Thermal Balloon Endometrial Ablation Research Articles

Modified Thermal Balloon Endometrial Ablation for Treatment of Heavy Menstrual Bleeding.

Objectives:The objective of this study was to determine the efficacy of modified thermal balloon ablation using Foley's catheter in the treatment of heavy menstrual bleeding (HMB).Materials and Methods:Twelve patients with HMB aged 35–55 years underwent modified thermal balloon ablation using Foley's catheter. Patients were selected after complete clinical evaluation and investigations. The procedure was undertaken in the operation theater under general anesthesia/intravenous sedation. Three cycles of modified thermal balloon ablation using Foley's catheter were performed to ablate the endometrium. The time given to each cycle was 7 min. All the cycles were performed in the same setting. The main outcome measures that were studied were reduction in the menstrual flow, the need for further treatment, and relief of dysmenorrhea if present. Outcome measure regarding reduction in menstrual flow was statistically analyzed using Fisher's exact test. Statistical significance was determined at a level of P < 0.05.Results:Eighty-two percent of patients experienced a reasonable reduction in menstrual blood flow at 3-month follow-up. Eighteen percent observed no change in bleeding pattern and needed further treatment after failure of the procedure. Forty-two percent of patients complained of minor side effects such as cramp lower abdominal pain and fever. Rupture of balloon during the procedure occurred in only one case (8%).Conclusion:Modified thermal balloon ablation with Foley's catheter can be a promising management of HMB in resource-poor settings. It is a cost-effective alternative to the original endometrial ablation techniques.

Patients Satisfaction Undergoing Endometrial Thermal Balloon Ablation for the Treatment of Intractable Menorrhagia

Background: Heavy amounts of menstrual blood loss regularly in three or more consecutive cycles are characterized as menorrhagia which has been shown to be present among in many peri-menopausal and premenopausal women. Aim: To determine the frequency of patients’ satisfaction with TBA for the treatment of intractable menorrhagia. Methods: This descriptive study was undertaken in Department of Obstetrics and Gynecology, Lady Wallington Hospital Lahore from January to July 2017. A sample size of 200 patients was calculated and informed consent was taken to fill predesigned Performa. Prophylactic dose of 1g Ceftriaxon antibiotic was administered and Foly’s catheters were placed simultaneously in uterine cavity of patients after curettage and dilations. The uterine balloon catheter was then entered into the uterus and balloon was filled with sterile fluid. Results: A high number of 157(78.5%) women were found to be satisfied with thermal balloon ablation while different age groups presented an insignificant difference on level of satisfaction. Level of education and BMI had insignificant difference (p &gt;0.05) while a significant difference (p&lt;0.05) was observed among patients suffering from long duration of &gt;6 months as compared to short duration of 3-6 months. Conclusion: Thermal balloon ablation is the method of choice for treatment of women suffering from menorrhagia and high number of patients revealed their trust on this method. Keywords: Menorrhagia, Dysmenorrhea, Blooding, Satisfaction, Endometrium.

Should diagnostic hysteroscopy be performed routinely following thermal balloon endometrial ablation? A case report of thermal bowel injury and literature review

Should diagnostic hysteroscopy be performed routinely following thermal balloon endometrial ablation? A case report of thermal bowel injury and literature review

Thermal Balloon Ablation for Dysfunctional Uterine Bleeding among Iranian Patients

Objective: dysfunctional uterine bleeding is a common gynecological condition which affects about 20-30% of premenopausal women. When medical treatments fail to provide adequate relief, surgical interventions, including hysterectomy or destruction of the endometrium, might be considered. The aim of the present study was to determine the menstrual outcomes and the satisfaction level, after thermal balloon endometrial ablation to treat this condition among Iranian patients. Design classification: A single-arm prospective study. Setting: University teaching hospital. patients:52 patients with dysfunctional uterine bleeding. Intervention: Patients underwent endometrial ablation using Cavaterm plus and were fallowed up for 12 months, Post operatively. Measurements: The pictorial blood loss assessment chart score of menstrual cycle, number of days in the cycle, degree of dysmenorrhea, satisfaction from treatment and any complication of treatment were assessed. Main results: Eighty-eight percent of patients responded to treatment; the mean number of days of bleeding per month decreased from a mean of 13.6 to 4days (p<0.001) and the mean amount of bleeding decreased from 535.4 to 38.6 in pictorial blood loss assessment chart (p<0/001). Also 45% of patients became amenorrheic after one year fallow up and 88% were satisfied with their treatment. Conclusions: Thermal balloon endometrial ablation among our patients showed a similar outcome to previous reported studies. It seems that this method represents an excellent alternative to hysterectomy, with high rate of success, a very low complications rate and high patients satisfaction. Keywords: Dysfunctional uterine bleeding, endometrial ablation, thermal balloon, pictorial blood loss, Iran.

