Uterine artery embolization as a treatment option for uterine myomas

Information is still being collected on the long-term clinical responses and appropriate patient selection for UAE. Prospective RCTs have not been performed to compare the clinical results from UAE with more conventional therapies for symptomatic uterine leiomyomata. At least three attempts at conducting such RCTs have been unsuccessful because of poor patient accrual that related to differing patient expectation and desires, clinical bias, insurance coverage, and the tendency that patients who have exhausted other treatment options may be disposed more favorably to less invasive treatments. Other comparative studies have serious limitations. For example, the retrospective study that compared outcomes after abdominal myomectomy with UAE suggested that patients who received UAE were more likely to require further invasive treatment by 3 years than were recipients of myomectomy. Lack of randomization introduced a selection bias because women in the group that underwent UAEwere older and were more likely to have had previous surgeries. A prospective study of "contemporaneous cohorts," which excluded patients who had sub-mucosal and pedunculated subserosal myomas, sought to compare quality of life measures and adverse events in patients who underwent UAE or hysterectomy. The investigators concluded that both treatments resulted in marked improvement in symptoms and quality of life scores, but complications were higher in the group that underwent hysterectomy over 1 year. In this study,however, a greater proportion of patients who underwent hysterectomy had improved pelvic pain scores. Furthermore, hysterectomy eliminates uterine bleeding and the risk for recurrence of myomas. Despite the lack of controlled studies that compared UAE with conventional surgery, and despite limited extended outcome data, UAE has gained rapid acceptance, primarily because the procedure preserves the uterus, is less invasive, and has less short-term morbidity than do most surgical options.The cost of UAE varies by region, but is comparable to the charges for hysterectomy and is less expensive than abdominal myomectomy. The evaluation before UAE may entail additional fees for diagnostic testing, such as MRI, to assess the uterine size and screen for adenomyosis. Other centers have recommended pretreatment ultrasonography, laparoscopy, hysteroscopy, endometrial biopsy, and biopsy of large fibroids to evaluate sarcoma. Generally,after UAE the recovery time and time lost from work are less; however, the potential need for subsequent surgery may be greater when compared with abdominal myomectomy. Any center that offers UAE should adhere to published clinical guidelines,maintain ongoing assessment of quality improvements measures, and observe strict criteria for obtaining procedural privileges. After McLucas advocated that gynecologists learn the skill to perform UAE for managing symptomatic myomas, the Society of Interventional Radiology responded with a precautionary commentary on the level of technical proficiency that is necessary to maintain optimum results from UAE. The complexity of pelvic arterial anatomy, the skill that is required to master modern coaxial microcatheters, and the hazards of significant patient radiation exposure were cited as reasons why sound training and demonstration of expertise be obtained before clinicians are credentialed to perform UAE.A collaboration between the gynecologist and the interventional radiologist is necessary to optimize the safety and efficacy of UAE. The primary candidates for this procedure include women who have symptomatic uterine fibroids who no longer desire fertility, but wish to avoid surgery or are poor surgical risks. The gynecologist is likely to be the primary initial consultant to patients who present with complaints of symptomatic myomas. Therefore, they must be familiar with the indications, exclusions, outcome expectations, and complications of UAE in their particular center. When hysterectomy is the only option, UAE should be considered. Appropriate diagnostic testing should aid in the exclusion of most, but not all, gynecologic cancers and pregnancy. Other contraindications include severe contrast medium allergy, renal insufficiency, and coagulopathy. MRI may be used to screen women before treatment in an attempt to detect those who have adenomyosis; patients should be aware that UAE is less effective in the presence of solitary or coexistent adenomyosis. Because some women may experience ovarian failure after UAE, additional studies to determine basal follicle-stimulating hormone and estradiol before and after the procedure may provide insight into UAE-induced follicle depletion.UAE is a unique new treatment for uterine myomas, and is no longer considered investigational for symptomatic uterine fibroids. There is international recognition that data are needed from RCTs that compare UAE with surgical alternatives. Current efforts to provide prospective objective assessment of treatment outcomes and complications after UAE will help to optimize patient selection and clinical guidelines. FIBROID should provide critical data for the assessment of safety and outcomes measures for women who receive UAE for symptomatic uterine myomas.     

Levonorgestrel intra-uterine system as a treatment option for complex endometrial hyperplasia

Objective

The objective of this study was to evaluate the potential treatment of atypical and non-atypical endometrial hyperplasia with the levonorgestrel intrauterine system (LNG-IUS).

