A Prospective Randomized Trial of Medical Therapy Versus Radiofrequency Endometrial Ablation in the Initial Treatment of Menorrhagia: Treatment Outcomes and Cost Utility Analysis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).
研究概览
简要总结
Excessive menstrual loss (menorrhagia) is a common condition that affects women of reproductive age, and can result in anemia, chronic fatigue and lost wages from work. The traditional first line management involves treatment with oral contraceptives or non-steroidal anti-inflammatory agents. Many women ultimately undergo hysterectomy, a major operative procedure associated with increased costs, loss of feeling of womanhood, debilitating complications and on rare occasions, death.
The newer global endometrial ablation (GEA) devices allow the destruction of the endometrial lining, without the removal of the uterus, in an ambulatory surgery setting. GEA offers a safe and effective alternative to hysterectomy with minimal risks and without unpleasant side-effects.
Presently, global endometrial ablation is offered as an alternative to hysterectomy, after medical intervention has failed. This study will determine the role of global endometrial ablation in the initial management of menorrhagia. Women seeking treatment for menorrhagia will be randomized to either the medical treatment arm or the global endometrial ablation arm.
This study will be the first to compare clinical efficacy and costs between oral contraceptive pills and global endometrial ablation in the initial management of menorrhagia and could potentially change the management of menorrhagia and impact millions of women who suffer from this condition.
详细描述
Goal of study: To evaluate the safety, effectiveness as well as cost- effectiveness of Global Endometrial Ablation (GEA) as an initial treatment for menorrhagia.
Specific aim #1: To determine if global endometrial ablation (GEA) is more effective than medical therapy in the initial management of menorrhagia.
Specific aim #2: To determine disease-specific resource utilization and costs associated with the treatment alternatives and the cost effectiveness of global endometrial ablation (GEA) compared with medical treatment (oral contraceptive pills) in the initial management of menorrhagia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female, ages 30-55, who is pre-menopausal and for whom childbearing is complete
- •Subjective symptom of excessive menstrual loss
- •Normal uterine cavity length (≥ 4cm) with a sound measurement of ≤10cm documented by sonohysterogram or hysteroscopy in the preceding 6 months
- •At least one normal Pap Test and no unexplained abnormal Pap Tests within 6 months of procedure
- •Prior history of permanent sterilization or use of reliable non-hormonal contraception during the 14 month study period or history of vasectomy in partner
- •Freely agree to participate in the study including all study related procedures and evaluations, and document this agreement by signing the informed consent document
排除标准
- •Pregnancy or desire for future childbearing
- •Active lower genital infection at the time of procedure
- •Active urinary tract infection at the time of procedure
- •Active pelvic inflammatory disease (PID) or recurrent chronic PID
- •Endometrial neoplasia, determined by endometrial biopsy taken within 12 months of study entry
- •Current or past history of cervical or endometrial cancer
- •Uterine sound measurement greater than 10cm
- •Submucous leiomyoma greater than 2cm or cavity distorting leiomyoma
- •History of myomectomy or classical cesarean section
- •Previous endometrial ablation
- •Oral hormonal treatment in the preceding 3 months, hormone releasing intrauterine contraceptive in the preceding month, or injectable hormone treatment in the preceding 12 months
- •Contraindication to hormonal therapy and non-steroidal anti-inflammatory agents.
- •History of a coagulopathy or endocrinopathy
- •Inability to follow up at 12 months
研究组 & 干预措施
Medical Therapy
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
干预措施: Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills (Drug)
Medical Therapy
Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
干预措施: Naproxen sodium pills (Drug)
Radiofrequency Endometrial Ablation
Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
干预措施: NovaSure® Radiofrequency Endometrial Ablation (Device)
结局指标
主要结局
Menstrual Blood Loss (MBL) as Measured by Pictorial Blood Loss Assessment Chart (PBLAC).
时间窗: Measured at 12 months following initial treatment
The PBLAC is a simple, pictorial tool used in women with menorrhagia to assess menstrual blood loss. The total score is calculated by adding up the sum of all scores for the tampons or sanitary napkin used in the menstrual cycle. For tampons: 1 for lightly stained, 5 for moderately soiled and 10 for completely saturated tampons. For sanitary napkins: 1 for lightly stained, 5 for moderately soiled, and 20 for completely saturated pads. Clots were given a score of 1 for small and 5 for large clots. Abnormal PBLAC bleeding score greater than or equal to 100, which correlates with menorrhagia, defined as greater than 80 mL of menstrual blood loss. Normal bleeding is defined as a score of 75 or less. A score of 0 indicates amenorrhea, or absence of menstruation.
次要结局
- Quality of Life Score Using the Short Form-12 (SF-12) Health Survey(Measured at 12 months following initial treatment)
- Quality of Life as Measured by the Menorrhagia Multi-Attribute Scale (MMAS )(Measured at 12 months following initial treatment)
- Hemoglobin at 12 Months(Measured at 12 months following initial treatment)
- Change in Hemoglobin(baseline, 12 months)
- Ferritin at 12 Months(Measured at 12 months following initial treatment)
- Change in Ferritin From Baseline(Measured at 12 months following initial treatment)
- Direct Medical Costs(Measured at 12 months following initial treatment)
- Indirect Medical Costs(Measured at 12 months following initial treatment)
- Bleeding Pattern at 12 Months(Measured at 12 months following initial treatment)
- Pain at 12 Months as Measured by the Pain Visual Analog Scale (VAS)(Measured at 12 months following initial treatment)
- Subject Satisfaction at 12 Months(Measured at 12 months following initial treatment)
研究者
Abimbola Famuyide
Consultant, Assistant Professor of Obstetrics-Gynecology
Mayo Clinic