Treatment of uterine prolapse stage 2 or higher: a randomized multicenter trial comparing sacrospinous fixation with vaginal hysterectomy (SAVE U trial)

Contains fulltext : 97471.pdf (publisher's version ) (Open Access)BACKGROUND: Pelvic organ prolapse is a common health problem, affecting up to 40% of parous women over 50 years old, with significant negative influence on quality of life. Vaginal hysterectomy is currently the leading treatment method for patients with symptomatic uterine prolapse. Several studies have shown that sacrospinous fixation in case of uterine prolapse is a safe and effective alternative to vaginal hysterectomy. However, no large randomized trials with long-term follow-up have been performed to compare efficacy and quality of life between both techniques.The SAVE U trial is designed to compare sacrospinous fixation with vaginal hysterectomy in the treatment of uterine prolapse stage 2 or higher in terms of prolapse recurrence, quality of life, complications, hospital stay, post-operative recovery and sexual functioning. METHODS/DESIGN: The SAVE U trial is a randomized controlled multi-center non-inferiority trial. The study compares sacrospinous fixation with vaginal hysterectomy in women with uterine prolapse stage 2 or higher. The primary outcome measure is recurrence of uterine prolapse defined as: uterine descent stage 2 or more assessed by pelvic organ prolapse quantification examination and prolapse complaints and/or redo surgery at 12 months follow-up. Secondary outcomes are subjective improvement in quality of life measured by generic (Short Form 36 and Euroqol 5D) and disease-specific (Urogenital Distress Inventory, Defecatory Distress Inventory and Incontinence Impact Questionnaire) quality of life instruments, complications following surgery, hospital stay, post-operative recovery and sexual functioning (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire). Analysis will be performed according to the intention to treat principle. Based on comparable recurrence rates of 3% and considering an upper-limit of 7% to be non-inferior (beta 0.2 and one sided alpha 0.025), 104 patients are needed per group. DISCUSSION: The SAVE U trial is a randomized multicenter trial that will provide evidence whether the efficacy of sacrospinous fixation is similar to vaginal hysterectomy in women with uterine prolapse stage 2 or higher. TRIAL REGISTRATION: Netherlands Trial Register (NTR): NTR1866

Dealing with complex overactive bladder syndrome patient profiles with focus on fesoterodine: in or out of the EAU guidelines?

John Heesakkers,1 Montserrat Espuña Pons,2 Philip Toozs Hobson,3 Emmanuel Chartier-Kastler4 1Department of Urology, Radboud University Medical Center, Nijmegen, Netherlands; 2Pelvic Floor Unit, ICGON, Hospital Clinic de Barcelona, University of Barcelona, Barcelona, Spain; 3Department of Urogynecology, Birmingham Women’s Hospital, Birmingham, UK; 4Department of Urology, Academic Hospital Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Pierre et Marie Curie Medical School, Paris 6 University, Sorbonne Universités, Paris, France Abstract: Overactive bladder (OAB) syndrome is a common, complex, and challenging condition. To assist the management of these patients, the European Association of Urology (EAU) updates its guidelines annually. This review reports the presentations from the symposium titled “Dealing with complex OAB patient profiles: in or out of the EAU guidelines?” held at the 32nd EAU Annual Congress in March 2017 in London. The symposium focused on three groups of OAB patients: women who may also suffer pelvic organ prolapse, stress urinary incontinence, the genitourinary syndrome of menopause (GSM); patients at risk of cognitive impairment; and elderly patients. The aim of the symposium was to determine how the 2017 EAU guidelines can best assist physicians, as well as to assess the benefits of fesoterodine in these patients. The EAU guidelines recommend antimuscarinic agents (grade A) for the medical treatment of OAB. In women, OAB is correlated with GSM, both of which are underdiagnosed and undertreated. Fesoterodine decreases OAB symptoms and the associated limitation of physical activity. A combination of fesoterodine and vaginal estrogens is appropriate for OAB associated with GSM. In patients at risk of cognitive impairment, prescribers should pay particular attention to the choice of medication. Fesoterodine is a Pgp substrate with limited ability to cross the blood–brain barrier, which may explain the lack of negative effects on the central nervous system observed in clinical trials of this agent. OAB should not be regarded as a normal consequence of aging. Fesoterodine has been extensively investigated in the elderly, and is the only anticholinergic drug licensed for OAB in this population, rated B (beneficial) according to the Fit for the Aged classification for lower-urinary-tract symptoms. The EAU guidelines are a valuable resource for physicians managing patients with OAB, and the pharmacological properties of fesoterodine offer credible clinical advantages in these three patient groups. Keywords: cognitive function, elderly, fesoterodine, guidelines, overactive bladder, wome