Open AccessThe safety and efficacy of MenoTreat TM , a new balloon device for thermal endometrial ablation
Author(s) -
Ulmsten Ulf,
Carstensen Hanne,
Falconer Christian,
Holm Leif,
Lannér Lars,
Nilsson Staffan,
Rasmussen Carsten,
Redvall Lars,
Rådestad Arne,
Simonsen Benthe,
Bergelin Ingemar
Publication year - 2001
Publication title -
acta obstetricia et gynecologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.401
H-Index - 102
eISSN - 1600-0412
pISSN - 0001-6349
DOI - 10.1034/j.1600-0412.2001.800110.x
Subject(s) - medicine , balloon , endometrial ablation , surgery , balloon catheter , quality of life (healthcare) , concomitant , ablation , metrorrhagia , adverse effect , menstrual bleeding , hysterectomy , gynecology , family planning , population , nursing , research methodology , environmental health
Background. An evaluation of the performance and safety of the prototype of a new device, MemoTreat TM (Atos Medical) for thermal endometrial balloon ablation in patients with menorrhagia. The evaluation was performed at four Swedish hospitals. Methods. In total 51 consecutive, premenopausal patients, suffering from menorrhagia due to benign causes and not responding to conventional treatment, were treated between March 1997 and March 1998. The treatment entailed heated (85 °C) sterile saline circulated in a uterine balloon at a treatment pressure of 200 mmHg for 11 minutes. The procedure was performed mainly under general anesthesia and no pre‐treatment endometrial thinning was performed. A validated pictorial assessment technique was used to evaluate changes in menstrual blood loss before and after treatment. Changes in quality of life and severity of dysmenorrhea were also evaluated. Data analysis was based on the ‘intention to treat’ method. Results. The success rate in terms of a 50% reduction in menstrual bleeding was 84.3% at 6 months after treatment. Five patients became amenorrheic. The quality of life assessment showed substantial improvement and the severity of dysmenorrhea was markedly reduced. No intra‐operative treatment complications occurred and the post‐treatment morbidity was similar to that reported for other similar treatment methods. Conclusions. MenoTreat significantly reduced menstrual bleeding in menorrhagic patients, with a concomitant improvement in quality of life. The findings in this study resulted in a redesigned device with a thinner balloon catheter, improved cervical protection and treatment temperatures kept at a constant level.