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Interstitial CystitisNCT00823030

Effect of Intravesical Lidocaine on Urodynamic and Symptomatic Parameters of Interstitial Cystitis

A study testing Urodynamic study, Lidocaine and Normal Saline in people with Interstitial Cystitis, run by Northwell Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Interstitial Cystitis
What is being tested?
Urodynamic study, Lidocaine and Normal Saline
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2009to Jan 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Smith Institute for Urology

    Lake Success, New York, 11040

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
Urodynamic study, Lidocaine, Normal Saline
Keywords
Interstitial Cystitis, Intravesical Lidocaine
Medical subject headings
Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Urodynamic studyProcedure or surgery

    Also called UDS

    A small catheter will be inserted into the bladder and water will slowly be instilled through the catheter and into your bladder. A series of measurements will then be taken to assess your bladder's capacity to hold liquid, the average and maximum urine flow rates, as well as bladder filling and leak point pressure readings.

  • LidocaineDrug

    20 cc of alkalinized lidocaine will be injected after the first UDS

  • Normal SalineOther

    20 cc of normal saline will be injected into the bladder after the first UDS

Study groups in NCT00823030
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo instillation: 20 ml of normal saline instilled intravesically
Receives: Procedure: Urodynamic study; Other: Normal Saline
experimental armExperimentalThe experimental instillation will include 8 ml of 2% lidocaine, 3 ml of sodium bicarbonate, and 9 ml of normal saline.
Receives: Procedure: Urodynamic study; Drug: Lidocaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Urodynamic parameters

    Measured: 2 hours, 1 baseline UDS will be checked and then another will be checked one hour after the interventional step

Secondary outcomes (1)
  1. symptom scores (Global response assessment, IPSS, VAS)

    Measured: baseline, after 2nd UDS, and at 3 and 7 days after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2009 (estimated)
  2. Study startJan 2009
  3. Primary completionJan 2013 (estimated)
  4. Study completionJan 2013 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00823030
Sponsor's protocol ID
08-221
Status last verified
Oct 2015
First submitted
14 Jan 2009
Last updated
14 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Parsons CL, Tatsis V. Prevalence of interstitial cystitis in young women. Urology. 2004 Nov;64(5):866-70. doi: 10.1016/j.urology.2004.06.044.

    PubMed 15533465
  • Parsons CL, Housley T, Schmidt JD, Lebow D. Treatment of interstitial cystitis with intravesical heparin. Br J Urol. 1994 May;73(5):504-7. doi: 10.1111/j.1464-410x.1994.tb07634.x.

    PubMed 8012771
  • Welk BK, Teichman JM. Dyspareunia response in patients with interstitial cystitis treated with intravesical lidocaine, bicarbonate, and heparin. Urology. 2008 Jan;71(1):67-70. doi: 10.1016/j.urology.2007.09.067.

    PubMed 18242367
  • Asklin B, Cassuto J. Intravesical lidocaine in severe interstitial cystitis. Case report. Scand J Urol Nephrol. 1989;23(4):311-2. doi: 10.3109/00365598909180345.

    PubMed 2595329
  • Parsons CL. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Urology. 2005 Jan;65(1):45-8. doi: 10.1016/j.urology.2004.08.056.

    PubMed 15667861
  • Srinivasan A, Shapiro E and Moldwin RM: Effects of Intravesical Lidocaine on Urodynamic Parameters in Patients with Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS).

Questions about this trial

What is this clinical trial studying?

A study testing Urodynamic study, Lidocaine and Normal Saline in people with Interstitial Cystitis, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urodynamic parameters (time frame: 2 hours, 1 baseline UDS will be checked and then another will be checked one hour after the interventional step). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00823030, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.

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