Active encouragement of older women with urinary incontinence in primary care to undergo diagnosis and treatment: a matched-pair cluster randomized controlled trial.

OBJECTIVES: The URINO trial investigated the effect of offering treatment to older women with urinary incontinence in the general population, who had not sought help on their own initiative. STUDY DESIGN: In a cluster randomized trial, 14 general practitioners were matched into pairs and randomly allocated to an intervention or a control group. Women aged ≥ 55 years registered in the participating practices were asked about urinary incontinence via a postal questionnaire. Patients in the intervention group were assessed and treated whereas patients in the control group received standard care. MAIN OUTCOME MEASURES: Primary outcome was improvement (yes or no) of the severity of symptoms at 12-month follow-up measured with the Incontinence Severity Index. Secondary outcomes were the number of incontinence episodes per day and quality of life. The primary analysis was on an intention-to-treat basis with multiple imputation of missing data. A logistic regression model with correction for cluster randomization was fitted to estimate odds ratios (ORs). RESULTS: At 12 months, the severity of symptoms had improved in more patients in the intervention group (n166) than in the controls (n184) (OR 1.9; 95% CI 1.1-3.3). Also, the number of patients with fewer episodes of incontinence had increased (OR 2.5; 95% CI 1.5-4.1). No between-group differences in changes in quality of life were apparent (p0.14). CONCLUSIONS: It is recommended to encourage women in the general population aged ≥ 55 years with urinary incontinence to undergo diagnosis and treatment.

Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care.

Pelvic floor muscle training (PFMT) and pessaries are commonly used in the conservative treatment of pelvic organ prolapse (POP). Because there is a lack of evidence regarding the optimal choice between these two interventions, we designed the "Pelvic Organ prolapse in primary care: effects of Pelvic floor muscle training and Pessary treatment Study" (POPPS). POPPS consists of two parallel open label randomized controlled trials performed in primary care, in women aged ≥55 years, recruited through a postal questionnaire. In POPPS trial 1, women with mild POP receive either PFMT or watchful waiting. In POPPS trial 2, women with advanced POP receive either PFMT or pessary treatment. Patient recruitment started in 2009 and was finished in December 2012. Primary outcome of both POPPS trials is improvement in POP-related symptoms. Secondary outcomes are quality of life, sexual function, POP-Q stage, pelvic floor muscle function, post-void residual volume, patients' perception of improvement, and costs. All outcomes are measured 3, 12, and 24 months after the start of treatment. Cost-effectiveness will be calculated based on societal costs, using the PFDI-20 and the EQ-5D as outcomes. In this paper the POPPS design, the encountered challenges and our solutions, and participant baseline characteristics are presented. For both trials the target numbers of patients in each treatment group are achieved, giving this study sufficient power to lead to promising results.

The 2013 EAU guidelines on chronic pelvic pain: is management of chronic pelvic pain a habit, a philosophy, or a science? 10 years of development.

CONTEXT: Progress in the science of pain has led pain specialists to move away from an organ-centred understanding of pain located in the pelvis to an understanding based on the mechanism of pain and integrating, as far as possible, psychological, social, and sexual dimensions of the problem. This change is reflected in all areas, from taxonomy through treatment. However, deciding what is adequate investigation to rule out treatable disease before moving to this way of engaging with the patient experiencing pain is a complex process, informed by pain expertise as much as by organ-based medical knowledge. OBJECTIVE: To summarise the evolving changes in the management of patients with chronic pelvic pain by referring to the 2012 version of the European Association of Urology (EAU) guidelines on chronic pelvic pain. EVIDENCE ACQUISITION: The working panel highlights some of the most important aspects of the management of patients with chronic pelvic pain emerging in recent years in the context of the EAU guidelines on chronic pelvic pain. The guidelines were completely updated in 2012 based on a systematic review of the literature from online databases from 1995 to 2011. According to this review, levels of evidence and grades of recommendation were added to the text. A full version of the guidelines is available at the EAU office or Web site (www.uroweb.org). EVIDENCE SYNTHESIS: The previously mentioned issues are explored in this paper, which refers throughout to dilemmas for the physician and treatment team as well as to the need to inform and engage the patient in a collaborative empirical approach to pain relief and rehabilitation. These issues are exemplified in two case histories. CONCLUSIONS: Chronic pelvic pain persisting after appropriate treatment requires a different approach focussing on pain. This approach integrates the medical, psychosocial, and sexual elements of care to engage the patient in a collaborative journey towards self-management.

The effect of systematic screening of older women for urinary incontinence on treatment uptake: the URINO trial.

