Cat He Jell Prospective 2009

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Reviews in Endourology

Intraurethral Lubricants: A Critical LiteratureReview and Recommendations

Vassilios Tzortzis, M.D., Ph.D., 1 Stavros Gravas, Ph.D., 1

Michel M. Melekos, Ph.D., 1 and Jean J. de la Rosette, Ph.D. 2

Abstract

In current clinical practice, lidocaine gel is widely used as a local anesthetic lubricant before various forms of transurethral instrumentation. Over the past few years, the value of local anesthesia during urethral catheteri-zation and exible or rigid cystoscopy has been questioned. Strong data are lacking, and the results from thedifferent studies are contradictory. As a result, the correct use of the intraurethral gels is, for the most part, left toindividual preference. The purpose of this review is to provide an overview of the characteristics of the in-traurethral gels, to assess the effectiveness, and to dene evidence-based indications for their use.

Introduction

The rst mention of a urethral lubricant in the form of

olive oil and aqueous gels from plant gums goes back toantiquity. The use of a topical anesthetic in urology was re-ported in 1884, when Pease 1 described the use of cocaineduring cystoscopy. Since then, numerous synthetic topicalanesthetic-lubricant agents have been introduced, includinglidocaine, tetracaine, tripelennamine, silicone, and dyclonine.Lidocaine was synthesized by Lofgren and Lundqvist 2 inSweden in 1943 and introduced in clinical practice in 1947.

In 1949, HainesandGrabstald 3 were rst to report theefcacyof intraurethral administration of 2% lidocaine in 250 patientswhounderwentcystoscopy.Similarly,in1953,PerskyandDavis 4

reported that 2% lidocaine was a safe, rapid, and adequate an-esthetic in a series of 622 cystoscopies. Since then, intraurethrallidocaine gel emerged as the anesthetic agent of choice based onits simultaneous role as lubricant and local anesthetic.

Controversial issues have been raised over the past fewyears regarding the need for local anesthesia during urethralinstrumentation. Strong data are lacking, and results from thedifferent studies are contradictory. Consequently, the correctuse of the intraurethral gels, is for the most part, left to indi-vidual preference. The purpose of this review is to provide anoverview of intraurethral gel characteristics, to assess the

current body of evidence on their effectiveness, and to deneevidence-based indications for their use.

Evidence

A formal literature search was performed of the majormedical citation databases, including Ovid Medline, PubMed,and Scopus. The formal search strategy was to include all re-lated articles between 1949 and September 2008. This pe-riod was selected because of the pioneering paper of Hainesand Grabstald 3 on intraurethral lidocaine. Search terms were:pain, anesthesia, lidocaine, local anesthetics, intraurethral gel,cystoscopy, and catheterization. All randomized controlledtrials (RCTs) and meta-analysis were included for the deter-mination of efcacy and level of evidence. In all studies thatreferred to catheterization and cystoscopy, intraurethral plainlubricating gelwas used in control groupsand 2% lidocainegelin treatment groups before the procedure. For all the men-tioned studies, primary outcome was pain evaluation by a vi-sual analog scale (VAS) pain score, scaled from 0 to 100 with0 denoting no pain and 100 denoting the worst pain possible.The recommendations provided are rated according to thelevels of evidence published by the U.S. Department of Healthand Human Services, Agency for Health Care Policy and Re-search. 5

1 Department of Urology, University of Thessaly School of Medicine, Larissa, Greece.2 Department of Urology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.

JOURNAL OF ENDOUROLOGYVolume 23, Number 5, May 2009 Mary Ann Liebert, Inc.Pp. 821826DOI: 10.1089 =end.2008.0650

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Based on the evaluation criteria mentioned above, 27 arti-cles were selected. Four articles deal with urethral catheteri-zation, 13 with cystoscopy (rigid and exible), and 10 withvariables that can alter anesthetic effectiveness, referred to inthe article as improving factors.

The Ideal Lubricant

The clinical signicance and the economic impact of thewide use of intraurethral lubricants in daily practice entail theneed for a critical evaluation of their characteristics. Gel mayguarantee safety, satisfactory lubrication to reduce frictionand protect the mucosa during instrumentation, optimalvisibility, fast and efcacious anesthetic effect, local control of theurethral microbialora, andhigh electrical conductivity toprevent thermal injuries. In addition, it must be easily han-dled and cost effective. The accomplishment of the above re-quirements is needed to dene an ideal gel.