Meta-analysis of bipolar radiofrequency endometrial ablation versus thermal balloon endometrial ablation for the treatment of heavy menstrual bleeding.

Heavy menstrual bleeding is a common problem that can severely affect quality of life. To compare bipolar radiofrequency endometrial ablation and thermal balloon ablation for heavy menstrual bleeding in terms of efficacy and health-related quality of life (HRQoL). Online registries were systematically searched using relevant terms without language restriction from inception to November 24, 2016. Randomized control trials or cohort studies of women with heavy menstrual bleeding comparing the efficacy of two treatments were eligible. Data were extracted. Results were expressed as risk ratios (RRs) or weighted mean differences (WMDs) with 95% confidence intervals (CIs). Six studies involving 901 patients were included. Amenorrhea rate at 12months was significantly higher after bipolar radiofrequency endometrial ablation than after thermal balloon ablation (RR 2.73, 95% CI 2.00-3.73). However, no difference at 12months was noted for dysmenorrhea (RR 1.04, 95% CI 0.68-1.58) or treatment failure (RR 0.78, 95% CI 0.38-1.60). The only significant difference for HRQoL outcomes was for change in SAQ pleasure score (12months: WMD -3.51, 95% CI -5.42 to -1.60). Bipolar radiofrequency endometrial ablation and thermal balloon ablation reduce menstrual loss and improve quality of life. However, bipolar radiofrequency endometrial ablation is more effective in terms of amenorrhea rate and SAQ pleasure.

Application of TB type thermal balloon endometrial ablation for the treatment of abnormal uterine bleeding

Objective: To investigate the clinical efficacy, safety and promotion value of TB type thermal balloon endometrial ablation in the treatment of abnormal uterine bleeding. Methods: Fourty three patients who had received TB type endometrial ablation system for treatment of abnormal uterine bleeding from January, 2015 to January, 2016 in theDepartment of gynecology, Beijing Chaoyang Hospital were enrolled in this study. The intra-operative and post-operative complications and improvement of abnormal uterine bleeding and dysmenorrhea were observed. Results: There were nointra-operative complication occurred, such as uterine perforation, massive hemorrhage or surrounding organ damage. At 6 months after operation, 32 patients developed amenorrhea, 6 developed menstrual spotting, 3 developed menstruation with a small volume and 1 had a normal menstruation. No menstruation with an increased volume occurred. The occurrence of amenorrhea was 76.19% and the response rate was 97.62%.At 6 months after operation, 1 case had no response, 2 cases had partial response and 11 cases had complete response among the 14 cases of pre-operative dysmenorrhea; only 3 cases still had anemia among the 23 cases of pre-operative anemia. Compared with before treatment, patients with dysmenorrhea and anemia both significantly reduced with a statistically significant difference(P<0.01). Conclusion: TB type thermal balloon endometrial ablation has a significant efficacy with high safety for the treatment of abnormal uterine bleeding, which could have clinical promotion practice.

A Comparison of the Efficacy and Safety of Thermal Balloon versus Bipolar Radiofrequency Endometrial Ablation: A Retrospective Review

A Comparison of the Efficacy and Safety of Thermal Balloon versus Bipolar Radiofrequency Endometrial Ablation: A Retrospective Review

Long-Term Clinical Outcomes of Thermal Balloon Endometrial Ablation (Thermablate EAS) with and without Concomitant Use of Levonorgestrel Intra-Uterine System in Women with Heavy Menstrual Bleeding: A Pilot Study

Long-Term Clinical Outcomes of Thermal Balloon Endometrial Ablation (Thermablate EAS) with and without Concomitant Use of Levonorgestrel Intra-Uterine System in Women with Heavy Menstrual Bleeding: A Pilot Study

Tratamento do sangramento uterino anormal: uma análise sob a perspectiva dos custos no Sistema Único de Saúde e da medicina suplementar