BACKGROUND: Female urinary incontinence is a common condition that has a negative influence on quality of life and generates high costs, but spontaneous help-seeking is limited. In the URINO trial the effects and cost-effectiveness of actively encouraging older women to undergo diagnostics and treatment for urinary incontinence were compared with usual care. OBJECTIVES: To describe the design of the URINO trial and to give data on the effect of treatment uptake after screening. In the discussion, the criteria of Wilson and Jungner are applied to discuss whether screening for urinary incontinence is suitable. METHODS: In a cluster randomized trial all registered female patients aged ≥55 years received a screening questionnaire. The intervention consisted of actively encouraging women to undergo diagnostics, after which tailored treatment was offered. In the control group care as usual was offered, but uptake of diagnostics and treatment was not encouraged. Results The response rate was 76%. 31% reported urinary incontinence; of these, 47% was willing to participate. All patients in the intervention group underwent diagnostics and treatment uptake was 80%; in the control group this was 2%. CONCLUSION: To increase treatment uptake, screening must be followed by active encouragement for further diagnostics and treatment. Based on the principles of Wilson and Jungner, female urinary incontinence is a condition suitable for screening. The effect of treatment however needs further evaluation before screening can be recommended. The results of the URINO trial will fill this gap in knowledge.

EAU guidelines on chronic pelvic pain.

CONTEXT: These guidelines were prepared on behalf of the European Association of Urology (EAU) to help urologists assess the evidence-based management of chronic pelvic pain (CPP) and to incorporate the recommendations into their clinical practice. OBJECTIVE: To revise guidelines for the diagnosis, therapy, and follow-up of CPP patients. EVIDENCE ACQUISITION: Guidelines were compiled by a working group and based on a systematic review of current literature using the PubMed database, with important papers reviewed for the 2003 EAU guidelines as a background. A panel of experts weighted the references. EVIDENCE SYNTHESIS: The full text of the guidelines is available through the EAU Central Office and the EAU Web site (www.uroweb.org). This article is a short version of the full guidelines text and summarises the main conclusions from the guidelines on the management of CPP. CONCLUSIONS: A guidelines text is presented including chapters on chronic prostate pain and bladder pain syndromes, urethral pain, scrotal pain, pelvic pain in gynaecologic practice, neurogenic dysfunctions, the role of the pelvic floor and pudendal nerve, psychological factors, general treatment of CPP, nerve blocks, and neuromodulation. These guidelines have been drawn up to provide support in the management of the large and difficult group of patients suffering from CPP.

Effect of recombinant activated factor VII on perioperative blood loss in patients undergoing retropubic prostatectomy: a double-blind placebo-controlled randomised trial.

BACKGROUND: Recombinant activated factor VII (factor VIIa) has prohaemostatic effects in bleeding patients with coagulation abnormalities. We aimed to test the hypothesis that recombinant factor VIIa could reduce perioperative blood loss in patients with normal coagulation systems. Therefore, we assessed safety and efficacy of this drug in patients undergoing retropubic prostatectomy, which is often associated with major blood loss and need for transfusion. METHODS: In a double-blind, randomised placebo-controlled trial, we recorded blood loss and transfusion requirements in 36 patients undergoing retropubic prostatectomy, who were randomised to receive an intravenous bolus of recombinant factor VIIa (20 microg/kg or 40 microg/kg) or placebo in the early operative phase. FINDINGS: Median perioperative blood loss was 1235 mL (IQR 1025-1407) and 1089 mL (928-1320) in groups given recombinant factor VIIa 20 microg/kg and 40 microg/kg, respectively, compared with 2688 mL (1707-3565) in the placebo group (p=0.001). Seven of twelve placebo-treated patients were transfused, whereas no patients who received 40 microg/kg recombinant factor VIIa needed transfusion. The odds ratio for receiving any blood product in patients treated with recombinant factor VIIa compared with control patients was 0 (95% CI 0.00-0.33) No adverse events arose. INTERPRETATION: An injection of recombinant factor VIIa can reduce perioperative blood loss and eliminate the need for transfusion in patients undergoing major surgery.

High-resolution endovaginal MR imaging in stress urinary incontinence.

The causes of stress urinary incontinence are not completely known. Recent papers have stressed the importance of more anatomical information, which may help to elucidate the mechanism of stress urinary incontinence. The purpose of this study was to evaluate the prevalence of lesions of the urethral support mechanism and lesions (defects and scars, thinning) of levator ani muscle with endovaginal MRI in a case-control study. Forty women (median age 52 years, age range 40-65 years)--20 patients with stress urinary incontinence (cases) and 20 age-matched healthy volunteers (controls)--underwent endovaginal MRI: axial, coronal, and sagittal T2-weighted turbo spin echo. The examinations were evaluated for the presence of lesions of urethral supporting structures and levator ani and scar tissue of the levator ani. The thickness of the levator ani muscle was measured. Lesions of the urethral support system and levator ani were significantly more prevalent in cases than in controls ( p<0.01). Median levator ani thickness in patients was significantly lower than in healthy controls [2.5 mm (range 0.9-4.1 mm) vs 3.9 mm (range 1.4-7 mm)] ( p<0.01). This study indicates a relationship between stress urine incontinence and the presence of lesions of the urethral support and levator ani and levator ani thinning.