Randomised controlled trial to assess efficacy of pelvic floor muscle training on bowel symptoms after low anterior resection for rectal cancer: study protocol.

INTRODUCTION: Radical surgery after a total mesorectal excision (TME) for rectal cancer often results in a significant decrease in the patient's quality of life, due to functional problems such as bowel, urinary and sexual dysfunction. The effect of pelvic floor muscle training (PFMT) on these symptoms has been scarcely investigated. We hypothesise that the proportion of successful patients will be significantly higher in the intervention group, receiving 12 weeks of PFMT, compared with the control group without treatment. The primary outcome of this trial is the severity of bowel symptoms, measured through the Low Anterior Resection Syndrome questionnaire, 4 months after TME or stoma closure. Secondary outcomes are related to other bowel and urinary symptoms, sexual function, physical activity and quality of life. METHODS AND ANALYSIS: This research protocol describes a multicentre single blind prospective, randomised controlled trial. Since January 2017, patients treated for rectal cancer (n=120) are recruited after TME in three Belgian centres. One month following surgery or, in case of a temporary ileostomy, 1 month after stoma closure, patients are randomly assigned to the intervention group (n=60) or to the control group (n=60). The assessments concern the preoperative period and 1, 4, 6, 12 and 24 months postoperatively. ETHICS AND DISSEMINATION: The study will be conducted in accordance with the Declaration of Helsinki. Ethics approval was granted by the local Ethical Committee of the University Hospitals Leuven (s59761) and positive advice from the others centres has been obtained. Dissemination of the results will be accomplished via guidelines and (non-)scientific literature for professionals as well as organisation of patient symposia. TRIAL REGISTRATION NUMBER: NTR6383.

Influence of pelvic floor muscle exercises on full spectrum therapy for nocturnal enuresis.

PURPOSE: We investigated the effect of pelvic floor muscle training on the efficacy of full spectrum therapy and maximal voided volume in children with nocturnal enuresis. We also determined factors predicting treatment outcome, full spectrum therapy duration and the relapse rate. Full spectrum therapy is a combination of alarm, reward, timed voiding and drinking, over learning and pelvic floor muscle training. MATERIALS AND METHODS: A total of 63 consecutive children were referred to the physiotherapy department for full spectrum therapy to resolve nocturnal enuresis, including 32 in the experimental group who underwent full spectrum therapy with pelvic floor muscle training and 31 in the control group who underwent full spectrum therapy without training. RESULTS: There was no significant difference in treatment outcome, duration, maximal voided volume and relapse between the 2 groups. Of all children 89% became dry within 6 months. During the year after treatment 33.3% and 37.9% of the experimental and control groups relapsed, while the relapse rate at 1 year was 7.4% and 20.7%, respectively. Age and child motivation were associated with the duration of success (p = 0.04 and <0.01, respectively). Secondary enuresis and psychosocial problems were factors significantly related to relapse (each p <0.01). CONCLUSIONS: There is no beneficial effect of including pelvic floor muscle training in full spectrum therapy. Older children and those with better motivation experienced more rapid success. Factors predicting relapse were secondary enuresis and psychosocial problems.