Fibroid Clinical Trial
Official title:
Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma
The uterine leiomyoma is the most common female benign disease. Submucosal fibroid are about 10%, they distort the endometrial cavity causing heavy and/or irregular bleeding (AUB) and infertility. Hysteroscopic removal of submucosal myomas improves this conditions. GnRH analogues are commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are expensive, have potential side effects and lack a robust evidence base to support this practice. Ulipristal acetate treatment was able and faster to control in 90% of cases uterine bleeding associated with fibroids than GnRH agonists. UPA significantly improved quality of life and pain reduction.
The uterine leiomyoma is the most common benign tumor of the female genital tract. The
myomas are usually clinically apparent in 25% of patients. Submucosal fibroid are about 10%
of all uterine myoma; they distort the endometrial cavity causing heavy and/or irregular
bleeding (AUB) and infertility. According to the degree of myometrial penetration, the
European Society for Gynaecological Endoscopy (ESGE) classified submucosal myomas in Type 0
(totally intracavitary fibroids), Type I (<50% myometral penetration), or Type II (>50%
myometral penetration).
Hysteroscopic removal of submucosal myomas improves menorrhagia and AUB. GnRH analogues are
commonly used before hysteroscopic myomectomy to make surgery easier and safer, but they are
expensive, have potential side effects and lack a robust evidence base to support this
practice. A recent meta-analysis of data demonstrated that symptomatic relief in patients
undergoing surgery was similar either following pre-operative GnRH-a administration or
without GnRH-a administration, mainly due to the persistence of abnormal bleeding due to the
protrusion of the myoma into the uterine cavity.
In recent studies, Ulipristal acetate treatment was able to control uterine bleeding
associated with fibroids in more than 90% of cases. Moreover, it controlled bleeding faster
than GnRH agonists, with median times to amenorrhea of 5-7 days in patients receiving UPA
compared to 21 days in patients receiving a GnRH agonist. It was demonstrated that UPA
significantly improved also quality of life. Pain, as measured by the visual analogue scale,
showed a degree of relief similar to that achieved for postoperative pain with narcotic and
non-narcotic analgesics. This pain reduction is related to the high amenorrhea rate during
treatment (severe bleeding being responsible for uterine contractions and prostaglandin
secretion). No sub-analysis have been conducted on submucosal fibroids but, according to our
experience, this subgroup of myomas may be the one who most benefits from the administration
of UPA.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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