Study design

A prospective observational study was undertaken at Queen's Medical Centre's menstrual disorder clinic between 2001 and 2008. Women presenting with abnormal perimenopausal and postmenopausal bleeding, underwent an endometrial biopsy followed by the insertion of a levonorgestrel intrauterine system (LNG-IUS). The study population comprised of 51 patients. The histology of 32 patients (Group A) showed complex hyperplasia without atypia, and in 19 patients (Group B), biopsy revealed atypical endometrial hyperplasia. These patients chose to be managed conservatively with repeat sampling of the endometrium.

Results

Group A: 28 (87.5%) patients out of 32 had regression of their endometrial hyperplasia within the first 12 months of follow-up. Three of the patients achieved regression by 24 months increasing regression rate to 96.8% and the remaining one had a hysterectomy due to a rare side effect. Group B: 16 (84.2%) of 19 patients had regression of the atypical hyperplasia after treatment with the intrauterine system within 12 months of treatment. One patient achieved regression of the hyperplasia by 24 months and two patients went on to have surgical management due to persistent atypia and severe atypia respectively.

Conclusion

This study contribute further evidence that illustrates that levonorgestrel intrauterine systems have a potential role in patients requiring non-operative management although close follow-up is essential.     

Successful treatment of a cervical pregnancy with a single low dose methotrexate regimen

Until very recently cervical pregnancies have been treated with surgery, usually hysterectomy. The development of endovaginal ultrasound, which allows early diagnosis, and methotrexate chemotherapy have opened up new therapeutic options. A 45-year-old multigravida presented at 8 weeks' gestation with vaginal bleeding. Endovaginal ultrasound demonstrated a cervical pregnancy with a fetal pole, 1.2 × 1.4 cm sac, no cardiac pulsations, and an empty uterus. After discussion with the patient, single low dose methotrexate 1.5 mg/m² was given intramuscularly. The patient's hCG titre was 5882 IU-(Third International Standard). Over a 5-week period the hCG titres fell, and the gestational sac disappeared. The patient experienced intermittent vaginal bleeding and cramping but was managed as an outpatient. Single low dose methotrexate may be a successful management option in selected cases of cervical pregnancy.     

Very low dose of flutamide in the treatment of hyperandrogenism

Hyperandrogenism is a condition affecting 5–10% of adolescents. The aim of this study was to evaluate the efficacy of very low dose of flutamide in the treatment of hyperandrogenism in adolescence. One hundred and fifty-eight patients, presenting severe acne and/or hirsutism, received 62.5?mg/day of flutamide?+?ethinylestradiol?+?gestodene for 18 months. The patients were subjected to assessments of hepatic enzymes levels. Thirty subjects treated with drospirenone?+?ethinylestradiol represented the control group. After 18 months of treatment, it was obtained a decrease of hirsutism (?39.9%), an almost recovery of acne (98% of patients) with better results of those obtained in control group. Only one case of light hypertransaminasemia was recorded, regressed spontaneously. Very low dose of flutamide was successful and safe and in the treatment of hyperandrogenism in adolescence.     

Magnetic resonance imaging-guided focused ultrasound surgery for symptomatic uterine fibroids: estimation of treatment efficacy using thermal dose calculations

Objective

To study the correlation between the predicted thermal dose volume (TDV) and the actual ablation volumes in MR-guided focused ultrasound surgery (MRgFUS) for symptomatic uterine fibroids, and to follow up the outcome for 12 months post-treatment.

Study design

Phase-difference fast spoiled gradient-echo MR images were used to analyze thermal change during the energy deliveries of MRgFUS in 60 consecutive patients treated for symptomatic uterine fibroids. The TDV obtained through analysis of these MR images was compared with the non-perfused volume (NPV) measured on post-treatment contrast enhanced T1-weighted images. Final values of TDV ratio and NPV ratio were obtained by dividing these values by original fibroid volume. Patients were followed for 12 months post-treatment to assess symptomatic relief using the symptom severity score (SSS).

Results

Treatments in which we managed to reach a TDV ratio larger than 27% of the treated fibroid yielded a ratio of NPV to TDV of 1.1 ± 0.5, indicating accurate control of the non-invasive procedure. Patient symptoms, as measured by the SSS, continuously decreased from a mean baseline score of 50 ± 22 to 19 ± 12 (P < 0.0001) 12 months post-treatment.

Conclusions

At large treatment volumes (exceeding 27% TDV ratio), thermal dose estimates correspond very closely to non-perfused volumes measured immediately post treatment. These large treatment volumes result in continuous clinical improvement throughout the first 12 months after MRgFUS.     

