Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis
| Status: | Withdrawn |
|---|---|
| Conditions: | Other Indications, Urology, Urology |
| Therapuetic Areas: | Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | January 2009 |
| End Date: | January 2013 |
The purpose of this study is to determine the amount of improvement in bladder function and
pain relief with the administration of 2% alkalinized lidocaine in patients with
interstitial cystitis. Specifically, we want to see if the administration of 2% alkalinized
lidocaine treatments in the bladder improves urodynamic test result values. We hope to
enroll approximately 40 patients in this study.
Previous research has shown that the administration of 2% alkalinized lidocaine in the
bladder may improve the bladder's capacity to hold urine and urine flow rates while
simultaneously providing pain relief. As part of standard of care at the Smith Institute of
Urology Pelvic Pain Center, we routinely offer our IC patients 2% alkalinized lidocaine with
follow up urodynamic evaluation. Our research looks to expand upon the prior studies and
confirm the findings of improved bladder function and enhanced pain control of 2%
alkalinized lidocaine versus placebo by performing a second urodynamic evaluation, which is
not routinely performed.
pain relief with the administration of 2% alkalinized lidocaine in patients with
interstitial cystitis. Specifically, we want to see if the administration of 2% alkalinized
lidocaine treatments in the bladder improves urodynamic test result values. We hope to
enroll approximately 40 patients in this study.
Previous research has shown that the administration of 2% alkalinized lidocaine in the
bladder may improve the bladder's capacity to hold urine and urine flow rates while
simultaneously providing pain relief. As part of standard of care at the Smith Institute of
Urology Pelvic Pain Center, we routinely offer our IC patients 2% alkalinized lidocaine with
follow up urodynamic evaluation. Our research looks to expand upon the prior studies and
confirm the findings of improved bladder function and enhanced pain control of 2%
alkalinized lidocaine versus placebo by performing a second urodynamic evaluation, which is
not routinely performed.
Interstitial cystitis (IC) is a chronic bladder condition that includes symptoms of bladder
or pelvic pain as well as irritative voiding symptoms (urgency, frequency, nocturia,
dysuria). The syndrome is usually diagnosed clinically after ruling out any possible
infectious or neoplastic causes. Due to the lack of standardized diagnostic criteria, the
reported prevalence of IC in the United States varies widely from 35 to 24,000 per 100,000
persons1,2. Regardless, there is no doubt that IC is a source of much distress and
profoundly affects quality of life. IC patients have been reported to have lower quality of
life than dialysis patients. They are 6 times more likely than the general population to cut
down on work time owing to health problems and have higher reported incidences of
depression, chronic pain, anxiety and overall mental health2,
The exact pathophysiology or etiology of IC is not completely understood but there have been
much advancement in knowledge. The etiology is most likely multifactorial and studies have
shown a role for epithelial dysfunction, inflammatory events as well as neurological
dysfunction [Figure 1]. An initiating event such as infection, trauma, or autoimmune
disorder leads to dysfunctional urothelium4. Activation and upregulation of sensory nerves
occurs, leading to mast cell activation and release of histamine and other mediators5,6.
This, in turn, leads to a cycle of symptoms for the IC patient.
Due to the multifactorial nature of its pathogenesis, IC treatment is complicated and
involves multimodal treatments that target different factors. Tricyclic antidepressants
control the regulation and activation of the nerves7. Antihistamines target mast cell
activation8 while heparinoids such as pentosan polysulfate sodium (PPS) or heparin targets
the dysfunction epithelium. Heparin is one of the most commonly used intravesical agent for
the treatment of IC. It has been found to be effective is almost 50% of patients9. While
heparinoid therapy enhances the barrier effect of the disrupted urothelium, it does not
directly target the sensory nerves of the bladder. Hence, it may take more than 2 years of
treatment for severely affected patients to feel any symptomatic relief10. Furthermore, once
symptomatic relief is achieved, it is not sustained for very long11. Urologists aimed to
develop therapy that would directly affect the sensory nerves of the bladder and provide
immediate symptomatic relief.
The use of intravesical lidocaine in severe IC was first reported in Sweden in 1989. Asklin
et al., reported on one patient who received repeated intravesical instillations of
lidocaine and achieved much relief13. Success with the treatment was subsequently reported
for another patient in 199214. Surprisingly, there have been very few studies on the
clinical efficacy of intravesical lidocaine in IC patients since then. To date, all studies
involving intravesical lidocaine lack randomization or a control group. It is difficult to
determine the influence of any existing placebo effect of intravesical instillations.
One such study was conducted in 2005 by Parsons et al., which tested the efficacy of heparin
combined with intravesical lidocaine in 47 newly diagnosed IC patients. 75% of patients
reported significant improvement in symptoms after just one instillation with symptomatic
relief lasting at least 4 hours. Significant improvement in symptoms was reported in 94% of
patients who received a second instillation using a higher concentration of lidocaine. Of 20
patients who received a course of 6 instillations over 2 weeks, 80% reported sustained
relief15.
Welk and Telchman looked specifically at dyspareunia response to intravesical lidocaine in
23 IC patients. 57% reported resolution of dyspareunia. They also found a significant
difference in response rate between patients with bladder tenderness and patients with
multiple tender locations on vaginal exam (85% versus 29% respectively)16.
