The specific aim of this trial is to determine if hydrodistention at the time of intradetrusor injection of botulinum toxin A has additional benefit in patients with refractory overactive bladder (OAB) and urgency symptoms compared to intradetrusor injection of botulinum toxin A alone. Consented patients will be randomized to hydrodistention at a pressure of 80 cm H2O for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin A (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin A alone (botulinum toxin A alone group). The primary aim will be subjective improvement measured as change from baseline at 12 weeks using the OAB-q bother subscale.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3
The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.
Intradetrusor injection of 100 units of botulinum toxin a
University of Alabama Birmingham Hospital
Birmingham, Alabama, United States
Symptom Bother
The primary outcome will be measured as change from baseline at 12 weeks using the OAB-q bother subscale which consists of eight questions assessing symptom bother with a possible score from 0 to 100 with a higher score indicating greater symptom bother.
Time frame: 12 weeks
Urge Urinary Incontinence Episodes
Number of UUI episodes as reported in a 3-day bladder diary at 12 weeks as measured in change from baseline.
Time frame: 12 weeks
Total Number of Voids
Total number of voids reported in the 3-day bladder diary at 12 weeks as measured in change from baseline.
Time frame: 12 weeks
Subjects Requiring Clean Intermittent Self-catheterization
Proportion of subjects requiring clean intermittent self-catheterization (CISC) post-operatively as reported at 2 week post-operative visit. CISC will be initiated at post-void residual volumes of \> 300 mL or \> 150 mL in the presence of bothersome retention symptoms.
Time frame: 2 weeks
Post Void Residual Volume
Post-void residual volume (PVR) at the 2 week follow-up visit measured with catheter or bladder scan.
Time frame: 2 weeks
Rate of UTI
Rate of urinary tract infection (UTI) as assessed by positive urine culture in patients having symptoms (dysuria, urgency, frequency, temperature ≥ 38 degrees Celcius, and/or suprapubic pain) at the 2 weeks post-operative visit. Subjects who call throughout the study complaining of symptoms but are unable to give a urine culture in clinic will also be treated and reported as having had a UTI.
Time frame: 2 weeks
Quality of Life Measures
Health related quality of life (HRQL) will be measured as a change from baseline at 12 weeks using the OAB-q HRQL subscale part which consists of 25 questions that assess HRQL addressing coping, concern, sleep, and social interaction where the scoring scale is from 0 to 100 with a higher score indicating a better quality of life.
Time frame: 12 weeks
Patient Impression of Improvement
Patient global impression of improvement at 12 weeks as measured using the Patient Global Impression of Improvement Questionnaire (PGI-I).
Time frame: 12 weeks
Patient Satisfaction
Patient satisfaction at 12 weeks as measured using Patient Satisfaction Questionnaire (PSQ).
Time frame: 12 weeks
Quality of Life Measures
Subjective outcome at 24 weeks using the OAB-q
Time frame: 24 weeks
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