Uterine Balloon Therapy Research Articles

Quality of Life, Anxiety and Depression in Women Treated with Hysteroscopic Endometrial Resection or Ablation for Heavy Menstrual Bleeding: Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background and Objectives: Hysteroscopic endometrial resection (ER) or global endometrial ablation (GEA) are feasible methods to treat heavy menstrual bleeding (HMB). The aim of this systematic review and meta-analysis of randomized controlled trials (RCTs) was to assess patient's quality of life (QoL) in women treated with ER/GEA compared to hysterectomy. Materials and Methods: Electronic searches in MEDLINE Scopus, ClinicalTrials.gov, EMBASE, PROSPERO and Cochrane CENTRAL were conducted from their inception to July 2022. Inclusion criteria were RCTs of premenopausal women with HMB randomized to conservative surgical treatment (ER/GEA) or hysterectomy. The primary outcome was the evaluation of QoL using the SF-36 score. Results: Twelve RCTs (2773 women) were included in the analysis. Women treated with hysteroscopic ER/GEA showed significantly lower scores for the SF-36 general health perception (mean difference (MD) -8.56 [95% CI -11.75 to -5.36]; I2 = 0%), social function (MD -12.90 [95% CI -23.90 to -1.68]; I2 = 91%), emotional role limitation (MD -4.64 [95% CI -8.43 to -0.85]; I2 = 0%) and vitality (MD -8.01 [95% CI -14.73 to -1.30]; I2 = 74%) domains relative to hysterectomy. Anxiety, depression scores and complication rates were similar between treatments. Relative to uterine balloon therapy, amenorrhea was more common with EA/GER (relative risk 1.51 [95% CI 1.03 to 1.20] I2 = 28%), but posttreatment satisfaction was similar. Conclusions: Women's perception of QoL might be seen to be less improved after hysteroscopic ER/GEA rather than hysterectomy. However, such findings need to be confirmed by additional trials due to the high number of outdated studies and recent improvements in hysteroscopic instrumentation and techniques.

Clinical Evaluation of Long-term Safety and Effectiveness of a Third-Generation Thermal Uterine Balloon Therapy System for Heavy Menstrual Bleeding

Study ObjectivesTo estimate the incidence of amenorrhea at 36 months after treatment using a third-generation thermal uterine balloon therapy (UBT) system and to compare it with the first-generation UBT system. The secondary objective was to estimate the effect of post-procedure curettage on patient outcomes at 36 months after endometrial ablation. DesignMulticenter controlled study (Canadian Task Force classification I). SettingThirteen hospitals: 12 in the United States and 1 in Mexico. PatientsTwo-hundred fifty premenopausal women aged at least 30 years with heavy menstrual bleeding not responsive to previous medical therapy for at least 3 months. InterventionAfter treatment with a third-generation thermal UBT system, patients were randomly assigned to receive post-procedure curettage (PPC) or no PPC. Measurements and Main ResultsAmenorrhea was estimated at 12 months using individual success defined by a pictorial blood loss assessment chart score of 0, and at 24- and 36-month follow-up by patient response of amenorrhea on a 5-point scale (amenorrhea, spotting, and light, normal, or excessive bleeding). In the intention-to-treat population, at 36 months after ablation, the amenorrhea rate was 26.8% with the third-generation UBT system, and 13.0% with the first-generation UBT system. Results by assigned intervention were 29.8% in the no PPC group vs 23.8% in the PPC group. ConclusionAt extended 36-month follow-up, results were similar to the previously reported results at 1 year using prospectively defined matched-pair analysis, and demonstrated superiority in treating amenorrhea using the third-generation UBT system vs the first-generation UBT system.

