Aarre Kivelä

Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial

BACKGROUND Heavy menstrual blood loss is a common reason for women to seek medical care. The levonorgestrel-releasing intrauterine system (IUS) is an effective medical treatment for menorrhagia. We report a randomised comparison of this approach with hysterectomy in terms of the quality of life of women with menorrhagia and cost-effectiveness. METHODS Of 598 women referred with menorrhagia to five university hospitals in Finland, 236 were eligible and agreed to take part. They were randomly assigned treatment with the levonorgestrel-releasing IUS (n=119) or hysterectomy (n=117). The amount of menstrual blood loss was objectively measured. The primary outcome measure was health-related quality of life at 12-month follow-up. Analyses were by intention to treat. FINDINGS In the group assigned the levonorgestrel-releasing IUS, 24 (20%) women had had hysterectomy and 81 (68%) continued to use the system at 12 months. Of the women assigned to the hysterectomy group, 107 underwent the operation. Health-related quality of life improved significantly in both the IUS and hysterectomy groups (change 0.10 [95% CI 0.06-0.14] in both groups) as did other indices of psychological wellbeing. There were no significant differences between the treatment groups except that women with hysterectomy suffered less pain. Overall costs were about three times higher for the hysterectomy group than for the IUS group. INTERPRETATION The significant improvement in health-related quality of life highlights the importance of treating menorrhagia. During the first year the levonorgestrel-releasing IUS was a cost-effective alternative to hysterectomy in treatment of this disorder.

Retropubic compared with transobturator tape placement in treatment of urinary incontinence: a randomized controlled trial.

OBJECTIVE: To compare the intraoperative and immediate postoperative performance of the retropubic tension-free vaginal tape (TVT) procedure with that of the transobturator tension-free vaginal tape (TVT-O) procedure as primary treatment for female urinary stress incontinence. METHODS: Randomized multicenter comparative trial including four university hospitals and three central hospitals in Finland. Assessment preoperatively and 2 months postoperatively included a cough stress test and the following condition-specific quality of life questionnaires: the Urinary Incontinence Severity Score (UISS), the Detrusor Instability Score, the Incontinence Impact Questionnaire–Short Form, the Urogenital Distress Inventory–Short Form, and a visual analog scale (VAS). Operation time, theater time, hospital stay, intraoperative and immediate postoperative complications were recorded. RESULTS: Of the 273 originally randomized patients, 267 underwent the allocated operation, 136 in the TVT group and 131 in the TVT-O group. No significant differences in objective or subjective cure rates were detected. Patients in the TVT-O group had a significantly longer hospital stay, needed significantly more postoperative opiate analgesia and had significantly more complications than the patients in the TVT group. Patients in both groups had a significant postoperative improvement in quality of life, as indicated by the results of all the questionnaires used, with no difference between the groups. CONCLUSION: The TVT and the TVT-O procedures perform equally in terms of objective and subjective cure. The statistically significant higher complication rate in the TVT-O group is not regarded as clinically significant. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00379314 LEVEL OF EVIDENCE: I

Tension-free vaginal tape and laparoscopic mesh colposuspension for stress Urinary incontinence

OBJECTIVE: To compare objective and subjective outcomes after the tension-free vaginal tape procedure (TVT) with laparoscopic mesh colposuspension as a primary treatment for female stress urinary incontinence. Objective outcome measures were stress test and 48-hour pad test. METHODS: In 6 departments of gynecology in Finland, including 4 university teaching hospitals and 2 central hospitals, 128 women with urodynamic stress incontinence were randomly allocated to 2 treatment groups. Seventy were treated with TVT and 51 by means of laparoscopic mesh colposuspension. There were 7 dropouts. Inclusion criteria were history of stress incontinence, positive stress test, and urodynamic conformation of stress incontinence. Exclusion criteria were age older than 70 years, previous incontinence surgery, more than 3 episodes of urinary tract infection within the last 2 years, coincident other gynecological surgery, body mass index more than 32 kg/m2, urethral closure pressure less than 20 cm H2O, and residual volume more than 100 mL in preoperative urodynamic evaluation. Assessment took place before treatment and at 12 months postoperatively with the cough stress test, Urge Score, 48-hour pad test, Kings College Health Questionnaire, Visual Analog Scale, and Urinary Incontinence Severity Score. RESULTS: When negative stress test was used as criteria for cure, 85.7% of women in the TVT group and 56.9% in the laparoscopic mesh colposuspension group were objectively cured. Subject satisfaction was significantly better after the TVT procedure than after laparoscopic mesh colposuspension. CONCLUSION: Treatment with TVT results in higher objective and subjective cure rates at 1 year than treatment by means of laparoscopic mesh colposuspension. LEVEL OF EVIDENCE: I

Comparison of a 10-mg controlled release oxybutynin tablet with a 5-mg oxybutynin tablet in urge incontinent patients.