The available intraurethral gels are composed of lidocaine,preservatives (methyl and propyl parabens), suspendingagents (carboxymethylcellulose or hydroxyethylcellulose),and clorexidine. Depending on the combination of theseconstituents, four categories can be distinguished: Lubricant-anesthetic-disinfectant (Instillagel , Farco-Pharma, GmBH,Cologne, Germany, Cathejell , Montavit, Austria, AT;lubricant-disinfectant (Cathejell S , Montavit, Austria,AT, Endosgel , Farco-Pharma, GmBH, Cologne, Germany;lubricant-anesthetic (Xylocaine , AstraZeneca LP, Wilming-ton, DE; and plain lubricant (K-Y Jelly . Johnson & JohnsonMedical, Arlington, VA, Lubrigel , Major Pharmaceuticals,Livonia, MI.

Characteristics

Safety

Despite the large safety range, undesired effects from thehigh blood levels of lidocaineor allergic reactions to lidocaine,to preservatives, to the suspending agent and =or to chlorex-idine have been registered. 68

Several clinical studies have suggested the safety of in-traurethral use. Eardley and associates 9 found that the instil-lation of 400 mg lidocaine gel before transurethral resection of the prostate results in plasma concentrations safely below thetoxic levels. Ouellette and colleagues 10 reported that plasmaconcentration after the intraurethral administration of 218 to550 mg of 2% lidocaine never reached levels that caused sys-temic toxicity, and Birch and Miller 11 conrmed the low peakconcentration after intravesical administration of 400mg of lidocaine.

Excessive amounts, short intervals betweendoses, and longduration of urethral exposure can result in high plasma levelsof lidocaine or its metabolites and serious adverse effects. Inaddition, mucosal integrity may play an important role. Incases of severe or multiple urethral injuries, absorption acrossthe damaged mucosa is rapid, and a high peak systemicconcentration from the absence of the hepatic rst-pass effectcanbe reached. Centralnervous system (CNS) toxicity usuallyprecedes the cardiovascular effects of the drug, because itoccurs at lower plasma concentrations. 12 Direct effects on theheart include slow conduction, negative inotropism, andeventually cardiac arrest. 13

Lubricant action

Carboxymethyl and hydroxyethyl cellulose are polysac-charide derivatives of cellulose. These highly hydrosolublesubstances confer the lubricant properties of the intraurethralgels. Their adhesion to the mucosa reduces friction by creatinga slippery barrier between urethra and instruments. 14

Anesthetic action Lidocaine or lidocaine hydrocloride or 2-(diethylamino)-2,

6-acetoxylidide is a lipid-soluble tertiary amide able to pene-trate the hydrophobic components of the cell membranes andto exert local anesthetic action by blocking the voltage oper-ated sodium channels. 15 Today it is known that pain of tubular organs such as the urethra is produced by mechanicalstretching. Shear stress forces stimulate urothelial cells to re-lease adenosine triphosphate that subsequently act on P2X 2 =3nociceptive receptors on suburothelial sensory nerve termi-nals, which then relay impulses to the CNS to be registered aspain. 16

Lidocaine acts on these suburothelial nerves by inhibitingneuronal impulse propagation and =or generation. Topicalanesthesia, however, does not efciently block pain sensationof the entire urethrabecause of the complex innervation of therhabdosphincter, and passage of the membranous urethraresults as the most painful part of cystoscopy. 1719

Anti-infective properties

Johnson and coworkers 20 reportedthat local anesthetics notonly serve as agents for pain control, but also possess anti-microbial activity and can be considered as an adjunct totraditional antimicrobial use in the clinical or laboratory set-ting. Sperling and colleagues 21 investigated the disinfectantaction of Instillagel in symptomatic patients with nongono-coccal urethritis and found that eradication of the infection

was obtained in 81.2% of patients, results comparable withsystemic antibiotic treatment effectiveness.

Electrical conductivity

The importance of gel electrical conductivity to preventurethral stenosis during transurethral resection was rst re-ported by Flachenecker and associates 22 Investigators foundthat when the conductivity of the gelis equal to or higher thanthat of the urethra, the dispersion of current between thesurface of the resection instrument and urethra is uniform andthe current density is low. In cases of low conductivity gel(insulator), electrical current is concentrated in a few pointsalong the sheath where the amount of gel is low or absent,

damaging the tissue and causing scar formation. Electricalconductivity of tissues that are highly perfused, such asthe urethra, range between 4 and 6 mS =cm, and, conse-quently, the ideal conductivity of a gel must be at the samerange. 23

Clinical Use

With the restriction of the limited number of RCTs and withthe small overall number of patients included, we tried toobtain conclusions about the clinical efcacy of the intra-urethral lidocaine gel.

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Urethral catheterization

Siderias and coworkers 24 compared the efcacy of in-traurethral lidocaine gel with that of a plain lubricant duringmale urethral catheterization and found a statistically signif-icant reducedpain associatedwith theuse of theanestheticgel[level of evidence (LVE) Ib, A]. In a similar trial, Tanabeand associates 25 reported that the most of the women in theirstudy, urethral catheterization was not very painful, and nodifference was noticed in pain scores associated with the typeof lubricant used before the procedure [Ib, A]. In children whowere 4 to 11 years old, pain score and observer-rated behav-ioral distress was signicantly lower in the lidocaine gelgroup than in the lubricant group 26 [Ib, A]. This was not valid,however, for children younger than 2 years. Vaughan andcolleagues 27 found that lubricant with 2% lidocaine gel wasnot helpful in alleviating pain that was associated with theprocedure [Ib, A].