Uterine Thermal Balloon Ablation versus Hysteroscopic Endometrial Resection in Treatment of Menorrhagia

Study design: A randomized clinical prospective comparative study. Setting: The study was conducted in the Department of Obstetrics and Gynecology, between May 2010 and August 2012. Objective: To compare the efficacy and safety of a uterine thermal balloon system with hysteroscopic endometrial resection in the treatment of selected cases of menorrhagia. Patients and methods: The study comprised seventy premenopausal women with persistent intractable menorrhagia, selected under strict inclusion criteria. Patients were randomized into two equal groups of 35 patients each. Patients of the first group were treated by uterine thermal balloon system (35 patients), while those of the other group were treated by hysteroscopic endometrial resection (35 patients). Quantification of pre-procedural and post-procedural menstrual blood was defined by pad count and self-assessment. Twelve-month follow-up data were presented on all women and compared statistically. Results: Twelve-month results indicated that both techniques significantly reduced menstrual blood flow with no clinically significant difference between the two groups. Success rates, as reflected by percent of patients who returned to normal bleeding or less, were comparable being 82.8% for the balloon group and 91.4% for the resection group. Procedural time was reduced significantly in the uterine balloon therapy group. Intra-operative complications occurred in three (8.5%) of the hysteroscopic resection patients, whereas no intra-operative complications occurred in the thermal balloon group. Conclusion: Uterine thermal balloon therapy is as efficacious as hysteroscopic resection in the treatment of selected cases of menorrhagia. Further studies are needed to confirm this conclusion.

Uterine balloon therapy for the treatment of menorrhagia

Objective(s) To evaluate the effectiveness of uterine balloon therapy for the treatment of menorrhagia and to determine its prognostic factors.

Clinical Evaluation of a Third-Generation Thermal Uterine Balloon Therapy System for Menorrhagia Coupled with Curettage

Study Objectives To estimate the incidence of amenorrhea 12 months after treatment with a third-generation thermal uterine balloon therapy (UBT) system. Secondary objectives were to compare the incidence of amenorrhea observed with this third-generation system with that of a first-generation system, to estimate the effect of postprocedure curettage on patient outcome, and to evaluate the workings of this new system. Design Multicenter, controlled study (Canadian Task Force classification I). Setting Thirteen hospitals: 12 in the United States and 1 in Mexico. Patients Two hundred fifty premenopausal women aged 30 years or older with menorrhagia not responsive to previous medical therapy for at least 3 months. Intervention After treatment with a third-generation thermal UBT system, patients were randomly assigned to receive postprocedure curettage or no further treatment. Measurements and Main Results The rate of amenorrhea 12 months after treatment with the third-generation thermal UBT system was similar in patients receiving postprocedure curettage (33.3%) and those receiving no further treatment (37.1%; p = .53). In addition, postprocedure curettage did not have any significant effect on any other patient outcome, for example, pain. Patients who were matched to historic control patients treated with the original first-generation system demonstrated a significantly greater success rate (amenorrhea) at 12 months (32.6%) compared with those treated with the first-generation system (13.7%). The third-generation thermal UBT instrument functioned as designed, with no unanticipated adverse device effects. Conclusion The third-generation thermal UBT system shows greater efficacy in producing amenorrhea than the original first-generation system, with no significant safety issues. Postprocedural curettage did not alter amennorhea rates.

Successful pregnancy after thermal balloon endometrial ablation followed by in vitro fertilization and embryo transfer

To describe a case of successful pregnancy after IVF-ET in a patient with previous thermal ablation of the endometrium by uterine balloon therapy (UBT). Case report. University hospital. Polymorbid patient who received UBT and became pregnant after IVF-ET. UBT, IVF-ET, and caesarean section. After UBT, the patient underwent IVF-ET and gave birth to a healthy newborn at 36 weeks' gestation with a birth weight 2900 g and placenta accreta. Patients who wish to become pregnant after endometrial ablation should undergo preconception consultation and hysteroscopic examination.

Uterine balloon therapy: An alternative therapy for menorrhagia

Background: Menorrhagia is a common problem in women of reproductive age. Its aetiology in the absence of organic pathology, hormonal or haematological disorders remains largely unknown. Traditional medical therapy may not be beneficial in the long run. Hysterectomy for this condition is an invasive over treatment. First generation endometrium ablation techniques aimed at destroying the endometrium, were associated with life threatening complications. The second generation endometrial ablation techniques like uterine thermal balloon therapy have reduced these problems. Methods: Fifty patients were selected for the procedure between 2002 and 2005. The patients qualified for the procedure if they had completed their family, had normal pelvic ultrasound findings, benign endometrial histology, normal PAP smear and clinically a normal size or bulky uterus. Results: 50% patients were in the age group of 35–45 years. 28(56%) procedures were done under local anaesthesia and 22(44%) under general anaesthesia. The patients were followed up for a period of 3 to 29 months (median 16 months). Seven(14%) had amenorrhoea and 40(80%) had normal periods or hypomenorrhoea. Three(6%) patients continued to have menorrhagia and were considered failures. 94% patients were satisfied with the procedure and there were no complications in this series. Conclusions: Uterine balloon therapy is a simple, safe and effective method for the treatment of menorrhagia in selected patients.

