Menorrhagia
Conditions
Keywords
randomized controlled trial, menorrhagia, LNG-IUS, hysterectomy
Brief summary
A randomised study including 236 women referred for essential menorrhagia to five university hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs.
Detailed description
A randomized VUOKKO trial was conducted between 1994-2008 to study hysterectomy and LNG-IUS in the treatment of menorrhagia.Overall, 236 women aged 35 to 49 years who were menstruating, had completed their family size, and were eligible for both treatments were randomized to either receive a LNG-IUS (n=119) or undergo hysterectomy (n=117). The follow-up visits took place six months and 12 months after the treatment, and again five and ten years after the randomization. The primary outcome measures were health related quality of life (HRQoL), other measures of psychosocial well-being (anxiety, depression, sexual functioning), and costs. The amount of menstrual blood loss was objectively measured before treatment and after one and five years. The one year the results were published in 2001 (Lancet 2001;357:273) and the five year results in 2004 (JAMA 2004; 291:1456).
Interventions
DRUGLNG-IUS
LNG-IUS releasing 25 microg of levonorgestrel
PROCEDUREHysterectomy
operation
Sponsors
University of Eastern Finland
University of Oulu
Tampere University
University of Turku
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
* heavy menstrual bleeding * 35-49 years * were menstruating * had completed their family size * were eligible for both treatments
Exclusion criteria
* submucous fibroids * endometrial polyps * ovarian tumours or cysts, * cervical pathology * urinary and bowel symptoms or pain due to large fibroids * lack of indication for hysterectomy * history of malignancies * menopause * severe depression * metrorrhagia as a main complaint * previous treatment failure with LNG-IUS * severe acne * uterine malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HRQoL (Health Related Quality of Life) | baseline and 5 years | HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline) |
| Costs | baseline, 6 and 12 months, 5 and 10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression | baseline, 6 and 12 months, 5 and 10 years |
Participant flow
Recruitment details
Two hundred and thirty-six women referred for essential menorrhagia to five university hospitals in Finland were randomly assigned to treatment with LNG-IUS (n= 119) or hysterectomy (n=117).
Pre-assignment details
All randomised women were analysed as intention-to-treat
Participants by arm
| Arm | Count |
|---|---|
| LNG-IUS Levonorgestrel releasing intrauterine system (LNG-IUS) | 119 |
| Hysterectomy Hysterectomy (abdominal,laparoscopical or vaginal) | 117 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
Baseline characteristics
| Characteristic | LNG-IUS | Hysterectomy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 119 Participants | 117 Participants | 236 Participants |
| Age Continuous | 43.1 years STANDARD_DEVIATION 3.5 | 43.0 years STANDARD_DEVIATION 3.2 | 43 years STANDARD_DEVIATION 3.3 |
| Sex: Female, Male Female | 119 Participants | 117 Participants | 236 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 80 / — | 25 / — |
| serious Total, serious adverse events | 0 / — | 5 / — |
Outcome results
Primary
Costs
Time frame: baseline, 6 and 12 months, 5 and 10 years
Primary
HRQoL (Health Related Quality of Life)
HRQoL was measured by the 5-Dimensional EuroQol (EQ-5D) questionnaire which measures HRQoL in 5 dimensions of life (scale 0-1)(from very poor=0 to very good=5). The results are the change of HRQoL from baseline at 5 years (EQ-5D score at 5 years - EQ-5D score at baseline)
Time frame: baseline and 5 years
Population: The power calculation was made on the basis of an EQ-5D score SD of 19% and alfa=0.05. The study had 80% power to detect a 7.5% difference between the groups
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LNG-IUS | HRQoL (Health Related Quality of Life) | 0.08 points on a scale |
| Hysterectomy | HRQoL (Health Related Quality of Life) | 0.10 points on a scale |
Secondary
Depression
Time frame: baseline, 6 and 12 months, 5 and 10 years