48 individuals with fibroids who did not desire to have more children but did not want to undergo a hysterectomy. Individuals returned for follow-up examinations at weeks three, six, and twelve, then months six and twelve; 15 individuals also followed up after three years. The mean decrease in fibroid size was assessed after six months and was 41 percent. There were 15 individuals who underwent a laparoscopy six months after the procedure. Eight of these individuals had dense fibrous adhesions between the fibroids and other nearby structures. Adhesiolysis was performed on these fibroids, but for two individuals, it was decided to perform myomectomies. Of the 15 individuals who followed up after three years, ten individuals demonstrated fibroids that had remained small and appeared slightly different in appearance with ultrasound to the surrounding tissue. Three individuals had stable fibroids compared to previous follow up. Two individuals experienced reappearance of fibroids in other locations and subsequently underwent hysterectomies. A few adhesions were reported. Based on the risk of bowel adhesions, additional studies with a different type of laser fiber were recommended.
Goldfarb (1995) reported on a prospective, observational, comparative study in which 150 individuals underwent treatment with laser coagulation and 150 individuals underwent bipolar needle coagulation for their symptomatic myomas. All the individuals underwent pre-procedure treatment with GnRH agonist therapy. The individuals were followed up for six months. Complications were rare. Both methods produced a similar outcome with myomas reducing by 50 to 70 percent. There was no reported regrowth at follow up.
The literature on laser or bipolar needles was published in the 1990's. The literature consisted of case series with a paucity of reported long-term follow up to assess for complications or recurrence of symptoms. There are reports of damage to surrounding healthy tissue and the development of adhesions. Use of the laser is reported to produce large amounts of smoke that can interfere with visibility. These procedures were not directly compared to other procedures used to treat uterine fibroids. The evidence is insufficient to determine that the procedures result in a net health improvement.
CRYOMYOLYSIS
Cryomyolysis involves placing a probe into a port hole through the abdomen and uterus into the fibroid then freezing the tissue to a temperature of -90o to -180o C until an ice ball encompasses the entire fibroid or has reached maximum size. It may take several freezing and thawing cycles to obtain maximum tissue destruction. The destroyed tissue is then removed through a separate irrigator-aspirator port. Care must be taken to not damage surrounding healthy tissue. The individual may be pre-treated for a minimum of two months with a GnRH agonist to help shrink the fibroid and reduce its blood supply prior to the procedure.
Zreik et al., (1998) reported on the use of cryomyolysis in a single-arm, prospective, open-label pilot study of 14 individuals. Two individuals were lost to follow up, three individuals had no additional improvement beyond the mild to moderate improvement they experienced after receiving the GnRH agonist as pre-procedure treatment, one individual reported subjective improvement but experienced recurrent irregular bleeding nine months after the procedure, and eight individuals experienced continued improvement at 15 to 17 months after the procedure. Myoma volume decreased by a mean of six percent post procedure. There were no complications from the procedure, but one individual was hospitalized overnight due to the length of time needed for the procedure. Six individuals underwent an office laparoscopy within two weeks of having undergone the procedure. Two individuals were adhesion free, two individuals had filmy adhesions, and two individuals had moderate to severe dense adhesions which were felt to be due to the probe size for the individual with the severe adhesions.
Ciavattini et al., (2004) reported on a single-arm, prospective, open-label pilot study to evaluate the feasibility and efficacy of laparoscopic cryomyolysis in 61 individuals who had refused either a hysterectomy or myomectomy but desired a uterine-conserving treatment. Variables of interest that were reported on included laparoconversion, post-procedure pain, fever, changes in hemoglobin/hematocrit levels, and hospital length of stay. Myoma volume and symptoms were evaluated at 1-, 3-, 6-, and 12-months post procedure. One individual underwent laparoconversion due to intra-operative bleeding and underwent a subsequent hysterectomy. There were no other complications reported. Mean myoma volume reduction measured at 12 months was 60.3 percent. Thirteen of 76 treated myomas remained unchanged at 12 months. Twenty-seven individuals were followed for 24 months. The mean myoma volume reduction for these individuals was 69.8 percent with only three myomas not having a reduction in volume. Complete resolution of symptoms was observed in 83.6 percent of the individuals. For the remainder of the individuals, there was no variation or worsening of their symptoms. In four individuals, there was relief of symptoms despite there being no reduction in volume of their myomas. Other observed parameters demonstrated minimal blood loss during the procedure, only 8.3 percent of individuals experienced post-procedure pain, and only five percent of the individuals experienced post-procedure fever. Individuals who desired future pregnancy were excluded from this study, so the effects of the procedure on fertility were not assessed. Rates of symptom recurrence, scar tissue formation, and adhesion formation were not reported.