Concomitant Essure® tubal sterilization and Thermachoice® endometrial ablation: feasibility and safety

To evaluate the feasibility and safety of combining endometrial ablation (EA) with a thermal balloon endometrial ablation system (Gynecare Thermachoice IIIC Uterine Balloon Therapy System; Ethicon Inc., Somerville, NJ) and transcervical sterilization by intratubal insert (Essure Permanent Birth Control System; Conceptus, San Carlos, CA). Feasibility and safety studies. University hospital in Chihuahua, Mexico. There were 40 volunteers in the feasibility study and 9 in the safety study, all requiring hysterectomies for benign uterine bleeding. In the feasibility study, both procedures were performed just before hysterectomy; in the safety study, thermocouples were inserted under the tubal serosa to assess heat transmission from the intratubal insert devices to the tubes and surrounding organs during EA. Completeness of EA and possible device dislodgement in the feasibility study; temperature readings in the safety study. No disturbance of the intratubal insert devices was noted, and EA by the thermal balloon endometrial ablation system was complete visually and histologically, although small areas near the tubal ostia exhibited less endometrial destruction. Mean tubal temperatures ranged from 37.1 degrees C to 37.5 degrees C and did not reach the critical temperature of 45 degrees C. No damage to the tubes was noted. Performance of EA and sterilization with these two systems in a one-step approach is safe for women who require EA and permanent contraception.

The medium- and long-term outcome of endometrial ablative techniques

Objective: To determine the medium-term (1–3 years) and long-term (3–5 years) outcome for women who underwent endometrial ablative techniques. To determine the uptake of these operations and the outcome results. Study design: The hospital records of all women who underwent either Uterine Balloon Therapy (UBT) or VESTA (Multiple Electrode Device) since our commencement of use of these procedures in the Rotunda Hospital, Dublin were reviewed. Medium-term assessment was by retrospective analysis of the patient records for the incidence of complications and the necessity of further medical and surgical treatment. Long-term outcome was assessed by completion of a questionnaire by all patients. Demography, complications, patient satisfaction, new symptomatology and the need for further treatment were assessed. Forty-four women who underwent UBT and 40 women who had VESTA ablation formed our study group. Results: Our main outcome measures were assessment of the amenorrhoea rate and patient satisfaction in the long-term. Medium-term follow-up revealed a 90% success rate. Long-term follow-up showed on overall treatment success of 80% and a patient satisfaction rate of 73%. Conclusion: Both UBT and VESTA were associated with high rates of amenorrhoea and patient satisfaction in the long-term.

Thermal Balloon Ablation in Patients with Multiple Morbidity: 3-Year Follow-up

Study Objective To evaluate the effectiveness of a thermal uterine balloon therapy system in a specific group of patients with multiple morbidity. Design Retrospective cohort analysis (Canadian Task Force classification II-2). Setting Department of Obstetrics and Gynecology in two university teaching hospitals. Patients Seventy women with severe systemic disease (American Association of Anesthesiologists physical status score ≥ III) and severe menorrhagia. Intervention Uterine balloon therapy under local anesthesia and 3 years of follow-up. Measurements and Main Results The women had a mean age of 44.3 years (range, 24–76). After treatment, 25.7% of the patients had no bleeding, 45.7% hypomenorrhea, and 21.4% normal menstrual flow. The procedure was repeated successfully for one patient, and five failures (7.1%) were observed. The blood count values differed significantly (p <.001) before and after balloon therapy. Conclusion Uterine balloon therapy is a suitable and useful option for women with severe uterine bleeding and concomitant severe systemic nongynecologic disease.

Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: Long-term multicenter follow-up study

Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: Long-term multicenter follow-up study

Extirpated uteri study of next generation conforming ThermaChoice 3 uterine balloon therapy catheter

Extirpated uteri study of next generation conforming ThermaChoice 3 uterine balloon therapy catheter

Uterine endometrial thermal balloon therapy for the treatment of menorrhagia: long-term multicentre follow-up study.

Initial reports from observational and randomized trials of uterine endometrial thermal balloon therapy (UBT) suggested good results as judged by return to eumenorrhoea or less and patient satisfaction. Long-term follow-up data remained limited by the small numbers of patients and duration of follow-up. We present long-term (4-6 years) follow-up data from a cohort of women previously treated with UBT for menorrhagia. Of the 260 questionnaires sent to women eligible for long-term follow-up from 10 centres, 188 (72%) replies were received. The primary outcome measure was avoidance of hysterectomy. In women who responded to the questionnaire, 25 had undergone hysterectomy and 21 had had repeat ablation. At 4-6 years after UBT, the probability of avoiding hysterectomy was 86% of all women, and of avoiding re-ablation was 88% of non-hysterectomized women. Overall, the probability of avoiding any surgery was 75%. Women with an axial or retroverted uterus were at greater risk of hysterectomy or re-ablation. Among the participants, 47% of the non-hysterectomized women were amenorrhoeic, 30% were hypomenorrhoeic, 13.6% were eumenorrhoeic and 8.5% had heavy periods. This is the first long-term follow-up report of a second-generation endometrial ablation procedure and confirms our initial experience. The high rate of hysterectomy avoidance over 5 years or more is very encouraging for this technology.

Five-Year Follow-up of Patients Participating in a Randomized Trial of Uterine Balloon Therapy versus Rollerball Ablation for Treatment of Menorrhagia

Study Objective To collect long-term follow-up information from women who participated in a randomized trial comparing uterine balloon therapy (UBT; Gynecare, Somerville, NJ) with rollerball ablation for treatment of menorrhagia. Design Five-year contact of participants treated in a 1996 multicenter, randomized trial (Canadian Task Force classification I). Setting Twelve North American university and private practice centers. Patients Women treated with endometrial ablation for menorrhagia who were available for 5-year follow-up. Intervention Uterine balloon therapy or rollerball ablation. Measurements and Main Results Of 255 women treated under the original protocol,147 were available to be interviewed 5 years after the procedure. Of these, 25 patients reported hysterectomy, repeat ablation, or dilatation and curettage (D&C) between years 3 and 5, leaving 122 eligible for analysis (61 UBT, 61 rollerball). Of these 122 patients, 58 (95%) having UBT and 59 (97%) having rollerball ablation reported normal or less bleeding. Similarly, 93% and 100%, respectively, were satisfied with the procedure. Among the total population of 255 women, 42 hysterectomies (21 UBT, 21 rollerball), 5 repeat ablations (3 UBT, 2 rollerball), and 1 D&C (rollerball) were reported by year 5. Thirty-five hysterectomies (83%) were performed because of bleeding and/or pelvic pain; one-third of them were associated with myomas. Nearly 7 of 10 women were cured of menorrhagia without additional intervention 5 years after ablation. Conclusion UBT continues to be an effective, simple treatment of menorrhagia, with clinical outcomes similar to those of rollerball ablation at 5-year follow-up.

Uterine balloon therapy for menorrhagia: A feasibility study of its use in the community setting

ObjectivesTo determine whether uterine balloon therapy (UBT) for menorrhagia can be performed safely in the community setting, obviating the need for hospital admission or general anaesthesia.DesignProspective case studies of 20...

