CYSTODISTENSION AS A TREATMENT FOROVERACTIVE BLADDER - RESULTS OF AN RCT
A. BALACHANDRAN1, N.L. CURTISS 2, J. DUCKETT 3;
1Obstetricsand Gynaecology, Medway NHS Fndn. Trust, Kent, United Kingdom,2Medway NHS Foundation Trust, Medway NHS Fndn. Trust,Kent, United Kingdom, 3Obstetrics and Gynaecology, MedwayNHS Fndn. trust, Gillingham, United Kingdom.
Introduction: Cystodistensionmay be considered as a treatment option in refractory cases ofoveractive bladder (OAB) and can be performed at the same time ascystoscopy. The literature on this subject is of a poor quality.Despite the lack of strong evidence of its benefits, it is a commonlyused therapy for the management of urinary symptoms. There arecurrently no randomised controlled studies available to evaluate theuse of routine cystodistension in the treatment of OAB.
Objective:This RCT was designed to evaluate the effect of any subjectiveimprovement of OAB symptoms in patients who received cystodistensioncompared to cystoscopy alone using global, quality of life andsymptom scores.
Methods: A prospective cohort of patientswith refractory OAB were recruited between October 2013 and 2015. Thestudy was reported as per CONSORT guidelines. Ethical approval wasobtained from the national research ethics service. All patientsprovided written informed consent. Inclusion criteria required studypatients to have a diagnosis of OAB and have failed conservativemeasures and at least one antimuscarinic or mirabegron. The study wasdesigned to show a difference of 30% between the two arms with an 80%power and a significance level of 0.05 with a sample size of 70 (35in each arm). Patients were randomised (opaque envelopes once thepatient was anaesthetised - ratio 1:1) and blinded into either thecystoscopy only or cystoscopy and cystodistension arm.Cystodistension was performed for 3 minutes as per previouslydescribed . The primary outcome was assessed at 6 weeks and 6months using the Urgency Perception Scale (UPS). Secondary outcomeswere assessed using the International Consultation on IncontinenceModular Questionnaire long-form (ICIQ-LF) and Pelvic Floor DistressInventory (PFDI) questionnaire.
Results: A total of 77patients were recruited into the study with 42 in the cystodistensionarm and 35 in the cystoscopy only arm. Two patients were lost tofollow-up at 6 months. There was no difference in demographics andcystoscopic findings between both arms of the study. At 6 weeks,there was no significant difference (p=0.82) in UPS scores betweenthe cystodistension and cystoscopy alone arm. Based on the ICIQ-LF,there was no improvement of symptoms in the cystodistension arm with2 patients developing worsening symptoms. In the cystoscopy arm,there was significant improvement in filling (p=0.05), voiding(p=0.02) and total scores (p=0.008). The urinary distress inventoryscore showed significant improvement in quality of life in both arms[Table 1]. All patients reported return of OAB symptoms at 6 monthsafter cystodistension. Two urothelial malignancies wereidentified.
Conclusions: Overall the findings of this trialsuggest that cystodistension is less effective than cystoscopy alonein improving short term OAB symptoms. Long term benefits of eitherintervention are limited. Cystoscopy is important to excludesignificant bladder pathology in a small percentage ofpatients.
References: 1. Eur Urol 2004; 45: 662-669