Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®)
Autor(a) principal: | |
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Data de Publicação: | 2012 |
Outros Autores: | , , , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UNESP |
Texto Completo: | http://hdl.handle.net/11449/226727 |
Resumo: | Painful bladder syndrome associated with interstitial cystitis (PBS/IC) is a clinical condition characterized pelvic pain, urinary urgency, and urinary frequency. In this study, 22 patients were assigned to make two visits over a three weeks period. The patients were randomly, double-blinded assigned in two groups. The first group received Cystex® capsules. The second group received placebo capsules. Two capsules were taken three times a day away from meals. The change from baseline in the O'Leary-Sant IC symptom and problem index was the primary outcome parameter. Changes in functional bladder capacity and intensity of pain and urgency have been chosen as secondary outcome parameters. Mood as well as physical and sexual activity were rated by 10 questions on a scale 0 to 6. The ratings were analyzed and the average for each patient in both groups Cystex® and placebo was determined as the quality of life index. For the primary outcome there was a statistically significant difference between the groups. Mean symptom score-sum decreased from 28.4 to 20.5 in the Cystex® group compared with 29.5 to 26.8 in the placebo group (p<0.05). For the secondary end points, pain and urgency intensity improved statistically significantly in the Cystex® group compared with the placebo group (p<0.05). The frequency and functional bladder capacity improved to greater degree in the Cystex® group. The differences were statistically significant for comparison of frequency (p<0.05) and not for functional bladder capacity (p>0.05). In our study, Cystex® enhanced quality of life over the placebo showing a statistically significant. This trial have shown that the efficacy and safety of therapy with Cystex® in the treatment of interstitial cystitis and is an alternative for patients suffering from this pathology. Therefore, it can be concluded that the composition of Cystex®, increased the quality of life in treated patients. |
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Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®)Clinical trialInterstitial cystitisPainful bladderQuality of lifePainful bladder syndrome associated with interstitial cystitis (PBS/IC) is a clinical condition characterized pelvic pain, urinary urgency, and urinary frequency. In this study, 22 patients were assigned to make two visits over a three weeks period. The patients were randomly, double-blinded assigned in two groups. The first group received Cystex® capsules. The second group received placebo capsules. Two capsules were taken three times a day away from meals. The change from baseline in the O'Leary-Sant IC symptom and problem index was the primary outcome parameter. Changes in functional bladder capacity and intensity of pain and urgency have been chosen as secondary outcome parameters. Mood as well as physical and sexual activity were rated by 10 questions on a scale 0 to 6. The ratings were analyzed and the average for each patient in both groups Cystex® and placebo was determined as the quality of life index. For the primary outcome there was a statistically significant difference between the groups. Mean symptom score-sum decreased from 28.4 to 20.5 in the Cystex® group compared with 29.5 to 26.8 in the placebo group (p<0.05). For the secondary end points, pain and urgency intensity improved statistically significantly in the Cystex® group compared with the placebo group (p<0.05). The frequency and functional bladder capacity improved to greater degree in the Cystex® group. The differences were statistically significant for comparison of frequency (p<0.05) and not for functional bladder capacity (p>0.05). In our study, Cystex® enhanced quality of life over the placebo showing a statistically significant. This trial have shown that the efficacy and safety of therapy with Cystex® in the treatment of interstitial cystitis and is an alternative for patients suffering from this pathology. Therefore, it can be concluded that the composition of Cystex®, increased the quality of life in treated patients.Laboratório de Farmacognosia, Escola de Farmácia Departamento de Farmácia Universidade Federal de Ouro Preto, Minas GeraisFaculdade de Filosofia e Ciências Departamento de Fonoaudiologia Universidade Estadual Paulista, São PauloDepartamento de Farmácia Centro Universitário Fundação Instituto de Ensino para Osasco, OsascoDepartamento de Ciências Biológicas Campus Diadema Universidade Federal de São Paulo, DiademaLaboratório de Pesquisa em Fármacos Universidade Federal do Amapá, Macapá, AmapáDepartamento de Ciências Exatas e da Terra Campus Diadema Universidade Federal de São PauloFaculdade de Filosofia e Ciências Departamento de Fonoaudiologia Universidade Estadual Paulista, São PauloUniversidade Federal de Ouro PretoUniversidade Estadual Paulista (UNESP)Instituto de Ensino para OsascoUniversidade Federal de São Paulo (UNIFESP)Universidade Federal do AmapáSouza, Gustavo H.B.Maistro, Edson L. [UNESP]Rodrigues, MarceloCarvalho, Jose C.T.Fonseca, Fernando L.A.Lopes, Andrey P.Perazzo, Fabio F.2022-04-29T02:43:34Z2022-04-29T02:43:34Z2012-03-07info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article423-427HealthMED, v. 6, n. 2, p. 423-427, 2012.1840-2291http://hdl.handle.net/11449/2267272-s2.0-84857768023Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengHealthMEDinfo:eu-repo/semantics/openAccess2024-08-09T17:40:17Zoai:repositorio.unesp.br:11449/226727Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-09T17:40:17Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false |