Physical plasma: a new treatment option in gynecological oncology

Non-thermal application of physical plasma is rapidly gaining importance for the future therapy and prevention of chronic inflammatory diseases and tumors. Here, we outline the importance of this innovative and less invasive therapy option, particulary for the treatment and prevention of gynecological cancers.     

Medical treatment of uterine fibroids with the LHRH antagonist: Cetrorelix

A depot preparation of the LHRH-antagonist Cetrorelix was used for the preoperative treatment of 20 premenopausal women with symptomatic uterine fibroids to undergo surgery. In an open, prospective and randomised study, 60 mg of this depot preparation were administered i.m. at the second day of cycle. Patients were randomised for a second dosage of 60 mg or 30 mg to be injected on day 21 or day 28 of treatment according to the degree of estradiols' suppression (< 50 pg/mL). The operation was carried out after six or eight weeks of treatment according to the timing of second dosages administration. Weekly transvaginal sonography as well as MRI before and after Cetrorelix treatment were performed for fibroids volume assessment; 16 patients showed satisfactory suppression of gonadotrophins and sexual steroids. No flare up effect was to be observed. In this group of patients the maximum reduction in fibroids size was of 33.5% at the end of treatment. After 14 days of treatment the reduction was of 31.3%. Within the group of good responders (reduction of fibroids size > 20%) the volume of the biggest fibroid after 14 days of treatment was of 56.7% of the initial assessment. Although MRI showed minor mean shrinkage rates of only 25.4% of the initial volume, these differences in comparison to transvaginal sonography were not statistically significant. The avoidance of any flare up phenomenon by the LHRH-antagonist may explain this fast reduction in size. The basic advantages of this treatment modality are the reduction of treatment time with a fast restoration of the ovarian function. The rate of poor responders may be reduced by improving the galenic preparation.     

Minilaparotomy hysterectomy: a valid option for the treatment of benign uterine pathologies

OBJECTIVE: To evaluate feasibility and outcome of minilaparotomy hysterectomy in a consecutive series of patients. STUDY DESIGN: Cohort analytic study. From October 1995 to March 2001, 148 out of 228 (65%) consecutive hysterectomies for benign gynecologic disease were performed by an abdominal route. Minilaparotomy hysterectomy (transversal cutaneous incision < 10 cm, within the pubic hair) was attempted in all patients with benign uterine disease and contraindications for vaginal surgery. Surgical parameters were prospectively assessed in terms of length of incision, operative time, estimated blood loss, duration of ileus, perioperative complications and length of postoperative stay. RESULTS: A minilaparotomic approach was performed in 118 patients (80%). Conversion to Pfannenstiel was necessary in three cases. The minilaparotomy incision, 8 cm (range 6-10) of median length, was performed below the pubic hair line. The median operating time was 50 min (range 34-88). No intraoperative complications or perioperative blood transfusions were reported, while minor postoperative complications occurred in 16 patients (14%). The median postoperative stay was three days (range 2-5). CONCLUSIONS: The minilaparotomy hysterectomy is feasible in the majority of women undergoing hysterectomy for benign disease. Because of the excellent outcome achieved, it should be considered a valid alternative to the classic abdominal hysterectomy.     

High-intensity focused ultrasound (HIFU) treatment for uterine fibroids: a meta-analysis

Purpose

High-intensity focused ultrasound (HIFU) is a non-invasive uterine-preserving treatment alternative to hysterectomy for women with fibroids.

Methods

We performed this meta-analysis to evaluate the efficacy of HIFU in the treatment of women with symptomatic fibroids comparing it to other approaches including medical treatment with mifepristone (Mife), traditional surgery with myomectomy or hysterectomy (MYC/HRM), and radiofrequency ablation (RF). 16 studies with 1725 women were included.

Results

The pooled data of HIFU comparing it to other methods in terms of complete or partial response rate (CR/PR) was not significantly better, but in subgroup analysis, the response rate was significantly higher than Mife, significantly lower than RF and comparable to MYC/HRM, respectively. For the endpoints of safety, the superiority of HIFU compared to MYC/HMR or Mife was found to be significant in terms of pain/discomfort, fever, transfusion, genital tract, gastrointestinal tract, and anesthesia-related complications, while no superiority was identified for skin burn, urinary tract, and nervous system complications.

Conclusion

These results suggest that HIFU treatment of uterine leiomyomas leads to clinical improvement with few significant clinical complications and adverse events.

