| 1. |
- Ahrendt, Hans-Joachim, et al.
(author)
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Efficacy, acceptability and tolerability of the combined contraceptive ring, NuvaRing, compared with an oral contraceptive containing 30 mug of ethinyl estradiol and 3 mg of drospirenone
- 2006
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In: Contraception. - : Elsevier BV. - 0010-7824. ; 74:6, s. 451-457
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Journal article (peer-reviewed)abstract
- PURPOSE: This randomized multicenter, open-label, trial compared efficacy, acceptability, tolerability and compliance of NuvaRing with a combined oral contraceptive (COC), containing 30 mug of ethinyl estradiol (EE) and 3 mg of drospirenone. METHOD: In this 13-cycle study, 983 women were randomized and treated (intent-to-treat population) with NuvaRing or COC. RESULTS: One in-treatment pregnancy occurred with NuvaRing (Pearl Index=0.25) (95% confidence interval [CI]: 0.006, 1.363) and four with the COC (Pearl Index=0.99) (95% CI: 0.269, 2.530). For both groups, compliance (89.2% NuvaRing, 85.5% COC) and satisfaction (84% NuvaRing; 87% COC) were high; the vast majority of women found NuvaRing easy to insert (96%) and remove (97%). Tolerability was similar; the most frequent adverse events with NuvaRing were related to ring use, whereas estrogen-related events were more common with the COC. CONCLUSION: NuvaRing has comparable efficacy and tolerability to a COC containing 30 mug of EE and 3 mg drospirenone. User acceptability of both methods was high.
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| 2. |
- Ali, Z, et al.
(author)
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Efficacy of a paracetamol and caffeine combination in the treatment of the key symptoms of primary dysmenorrhoea
- 2007
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In: Curr Med Res Opin. ; 23:4, s. 841-51
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Journal article (peer-reviewed)abstract
- OBJECTIVE: Primary dysmenorrhoea is characterised by pain, cramping and backache at the time of menses. Despite the high prevalence of dysmenorrhoea, few sufficiently powered, placebo-controlled studies have examined the efficacy of over the counter analgesics in this condition. Furthermore, even fewer studies have directly examined the efficacy of analgesics on specific dysmenorrhoea symptoms. Research design and main outcome measures: This was a single-dose, placebo-controlled, double blind, crossover study carried out in 320 women with moderate-to-severe dysmenorrhoea pain. At 2 h following dosing, 1 g paracetamol plus 130 mg caffeine led to significantly greater pain relief compared to 1 g paracetamol alone (p < 0.05), 130 mg caffeine alone (p < 0.01) or placebo (p < 0.01). The combination was also significantly more effective in relieving abdominal cramping and backache compared to the other treatment arms. No major treatment related adverse events were reported during this study. CONCLUSIONS: When taken at recommended doses, both paracetamol and the combination of paracetamol and caffeine are safe and effective treatments for primary dysmenorrhoea. Consistent with results from other acute pain states, caffeine acts as an analgesic adjuvant and enhances the efficacy of paracetamol.
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| 3. |
- Ankardal, Maud, 1957, et al.
(author)
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A randomised trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence
- 2004
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In: Bjog. - : Wiley. - 1470-0328. ; 111:9, s. 974-81
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To compare open Burch colposuspension using sutures with laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence. DESIGN: Multicentre, prospective randomised trial. SETTING: Departments of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Goteborg, Boras County Hospital and Orebro University Hospital, Sweden. POPULATION: Women with genuine stress urinary incontinence or mixed incontinence with a predominantly stress component were included, and were randomised to either open colposuspension (n= 120) or laparoscopic colposuspension (n= 120). METHODS: Women were randomised to open colposuspension with sutures or laparoscopic colposuspension with polypropylene mesh and staples. Anaesthesia/operation time, blood loss, complications and other related surgical parameters were compared. MAIN OUTCOME MEASURES: Objective and subjective cure rates from 48-hour frequency-volume chart, a 48-hour pad test and a subjective assessment of the woman's incontinence and quality of life performed one year after surgery. RESULTS: Objective and subjective cure rates were higher after open compared with laparoscopic colposuspension (P < 0.001). Quality of life was improved following surgery in both groups (P < 0.0001) and the improvement was significantly greater in the open colposuspension group (P < 0.05) with regard to physical activity. Performing an open colposuspension was less time consuming (P < 0.0001), resulted in more blood loss (P < 0.0001), longer catheterisation time (P < 0.01), greater risk of urinary retention (P < 0.01) and a longer hospital stay (P < 0.0001) compared with performing a laparoscopic colposuspension. The rate of serious complications was low in both groups. CONCLUSION: Open colposuspension had a higher objective and subjective cure rate one year after surgery but with a greater blood loss, greater risk of urinary retention and a longer hospital stay than laparoscopic colposuspension.