Zupi et al., (2004) reported on a single-arm, prospective, open-label pilot study of a group of 20 individuals who underwent cryomyolysis of their uterine fibroids. Size of the fibroids was limited to between four and eight cm. All of the individuals were discharged after 24 hours of observation and were sent home with a three-day course of antibiotics. There were no complications during or after the procedure observed at the time of discharge for any of the individuals. There was minimal blood loss related to the procedure. All of the individuals were followed up at one, three, and six months after the procedure. Mean fibroid size and vascularity were evaluated at each visit as well as the status of symptoms from the fibroids. In symptom follow up, it was identified that 15 of the individuals had complete elimination of their symptoms, four had marked improvement in their symptoms, and one individual's symptoms did not improve. At the one-month follow-up visit, sonographic exam demonstrated that there was no blood flow in any of the treated fibroids, and peripheral fibroid blood flow was either significantly reduced or totally eliminated. By the six-month follow-up visit, the mean volume reduction in the fibroid volume was 56.9 percent. Individuals who desired future pregnancy were excluded from this study, so the effects of the procedure on fertility were not assessed. Rates of symptom recurrence, scar tissue formation, and adhesion formation were not reported. Zupi et al., (2005) reported on the results of a one-year follow up of the same group of individuals. The individuals continued to experience an absence of symptoms and continued to experience mean fibroid volume shrinkage until approximately nine months after the procedure.
The literature on cryomyolysis was mostly published in the early 2000's. The studies reported on were single armed and included small case series. There were no comparison studies, and no long term follow up of the individuals post procedure to determine rates of recurrence of symptoms. The evidence is insufficient to determine that the procedure results in a net health improvement.
MAGNETIC RESONANCE IMAGING (MRI)-GUIDED LASER ABLATION
The first step in MRI-guided laser ablation is to perform a baseline MRI to determine the fibroid size and location. MRI-compatible needles are then inserted percutaneously into the fibroid. Laser probes are threaded through the needles into the fibroid. Thermal energy is delivered into the fibroid from the laser-producing device. The fibroid is scanned throughout the procedure to help determine the level of tissue damage being achieved by the laser. The repeated scanning allows the provider the ability to know when the procedure can be stopped due to adequate treatment of the fibroid and also help avoid damaging any surrounding healthy tissue or structures.
Law et al., (1999) reported on a single arm, prospective, open-label pilot study of a group of 12 individuals with symptomatic fibroids who were awaiting undergoing a hysterectomy who instead underwent MRI-guided laser ablation of their fibroids. Four of the individuals proceeded to undergo the hysterectomy. Examination of their treated fibroids demonstrated well-defined areas of necrosis within the fibroids. The remaining eight individuals declined to proceed with the hysterectomy as their symptoms had improved after the ablation. MRI monitoring demonstrated a mean fibroid volume decrease of 37.5 percent three months after the procedure. Because the procedure was performed on an outpatient basis, there were no associated hospital costs.
Hindley et al., (2002) reported on a prospective, open-label pilot study on a group of 66 individuals with symptomatic fibroids who did not desire to undergo surgery. Outcome measures of interest were changes in fibroid volume up to 12 months after the procedure, variations in menstrual blood loss from prior to the procedure compared to after the procedure, and self-reported outcomes questionnaires on quality of life (QOL) and menorrhagia outcomes. Questionnaire results from the current treatment cohort were compared to the group of historical controls from the validation studies performed on the questionnaires. Menstrual blood loss was measured by having the individuals collect their sanitary supplies containing as much menstrual flow as possible both before and three months after the procedure and comparing the differences in volume. Of the 66 individuals who were treated, only 47 underwent the 3-month follow-up MRI. The mean volume reduction in fibroid size was 31 percent (range +21 to -76 percent; p<0.001). At one-year post procedure, 24 individuals underwent an MRI. The mean fibroid volume reduction was 41 percent (range +13 to -78 percent; p<1.001). Thirty-five individuals responded to the questionnaires. The results demonstrated a significantly (p=0.02) higher score for the menorrhagia outcome questionnaire for the laser-treated individuals as compared to the hysterectomy controls which represents a worse overall outcome. The quality-of-life questionnaire did not show a statistically significant (p=0.06) difference in scores between the laser-treated individuals and the hysterectomy controls. On some individual questions from the questionnaires, 80 percent of the laser-treated individuals did respond that they would recommend the procedure to a friend who had a similar problem, 69 percent felt their symptoms had improved since undergoing the procedure, and 69 percent felt better after undergoing the procedure. All of the individuals who followed up at three months experienced a decrease in their menstrual blood loss. The mean change in menstrual blood loss three months after the procedure decreased by 81.2 ml (range 26.8 to 157.4 ml; p=0.012). From a safety standpoint, only one individual was admitted to the hospital after the procedure because she lived alone. All of the individuals were sent home on simple analgesia without any of them requiring additional medication. Three of the individuals were treated for urinary tract infections and two individuals were treated for minor skin burns. Six individuals did experience a substantial increase in fibroid volume between the three- and 12-month follow-up MRI which could demonstrate regrowth of the fibroids.
There has been a paucity of literature published on the use of MRI-guided laser ablation of fibroids. Most of the literature was published around the year 2000 and appeared to be from the same group of professional providers. The studies were small case series and had no follow up beyond 12 months. Although individuals who had undergone the procedure reported improvement in their quality of life and symptoms, scores were worse on questionnaires compared to a historical cohort of individuals who had undergone a hysterectomy. There was no long-term follow up or reporting on recurrency rates for the fibroids. The evidence is insufficient to determine that the procedure results in a net health improvement.
