RESUMEN
OBJECTIVE: To evaluate the efficacy and safety of a new variant of the levonorgestrel-intrauterine system (LNG-IUS)-Emily-for the treatment of abnormal uterine bleeding (AUB). METHODS: A prospective, multicenter, single-arm, phase 4 study was conducted at six centers in India between July 2012 and August 2013. Eligible women were aged 30-50years, had completed their family, had AUB, and a pictorial bleeding assessment chart (PBAC) score of at least 100. After screening (visit 1) and insertion of the device (visit 2), participants were followed up at 1week, 1month, 3months, and 6months. The primary outcomes were menstrual blood loss (assessed by PBAC) and quality of life (assessed by the EQ-5D-3L questionnaire). RESULTS: Among 63 participants, 45 (71%) completed the study. Mean PBAC score decreased from 238.0±128.7 at screening to 13.1±19.2 at 6months (P<0.001). EQ-5D-3L score increased from 79.0±14.1 at visit 2 to 86.3±9.0 at 6months (P=0.003). No serious adverse events related to the device were reported. CONCLUSION: Among women with AUB, use of the Emily LNG-IUS significantly reduces menstrual bleeding and improves quality of life. Clinical Trials Registry of India: CTRI/2012/07/002843.
Asunto(s)
Anticonceptivos Femeninos/administración & dosificación , Dispositivos Intrauterinos Medicados , Levonorgestrel/administración & dosificación , Menorragia/tratamiento farmacológico , Adulto , Femenino , Humanos , Menorragia/psicología , Menstruación/efectos de los fármacos , Persona de Mediana Edad , Estudios Prospectivos , Calidad de Vida , Factores de TiempoRESUMEN
Multiple fractions of High Dose Rate (HDR) brachytherapy along with external beam therapy is the common method of treatment for cancer of the uterine cervix. Urinary bladder and rectum are the organs at risk (OARs) that receive a significant dose during treatment. To reduce the dose to these organs, a majority of hospitals use vaginal gauze packing, as it is a simple, nontraumatic, and easy method. This article describes the design and development of an inflatable balloon that can be used along with the applicator as a substitute for gauze packing. The balloon has two parts-the bladder part (B-part) and the rectum part (R-part), both of them are independently inflatable. The selection of the material, its width, length, and thickness are described. A mould/former for making the balloon was designed. Polished steel was used as the mould. This was dipped in specially prepared natural rubber latex (NRL) solution several times; the layers were dried and stripped to get the balloon. The composition of NRL and the compounding recipe of the latex are also described. Physical tests like tensile strength, elongation at break, bursting volume, and radiation attenuation caused by the balloon, were checked. Biological tests for assessing type I and type IV allergies, like dermal irritation and skin irritation tests, were also done.