VUOKKO: Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
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).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: LNG-IUS Levonorgestrel releasing intrauterine system |
Drug: LNG-IUS
LNG-IUS releasing 25 microg of levonorgestrel
Other Names:
Procedure: Hysterectomy
operation
Other Names:
|
Other: Hysterectomy Hysterectomy |
Drug: LNG-IUS
LNG-IUS releasing 25 microg of levonorgestrel
Other Names:
Procedure: Hysterectomy
operation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Depression [baseline, 6 and 12 months, 5 and 10 years]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Helsinki
- University of Eastern Finland
- University of Oulu
- Tampere University
- University of Turku
Investigators
- Principal Investigator: Ritva S Hurskainen, MD, PhD, Helsinki University Central Hospital
- Study Director: Jorma Paavonen, prof, University of Helsinki
- Study Chair: Juha Teperi, prof, National Istitute For Health and Welfare, Finland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Finnish Academy-project 29168
Study Results
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 Detail | All randomised women were analysed as intention-to-treat |
Arm/Group Title | LNG-IUS | Hysterectomy |
---|---|---|
Arm/Group Description | Levonorgestrel releasing intrauterine system (LNG-IUS) | Hysterectomy (abdominal,laparoscopical or vaginal) |
Period Title: Overall Study | ||
STARTED | 119 | 117 |
COMPLETED | 115 | 114 |
NOT COMPLETED | 4 | 3 |
Baseline Characteristics
Arm/Group Title | LNG-IUS | Hysterectomy | Total |
---|---|---|---|
Arm/Group Description | Levonorgestrel releasing intrauterine system (LNG-IUS) | Hysterectomy (abdominal,laparoscopical or vaginal) | Total of all reporting groups |
Overall Participants | 119 | 117 | 236 |
Age (Count of Participants) | |||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
119
100%
|
117
100%
|
236
100%
|
>=65 years |
0
0%
|
0
0%
|
0
0%
|
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
43.1
(3.5)
|
43.0
(3.2)
|
43
(3.3)
|
Sex: Female, Male (Count of Participants) | |||
Female |
119
100%
|
117
100%
|
236
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | HRQoL (Health Related Quality of Life) |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | LNG-IUS | Hysterectomy |
---|---|---|
Arm/Group Description | Levonorgestrel releasing intrauterine system (LNG-IUS) | Hysterectomy (abdominal,laparoscopical or vaginal) |
Measure Participants | 115 | 114 |
Mean (95% Confidence Interval) [points on a scale] |
0.08
|
0.10
|
Title | Costs |
---|---|
Description | |
Time Frame | baseline, 6 and 12 months, 5 and 10 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Title | Depression |
---|---|
Description | |
Time Frame | baseline, 6 and 12 months, 5 and 10 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | LNG-IUS | Hysterectomy | ||
Arm/Group Description | Levonorgestrel releasing intrauterine system (LNG-IUS) | Hysterectomy (abdominal,laparoscopical or vaginal) | ||
All Cause Mortality |
||||
LNG-IUS | Hysterectomy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
LNG-IUS | Hysterectomy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/ (NaN) | 5/ (NaN) | ||
Surgical and medical procedures | ||||
bladder perforation | 0/50 (0%) | 0 | 3/109 (2.8%) | 3 |
peritonitis | 0/50 (0%) | 0 | 1/109 (0.9%) | 1 |
vesicovaginal fistula | 0/50 (0%) | 0 | 1/109 (0.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
LNG-IUS | Hysterectomy | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 80/ (NaN) | 25/ (NaN) | ||
Surgical and medical procedures | ||||
hormonal symptoms | 18/119 (15.1%) | 18 | 0/117 (0%) | 0 |
menstrual bleeding problems | 61/119 (51.3%) | 61 | 2/117 (1.7%) | 2 |
wund infection | 9/50 (18%) | 9 | 20/109 (18.3%) | 20 |
perioperative bleeding | 1/50 (2%) | 1 | 1/109 (0.9%) | 1 |
postoperative bleeding | 1/50 (2%) | 1 | 2/109 (1.8%) | 2 |
urinary retention | 1/119 (0.8%) | 1 | 4/117 (3.4%) | 4 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Ritva Hurskainen |
---|---|
Organization | Helsinki University |
Phone | +23845872267 |
ritva.hurskainen@hus.fi |
- Finnish Academy-project 29168