Ian Milsom

How widespread are the symptoms of an overactive bladder and how are they managed? A population‐based prevalence study

Objective To determine the prevalence of chronic and debilitating symptoms of the overactive bladder, defined here as the presence of chronic frequency, urgency and urge incontinence (either alone or in any combination), and presumed to be caused by involuntary detrusor contractions.

Fourth international consultation on incontinence recommendations of the international scientific committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence†‡§¶‖

P. Abrams , K.E. Andersson, L. Birder, L. Brubaker, L. Cardozo, C. Chapple, A. Cottenden, W. Davila, D. de Ridder, R. Dmochowski, M. Drake, C. DuBeau, C. Fry, P. Hanno, J. Hay Smith, S. Herschorn, G. Hosker, C. Kelleher, H. Koelbl, S. Khoury,* R. Madoff, I. Milsom, K. Moore, D. Newman, V. Nitti, C. Norton, I. Nygaard, C. Payne, A. Smith, D. Staskin, S. Tekgul, J. Thuroff, A. Tubaro, D. Vodusek, A. Wein, and J.J. Wyndaele and the Members of the Committees

The impact of overactive bladder, incontinence and other lower urinary tract symptoms on quality of life, work productivity, sexuality and emotional well‐being in men and women: results from the EPIC study

To examine the effect overactive bladder (OAB) and other lower urinary tract symptoms (LUTS) on health‐related quality of life (HRQoL) in a population sample, as OAB often occurs in conjunction with many other LUTS.

Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction

Study Type – Symptom prevalence (prospective cohort)

Advanced Maternal Age and Adverse Perinatal Outcome

OBJECTIVE: The aim of this study was to investigate the influence of maternal age on perinatal and obstetric outcome in women aged 40–44 years and those 45 years or older and to estimate whether adverse outcome was related to intercurrent illness and pregnancy complications. METHODS: National prospective, population-based, cohort study in women aged 40–44 years and those 45 years or older and in a control group of women aged 20–29 years who delivered during the period 1987–2001. Adjusted odds ratios (OR) were calculated after adjustments for significant malformations, maternal pre-existing diseases, and smoking. Main outcome measures were perinatal mortality, intrauterine fetal death, neonatal death, preterm birth, and preeclampsia. RESULTS: During the 15-year period, there were 1,566,313 deliveries (876,361 women were 20–29 years of age, 31,662 were 40–44 years, and 1,205 were ≥ 45 years). Perinatal mortality was 1.4%, 1.0%, and 0.5% in women 45 years or older, 40–44, and 20–29 years, respectively. Adjusted OR for perinatal mortality was 2.4 (95% confidence interval [CI] 1.5–4.0) in women aged 45 years or older, compared with 1.7 (95% CI 1.5–1.9) in women 40–44 years. Adjusted OR for intrauterine fetal death was 3.8 (95% CI 2.2–6.4) in women aged 45 years or older, compared with 2.1 (95% CI 1.8–2.4) in women 40–44 years. Preterm birth, gestational diabetes, and preeclampsia were more common among women 40–44 years of age and those 45 years or older. Perinatal mortality was increased in women with intercurrent illness or pregnancy complications compared with women without these conditions, but there was no evidence that these factors became more important with increasing age. CONCLUSION: Perinatal mortality, intrauterine fetal death, and neonatal death increased with age. There was also an increase in intercurrent illnesses and pregnancy complications with increasing age, but this did not entirely explain the observed increase in perinatal mortality with age. LEVEL OF EVIDENCE: II-3

An epidemiologic study of young women with dysmenorrhea

The prevalence of dysmenorrhea was studied in a random sample of 19-year-old women from an urban Swedish population. Dysmenorrhea was reported by 72% of the women. Fifteen percent suffered from dysmenorrhea which limited daily activity and was unimproved by analgesics. Dysmenorrhea occurred significantly (p less than 0.01) more often in women not using oral contraceptives. A significant correlation (p less than 0.01) was found between early menarche and an increased severity of dysmenorrhea. There was a significant correlation (p less than 0.01) between the severity of dysmenorrhea and the amount of menstrual flow. Parous women had significantly (p less than 0.01) less dysmenorrhea than women who had never been pregnant or women who had experienced a legal or spontaneous abortion. Smokers as compared to nonsmokers had significantly (p less than 0.01) less dysmenorrhea. The severity of dysmenorrhea was not affected by height, weight, or regularity of the menstrual cycle. Absenteeism as a result of dysmenorrhea was evaluated.

The influence of age, parity, oral contraception, hysterectomy and menopause on the prevalence of urinary incontinence in women.

The influence of age, parity, duration of previous oral contraceptive use, hysterectomy and menopause on the prevalence of urinary incontinence was evaluated by means of a postal questionnaire in women 46 to 86 years old who resided in the city of Göteborg, Sweden. A sample of 10,000 women from the 7 birth cohorts of 1900 to 1940 was obtained at random from the population register. The overall response rate was 74.6%. The prevalence of urinary incontinence increased (p < 0.001) in a linear fashion from 12.1% in the 1940 birth cohort to 24.6% in the 1900 birth cohort. The prevalence of urinary incontinence in nulliparous women was 7.7% in the 1930 birth cohort and 5.5% in the 1940 birth cohort. The corresponding figures for women who had experienced 1 delivery were 11.1% and 10.6%, compared to 14.0% and 16.4% among women who had had 3 or more deliveries. Urinary incontinence was more prevalent in women who had undergone hysterectomy (p < 0.05). The prevalence of urinary incontinence was unaffected by the duration of previous oral contraceptive use and there was no evidence to suggest that the prevalence of urinary incontinence increased at the time of the last menstrual period.

The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study

To estimate and compare the prevalence and associated bother of lower urinary tract symptoms (LUTS) in the general populations of the USA, UK and Sweden using current International Continence Society (ICS) definitions, as no previous population‐based studies evaluating the prevalence of LUTS in the USA, using the 2002 ICS definitions, have been conducted.

Efficacy and Tolerability of Mirabegron, a β3-Adrenoceptor Agonist, in Patients with Overactive Bladder: Results from a Randomised European–Australian Phase 3 Trial

BACKGROUND Mirabegron, a β(3)-adrenoceptor agonist, has been developed for the treatment of overactive bladder (OAB). OBJECTIVE To assess the efficacy and tolerability of mirabegron versus placebo. DESIGN, SETTING, AND PARTICIPANTS Multicenter randomised double-blind, parallel-group placebo- and tolterodine-controlled phase 3 trial conducted in 27 countries in Europe and Australia in patients ≥ 18 yr of age with symptoms of OAB for ≥ 3 mo. INTERVENTION After a 2-wk single-blind placebo run-in period, patients were randomised to receive placebo, mirabegron 50mg, mirabegron 100mg, or tolterodine extended release 4 mg orally once daily for 12 wk. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Patients completed a micturition diary and quality-of-life (QoL) assessments. Co-primary efficacy end points were change from baseline to final visit in the mean number of incontinence episodes and micturitions per 24h. The primary comparison was between mirabegron and placebo with a secondary comparison between tolterodine and placebo. Safety parameters included adverse events (AEs), laboratory assessments, vital signs, electrocardiograms, and postvoid residual volume. RESULTS AND LIMITATIONS A total of 1978 patients were randomised and received the study drug. Mirabegron 50-mg and 100-mg groups demonstrated statistically significant improvements (adjusted mean change from baseline [95% confidence intervals]) at the final visit in the number of incontinence episodes per 24h (-1.57 [-1.79 to -1.35] and -1.46 [-1.68 to -1.23], respectively, vs placebo -1.17 [-1.39 to -0.95]) and number of micturitions per 24h (-1.93 [-2.15 to -1.72] and -1.77 [-1.99 to -1.56], respectively, vs placebo -1.34 [-1.55 to -1.12]; p<0.05 for all comparisons). Statistically significant improvements were also observed in other key efficacy end points and QoL outcomes. The incidence of treatment-emergent AEs was similar across treatment groups. The main limitation of this study was the short (12-wk) duration of treatment. CONCLUSIONS Mirabegron represents a new class of treatment for OAB with proven efficacy and good tolerability. TRIAL IDENTIFICATION: This study is registered at ClinicalTrials.gov, identifier NCT00689104.

The prevalence of urinary incontinence and its influence on the quality of life in women from an urban Swedish population

OBJECTIVES To assess the prevalence of urinary incontinence and its influence on the quality of life. MATERIAL AND METHODS A random sample of every fourth woman aged > or =20 years resident in a primary health care district of the city of Göteborg was obtained from the population register (n=2911). The women were invited by letter to complete a questionnaire concerning urinary incontinence. The women were also requested to assess their quality of life using a visual analogue scale. RESULTS The overall response rate was 77%. The prevalence of urinary incontinence increased (p<0.001) in a linear fashion from 3% in the cohort 20-29 years to 32 % in the cohort of women aged > or =80 years. The proportion of women suffering from stress incontinence decreased (p<0.001) with increasing age, while the proportion of women suffering from urge and mixed incontinence increased (p<0.01) with increasing age. Women with stress incontinence had a greater body weight and had given birth to a greater number of children compared to continent women. There was, however, in this respect no difference between women with urge incontinence and continent women. Women with urinary incontinence reported a poorer quality of life compared to continent women (p<0.01). Women with urge incontinence and women with mixed incontinence reported a poorer quality of life compared to women with stress incontinence (p<0.05). Only 6% of the women from this population had sought medical attention for urinary incontinence. CONCLUSIONS Although urinary incontinence was a prevalent condition, particularly among the elderly and had a negative influence on the quality of life, only a small number of women had sought medical care.