Revisão sistemática sobre terapia oral para tratamento dos sintomas da síndrome da bexiga dolorosa: as diretrizes brasileiras

Santos, Thaís Guimarães dos; Miranda, Isabela Albuquerque Severo de; Nygaard, Christiana Campani; Schreiner, Lucas; Castro, Rodrigo de Aquino; Haddad, Jorge Milhen

doi:10.1055/s-0037-1609049

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Revista Brasileira de Ginecologia e Obstetrícia

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Sumário

Review Article • Rev. Bras. Ginecol. Obstet. 40 (02) • Fev 2018 • https://doi.org/10.1055/s-0037-1609049 copiar

Revisão sistemática sobre terapia oral para tratamento dos sintomas da síndrome da bexiga dolorosa: as diretrizes brasileiras^* * This study has the approval of the Febrasgo Specialized National Commission of Urogynelogy.

Autoria SCIMAGO INSTITUTIONS RANKINGS

Resumo

Cistite intersticial (IC), incluindo a síndrome da bexiga dolorosa (SBD), é uma doença crônica e debilitante que afeta principalmente mulheres. É caracterizada por dor pélvica associada à urgência miccional, frequência urinária, noctúria e exame cultural de urina negativo, com citologia normal. A cistite intersticial pode ser suficientemente severa para ter um efeito devastador na qualidade de vida, mas também pode estar associada a sintomas moderados e menos debilitantes. Embora existam vários ensaios clínicos para avaliar terapias orais e intravesicais, o tratamento para IC permanece longe do ideal. Esta revisão sistemática avaliou ensaios clínicos randomizados publicados sobre medicamentos orais usados para tratar sintomas de SBD. Este estudo foi realizado de acordo com ométodo preferred reporting items for systematic reviews and meta-analyses (PRISMA). Dois revisores independentes examinaram os estudos para determinar sua inclusão ou exclusão e para realizar a análise metodológica. Os critérios de inclusão foram: ensaios clínicos randomizados publicados entre abril de 1988 e abril de 2016 que usaram medicações orais no tratamento dos sintomas da SBD ou CI. De acordo com a revisão sistemática realizada, a melhor opção de medicação oral para o tratamento dos SBD é o pentosano polissulfato sódico. No entanto, esta droga não está disponível no Brasil. A amitriptilina administrada por via oral é um tratamento eficaz para SBD e deve ser oferecida como primeira escolha.

Descritores:
síndrome da bexiga dolorosa; cistite intersticial; terapia oral

First Author/Year	n	Groups	Outcomes Measured	Results	Significance between groups	Jadad Scale¹¹11 Silva Filho CR, Saconato H, Conterno LO, Marques I, Atallah AN. Assessment of clinical trial quality and its impact onmeta-analyses. Rev Saude Publica 2005;39(06):865-873. Doi: 10.1590/S0034-8910 2005000600001 https://doi.org/10.1590/S0034-8910... score
Cartledge et al (2000)⁸8 Cartledge JJ, Davies AM, Eardley I. A randomized double-blind placebo-controlled crossover trial of the efficacy of L-arginine in the treatment of interstitial cystitis. BJU Int 2000;85(04): 421-426. Doi: 10.1046/j.1464-410x.2000.00490.x https://doi.org/10.1046/j.1464-410x.2000...	16	l-arginine x placebo	ICSI scoreVoiding Diary	Significant improvement compared with initial assessment. No difference between groups.	p= 0.16	3
Korting et al (1999)²2 Korting GE, Smith SD, Wheeler MA, Weiss RM, Foster HE Jr. A randomized double-blind trial of oral L-arginine for treatment of interstitial cystitis. J Urol 1999;161(02):558-565. Doi: 10.1016/S0022-5347(01)61950-5 https://doi.org/10.1016/S0022-5347(01)61...	53	l-arginine x placebo	Symptoms ScoreLikert ScaleVoiding Diary	No difference between groups.	p= 0.31 (intention to treat)	5