     

Vaginal apex resection: a treatment option for vaginal apex pain

OBJECTIVE: Vaginal apex pain is a subset of chronic pelvic pain commonly treated with surgical excision of the vaginal apex. Our objective was to estimate long-term postoperative pain levels, recovery time, and return to sexual function in women who have undergone vaginal apex repair for chronic vaginal apex pain. METHODS: Since 1995, 45 women have undergone vaginal apex repair at our institution. All were asked to complete a questionnaire describing pain levels, sexual function, daily activities, ability to work, and medical therapy before and after surgical repair of the vaginal apex. Demographic background, previous medical history, and surgical history were abstracted from the medical records. Fisher exact and Wilcoxon rank sum tests were used to determine associations among baseline characteristics and various outcomes. McNemar chi(2) testing was use to compare before and after pain levels. RESULTS: Twenty-seven women constituted the study sample and were available for evaluation before and after vaginal apex repair. Sixty-seven percent of respondents experienced resolution of pelvic pain after vaginal apex repair for a median of 20 months. The number of women experiencing pain with daily activities decreased from 92% before vaginal apex repair to 41% after vaginal apex repair, and 30% reported sexual activity without dyspareunia after vaginal apex repair (P = .004). Sixty-one percent of women returned to work after vaginal apex repair. Most patients required continued medical therapy after vaginal apex repair. CONCLUSION: Vaginal apex repair improves general levels of pelvic pain in some patients diagnosed with vaginal apex pain. Pain relief after vaginal apex repair is temporary, and women are likely to need continued medical therapy.     

Hysteroscopic treatment of symptomatic submucous fibroids using a bipolar intrauterine system: a feasibility study

Objective: To determine the feasibility (safety, potential efficacy and cost effectiveness) of a miniature endoscopic bipolar electrosurgical intrauterine system in the treatment of symptomatic submucous fibroids. Study Design: A total of 37 women with symptomatic submucous fibroids were identified on outpatient hysteroscopy. All underwent hysteroscopic excision or ablation using a bipolar intrauterine system (Versapoint™). The main outcomes measures were change in uterine bleeding symptoms measured on a continuous and ordinal scale, patient satisfaction, time of work and use of health service resources at 6 months following treatment. Results: 36/37 (97%) women returned completed outcome questionnaires. The mean amount of abnormal uterine bleeding was reduced at 6 months compared to immediately prior to treatment (P=0.0001). Improvement in bleeding symptoms was reported by 28/36 (78%) women and satisfaction with treatment by 33/36 (92%) women. All procedures were successfully completed, there were no serious operative complications and at 6 months no repeat hysteroscopic procedures were necessary. The mean cost of diagnosis and treatment of submucous fibroids using an endoscopic bipolar intrauterine system was 40% cheaper at 6 months follow-up than a hysterectomy or open myomectomy (£ 1266 versus £ 2123). Conclusion: Hysteroscopic treatment of symptomatic submucous fibroids appears to be safe, efficacious and cost effective. It seems feasible to launch a randomised controlled trial to confirm these provisional results in both the short and longer term.     

Cryomyolysis,a new procedure for the conservative treatment of uterine fibroids

Conservative surgical options for uterine myomata traditionally were abdominal myomectomy, laparoscopic myomectomy, and, more recently, myolysis. Each of these procedures has distinct advantages, but also apparent disadvantages. We attempted to introduce an additional option for conservative surgical treatment of fibroids by freezing the structures, a procedure termed cryomyolysis. In this pilot study, 14 women were pretreated with a gonadotropin-releasing hormone (GnRH) agonist for a minimum of 2 months preoperatively to minimize uterine and myoma size. Cryomyolysis was performed and the GnRH agonist was discontinued. Magnetic resonance imaging scans were performed in 10 of the 14 women after GnRH agonist treatment but before surgery, and 4 months postoperatively. Total uterine volume ranged from 41.3 to 1134.8 ml preoperatively, and 49.5 to 1320 ml postoperatively (mean increase 22% after discontinuation of GnRH agonist). Normal uterine volume ranged from 35.6 to 548.7 ml preoperatively and 45.1 to 729.6 ml postoperatively (mean increase 40%); however, myoma volume showed a mean decrease of 6% (range-87-28%). Analysis of only frozen myomata revealed a mean volume decrease of 10%. Cryomyolysis maintains at or slightly reduces these lesions to post-GnRH agonist size, and all other uterine tissue returns to pretreatment size. We believe cryomyolysis may be an effective conservative surgical approach to uterine fibroids.