Three-Year Comparison of Thermal Balloon and Rollerball Ablation in Treatment of Menorrhagia

Study Objective To compare uterine balloon therapy and hysteroscopic rollerball endometrial ablation with respect to efficacy and safety in treatment of menorrhagia. Design Multicenter, prospective, randomized study (Canadian Task Force classification I). Setting Fourteen North American university and private practice sites. Patients Women undergoing endometrial ablation for menorrhagia. Intervention Rollerball endometrial ablation or uterine balloon therapy. Measurements and Main Results Of 275 women randomized to one of these procedures, 255 were treated under the protocol and 214 were followed for 3 years. Results of uterine balloon therapy and rollerball endometrial ablation remained similar, with little difference at 3 years compared with results at 1 year. We noted a suggestion of an increase in hysterectomies in the rollerball group (14) compared with the uterine balloon therapy group (8) at 3 years. Conclusion Endometrial ablation with the ThermaChoice uterine balloon or rollerball continues at 3 years to be a successful method for treating menorrhagia, avoiding hysterectomy, decreasing dysmenorrhea and premenstrual symptoms, and improving quality of life.

Thermal balloon and rollerball ablation to treat menorrhagia: Two-year results of a multicenter, prospective, randomized, clinical trial

To evaluate 2-year follow-up results in patients participating in a randomized, clinical trial comparing uterine balloon therapy with rollerball endometrial ablation. Prospective, randomized, clinical trial (Canadian Task Force classification I). Fourteen university-affiliated and private practice sites. Two hundred fifty-five women with menorrhagia. Patients were randomized to rollerball or uterine balloon endometrial ablation. Patient satisfaction with both treatments was consistently high. Only 15 hysterectomies had been performed (6 for menorrhagia) at the end of 2 years, 11 in the rollerball group, 4 in the balloon therapy group. Endometrial ablation by both procedures was highly successful in avoiding hysterectomy and relieving symptoms of menorrhagia. Additional benefits were reduction in dysmenorrhea and premenstrual syndrome.

Evaluation of two endometrial-thinning modalities with a new ThermaChoice uterine balloon therapy system

Evaluation of two endometrial-thinning modalities with a new ThermaChoice uterine balloon therapy system

Balloon Endometrial Ablation as a Safe Alternative to Hysterectomy

Each year, 600,000 hysterectomies are performed in the United States, costing an estimated $4 billion. Approximately 50% of these hysterectomies are performed for menorrhagia or abnormal uterine bleeding. Menorrhagia can have a negative impact on a woman's lifestyle and self-perception, often leading her to seek definitive treatment. Pharmacologic treatment for menorrhagia is not always successful, and dilatation and curettage provides relief for only the first few menstrual cycles. Surgical options include hysterectomy and two forms of endometrial ablation. Current research demonstrates that thermal uterine balloon therapy is the safest of these options. Uterine balloon therapy, an outpatient procedure, has resulted in successful reduction in menstrual flow in 70% to 90% of patients, and it soon may be performed as an office-based procedure.

Uterine balloon therapy to treat menorrhagia

Objective: To study the clinical efficacy, safety and acceptability of the thermal balloon endometrial ablation (TBEA) in patients with dysfunctional uterine bleeding. Methods: Thirteen patients with DUB who did not respond to medical treatment and dilatation and curettage consented to a trial of TBEA with EASYTM model of balloon catheter by Gynecare. All procedures were done under intravenous (IV) sedation and paracervical block. Patients were mostly discharged within 48 h. Follow-up of 2–19 months is reported. Transvaginal ultrasound and hysteroscopy were performed in six patients after 6 months of TBEA. Results: Twelve patients (92.3%) reported a significant reduction in bleeding. Two patients (15.4%) experienced amenorrhea. Only two patients (15.4%) underwent subsequent hysterectomy, one for persistent menorrhagia and the other for severe pelvic pain. In successful patients of TBEA, transvaginal ultrasonography revealed marked reduction in endometrial thickness and no endometrium was visible in one patient who had developed amenorrhea. In successful cases follow-up hysteroscopy revealed scarring in more than two-thirds of the endometrium. Conclusions: Thermal balloon endometrial ablation is a safe, simple, effective, easy and minimally invasive procedure which can be done under IV sedation and paracervical block in an office setting. It has several advantages over hysterectomy, including preservation of the uterus, avoidance of surgical incision and potential to perform on an outpatient basis. It is a good alternative to hysteroscopic endometrial ablation with a comparable success rate with minimal risk and no limiting factors except the cost of the balloons. However, large scale randomized controlled studies are needed with TBEA and other endometrial ablation procedures.