Cystoscopy

Rigid cystoscopy. Stein and associates 28 compared theefcacy of 2% intraurethral lidocaine gel to plain lubricant inpain management during cystoscopy. In this study, the in-traurethral dwell time was 5 and 10 minutes, but the amountof gel was not reported. Using a VAS, the investigators foundno difference in pain perception between patients (men andwomen) who received lidocaine or plain lubricant. [Ib, A]. Incontrast, Goldscher and colleagues 29 found that 30 mL of lidocaine gel dwelling in the urethra for 20 minutes beforecystoscopy offers no advantageover plain lubricant regardingpain control during cystoscopy in women. It can, however,signicantly decrease pain in men [Ib, A].

The importance of the gel amount during cystoscopy isreported by Brekkan and coworkers. 30 They evaluated theinuence of instilled volume (11 vs 20mL) in pain perceptionand found a signicant pain reduction in the group of malepatients with the use of 20 mL of the anesthetic lubricant. Nodifference was found among the two groups of women [Ib,A]. In a recent study by Choe and associates, 31 however, astatistical signicant reduction in pain score was found afterapplication of anesthetic gel in women during cystoscopy[Ib, A].

Flexible cystoscopy. The advent of exible cystoscopyand digital chip technology has signicantly increased toler-ability during cystoscopy. Consequently, the value of lido-caine gel in alleviating pain during this procedure has beenreevaluated by many authors with contradictory results. 3238

Patel and coworkers 39 performed a meta-analysis of the re-sults of the above clinical trials. Pooled data, including morethat 800 male patients from nine trials, identied no statisti-cally signicant difference in the efcacy of pain control be-tween 2% lidocaine and plain gel during exible cystoscopy[Ia, A]. More recently, the same results have been reported byChitale and colleagues 40 in a RCT study [Ib, A]. No studieshave been found regarding the need for local anesthesiasduring exible cystoscopy in women.

Cost-effectiveness

The cost-effectiveness of intraurethral gel use has been lessfrequently argued. Considering the wide use, however, cost is

an important issue. McFarlane and associates 38 found that thecost savings at their institute would be more than $5000 a yearif lidocaine gel was eliminated from all outpatient cystoscopyprocedures. Chen and colleagues 35 reported that lidocaine gelis more than three times more expensive than plain gel inTaiwan. Patel and coworkers 30 reported that the cost of 10mLof lidocaine gel, which is $4.64 vs $0.86 for 4 ounces of plaingelat their institution, is not reimbursed and must be borne by

the urology practice.Improving Factors

The instillation of topical anesthetics provokes discomfortand may negatively inuence pain perception of the proce-dure. 41 Several studies examined strategies to overcome dis-comfort during urethral instillation to increase clinicaleffectiveness of lidocaine gel.

Decreasing pain during initial instillation

Temperature. Thomson and coworkers 42 investigated therole of temperature in the perception of pain during gel in-stillation. They found that the reduction of the gels tempera-

ture at 48

C was signicantly caused less pain compared withgelsat 22 8 Cor40 8 C. They postulate that this is a cryoanalgesicphenomenon relating to the temperature of the gel and itsthermal effect on nociceptors [Ib, A]. In a similar study, Goeland Aron 43 conrmed the previous results [Ib, A].

Delivery rate. Pain in tubular and sacular organs iscaused by distension. Consequently, instillation gel rate mayinuence the extent of urethral distention and pain percep-tion. Khan and colleagues 44 compared 2 vs 10 sec intraurethralgel delivery rate into 100 patients and found that the instil-lation discomfort, which may inuence perceived pain in theentire procedure, may be signicantly reduced by slowing geladministrationrate [Ib, A].

Chemical composition. The role of chemical compositionas a cause of pain during instillation was studied by Ho andassociates. 45 They found statistically less discomfort in pa-tients who received plain aqueous gel compared with thegroup who received lidocaine-chlorhexidine gluconate gel[Ib, A]. Jayathillake and coworkers 46 randomized 141 pa-tients to receive either urethral gel that contained 10 mL of 2% lidocaine with 0.05% chlorhexidine gluconate or K-Y geland 2% lidocaine solution. They found no signicant differ-ence in pain at insertion, during, or immediately after exiblecystoscopy. Pain during rst void, however, was statisticallygreater in patients in whom gels that contained chlorexidine

were used [Ib, A].