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| 4. |
- Ankardal, Maud, 1957, et al.
(author)
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A three-armed randomized trial comparing open Burch colposuspension using sutures with laparoscopic colposuspension using sutures and laparoscopic colposuspension using mesh and staples in women with stress urinary incontinence
- 2005
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In: Acta Obstet Gynecol Scand. - : Wiley. - 0001-6349. ; 84:8, s. 773-9
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To compare open Burch colposuspension using sutures (OC) with laparoscopic colposuspension using sutures (LCS) and laparoscopic colposuspension using mesh and staples (LCM) in women with stress urinary incontinence. DESIGN: Prospective randomized trial. Setting: Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Goteborg, Sweden. POPULATION: Women with genuine stress urinary incontinence or mixed incontinence with a predominantly stress component attending the Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Goteborg, Sweden. METHODS: The women were assessed objectively using a 48-h frequency-volume chart, a 48-h pad test and a standardized stress test. Subjectively, the women were assessed by a questionnaire including influence on quality of life. The women were randomized to OC using sutures (n = 79), LCS (n = 53) or LCM (n = 79). Anaesthesia/operation time, blood loss, complications and other related surgical parameters were compared. Main outcome measures. Objective and subjective cure rate. RESULTS: Objective cure rates 1 year after surgery were significantly higher in the OC and LCS groups compared to the LCM group analyzed by a standardized stress test. Subjective findings were in concordance with the objective results. Performing an OC was less time consuming than performing a LCS and resulted in more blood loss compared to the two laparoscopic techniques. Patients in the LCM group had a shorter duration of catheter use and hospital stay. CONCLUSION: The use of sutures, irrespective of whether the surgical approach was laparoscopic or open surgery, was superior to the laparoscopic mesh and staple technique.
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| 5. |
- Ankardal, Maud, 1957, et al.
(author)
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Comparison of health care costs for open burch colposuspension, laparoscopic colposuspension and tension-free vaginal tape in the treatment of female urinary incontinence
- 2007
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In: Neurourol Urodyn.
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Journal article (peer-reviewed)abstract
- AIMS: To compare direct health care costs of treatment for stress urinary incontinence in Sweden with four different procedures: (i) open Burch colposuspension (OBC); (ii) laparoscopic colposuspension with sutures (LCS); (iii) laparoscopic colposuspension with mesh and staples (LCM), and (iv) Tension-free Vaginal Tape (TVT). MATERIAL AND METHODS: A model was constructed representing a hospital with standardized surgical equipment, staff and average unit costs in 2003 Euros. The time used for anesthesia and surgery was calculated. Clinical data was collected from three different sources, a multicenter, randomized, prospective study comparing OBC with LCM with 1 year follow-up, a three-armed, prospective study where women were randomized to either OBC, LCM, or LCS with 1 year follow-up and a descriptive study reporting results of TVT with 5 year follow-up. Data collected from the studies and hospital cost data were put into the model to create the different cost elements. RESULTS: The total cost per individual, showed a lower cost for TVT compared to the other alternatives. The direct costs for a TVT, euro1,366 were only 56% of the costs for an OBC, euro2,431 (P < 0.001) and 59% of the costs for a LCS, euro2,310 (P < 0.001). CONCLUSIONS: When using a model and comparing health care costs for surgical treatment of female stress urinary incontinence in Sweden, the TVT procedure generated a lower direct cost than both open and laparoscopic colposuspension. Neurourol. Urodynam. (c) 2007 Wiley-Liss, Inc.
