Clinical Trials Logo

Clinical Trial Summary

This will be a prospective double-blinded randomized controlled trial comparing two pre-treatment protocols for patients undergoing intradetrussor botox injections to determine if a buffered lidocaine solution offers superior pain control.


Clinical Trial Description

Lidocaine is a commonly used amide-type local anesthetic. Lidocaine exists as both a quaternary water soluble structure, and a tertiary lipid-soluble structure. Only the tertiary lipid-soluble structure can cross the lipid bilayer of a cell membrane and thereby enter a neurons axoplasm and induce the desired effect. The ionization constant of lidocaine is 7.7 which means that at a pH of 7.7, 50% of lidocaine is available in the tertiary lipid-soluble structure. At a physiologic pH between 7.35 and 7.45 only around 44% of lidocaine is in the tertiary lipid-soluble structure. However, for lidocaine to be stable in solution, it is typically formulated as a hydrochloride salt and the pH of most commercially available lidocaine solutions are at a pH of 6.09. In an acidic solution the majority of lidocaine is available in the quaternary water-soluble structure and at this pH only 2.5% of lidocaine is in the tertiary lipid-soluble structure. A Cochrane review found that increasing the pH of lidocaine prior to injection decreased pain and increased patient satisfaction perhaps because of the aforementioned pharmacokinetic principles. Lidocaine is typically used as anesthetic for intradetrussor injections of onabotulinum toxin A for the treatment of refractory overactive bladder. In 2003, a technique for intradetrussor injections of onabotulinum toxin A was first described using only local anesthesia. At that time, the procedure involved intrauerthral lidocaine. The procedure has evolved since that time and currently many physicians utilize protocols with both utraurethral and intravesical lidocaine. At baseline intradetrusor onabotulinum toxin A injections are generally well tolerated and with reported mean VAS scores around 3. For patients with refractory overactive bladder, the standard of care is intradetrussor onabotulinum toxin A injections. The standard protocol used by the investigators involves emptying the bladder then retrograde filling the bladder with a 1:1 mixture of 1% lidocaine normal saline. This solution remains in the bladder for approximately 15 minutes prior to injection. Given that urine is typically acidic and commercially available lidocaine solutions are similarly acidic, it is likely that only a fraction of intravesical lidocaine is in the active tertiary lipid-soluble form. The goal of this study is to determine if the investigators can improve the procedural pain of intradetrusor onabotulinum toxin A injections using a buffered solution compared to our standard solution. After approval by the IRB, investigators will approach possible participants who are having intradetrussor botox injection for overactive bladder which is the standard of care for patients with refractory overactive bladder. If the patient meets eligibility criteria, consent forms will be signed and the patient will be randomized 1:1 to receive either our standard pretreatment regimen with 50 mL 1% lidocaine + 50ml of 0.9% normal saline or our buffered bicarbonate protocol with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate. The primary end point of this trial is to assess the pain scores measured on a Visual Analogue Scale (VAS) immediately following the procedure. Secondary end points include patient satisfaction, willingness to undergo repeat treatment and adverse events. All subjects will be randomized 1:1 at the first intervention visit to one of the two protocols using a random block design . At the completion of the procedure, patients will be asked to complete a brief questionnaire about their experience. Patients will follow up in clinic for a post-void residual check two weeks after the procedure as is standard for our clinical practice. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04270526
Study type Interventional
Source Boston Urogynecology Associates
Contact
Status Completed
Phase Phase 4
Start date August 15, 2020
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04578899 - "The Effectiveness of Transvertebral Magnetic Neuromodulation in Patients With Detrusor Overactivity" N/A
Active, not recruiting NCT03556891 - Pivotal Study of eCoin for Overactive Bladder With Urgency Urinary Incontinence N/A
Not yet recruiting NCT05977634 - Transcutaneous Tibial Nerve Stimulation for Idiopathic Overactive Bladder N/A
Completed NCT01955408 - Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment N/A
Recruiting NCT06201013 - Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children N/A
Recruiting NCT03727711 - TPTNS: Home vs Hospital Treatment for Overactive Bladder N/A
Completed NCT00768521 - A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) Phase 1
Completed NCT03625843 - Mindfulness Exercises to Reduce Anxiety and Pain During Urodynamic Testing N/A
Completed NCT02211846 - A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Mirabegron OCAS (Oral Controlled Absorption System) in Pediatric Subjects With Neurogenic Detrusor Overactivity or Overactive Bladder Phase 1
Completed NCT02835846 - Investigation of the Effect of the Female Urinary Microbiome on Incontinence Phase 4
Completed NCT02857816 - PRospective Study to Evaluate EffectivenesS With the NURO™ PErcutaneous Tibial Neuromodulation System in Patients With OAB N/A
Withdrawn NCT02320201 - Foot Neuromodulation for Overactive Bladder in Children N/A
Completed NCT02202031 - Controlling Urgency Through Relaxation Exercises N/A
Completed NCT01437670 - Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin N/A
Not yet recruiting NCT01409512 - Evaluation of Autonomic System Before and After Anticholinergic Treatment in Women With Overactive Bladder N/A
Completed NCT01458197 - A Phase 2 Study to Compare the Efficacy and Tolerability of Tarafenacin 0.2 mg and Tarafenacin 0.4 mg to Placebo in Patients Suffering From Overactive Bladder. Phase 2
Not yet recruiting NCT01423838 - Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder Phase 4
Terminated NCT01758848 - Physical Therapy for Overactive Bladder N/A
Withdrawn NCT01210859 - Effects of Antimuscarinic Drugs on Overactive Bladder (OAB) Symptoms After Insertion of Ureteral Stents N/A
Completed NCT00910520 - Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence Phase 3