ObjectivesTo compare direct and indirect costs of the levonorgestrel‐releasing intrauterine system (LNG‐IUS), thermal balloon endometrial ablation (TBEA) and hysterectomy in the treatment of women with abnormal uterine bleeding (AUB). Methods88 patients treated for AUB by LNG‐IUS (n = 30), TBEA (n = 28) and hysterectomy (n = 30) were retrospectively evaluated. All procedures, medical appointments and tests involved in the treatment of patients were considered for a period of five years, as well as all costs arising from failures of the treatments used. The costs for the Unified Health System (SUS) and the private health care system were estimated. Differences between groups were evaluated by the test t of Student or ANOVA. ResultsThe cost of the treatment of AUB with TBEA was significantly higher versus LNG‐IUS and hysterectomy after a five‐year follow‐up in both SUS and private health care system (p <0.001). In SUS, the treatment with the LNG‐IUS represented 38.2% of the hysterectomy cost in the first year (R$ 769.61 vs. R$ 2,012.21, p <0.001) and 45.2% after five years (R$ 927.83 vs. R$ 2,052.21, p <0.001). As for the private health care system, this difference was even more significant. In this context, the cost of LNG‐IUS represented 29.1% of the hysterectomy cost in the first year (R$ 1,551.92 vs. R$ 5,324.74, p <0.001) and 37.4% after five years (R$ 2,069.35 vs. R$ 5,538.74, p <0.001). ConclusionsThe use of LNG‐IUS results in lower direct and indirect costs versus TBEA and hysterectomy in the treatment of women with AUB. The cost‐effectiveness of LNG‐IUS, together with the reversibility and also by this being an outpatient procedure, highlights its role in the treatment of women with AUB, both in SUS perspective as in private health care system's.

Menorrhagia: Outcome of Minimally Invasive Treatments (MOMITs): Three to Five-Year Follow-Up of Outcomes Following Thermal Balloon Endometrial Ablation (TBEA) and Levonorgestrel Intra-Uterine System (LNG-IUS) Insertion

To determine the effectiveness of, and compare, TBEA and LNG-IUS with respect to objective menstrual blood loss(OMBL), quality of life(QOL) and patient satisfaction(PS).

Two Minute Thermal Balloon Endometrial Ablation (Thermablate EAS™) with and without Concomitant Hysteroscopic Fallopian Tube Micro-Inserts (Essure™) Placement

Two Minute Thermal Balloon Endometrial Ablation (Thermablate EAS™) with and without Concomitant Hysteroscopic Fallopian Tube Micro-Inserts (Essure™) Placement

Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5‐year follow up of a randomised controlled trial

To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall). Follow up of a prospective, double-blind randomised controlled trial at 5years. A teaching hospital in the UK. A total of 320 women eligible for and requesting endometrial ablation. Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database. The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery. Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%). At 5years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation.

Thermal balloon endometrial ablation in the treatment of heavy menstrual bleeding.

Aim:Heavy menstrual bleeding is one of the common health problems in women. The first-line therapy of heavy menstrual bleeding is the medical therapy, but this is not successful. Currently, global ablation procedures were introduced for treating of heavy menstrual bleeding. The aim of this study was to the analysis of the patient with menorrhagia performed operations of Cavaterm in our university affiliated hospital, and explores its effectiveness and acceptability.Methods:A retrospective study was conducted on 30 patients with menorrhagia who were unresponsive to hormone therapy or not candidates for hysterectomy underwent endometrial ablation using Cavaterm. Preoperative and postoperative PBAC Scoring System was used to assess menorrhagia. Outcome measures were amenorrhea rates, reduction of menstrual flow rates, heavy bleeding, menstrual and patients’ satisfaction rates at 3, 6 and 12 months postoperative.Results:After a follow-up at 3, 6, and 12 months postoperative, 36.7%, 43.3%, and 36.7% of women had a reduction in vaginal bleeding, respectively. Amenorrhea rates were 56.7%, 50.0%, and 56.7% in the Cavaterm at 3, 6, and 12 months. The rate of women’s reported good or excellent satisfaction was 93.3% in 12 months. During the follow-up period, no woman received a subsequent hysterectomy.Conclusion:The findings of this research indicated that outcome with the Cavaterm was as good for women with menorrhagia. Therefore, it is necessary to emphasize on lower operative and post-operative procedural risk and a deleterious effect on patients who were unresponsive to hormone therapy.