First Author/Year	Drug tested	n	Groups	Outcomes Measured	Results	Significance between groups	Jadad Scale¹¹11 Silva Filho CR, Saconato H, Conterno LO, Marques I, Atallah AN. Assessment of clinical trial quality and its impact onmeta-analyses. Rev Saude Publica 2005;39(06):865-873. Doi: 10.1590/S0034-8910 2005000600001 https://doi.org/10.1590/S0034-8910... score
Nickel et al (2012)³3 Nickel JC, Crossland A, Davis E, et al. Investigation of a Ca2+ channel ±a2d ligand for the treatment of interstitial cystitis: results of a randomized, double-blind, placebo controlled phase II trial. J Urol 2012;188(03):817-823. Doi: 10.1016/j.juro.2012.05.010 https://doi.org/10.1016/j.juro.2012.05.0...	PD-0299685	161	PD-0299685 30 mg x PD-0299685 60 mg x placebo	ICSI scoreseverity score of pain worsening	No difference between groups and placebo.	p= 0.08	2
Sairanen et al (2005)⁹9 Sairanen J, Tammela TLJ, Leppilahti M, et al. Cyclosporine A and pentosan polysulfate sodium for the treatment of interstitial cystitis: a randomized comparative study. J Urol 2005;174(06): 2235-2238. Doi: 10.1097/01.ju.0000181808.45786.84 https://doi.org/10.1097/01.ju.0000181808...	Cyclosporine A	64	Cyclosporine A x Pentosan polysulfate	daily micturition frequencyVolume voidedNocturiaScale of painGRA	Significant improvement in parameters regarding pentosan polysulfate	p < 0.01	3
Chen et al (2014)¹²12 Chen H,Wang F, Chen W, et al. Efficacy of daily low-dose sildenafil for treating interstitial cystitis: results of a randomized, doubleblind, placebo-controlled trial-treatment of interstitial cystitis/ painful bladder syndrome with low-dose sildenafil. Urology 2014;84(01):51-56. Doi: 10.1016/j.urology.2014.02.050 https://doi.org/10.1016/j.urology.2014.0...	Sildenafil	48	Sildenafil x Placebo	Voiding diaryICSI scoreICPIVisual analog scaleUrodynamic parametersSymptoms global improvement rate	Significant improvement in parameters regarding placebo.	p < 0.05	3
Warren et al (2000)⁷7 Warren JW, Horne LM, Hebel JR, Marvel RP, Keay SK, Chai TC. Pilot study of sequential oral antibiotics for the treatment of interstitial cystitis. J Urol 2000;163(06):1685-1688. Doi: 10.1016/S0022- 5347(05)67520-9 https://doi.org/10.1016/S0022-...	Antibiotics	50	AntibioticsxPlacebo	Semi-quantitative assessment of bladder pain	No significant difference in global improvement between groups.	p= 0.14	1

First Author/Year	n	Groups	Outcomes Measured	Results	Significance between groups	Jadad Scale¹¹11 Silva Filho CR, Saconato H, Conterno LO, Marques I, Atallah AN. Assessment of clinical trial quality and its impact onmeta-analyses. Rev Saude Publica 2005;39(06):865-873. Doi: 10.1590/S0034-8910 2005000600001 https://doi.org/10.1590/S0034-8910... score
van Ophoven et al (2004)¹1 van Ophoven A, Pokupic S, Heinecke A, Hertle L. A prospective, randomized, placebo controlled, double-blind study of amitriptyline for the treatment of interstitial cystitis. J Urol 2004;172(02): 533-536. Doi: 10.1097/01.ju.0000132388.54703.4d https://doi.org/10.1097/01.ju.0000132388...	50	Amitriptyline 25 to 100 mg/day x Placebo	ICSIVisual pain scale	Significant improvement in pain symptoms and urgency intensity scores.	p= 0.05 (score) p< 0.001 (pain/urgency)	4
Foster et al (2010)⁶6 Foster HE Jr, Hanno PM, Nickel JC, et al; Interstitial Cystitis Collaborative Research Network. Effect of amitriptyline on symptoms in treatment naïve patients with interstitial cystitis/painful bladder syndrome. J Urol 2010;183(05):1853-1858. Doi: 10.1016/j.juro. 2009.12.106 https://doi.org/10.1016/j.juro...	271	Amitriptyline 10 to 75 mg/day x Placebo	GRA, ICSISF-36, FSFI	Group using Amitriptyline, at least 50 mg/day, had significant improvement.	p < 0.01 (for dose of at least 50 mg/day)	3