Oxybutynin has long been used for the treatment of patients with detrusor overactivity and urinary urge incontinence. The short half‐life of oxybutynin administered as a conventional tablet formulation or syrup requires 2–3 times daily dosage to be effective. A new controlled release (CR) tablet for once‐daily administration has been developed. The efficacy and tolerability of this new controlled release tablet was compared to that of a 5‐mg conventional oxybutynin tablet administered twice daily. Seventeen female incontinent patients were studied in a double‐dummy crossover trial. Efficacy and tolerability were assessed by using a voiding diary, pad‐weighing test, visual‐analogue scale (VAS), and questionnaire. Adverse events were recorded spontaneously on a questionnaire by the patients themselves throughout the study. Serum concentrations of oxybutynin and its active metabolite N‐desethyloxybutynin were studied after both a single dose and multiple dosage.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on sexual functioning among women with menorrhagia : a 5-year randomised controlled trial

Objective  To compare among women with menorrhagia the effect of hysterectomy or levonorgestrel‐releasing intrauterine system (LNG‐IUS) on sexual functioning .

Combined laboratory and diary method for objective assessment of menstrual blood loss

BACKGROUND To develop an objective measurement system for menstrual blood loss applicable in clinical practice. METHODS One hundred and fifty-six patients were enrolled in a randomized trial of the treatment of menorrhagia in all five gynecology departments of the university teaching hospitals in Finland. Correlation between venous blood hemoglobin concentration (Hb) and absorbance at 564 nm (A564) was investigated in experiments with blood samples. Amount of collected menstrual blood and menstrual diary data were analyzed. RESULT Hb concentration and A564 of the blood were linearly correlated (r=0.99). One hundred and fifty-four women (99%) returned used sanitary protection and menstrual diaries. On average, 12% (range 0-57%) of menstrual blood was lost during collection. The median amount of blood recovered from sanitary protection was 89 ml (range 14-724 ml), with 58% (n=90) of the women exceeding 80 ml per cycle. When the spilled blood was taken into account, the corresponding figures were 104 ml (range 15-724 ml) and 66% (n= 101). CONCLUSIONS The spectrophotometric measurement of venous blood in the conventional alkaline hematin method can be replaced by measurement of Hb concentration. All blood incompletely collected should be recorded. Objective measurement of menstrual blood loss can be applied in routine clinical practice.

The clinical significance of an absent end-diastolic velocity in the umbilical artery detected before the 34th week of pregnancy

Background. The aim of this study was to evaluate the clinical significance of absent or reversed (ARED) flow detected in the late second or early third trimester in the umbilical artery in high‐risk pregnancies.

MELATONIN IN INFANTS AND MOTHERS AT DELIVERY AND IN INFANTS DURING THE FIRST WEEK OF LIFE

To evaluate the possible effect of the extreme and permanent changes in the hormonal milieu and in the lighting conditions at birth on the pineal hormone, melatonin (MT), we measured maternal vein and umbilical artery concentrations of MT in 19 parturients, post‐partum urinary concentrations of MT in 14 mothers and their infants, and daytime (0800‐2000 h) and night‐time (2000‐0800 h) urinary concentrations of MT and 6‐sulphatoxymelatonin in 22 infants during the first 8 days of life. The mean MT concentrations in maternal venous blood and umbilical arterial blood did not differ significantly from each other and there was a positive correlation between them. The same was true for postpartum urinary MT of the mothers and their infants. There was no diurnal rhythm of MT during the first week of life. MT excretion in neonates was 2‐5 pmol/12 h (only 1‐5% in comparison with adults) and that of 6‐sulphatoxymelatonin 150‐300 pmol/12 h. In reverse phase high pressure liquid chromatography (HPLC) studies, 84‐100% of total MT immunoreactivity was eluted at the same position as synthetic MT, and a small amount of hydrophobic MT‐like immunoreactive material was also detected in five of the 10 urine extracts studied. This material (perhaps a novel neonatal metabolite of MT) may be indicative of immaturity of neonatal metabolism of MT although 6‐hydroxylation is also functional in neonates. Although infant MT immediately after delivery at least partly reflects maternal MT secretion, our results show that the pineal gland is capable of producing MT at this time. However, the diurnal rhythm of MT is not yet developed, possibly because of the inability of the pineal gland to react to external stimuli at this stage, or because increased secretion of gonadotrophins after delivery suppresses the pineal gland.

Levonorgestrel-releasing intrauterine system or hysterectomy in the treatment of essential menorrhagia: predictors of outcome

Levonorgestrel‐releasing intrauterine system (LNG‐IUS) has been advocated as an effective alternative to hysterectomy in the treatment of menorrhagia. The outcome predictors have been poorly known. In this study the amount of menstrual blood loss (MBL) turned out to be the single most important outcome predictor of these treatments. However, the treatment with LNG‐IUS seemed to be an appropriate alternative to hysterectomy for all women who perceived their MBL heavy.

Psychosocial and other characteristics of women complaining of menorrhagia, with and without actual increased menstrual blood loss

Objective To discover whether psychosocial factors can explain why many women with normal menstrual blood loss seek care for menorrhagia.