dc.title.none.fl_str_mv |
Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®) |
title |
Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®) |
spellingShingle |
Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®) Souza, Gustavo H.B. Clinical trial Interstitial cystitis Painful bladder Quality of life |
title_short |
Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®) |
title_full |
Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®) |
title_fullStr |
Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®) |
title_full_unstemmed |
Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®) |
title_sort |
Phase II clinical study of an association for the treatment of interstitial cystitis (Cystex®) |
author |
Souza, Gustavo H.B. |
author_facet |
Souza, Gustavo H.B. Maistro, Edson L. [UNESP] Rodrigues, Marcelo Carvalho, Jose C.T. Fonseca, Fernando L.A. Lopes, Andrey P. Perazzo, Fabio F. |
author_role |
author |
author2 |
Maistro, Edson L. [UNESP] Rodrigues, Marcelo Carvalho, Jose C.T. Fonseca, Fernando L.A. Lopes, Andrey P. Perazzo, Fabio F. |
author2_role |
author author author author author author |
dc.contributor.none.fl_str_mv |
Universidade Federal de Ouro Preto Universidade Estadual Paulista (UNESP) Instituto de Ensino para Osasco Universidade Federal de São Paulo (UNIFESP) Universidade Federal do Amapá |
dc.contributor.author.fl_str_mv |
Souza, Gustavo H.B. Maistro, Edson L. [UNESP] Rodrigues, Marcelo Carvalho, Jose C.T. Fonseca, Fernando L.A. Lopes, Andrey P. Perazzo, Fabio F. |
dc.subject.por.fl_str_mv |
Clinical trial Interstitial cystitis Painful bladder Quality of life |
topic |
Clinical trial Interstitial cystitis Painful bladder Quality of life |
description |
Painful bladder syndrome associated with interstitial cystitis (PBS/IC) is a clinical condition characterized pelvic pain, urinary urgency, and urinary frequency. In this study, 22 patients were assigned to make two visits over a three weeks period. The patients were randomly, double-blinded assigned in two groups. The first group received Cystex® capsules. The second group received placebo capsules. Two capsules were taken three times a day away from meals. The change from baseline in the O'Leary-Sant IC symptom and problem index was the primary outcome parameter. Changes in functional bladder capacity and intensity of pain and urgency have been chosen as secondary outcome parameters. Mood as well as physical and sexual activity were rated by 10 questions on a scale 0 to 6. The ratings were analyzed and the average for each patient in both groups Cystex® and placebo was determined as the quality of life index. For the primary outcome there was a statistically significant difference between the groups. Mean symptom score-sum decreased from 28.4 to 20.5 in the Cystex® group compared with 29.5 to 26.8 in the placebo group (p<0.05). For the secondary end points, pain and urgency intensity improved statistically significantly in the Cystex® group compared with the placebo group (p<0.05). The frequency and functional bladder capacity improved to greater degree in the Cystex® group. The differences were statistically significant for comparison of frequency (p<0.05) and not for functional bladder capacity (p>0.05). In our study, Cystex® enhanced quality of life over the placebo showing a statistically significant. This trial have shown that the efficacy and safety of therapy with Cystex® in the treatment of interstitial cystitis and is an alternative for patients suffering from this pathology. Therefore, it can be concluded that the composition of Cystex®, increased the quality of life in treated patients. |
publishDate |
2012 |
dc.date.none.fl_str_mv |
2012-03-07 2022-04-29T02:43:34Z 2022-04-29T02:43:34Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
HealthMED, v. 6, n. 2, p. 423-427, 2012. 1840-2291 http://hdl.handle.net/11449/226727 2-s2.0-84857768023 |
identifier_str_mv |
HealthMED, v. 6, n. 2, p. 423-427, 2012. 1840-2291 2-s2.0-84857768023 |
url |
http://hdl.handle.net/11449/226727 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
HealthMED |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
423-427 |
dc.source.none.fl_str_mv |
Scopus reponame:Repositório Institucional da UNESP instname:Universidade Estadual Paulista (UNESP) instacron:UNESP |
instname_str |
Universidade Estadual Paulista (UNESP) |
instacron_str |
UNESP |
institution |
UNESP |
reponame_str |
Repositório Institucional da UNESP |
collection |
Repositório Institucional da UNESP |
repository.name.fl_str_mv |
Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP) |
repository.mail.fl_str_mv |
|
_version_ |
1808128207559327744 |