Decreasing pain during cystoscopy

Volume of local anesthetic. The value of adequate vol-ume during rigid cystoscopy was outlined by Goldsher andassociates 29 and conrmed by Brekkan and coworkers 30 andHolmes and colleagues. 36 They found that a minimal volumeof 20 mL is necessary to increase anesthetic efcacy.

Urethral exposure time. There are two studies, alreadymentioned, that deal with time exposure before rigid

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cystoscopy. Stein and associates 28 [Ib, A] found no differencein pain reduction during rigid cystoscopy after intraurethralexposure time of 5 and 10 minutes compared with Goldsherand colleagues 29 who found that an exposure time of 20 min-utes is necessary for signicant pain reduction [Ib, A].Eggersmann and coworkers 47 showed, in a randomized,double-blind, placebo-controlled study that measured sen-sory thresholds of the male urethra, that the pain-relieving ef-

fect of lidocainegel needs an exposureof more than 10 minutes.Choong and colleagues, 32 in a study that consisted of twoconsecutive parts, tried to study the importance of the expo-sure time of lidocaine gel in pain reduction during exiblecystoscopy. In the rst part of the study, 90 men were as-signed to four groups who received 20mL of 2% lidocaine gelor plain aqueous gel over a 5- or 25-minute exposure time.This showed a signicant difference in pain reduction forpatients who received 2% lidocaine gel over an exposure timeof 25 minutes. Sixty men entered the second part of the study,to compare pain perception between exposure times of 15 and25 minutes; no difference was detected between these expo-sure times. The authors concluded that intraurethral deliveryof 20mL of 2% lidocaine gel over an exposure time of

15 minutes is preferred.

Combination treatment. Demir and associates 48 assessedthe efcacy of intraurethral lidocaine (group 1) vs the combination of DMSO with lidocaine (group 2) in male patientsundergoing rigid cystoscopy. Exposure urethral time was15 minutes and 5 minutes in group 1 and group 2, respec-tively. Immediately after cystoscopic examination, pain wasscored on a VAS. They found that dimethyl sulfoxide withlidocaine caused signicantly less delivery discomfort andless pain perception in a shorter exposure time.

Fields for Future Research

Various new minimally invasive techniques, includingthermal-based therapies, bipolar resection, laser therapy, andother new modality treatments, have been developed for themanagement of lower urinary tract symptoms caused by be-nign prostatic obstruction. The wide acceptance and applica-tion of the new high-energy techniques may generate the need

for new specialized products for the protection of the ure-thra. Recently, Faul and coworkers 49 reported the importanceof intraurethral gel quality and conductivity as a preventivefactor with regard to urethral thermal injury and stenosisduring bipolar transurethral resection.

Indications for Proper Use

Available data suggest that anesthetic lubricants are neededduring catheterization in men and children older than 4 years.Plain lubricantsare sufcient during catheterizationin womenand in exible cystoscopy in men. A slow instillation rate of more than 20 mL of cooled anesthetic gel, with an exposuretime of 10 to 20 minutes decreases initial pain perceptionand increases patient tolerance during rigid cystoscopy(Table 1).

Although there are no data, it is common sense that inpatients who are under anesthesia, the use of anesthetic lubricants is not justied. The use of the less-expensive plainlubricants may contribute to the overall safety and cost re-duction. The use of disinfectant lubricants may be useful inreducing infections after urethral manipulation; however,chlorhexidine appears to signicantly increase the levels of pain and urgency.

Conclusions

While the available evidence for best practice in terms of treatment is continuously evolving, the important issues re-garding the correct use of intraurethral gels are, for the mostpart, left to individual preference. Data indicate that forcatheterization in women and for exible cystoscopy in men,the need of an anesthetic-lubricant gel is questionable. Ap-propriate use, in terms of instillation rate, amount, and dwellintraurethral time, may be helpful during rigid cystoscopy inmen. In the modern era of minimally invasive treatments of

lower urinary tract symptoms, however, further studies thataddress specic issues are needed.

Disclosure Statement

No competing nancial interests exist.

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Table 1. Indications for the Proper Useof Intraurethral Anesthetic Gel

ProcedureIntraurethral

anesthesia LVE

Cystoscopy Rigid Male a

Ib: AFemale Inc

Flexible Male Ia: AFemale b

Catheterization Pediatric c Ib: AMale Ib: AFemale Ib: A

a Instillation rate 10 sec, volume 20mL, temperature of 4 8 C, ex-posure time of 10 to 20 minutes.

b No data.c Children older than 4 years.LVE level of evidence; Inc inconclusive.

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Address reprint requests to:Vassilios Tzortzis, M.D.Department of Urology

University of Thessaly School of Medicine Mezourlo 411 10

LarissaGreece

E-mail: [email protected]

Abbreviations Used

CNS central nervous systemRCT randomized controlled trialVAS visual analog scale

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