Long-term patient satisfaction with thermal balloon ablation for abnormal uterine bleeding.

Background and Objective:Thermal balloon ablation is a minimally invasive surgical technique that can be used to treat abnormal uterine bleeding/heavy menstrual bleeding (AUB/HMB). Most published studies to date provide information on short-term patient satisfaction and outcomes. The purpose of this study was to determine long-term patient satisfaction after thermal balloon endometrial ablation 7 to 10 years postoperatively in a population previously surveyed at the Penn State Milton S. Hershey Medical Center at 1 to 5 years postoperatively.Methods:Two-hundred fourteen patients were identified who underwent thermal balloon ablation at our institution between January 1, 2001 and December 31, 2004. These patients were mailed a 2-page survey asking for information on demographics, patient satisfaction, postoperative bleeding patterns, and the need for subsequent surgery. Satisfaction rates, amenorrhea rates, and the rates of women who required hysterectomy were calculated as percentages.Results:Ninety-seven patients returned completed surveys. The survey response rate was 62%, excluding 57 surveys that were returned as undeliverable. The follow-up interval was 93 to 129 months. Eighty-seven percent of respondents were satisfied with the results of their procedure compared with 88% in the original study. Subsequent hysterectomy was required in 21.6% of women after 7 to 10 years compared with 9% after the 1- to 5-year follow-up period. Of the 76 women who did not undergo hysterectomy, 58% reported amenorrhea and 35.5% reported minimal to light bleeding.Conclusion:This study demonstrates a consistently high patient satisfaction rate with thermal balloon ablation at our institution at 7 to 11 years postoperatively compared with 1 to 5 years postoperatively. The hysterectomy rate, however, was 2.4 times greater in the long-term follow-up period.

Clinical Outcomes of Thermal Balloon Endometrial Ablation (Thermablate EAS) with and without Concomitant Use of Levonorgestrel Intra-Uterine System (LNG-IUS) in Women with Abnormal Uterine Bleeding: A Pilot Study

The LNG-IUS is an effective treatment of heavy menstrual bleeding (HMB) in up to 70% of women. The Thermablate balloon endometrial ablation (TBEA) system is comparable to all other nonhysteroscopic devices in treating HMB in up to 70% of women. In the present study, we hypothesized that combining the TBEA and LNG-IUS will increase clinical outcomes in over 70% of women.

Does postoperative pain predict the outcome of endometrial ablation?

In this article, we hypothesized that significant pain in the immediate postoperative period is due to a deeper degree of thermal ablation, down to the myometrial layer, and consequently an increased likelihood of successful outcome. We retrospectively reviewed the medical records of 87 subjects who underwent thermal balloon endometrial ablation as the sole procedure under general anesthesia, administered by the same anesthetist using a standard protocol over a 10-year period from 2000 to 2010 at Thornbury Hospital, Sheffield, UK. All the cases were performed by the same surgeon in one hospital. Twenty-eight (32.2%) subjects experienced severe or intractable pain within 1 h after the thermal balloon endometrial ablation procedure, while 26 (29.9%) subjects required morphine injection in the postoperative period. Overall, more than 70% of women experienced significant reduction in their menstrual flow. There was no difference in the clinical outcome between those who did or did not experience severe pain or between those who did or did not require morphine injection in the postoperative period. The amount of postoperative pain did not predict the outcome of thermal balloon endometrial ablation.

Outcome and uterine arteries Doppler velocimetry after thermal balloon endometrial ablation in menorrhagia

Objective This prospective study was designed to evaluate the outcome and the changes in uterine artery blood flow after thermal balloon endometrial ablation (TBEA) in cases of menorrhagia. Study design Prospective study. Patients and methods Eighty-two premenopausal women with menorrhagia were included in this study. The TBEA was carried out on cycle days 3–8. Transvaginal color Doppler measurements were obtained from the uterine arteries on both sides before ablation and repeated on the first day, 3, 6, and 12 months after TBEA. Results Of 82 women, 78 (95.12%) were satisfied and experienced improvement after TBEA. The end-diastolic velocity was significantly decreased 6 and 12 months after TBEA (5.0±2.5 and 4.6±3.0; respectively); also, the time-averaged maximum velocity was significantly decreased 6 and 12 months after TBEA (14.8±3.4 and 13.9±3.4, respectively). The pulsatility index was significantly increased 6 and 12 months after TBEA (1.6±0.9 and 1.63±0.8, respectively); also, the resistance index was significantly increased 6 and 12 months after TBEA (0.89±0.2 and 0.90±0.3, respectively). Conclusion TBEA induces increase in impedance of the uterine blood flow because of fibrosis in the endometrium and subendometrial layers, with a subsequent reduction in the menstrual flow.

