A Phase 4 interventional study of Phenazopyridine and Lidocaine 2% Injectable Solution in Overactive Bladder Syndrome, Urge Incontinence and Urinary Incontinence, sponsored by Women and Infants Hospital of Rhode Island. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-05-29.
Sponsored by Women and Infants Hospital of Rhode Island · Phase 4, Interventional, and Treatment
OnabotulinumtoxinA (Botox®) bladder injections are a highly effective treatment for overactive bladder and urgency urinary incontinence. The procedure is typically performed in the office setting with one of two medications to control comfort. However, the effectiveness of these medications has never been compared. The goal of this study is to determine which medication is better at providing comfort during bladder Botox® injections.
The primary aim of this randomized clinical trial is to compare the analgesic effect of oral phenazopyridine to that of intravesical lidocaine during intradetrusor injections of onabotulinumtoxinA performed for idiopathic overactive bladder. The investigators will achieve this by measuring the mean visual-analog pain scores (VAS) in women who are randomized to receive either oral phenazopyridine or intravesical lidocaine.
Secondary aims include assessment of:
242 studies on the registry are indexed under Urinary Incontinence, Urge; 39 are open to participants now.
This study's planned enrollment of 110 is above the median of 86 across 190 interventional studies indexed under Urinary Incontinence, Urge.
Browse Urinary Incontinence, Urge studies →Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to the oral phenzopyridine arm will receive 200mg phenazopyridine to take by mouth 1-2 hours before their scheduled procedure.
Drug: Phenazopyridine
Patients randomized to the intravesical lidocaine arm will have the bladder back-filled with 30mL 2% lidocaine for the 20 minutes immediately preceding their procedure.
Drug: Lidocaine 2% Injectable Solution
200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure
30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure
Analgesic Effect Measured with 100mm Visual Analog Scale
The visual analog scale is a visual representation of pain severity rated from 0 (no pain) to 10 (worst pain imaginable). Therefore higher numbers represent more pain.The scale is represented visually using a 100 millimeter line and patients indicate their level of pain by pointing to a location on the line.
Time frame: Immediately post-procedure
Overall Patient Satisfaction
Overall patient satisfaction with the onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. Overall satisfaction will be measured with a single-item question utilizing a Likert scale with options ranging from very satisfied to very unsatisfied.
Time frame: Immediately post-procedure
Ease of Procedure
Physician's perception of ease of onabotulinumtoxinA injection procedure in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured with a single item, five point Likert scale with options ranging from no difficulty to great difficulty.
Time frame: Immediately post-procedure
Office Efficiency/Total Appointment Duration
Total appointment time or total time spent in an office exam/procedure room in women randomized to pre-procedure oral phenazopyridine versus those randomized to intravesical lidocaine instillation. This will be measured by subtracting the appointment start time (time the patient was placed in the exam room) from the appointment end time (time of patient check-out).
Time frame: Immediately post-procedure
Plan to share: No
This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Phenazopyridine · Lidocaine
Women and Infants Hospital of Rhode Island