First Author/Year	n	Groups	Outcomes Measured	Results	Significance between groups	Jadad Scale¹¹11 Silva Filho CR, Saconato H, Conterno LO, Marques I, Atallah AN. Assessment of clinical trial quality and its impact onmeta-analyses. Rev Saude Publica 2005;39(06):865-873. Doi: 10.1590/S0034-8910 2005000600001 https://doi.org/10.1590/S0034-8910... score
Nickel et al (2014)¹⁵15 Nickel JC, Herschorn S, Whitmore KE, et al. Pentosan polysulfate sodium for treatment of interstitial cystitis/bladder pain syndrome: insights from a randomized, double-blind, placebo controlled study. J Urol 2015;193(03):857-862. Doi: 10.1016/j. juro.2014.09.036 https://doi.org/10.1016/j...	368	PPS 100 mg xPPS 300 mg xPlacebo	PORISICSIGRA	No significant difference in symptoms.	p > 0.08	2
Mulholland et al (1990)¹³13 Mulholland SG, Hanno P, Parsons CL, Sant GR, Staskin DR. Pentosan polysulfate sodiumfor therapy of interstitial cystitis. Adouble-blind placebo-controlled clinical study. Urology 1990;35(06):552-558. Doi: 10.1016/0090-4295(90)80116-5 https://doi.org/10.1016/0090-4295(90)801...	110	PPS 300 mg x placebo	Voiding diary.Pain and urgency scales.	PPS was more effective than placebo.	p= 0.03	5
Sant et al (2003)¹⁴14 Sant GR, Propert KJ, Hanno PM, et al; Interstitial Cystitis Clinical Trials Group. A pilot clinical trial of oral pentosan polysulfate and oral hydroxyzine in patients with interstitial cystitis. J Urol 2003; 170(03):810-815. Doi: 10.1097/01.ju.0000083020.06212.3d https://doi.org/10.1097/01.ju.0000083020...	121	Combined therapy (PPS + hydroxyzine) x PPS alone x hydroxyzine alone x placebo	GRAThe University of Wisconsin Symptom ScoreICSI	1. PPS + Hydroxyzine: lower urinary frequency.2. Hydroxyzine x No Hydroxyzine: no significant difference.3. PPS × no PPS: better response trend in the PPS group.	1. p= 0.00362. p= 0.263. p= 0.064	2
Nickel et al (2005)⁴4 Nickel JC, Barkin J, Forrest J, et al; Elmiron Study Group. Randomized, double-blind, dose-ranging study of pentosan polysulfate sodium for interstitial cystitis. Urology 2005;65(04):654-658. Doi: 10.1016/j.urology.2004.10.071 https://doi.org/10.1016/j.urology.2004.1...	380	PPS 300 mg × 600 mg × 900 mg/day	ICSIPORIS	All dosages had significant clinical response. Efficacy: no significant difference between dosages.	p < 0.001	1
Davis et al (2008)¹⁶16 Davis EL, El Khoudary SR, Talbott EO, Davis J, Regan LJ. Safety and efficacy of the use of intravesical and oral pentosan polysulfate sodium for interstitial cystitis: a randomized doubleblind clinical trial. J Urol 2008;179(01):177-185. Doi: 10.1016/j. juro.2007.08.170 https://doi.org/10.1016/j...	41	Intravesical PPS + oral PPSx intravesical placebo + oral PPS	ICSIPUFSF-36	The change in total ICSI score and improvement in quality of life was significantly higher in the group treated.	p= 0.04p ≤ 0.001	5

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[1] Address for correspondence Thaís Guimarães dos Santos, PhD, (e-mail: thaisgsantos@gmail.com).

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Revisão sistemática sobre terapia oral para tratamento dos sintomas da síndrome da bexiga dolorosa: as diretrizes brasileiras* * This study has the approval of the Febrasgo Specialized National Commission of Urogynelogy.

Resumo

Revisão sistemática sobre terapia oral para tratamento dos sintomas da síndrome da bexiga dolorosa: as diretrizes brasileiras^* * This study has the approval of the Febrasgo Specialized National Commission of Urogynelogy.