Uterine Clostridial Myonecrosis After Thermal Balloon Endometrial Ablation

We present a case of a patient who had development of uterine clostridial myonecrosis after elective thermal balloon endometrial ablation in the absence of identifiable risk factors. A 51-year-old woman underwent uneventful thermal balloon endometrial ablation for the treatment of menorrhagia. The next day, she presented with acute inflammatory syndrome, severe intravascular hemolysis, and acute kidney injury. The blood cultures and the high vaginal swab showed moderate growth of Clostridium species. A total abdominal hysterectomy and bilateral salpingo-oophorectomy were performed. Her postoperative course was uneventful, and renal function gradually recovered. Clostridial myonecrosis after uncomplicated surgery, although rare, should be considered in the differential diagnosis of the acutely septic patient with massive hemolysis, regardless of the presence of patient's risk factors.

Endometrial thermal balloon ablation by a simple technique using Foley’s catheter with or without pre ablation endometrial curettage to treat cases with intractable menorrhagia

Abstract Objectives To assess the efficacy and safety of endometrial thermal ablation by a technique using Foley’s catheter to treat cases with intractable menorrhagia and to compare between results with and without pre procedure curettage. Study design Prospective randomized controlled study. Patients and methods Forty eight patients aged from 39 to 52 years complaining of menorrhagia not responding to treatment for at least 6 months were included in the study, pre ablation endometrial curettage was done for 24 randomly selected cases (group 1) and ablation without curettage for the other 24 cases (group 2). A latex silicon coated Foley’s catheter with 30–50 ml capacity was tested and inserted into uterine cavity then inflated by a variable volume of boiling saline as the uterine cavity permits under moderate pressure and replaced every 2 min with a new boiling saline, for 8 min duration. Then follow up for 6 months and hysteroscopic examination were done to detect endometrial scarring. Outcome measures Patients satisfaction, menstrual outcome, hysteroscopic diagnosed scarred endometrium. Results This study showed a satisfaction rate of 83.3%, improvement in menstrual bleeding (79.2%) and hysteroscopic diagnosed scarring of the endometrium (75%). Cases in group 1 had a significantly higher satisfaction rate (95.8%) than in group 2 (70.8%) and significantly lower incidence of persistent menorrhagia after ablation than cases in group 2 (4.2% versus 37.5%, respectively). Hysteroscopic diagnosed endometrial scarring was significantly higher in group 1 (91.7%) versus (53.8%) for group 2. Conclusion Endometrial thermal balloon ablation by a technique using Foley’s catheter is a safe, simple, cheap and effective procedure as an alternative to hysterectomy for treatment of menorrhagia in properly selected cases. Pre ablation endometrial curettage increases the satisfaction rate and improves menstrual outcome.

Incidence of de Novo Pelvic Pain After Radiofrequency or Thermal Balloon Global Endometrial Ablation Therapy

Abstract Objective: The purpose of this study was to determine the incidence of new-onset pelvic pain within 2 years after either radiofrequency (RF) or thermal balloon (TB) endometrial ablation for menorrhagia. Study design: This study was a retrospective cohort study of consecutive patients treated by radiofrequency or thermal balloon global endometrial ablation (GEA) between 2003 and 2008. Setting: The study took place in an inner-city, academic teaching hospital (RF cohort), inner-city community-based obstetrics and gynecology private practice (TB cohort). Intervention: Procedures performed were hysteroscopy and endometrial ablation by either radiofrequency (under general anesthesia) or thermal balloon (under local paracervical block). Outcome measure: The primary outcome measure was the incidence of new-onset pelvic pain at 3, 6, 12, 18, and 24 months, and the secondary outcome measure was the mean visual analogue scale (VAS) pain score per modality, per time endpoint. Results: De novo pelvic pain oc...