Urodynamic studies performed in IC patients generally demonstrate normal cystometry,
although IC patients have characteristic reductions in bladder capacity secondary to pain
and hypersensitivity to bladder dilation3. In a recent retrospective study, Srinivasan et al
observed that a statistically significant difference was appreciable when comparing pre and
post lidocaine UDS evaluation in bladder capacity, maximum flow rate, and first strong
sensation to void. 12 The impact of alkalinized lidocaine on UDS parameters, however,
remains elusive and deserving of a well designed randomized control trial.
or pelvic pain as well as irritative voiding symptoms (urgency, frequency, nocturia,
dysuria). The syndrome is usually diagnosed clinically after ruling out any possible
infectious or neoplastic causes. Due to the lack of standardized diagnostic criteria, the
reported prevalence of IC in the United States varies widely from 35 to 24,000 per 100,000
persons1,2. Regardless, there is no doubt that IC is a source of much distress and
profoundly affects quality of life. IC patients have been reported to have lower quality of
life than dialysis patients. They are 6 times more likely than the general population to cut
down on work time owing to health problems and have higher reported incidences of
depression, chronic pain, anxiety and overall mental health2,
The exact pathophysiology or etiology of IC is not completely understood but there have been
much advancement in knowledge. The etiology is most likely multifactorial and studies have
shown a role for epithelial dysfunction, inflammatory events as well as neurological
dysfunction [Figure 1]. An initiating event such as infection, trauma, or autoimmune
disorder leads to dysfunctional urothelium4. Activation and upregulation of sensory nerves
occurs, leading to mast cell activation and release of histamine and other mediators5,6.
This, in turn, leads to a cycle of symptoms for the IC patient.
Due to the multifactorial nature of its pathogenesis, IC treatment is complicated and
involves multimodal treatments that target different factors. Tricyclic antidepressants
control the regulation and activation of the nerves7. Antihistamines target mast cell
activation8 while heparinoids such as pentosan polysulfate sodium (PPS) or heparin targets
the dysfunction epithelium. Heparin is one of the most commonly used intravesical agent for
the treatment of IC. It has been found to be effective is almost 50% of patients9. While
heparinoid therapy enhances the barrier effect of the disrupted urothelium, it does not
directly target the sensory nerves of the bladder. Hence, it may take more than 2 years of
treatment for severely affected patients to feel any symptomatic relief10. Furthermore, once
symptomatic relief is achieved, it is not sustained for very long11. Urologists aimed to
develop therapy that would directly affect the sensory nerves of the bladder and provide
immediate symptomatic relief.
The use of intravesical lidocaine in severe IC was first reported in Sweden in 1989. Asklin
et al., reported on one patient who received repeated intravesical instillations of
lidocaine and achieved much relief13. Success with the treatment was subsequently reported
for another patient in 199214. Surprisingly, there have been very few studies on the
clinical efficacy of intravesical lidocaine in IC patients since then. To date, all studies
involving intravesical lidocaine lack randomization or a control group. It is difficult to
determine the influence of any existing placebo effect of intravesical instillations.
One such study was conducted in 2005 by Parsons et al., which tested the efficacy of heparin
combined with intravesical lidocaine in 47 newly diagnosed IC patients. 75% of patients
reported significant improvement in symptoms after just one instillation with symptomatic
relief lasting at least 4 hours. Significant improvement in symptoms was reported in 94% of
patients who received a second instillation using a higher concentration of lidocaine. Of 20
patients who received a course of 6 instillations over 2 weeks, 80% reported sustained
relief15.
Welk and Telchman looked specifically at dyspareunia response to intravesical lidocaine in
23 IC patients. 57% reported resolution of dyspareunia. They also found a significant
difference in response rate between patients with bladder tenderness and patients with
multiple tender locations on vaginal exam (85% versus 29% respectively)16.
Urodynamic studies performed in IC patients generally demonstrate normal cystometry,
although IC patients have characteristic reductions in bladder capacity secondary to pain
and hypersensitivity to bladder dilation3. In a recent retrospective study, Srinivasan et al
observed that a statistically significant difference was appreciable when comparing pre and
post lidocaine UDS evaluation in bladder capacity, maximum flow rate, and first strong
sensation to void. 12 The impact of alkalinized lidocaine on UDS parameters, however,
remains elusive and deserving of a well designed randomized control trial.
Inclusion Criteria:
- Male or female patients aged ≥ 18
- Clinical diagnosis of Interstitial cystitis based on the National Institute of
Diabetes, Digestive and Kidney Diseases (NIDKK) criteria. According the NDIKK
criteria, IC patients must have either glomerulations on cystoscopic examination or
classic Hunner Ulcers and must also have either pain associated with the bladder or
urinary urgency. Symptoms of abnormal urinary frequency and bladder pain/discomfort
must have been present for at least 3 months prior to study entry
- Able to understand and complete a VAS/GRA/modified IPSS assessment
- Written informed consent
Exclusion Criteria:
- Currently asymptomatic
- Severely debilitating or urgent concurrent medical condition
- History of pelvic radiation therapy, tuberculous cystitis, neurologic disease
affecting bladder function, bladder cancer, or carcinoma in situ, or urethral cancer
- Presence of bladder, urethral, or ureteral calculi
- Clinical evidence of urethritis
- Unlikely to be compliant due to unmanaged medical or psychological problem, including
neurological, psychological or speech/language problems that will interfere with
ability to complete the study
- Allergy to lidocaine or any of the other anesthetics in the amide family.
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