We completed a phase 1/2 trial to evaluate the safety and potential efficacy of direct intravesical instillation of a botulinum type A toxin/dimethyl sulfoxide (DMSO) solution for treatment of idiopathic detrusor overactivity in women. Twenty-five women with medication-resistant, urodynamic-confirmed idiopathic detrusor overactivity were enrolled. A total of 9 patients were treated in phase 1 of the study. Three patients were given a 66% dosing of solution; 22 patients received the full 300 units of botulinum toxin and 50 mL of DMSO (50% concentration). Adverse effects, 24-hour pad weights, episodes of incontinence, postvoid residuals, and scores on the Blaivas-Groutz anti-incontinence scale, Indevus Urgency Severity Scale, Incontinence Impact Questionnaire-short form, and Urogenital Distress Inventory (6 items) questionnaire were recorded at baseline, 1 month, and 3 months after instillation. No serious adverse effects or clinically important increases in postvoid residual occurred. Among the 21 women who completed phase 2 of the study, the median number of incontinent episodes decreased from 4 at baseline to 2 at 1 month (P=.004) and increased to 4 at 3 months (P=.81). Median scores improved from baseline to 1 month on the Incontinence Impact Questionnaire (from 13 to 7; P=.007) and Urogenital Distress Inventory (from 10 to 5; P=.003). Although 11 women (52%) reported severe urgency based on the Indevus Urgency Severity Scale at baseline, only 1 (5%; P<.001) and 3 (14%; P=.004) women reported severe scores at 1 and 3 months, respectively. Direct instillation of botulinum toxin/DMSO solution is safe. Its promising clinical effect warrants further evaluation in a randomized, placebo-controlled phase 3 setting.

Objective: To analyze the benefit of voiding chain cystourethrography (VCC) [placing a radiographic opaque chain into the urethra and bladder and asking the patient to void under fluoroscopy] in the urodynamic evaluation of female bladder outlet obstruction (BOO). Materials and Methods: Females with post anti-incontinence operation voiding dysfunction who underwent urodynamic evaluation augmented with VCC and later had urethrolysis were identified. Six diagnostic criteria for obstruction were applied to each patient: (1) VCC ( obstructed: chain was angulated and could not be voiding out) (2) Video urodynamic study (VUDS) (detrusor contraction combined with radiographic obstruction) (3) maximum flow (Q max ) ≤ 15 cc/sec, detrusor pressure (pDet)@ Q max ≥ 20 cm H 2 0 (4) Q max ≤ 11 cc/sec, pDet@ Q max ≥ 25 cm H 2 0 (5) Q max ≤ 12 cc/sec, pDet@ Q max ≥ 25 cm H 2 0 (6) Blaivas-Groutz (B-G) nomogram. Urethrolysis results were reviewed. Agreement in assessment of BOO criteria was assessed by estimating the proportion of pair-wise agreements along with an exact binomial 95% confidence interval (CI) and by estimating kappa along with a 95% CI. Results: Twenty-one patients were identified. Twenty of the 22 urethrolyses (91%) were clinically successful. Diagnosis of BOO was most common for VCC (86%) and then B-G Nomogram (67%). Agreement with the VCC was relatively poor for each of the five other methods (14%-62%) with the video urodynamic study (VUDS) being the best. Three patients with successful urethrolysis were diagnosed only by the VCC. All of kappa values regarding agreement with the VCC were low; the highest value of 0.15 was observed for VUDS. Conclusion: VCC may augment selection criteria for urethrolysis. INTRODuCTIONSelection for urethrolysis in symptomatic females with a history of an anti-incontinence procedure may be challenging, especially in the absence of immediate temporal association and/ or with a history of previous failed urethrolysis. While recognizing the value of the various pressure flow criteria developed for female bladder outlet obstruction (BOO), our clinic relies principally on the video urodynamic appearance of the bladder and urethra with voiding as described by Nitti et al.(1) and the Blaivas Groutz (B-G) nomogram (2). In some patients with a high index of clinical suspicion, the pressure flow criteria for obstruction were not strictly met and/or it was difficult to identify the urethra during testing.