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| 6. |
- Ankardal, Maud, 1957, et al.
(author)
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Short- and long-term results of the tension-free vaginal tape procedure in the treatment of female urinary incontinence
- 2006
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In: Acta Obstet Gynecol Scand. - : Wiley. - 0001-6349. ; 85:8, s. 986-92
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Journal article (peer-reviewed)abstract
- BACKGROUND: The aim was to describe the short- and long-term results of treatment for urinary incontinence (UI) in women using the tension-free vaginal tape (TVT) procedure at a single unit and to identify factors predictive of successful outcome. MATERIAL AND METHODS: Consecutive female patients (n = 707) treated for UI with the TVT procedure at Karlstad Hospital from November 1996 to June 2004 were included. After a standardized preoperative evaluation, the women were classified as having either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI). The results of surgery were evaluated after 1, 2, and 5 years, by means of a postal questionnaire. An objective evaluation was performed after 5 years in a subsample of the first patients included (n = 59). Factors influencing the cure rate were analyzed using multiple regression analysis. RESULTS: The subjective cure rate was 83% after 1 year and 73% after 5 years. The objective cure rate was 83% in the subgroup after 5 years. Surgical time was 30+/-9 min (mean+/-SD). The rate of bladder perforations was 1.7%. In patients with MUI the cure rate was lower than in patients with SUI (after 5 years 54.9% versus 81.0%). Type of incontinence was the only independent variable found to influence surgical outcome. CONCLUSIONS: The TVT procedure, performed in over 700 women at a single gynecological unit, was found to be a safe and efficient surgical procedure. Type of incontinence was the only independent variable found to predict for outcome of surgery.
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| 7. |
- Basra, R., et al.
(author)
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Design and Validation of a New Screening Instrument for Lower Urinary Tract Dysfunction: The Bladder Control Self-Assessment Questionnaire (B-SAQ)
- 2006
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In: Eur Urol. - 0302-2838.
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To develop and validate a short patient self-assessment screening questionnaire: bladder control self-assessment questionnaire (B-SAQ) for the evaluation of lower urinary tract symptoms. This first validation study was undertaken amongst women. PATIENTS AND METHODS: Three hundred twenty-nine women attending general gynaecology and urogynaecology clinics completed both the B-SAQ and Kings Health questionnaire prior to medical consultation, and independent physician assessment of the presence of lower urinary tract symptoms (LUTS) and need for treatment. The psychometric properties of the B-SAQ were subsequently analysed. RESULTS: The B-SAQ was quick and easy to complete, with 89% of respondents completing all items correctly in less than 5min. The internal consistency (Cronbach's alpha score 0.90-0.91), criterion validity (Pearson's correlation values of 0.79 and 0.81, p<0.0001 with the incontinence impact domain of the Kings Health questionnaire), and test-retest reliability of the questionnaire were good. The sensitivity and specificity of the questionnaire to identify patients with bothersome LUTS was 98% and 79%, respectively. CONCLUSIONS: LUTS are commonly underreported. Empowering patients to self-assess their bladder symptoms and the need for treatment will improve treatment-seeking behaviour. The B-SAQ is a psychometrically robust, short screening questionnaire that offers patients the ability to assess their bladder symptoms and the bother they cause, and the potential benefit of seeking medical help.
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| 8. |
- Blohm, Febe, 1951, et al.
