EARLY EXPERIENCE WITH DURASPHEREBLADDER NECK BULKING AGENT
D. G. TINCELLO1, R.C. TEO 2, C. MAYNE 3;
1HealthSciences, Univ. of Leicester, Leicester, United Kingdom, 2Univ.Hosp. Leicester, Leicester, United Kingdom, 3Urogynaecology,Univ. Hosp. of Leicester, Leicester, United Kingdom.
Introduction: Surgery for stressincontinence is effective but up to one woman in eight will be leftwith residual or recurrent incontinence. Secondary treatment is oftendifficult due to limited mobility of the tissues and the presence ofretropubic scarring. We have recently introduced Durasphere bladderneck bulking to our practice for women with recurrent stress urinaryincontinence and have audited the outcomes from the first year oftreatment.
Objective: To examine short term outcomes oftreatment with pyrolytic coated carbon bead urethral bulkinginjections (Durasphere) for recurrent stress urinary incontinence(SUI).
Methods: Patients were identified from aprospectively collected database of all cases. Previous history,previous surgery and baseline demographic data were recorded. Diseasespecific symptom severity was recorded prospectively using theICIQ-UI short form. Details of volume of material injected andsurgeon reported subjective impression of mucosal apposition werenoted. All patients were reviewed at 12 weeks and subjective curerecorded. For women who were not cured/improved, subsequentinvestigation and treatment noted and final continence status notedafter appropriate intervention.
Results: To date, ninewomen have been treated; seven were recurrent cases and two requestedbladder neck bulking as primary intervention. Median age was 75 years(43-90), and median number of previous continence procedures was 1(0-3). Eight procedures were done under general anaesthesia and oneunder local anaesthesia (patient request). The dose ranged from 1.5mleach side to 3ml each side. Mucosal apposition was rated as “good”for four women, “satisfactory” for four, and “excellent” forone. At 12 weeks, four patients reported being cured (3) or improved(1). ICIQ-UI short forms scores fell from 18 (15-21) to 8 (0-2)(p=0.027). One woman who reported failure described being dry for oneweek, before experience return of her symptoms. She had previouslyunderdone colposuspension, hysterectomy and sacrocolpopexy forsignificant pelvic floor laxity and subsequently was cured afterautologous fascial sling. Four patients described cure of stressincontinence but worsening urgency on close questioning; one reportedsignificant improvement after mirabegron, and one was found to haveonly detrusor overactivity and was rendered continent after botulinumtoxin treatment. One is awaiting review after transdermal oxybutytinand one is awaiting further urodynamics. Thus, of six women with a“final” outcome cure was achieved in three (50%), andsatisfactory improvement in two (33%), with a new OAB diagnosis inthree (50%).
Conclusions: Durasphere bladder neck bulkingappears a moderately effective treatment for women with recurrent SUIand a fixed bladder neck. It should be remembered that these patientshave had several previous surgeries and represent the “worst case”scenario. Cure/improvement is around 80% although new onset OAB is anissue. The use of Durasphere as primary treatment deservesconsideration, in view of the ongoing issues relating to midurethralmesh complications and may have a better cure rate than the datapresented here.