An interventional study of Patient-directed follow up in Overactive Bladder, Urinary Urgency and Urinary Incontinence, sponsored by Louisiana State University Health Sciences Center in New Orleans. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-17.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are:
Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.
Overactive bladder (OAB) is defined by symptoms of urinary urgency, frequency, or nocturia with or without incontinence in the absence of urinary tract infection or other attributable pathology. This disease affects up to 40% of women in the United States and can have a significant impact on quality of life. It is expected to increase in prevalence with the aging US population. There are a wide variety of treatment options for OAB which range from fluid management and lifestyle modifications (first line therapy), pelvic floor physical therapy and oral medications (second line therapy), and procedural interventions such as neuromodulation or intravesical botulinum toxin (BTX-A) injections (third line therapy).
BTX-A is a potent neurotoxin derived from the anaerobic bacterium Clostridium botulinum that inhibits presynaptic release of acetylcholine from motor neurons at the neuromuscular junction to induce flaccid paralysis of musculature. It has also been found to affect sensory responses of nerve afferent nerve fibers and likely has a complex multifactorial effect on the release of excitatory neurotransmitters. Because of this, injection of BTX-A into the detrusor muscle of the bladder has become a highly effective treatment option for OAB, first approved by the FDA in January 2013. Prior studies have demonstrated superior efficacy of intravesical BTX-A injections compared to anticholinergic medication and a greater reduction in urge urinary incontinence episodes than sacral neuromodulation.
The effect of intravesical BTX-A is temporary due to turnover of presynaptic molecules. Typical chemodenervation of muscular tissue lasts 3 to 6 months based on histologic evidence, however this does not translate directly to duration of OAB symptom control given the gradual nature of neurotransmitter repletion. The largest prior trial of intravesical BTX-A demonstrated a median interval of 350 days between first and second injection, but other studies have shown a wide range of duration from 5 to 15 months. The current FDA recommendation for repeat injection is to be "considered when the clinical effect from the previous injection has diminished" with a median interval in their double-blinded placebo-controlled studies of 169 days.
Despite this recommendation, there is a wide variety in practice patterns for repeat injections, including the use of a "one size fits all" approach with standardized repeat injections at 6-month intervals. Combined with varying rates of tolerability and treatment failure, this has resulted in inconsistent data on continuation and dropout rates for repeat injections, with reported continuation rates of 20-60% in different studies. Additionally, no prior studies have reported whether repeat injection intervals have been provider- or patient-determined, nor with data on patient satisfaction ratings. Further studies are needed to better delineate optimal injection interval as well as incorporate data on what methods lead to the highest patient satisfaction and symptom control.
The purpose of this study is to ascertain the optimal time interval to repeat injection will be when it is purely patient directed based on symptomatology. Investigators will also evaluate patient satisfaction with this approach compared to standardized repeat injection interval of six months. This has the potential to change the way OAB is managed by allowing patients to control the interval to repeat injection in a safe and controlled manner. Investigators hypothesize that a patient-centered approach to repeating BTX-A injections will be similar to the standard FDA 6-month interval while leading to higher patient satisfaction and continuation rates without compromising safety or efficacy.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's planned enrollment of 100 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard 6 month post-operative follow up interval for repeat injection
Post-operative follow up interval for repeat injection decided by patient based on OAB symptomatology (3-12 months)
Behavioral: Patient-directed follow up
Patients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval.
Injection interval
time to repeat injection (days)
Time frame: Days from initial injection to repeat injection, up to 365 days
Patient Satisfaction
Scores from the Surgical Satisfaction Questionnaire (SSQ-8), which contains 8 questions on satisfaction with a likert scale rating of 1-5. Higher scores indicate higher patient satisfaction.
Time frame: 1-2 weeks post-injection
Symptom Control
Scores from the Overactive Bladder Assessment Tool (OAB-Q), which contains 5 questions on symptoms and 5 questions on quality of life with a likert scale rating of 0-5. Higher scores on the symptom section indicate WORSE overactive bladder symptoms and higher scores on the quality of life section indicate higher levels of bother/WORSE quality of life.
Time frame: baseline scores immediately pre-injection, post-treatment scores 1-2 weeks post-injection
Plan to share: Undecided
This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Louisiana State University Health Sciences Center in New Orleans