(author)
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A prospective longitudinal population-based study of clinical miscarriage in an urban Swedish population
- 2008
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In: BJOG. - 1471-0528. ; 115:2, s. 176-82; discussion 183
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Journal article (peer-reviewed)abstract
- OBJECTIVE: To describe the incidence of clinical miscarriage and to investigate the factors influencing the occurrence of clinical miscarriage. DESIGN: Prospective study with both cross-sectional and longitudinal comparisons. SETTING: City of Goteborg, Sweden. POPULATION: Population-based study in cohorts of 19-year-old women followed longitudinally. MAIN OUTCOME MEASURES: Incidence of miscarriage and pregnancy outcome. MATERIAL AND METHODS: A postal questionnaire was sent to women born in 1962 and resident in the city of Goteborg in 1981 (n = 656) regarding pregnancy outcome, clinical miscarriage and other reproductive health factors. Responders in 1981 were contacted again and requested to answer a similar questionnaire every fifth year up to 2001. The same process was repeated in 1991 with women born in 1972 (n = 780) with follow up of these responders in 1996 and 2001. A third cohort of 19-year-old women born in 1982 (n = 666) was interviewed in 2001. The self-reported pregnancy data were verified from hospital files. RESULTS: Complete data were available for 341 women born in 1962 and assessed up to the age of 39 years (ever pregnant, n = 320, 94%). There were in total 887 pregnancies (live birth, n = 590, 67%; miscarriage, n = 108, 12%; legal abortion, n = 173, 20% and ectopic pregnancy, n = 16, 2%). Of the 320 'ever pregnant' women, 80 women (25%) had experienced a miscarriage. 76.3% had experienced one miscarriage, 16.3% had two miscarriages and 7.4% had three or more miscarriages. The clinical miscarriage rates in women at different ages were as follows: 20-24 years 13.5%, 25-29 years 12.3%, 30-34 years 10.3% and 35-39 years 17.5%. The corresponding miscarriage rate in the 1972 cohort followed from 19 to 29 years of age was 11%, and in the 1982 cohort assessed at 19 years of age, the miscarriage rate was 9%. No risk factor for miscarriage could be reliably identified. CONCLUSIONS: Clinical miscarriage constituted 12% of all pregnancies, and one in four women who had been pregnant up to 39 years of age had experienced a miscarriage. Three or more miscarriages were experienced by 7.4%. The occurrence of a miscarriage was not influenced by the order of the pregnancy.
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| 9. |
- Blohm, Febe, 1951, et al.
(author)
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A randomised double blind trial comparing misoprostol or placebo in the management of early miscarriage
- 2005
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In: Bjog. - : Wiley. - 1470-0328. ; 112:8, s. 1090-5
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Journal article (peer-reviewed)abstract
- OBJECTIVES: To study if misoprostol 400 microg, administered vaginally, increased the successful resolution of early miscarriage compared with placebo. DESIGN: Randomised, double blind placebo controlled study. SETTING: Sahlgrenska University Hospital, Goteborg, Sweden. SAMPLE: One hundred and twenty-six women seeking medical attention for early miscarriage. METHOD: Women with a non-viable, first trimester miscarriage were randomised to vaginal administration of misoprostol 400 microg or placebo. MAIN OUTCOME MEASURES: Main outcome measure was the proportion of successful complete resolution of miscarriage. Secondary outcomes were incidence of infection, bleeding, gastrointestinal side effects, pain, use of analgesics and length of sick leave between groups. RESULTS: Sixty-four patients were randomised to misoprostol and 62 to placebo. Eighty-one percent in the misoprostol and 52% in the placebo group had a complete miscarriage within one week of the primary visit (RR 1.57; 95% CI 1.20-2.06). Patients in the misoprostol group reported more pain as assessed on a visual analogue scale (60.4 [31.0] vs 43.8 [37.1] mm; P < 0.007) and required analgesics more often (83%vs 61%, RR 1.35; 95% CI 1.08-1.70). There were no significant differences in the occurrence of gastrointestinal side effects, infection, reduction in haemoglobin or sick leave between the groups. CONCLUSIONS: Treatment with 400 mug misoprostol administered vaginally increased the success rate of resolvement of uncomplicated early miscarriages compared with placebo. However, women who received misoprostol experienced more pain and required more analgesics than those who did not.
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| 10. |
- Blohm, Febe, 1951, et al.
(author)
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Expectant management of first-trimester miscarriage in clinical practice.
- 2003
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In: Acta obstetricia et gynecologica Scandinavica. - : Wiley. - 0001-6349. ; 82:7, s. 654-8
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Journal article (peer-reviewed)abstract
- The aim of this study was to evaluate treatment efficacy and patient compliance in women with an early miscarriage managed expectantly in routine clinical practice.
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