Clinical trial of the uterine thermal balloon for treatment of menorrhagia

Vilos, George A.; Fortin, Claude; Sanders, Barry; Pendley, Laura; Stabinsky, Seth A.

doi:10.1016/s1074-3804(05)80089-1

Cited by 62 publications

(35 citation statements)

References 20 publications

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“…1). These results are consistent with the findings in several non-randomised studies in which ThermaChoice ® is compared to TCRE [90][91][92], as well with the findings in several prospective observational studies [93,94]. Pretreatment of the endometrium can be performed with GnRH analogues or with suction curettage, in order to decrease the thickness of the endometrial layer prior to ablative treatment.…”

Section: Thermal Balloon Endometrial Ablationsupporting

confidence: 88%

Current treatment of dysfunctional uterine bleeding

Bongers¹,

Mol²,

Brölmann³

2004

Maturitas

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Section: Thermal Balloon Endometrial Ablationsupporting

confidence: 88%

Current treatment of dysfunctional uterine bleeding

Bongers¹,

Mol²,

Brölmann³

2004

Maturitas

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“…The same success rates are reported in such cases [6]. Currently, TBA is used for dysfunctional menorrhagia; comparative trials with hysteroscopic surgery were done, but there is no evidence in the literature of the effectiveness of thermal ballooon ablation in symptomatic myomatous uteri [29][30][31][32][33][34].…”

Section: Discussionmentioning

confidence: 90%

“…In contrast to minimally invasive hysteroscopic surgery, TBA was reported to be almost free of intraoperative complications and as effective as the former methods, showing consistent results because of the simplicity of the procedure [5,[29][30][31][32][33][34]. TBA is performed on an outpatient basis under local anesthesia, avoiding the inherent risks of general anesthesia, and does not require additional training [5,[29][30][31][32][33][34].…”

Section: Discussionmentioning

confidence: 99%

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Thermal Balloon Ablation in Myoma-Induced Menorrhagia under Local Anesthesia

Soysal

Vıcdan

2001

Gynecol Obstet Invest

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Objective: Our purposes were to compare the impact of surgery on menstrual blood flow reduction and on the increase in hemoglobin values as primary endpoints at 12 months, and operating time, complication rates, postoperative pain scores at 12 h and surgically induced amenorrhea rates at 12 months as secondary endpoints after roller ball endometrial ablation or thermal balloon ablation for myoma-induced menorrhagia. Materials and Methods: Menorrhagic women (documented by a validated pad scoring system) over 40 years of age, with a mobile myomatous uterus smaller than 12-week pregnancy, were enrolled in a prospective randomized trial to compare endometrial roller ball ablation and thermal balloon ablation after pharmacological endometrial thinning. One year after surgery, primary and secondary endpoints in both groups were compared. Results: Forty-five subjects underwent endometrial thermal balloon ablation under local anesthesia and 48 underwent endometrial roller ball ablation under general anesthesia. Statistically significant but similar decreases in mean pictorial blood assessment score and increases in mean hemoglobin values were noted for both groups at 12 months. Those who underwent endometrial roller ball ablation had experienced significantly more intraoperative complications. Conclusion: Thermal balloon ablation under local anesthesia for myoma-induced menor- rhagia provided both significant and statistically similar reductions in menstrual blood flow and increases in hemoglobin values with no intraoperative complication compared to roller ball endometrial ablation.

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“…If the pressure went below 120 mmHg, then the therapy cycle was restarted. This is in view of the fact that at lower intra uterine pressure the efficacy of the procedure is reduced [11]. After UBT the patients should be advised to use either natural or barrier contraception if not already sterilised, as this procedure does not guarantee contraception.…”

Section: Resultsmentioning

confidence: 99%