Microorganism in Overactive Bladder Patients
The objective of this prospective study is to determine the incidence of mycoplasma in women with overactive bladder (OAB) symptoms and whether antibiotic therapy targeting these organisms is effective.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Detection and Treatment Benefit of Microorganism (Chlamydia Trachomatis, Mycoplasma Hominis, Ureaplasma Urealyticum) in Overactive Bladder Patients|
- Percentage of positive cultures for M. hominis, U. urealyticum and C. trachomatis in women with OAB symptoms. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
- Reduction rate in urinary frequency after treatment in women with positive culture at baseline. [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
- Changes in mean urgency episodes, PPBC scores, BFLUTS questionnaire and PPTB after treatment in women with positive culture at baseline. [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
|Experimental: Antibiotics therapy||
Drug: azithromycin, doxycycline
azithromycin 1g once for women with positive cultures at baseline
doxycycline 100 mg twice daily for 7 days for women with persistent infection after treatment of azithromycin 1g
Overactive bladder (OAB) syndrome is described as 'urgency, with or without urge incontinence, usually with frequency and nocturia' by the 2002 ICS Terminology Committee. A variety of medical conditions share the symptoms of OAB, and it is important to exclude these in the process of diagnosis. Urinary tract infection (UTI) is the most frequent alternative diagnosis. Even in patients considered to have interstitial cystitis, OAB is a high probability of diagnosis due to its insidious onset of irritative symptoms.For these reasons, ICS Terminology Committee stated that the term OAB can be used only if there is no proven infection or other obvious pathology.
Isolating causative organisms through urine culture plays a crucial role, but is likely to reveal a positive result in less than half of patients presenting with irritative symptoms. Even though ordinary bacteria are not cultured from these patients, there is some evidence to suggest that atypical organisms, such as genital mycoplasma, may be associated with OAB symptoms. For example, 48% of patients with chronic voiding symptoms showed positive cultures for Ureaplasma urealyticum and Mycoplasma hominis. In 91% of the patients with positive culture, symptom severity and frequency were improved after treatment. Another evidence for mycoplasmal involvement in OAB symptoms derives from the improvements in symptoms in more than two-thirds of patients complaining of persistent frequency and urgency after the use of doxycyline which is effective against U. urealyticum, M. hominis and Chlamydia trachomatis.
Mycoplasmas are the simplest micro-organisms regarded as true bacteria. They are highly pleomorphic parasites of humans and the absence of a cell wall has been used to distinguish mycoplasma and to place them taxonomically in the class Mollicutes.Mycoplasmas are not generally viewed as being highly virulent, although they usually manifest a predilection for particular host tissues, such as the urogenital or respiratory tracts. It is now being recognized that these organisms play a more important role in human infections than was previously thought. Its slow-growing, non-culturable nature enables them to establish chronic infections, resist the effects of antibiotics and protect the organisms against immune system reactivity.Accordingly, for patients presenting with irritative bladder symptoms, and especially whose first culture is negative, a further culture may be indicated to test specifically for Mycoplasma or Chlamydia infection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00883818
|Korea, Republic of|
|Inha University College of Medicine|
|Inchon, Korea, Republic of|
|Asan Medical Center, