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Tincello D.G.,Royal Infirmary | Tincello D.G.,University of Leicester | Kenyon S.,University of Birmingham | Abrams K.R.,Royal Infirmary | And 4 more authors.
European Urology | Year: 2012

Background: Emerging data suggest botulinum toxin is an effective treatment for detrusor overactivity (DO), but large studies confirming efficacy and safety are lacking. Objective: Study the efficacy and safety of onabotulinumtoxinA (onaBoNTA) for the treatment of DO. Design, setting, and participants: A double-blind placebo-controlled randomised trial in eight UK urogynaecology centres was conducted between 2006 and 2009. A total of 240 women with refractory DO were randomised to active or placebo treatment and followed up for 6 mo. Intervention: Treatment consisted of 200 IU onaBoNTA or placebo injected into the bladder wall (20 sites; 10 IU per site in 1 ml saline). Measurements: Primary outcome was voiding frequency per 24 h at 6 mo. Secondary outcomes included urgency and incontinence episodes and quality-of-life data. Intention-to-treat analysis was used with imputation of missing data. Results and limitations: A total of 122 women received onaBoNTA and 118 received the placebo. Median (interquartile range) voiding frequency was lower after onaBoNTA compared with placebo (8.3 [6.83-10.0] vs 9.67 [8.37-11.67]; difference: 1.34; 95% confidence interval [CI], 1.00-2.33; p = 0.0001). Similar differences were seen in urgency episodes (3.83 [1.17-6.67] vs 6.33 [4.0-8.67]; difference: 2.50; 95% CI, 1.33-3.33; p < 0.0001) and leakage episodes (1.67 [0-5.33] vs 6.0 [1.33-8.33]; difference: 4.33; 95% CI, 3.33-5.67; p < 0.0001). Continence was more common after botulinum toxin type A (BoNTA; 31% vs 12%; odds ratio [OR]: 3.12; 95% CI, 1.49-6.52; p = 0.002). Urinary tract infection (UTI; 31% vs 11%; OR: 3.68; 95% CI, 1.72-8.25; p = 0.0003) and voiding difficulty requiring self-catheterisation (16% vs 4%; OR: 4.87; 95% CI, 1.52-20.33; p = 0.003) were more common after onaBoNTA. Conclusions: This randomised controlled trial of BoNTA for refractory DO, the largest to date, confirms efficacy and safety of the compound. UTI (31%) and self-catheterisation (16%) are common. A third of women achieved continence. Trial registration: The study received ethical committee approval from the Scottish Multicentre Research Ethics Committee (reference: 04/MRE10/67). The trial has a EudraCT number (2004-002981-39), a clinical trial authorisation from the UK Medicines and Healthcare Regulatory Agency, and it was registered on Current Controlled Trials (ISRCTN26091555) on May 26, 2005. © 2012 European Association of Urology. Source


Bodri D.,Clinica EUGIN | Bodri D.,University of Barcelona | Sunkara S.K.,Assisted Conception Unit | Coomarasamy A.,Birmingham Womens Hospital
Fertility and Sterility | Year: 2011

Objective: To compare GnRH agonists and antagonists in oocyte-donation IVF treatment cycles by a systematic review and meta-analysis of trials. Design: Systematic review and meta-analysis of randomized clinical trials (RCT). Systematic literature searches were conducted, and all randomized trials that compared GnRH agonists with antagonists in oocyte-donation IVF treatment cycles were included. Study selection, quality appraisal, and data extractions were performed independently and in duplicate. Setting: Tertiary fertility center. Patient(s): A total of 1,024 oocyte donors treated in eight RCTs. Intervention(s): Comparison of GnRH agonists versus antagonists in oocyte-donation IVF treatment. Main Outcome Measure(s): Ongoing pregnancy, oocytes retrieved, duration of stimulation, gonadotropin consumption, and ovarian hyperstimulation syndrome incidence (OHSS) per randomized oocyte donor. Result(s): Meta-analysis of these studies showed no significant difference in ongoing pregnancy rate between the GnRH agonists and antagonists (risk ratio [RR] 1.15, 95% confidence interval [CI] 0.97 to 1.36). The duration of stimulation was significantly lower with the GnRH antagonist protocol (weighed mean difference [WMD] -0.90 days, 95% CI -1.61 to -0.20). No significant differences were observed in the number of oocytes retrieved (WMD -0.60, 95% CI -2.26 to +1.07), gonadotropin consumption (WMD -264 IU, 95% CI -682 to +154), or OHSS incidence (RR 0.62, 95% CI 0.18 to 2.15). Conclusion(s): No significant differences were observed in ongoing pregnancy rate or the number of retrieved oocytes after donor stimulation with GnRH agonist or antagonist protocols. © 2011 American Society for Reproductive Medicine, Published by Elsevier Inc. Source


Toozs-Hobson P.,Birmingham Womens Hospital
Obstetrics, Gynaecology and Reproductive Medicine | Year: 2010

Overactive bladder (OAB) is a term describing a symptom complex accepted by the International Continence Society in 2002. The symptom complex describes a collection of irritative symptoms with urgency, as the key symptoms and is has been adopted in the latest guidance on terminology.The condition affects around 17% of the population with 2.4% having clinically significant, bothersome and socially disabling symptoms which have a significant impact on quality of life. In the UK the NICE guidelines highlight the importance of proper history taking and investigation including frequency-volume charts. Treatment should be based on lifestyle changes supplemented by pharmacotherapy.Anticholinergics remain the mainstay of drug therapy. Recent changes in the number of preparations and routes of administration may offer some advantages in reducing side effects and maximizing efficacy. In 20% of cases the patient will remain refractory and in such cases either Botulinum toxin or neuromodulation may confer an advantage. © 2010. Source


Qureshi N.S.,Birmingham Womens Hospital
Journal of Obstetrics and Gynaecology | Year: 2013

Certification in Colposcopy by the British Society for Colposcopy and Cervical Pathology (BSCCP) and the Royal College of Obstetricians and Gynaecologists is a formal pre- requisite to the practice of colposcopy within the UK. This certification is awarded after passing an Objective Structured Clinical Examination (OSCE). The aim of the project is to explore examiners' perceptions of the OSCE examination in colposcopy and consider whether it is the right tool to differentiate between safe and unsafe practice in colposcopy. A case study research methodology was employed for the project, and questionnaires were sent to 30 examiners for OSCE in Colposcopy. The project also included conducting semi-structured interviews with two examiners, two trainees and a senior manager of the BSCCP. The questionnaire had a response rate of 28 (94%). The satisfaction rate among the examiners about the standard of questions in OSCE in Colposcopy was 93%, and 89% of the examiners would allow a candidate passing the examination to carry out a clinic in their absence. A total of 26 (94%) examiners thought that the examination was fit for purpose. It was suggested that testing of practical skills should also be made part of the examination. It seems OSCE in Colposcopy is perceived well both by the examiners and the candidates. © 2013 Informa UK, Ltd. Source


Robinson D.,Kings College | Toozs-Hobson P.,Birmingham Womens Hospital | Cardozo L.,Kings College
Menopause International | Year: 2013

The female genital and lower urinary tracts share a common embryological origin, arising from the urogenital sinus and both are sensitive to the effects of the female sex steroid hormones throughout life. Estrogen is known to have an important role in the function of the lower urinary tract and estrogen and progesterone receptors have been demonstrated in the vagina, urethra, bladder and pelvic floor musculature. In addition estrogen deficiency occurring following the menopause is known to cause atrophic change and may be associated with lower urinary tract symptoms such as frequency, urgency, nocturia, urgency incontinence and recurrent infection. These may also co-exist with symptoms of urogenital atrophy such as dyspareunia, itching, vaginal burning and dryness. Epidemiological studies have implicated estrogen deficiency in the aetiology of lower urinary tract symptoms with 70% of women relating the onset of urinary incontinence to their final menstrual period.Whilst for many years systemic and vaginal estrogen therapy was felt to be beneficial in the treatment of lower urinary and genital tract symptoms this evidence has recently been challenged by large epidemiological studies investigating the use of systemic hormone replacement therapy as primary and secondary prevention of cardiovascular disease and osteoporosis.The aim of this paper is to examine the effect of the sex hormones, estrogen and progesterone, on the lower urinary tract and to review the current evidence regarding the role of systemic and vaginal estrogens in the management of lower urinary tract symptoms and urogenital atrophy. © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav. Source

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