Supporting the Choice for Conservative and Surgical Treatment in Female Stress Urinary Incontinence: Development and Evaluation of a Patient Decision Aid.

INTRODUCTION: Making a treatment decision for female stress urinary incontinence (SUI) can be challenging for patients and healthcare providers. Dutch guidelines advise to counsel both pelvic floor muscle therapy and midurethral sling surgery as primary treatment options in uncomplicated moderate to severe cases. The use of a patient decision aid (PDA) can support decision-making, reduce decisional conflict and decisional regret, and increase knowledge. The aim of this study was to develop and evaluate an online PDA for females (SUI). METHODS: This mixed-methods study was performed in consecutive stages by a multidisciplinary working group. PDA design was based on the International Patient Decision Aids Standards (IPDAS) and on outcomes of needs assessments amongst patients and healthcare providers. Content was based on Dutch guidelines, targeted literature searches and patient information from the Dutch scientific society for gynecology. The concept version was evaluated by patients, patients' advocates, and healthcare providers. RESULTS: Using the nominal group technique, the working group established the design and format of the PDA. Fifty-six out of 58 applicable items of the IPDAS were met. The PDA contains information on the condition, advice on lifestyle adaptations, and describes surgical and nonsurgical treatment options. The option grid contains comparisons of the primary treatment options. Furthermore, value clarification exercises and narratives were included. Acceptability and usability evaluation of the concept version was performed by 15 healthcare providers, three patients, and two patients' advocates. Comments were processed in the working group, resulting in the final version of the PDA, which was supported by all assessors. CONCLUSION: Our multidisciplinary working group developed an online PDA for women with moderate to severe SUI including conservative and surgical treatment options, based on IPDAS criteria, guidelines, scientific evidence, and needs assessments from patients and healthcare providers. This PDA is supported by patients, healthcare providers, scientific societies, and the Dutch patients' association. The next step is to evaluate and implement this PDA in daily practice. TRIAL REGISTRATION: ID 2014-308.

A prospective observational cohort study of the Ajust® single incision sling performed under conscious sedation with local infiltration.

AIMS: To evaluate the adjustable single-incision sling (Ajust®) in the treatment of stress urinary incontinence (SUI), when placed under conscious sedation with local infiltration, using the cough test during surgery. METHODS: In this multicenter observational study, 90 women who had moderate to severe SUI, were asked to have the Ajust® procedure performed under sedation with local infiltration with levobupivacain. This allowed for a perioperative cough test to adjust the sling to the urethra till continence was reached. The primary outcome of the study was subjective cure of stress incontinence at 1 year follow up. Secondary objectives were objective and subjective improvement, complications during and after the procedure, and postoperative pain scores. These results were compared with the results of a historical control group of 96 patients who received their Ajust® under general or regional (spinal) anesthesia. RESULTS: At 6 weeks and 12 months, there were no statistical significant differences in the results for subjective cure (83.6% and 71.6% sedation group, 88.4% and 77.2% general/regional anesthesia group), objective cure (96% and 86.9% sedation group, 88.1% and 91.8% general/regional anesthesia group), de novo urgency (10.5% and 6.7% sedation group, 7.1% and 24.1% general/regional anesthesia group) and the patients global impression of improvement (96% and 89.2% sedation group, 91.4% and 84.4% general/regional anesthesia group). CONCLUSION: The performance of a cough test during the placement of an adjustable single-incision sling for the treatment of SUI does not affect the functional outcome, and is therefore not necessary.

Does mode of hysterectomy influence micturition and defecation?

OBJECTIVE: Hysterectomy may affect bladder and bowel function. A retrospective study was performed to compare the prevalence of micturition and defecation symptoms between different modes of hysterectomy. METHODS: All pre-operatively asymptomatic patients, with uteral size < or =10 cm, who underwent hysterectomy between 1988 and 1997 were interviewed about the prevalence of micturition and defecation symptoms and the experienced physical and emotional limitations of these symptoms. Using logistic regression analysis, odds ratios (OR) were calculated for all symptoms of which the prevalence between modes of hysterectomy differed more than 10%. These odds ratios were adjusted for differences in other prognostic factors. RESULTS: Vaginal hysterectomy was performed on 68 patients, total abdominal hysterectomy on 109 patients and subtotal abdominal hysterectomy on 50 patients. An increased prevalence of urge incontinence (adjusted OR 1.5 (95% CI 0.8-3.1)) and feeling of incomplete evacuation (adjusted OR 1.9 (95% CI 1.0-4.0)) was observed among patients who had undergone vaginal hysterectomy as compared to patients who had undergone total abdominal hysterectomy. The prevalence of urge incontinence (adjusted OR 1.8 (95% CI 0.8-4.2)) and difficulty emptying the rectum (adjusted OR 1.8 (95% CI 0.7-4.4)) was higher among patients who had undergone vaginal hysterectomy than among patients who had undergone subtotal abdominal hysterectomy. Statistically significant odds ratios were not observed. Relevant differences in physical and emotional limitations related to micturition and defecation symptoms were not observed between groups. CONCLUSION: Our results suggest that technique of hysterectomy may influence the prevalence of micturition and defecation symptoms following hysterectomy.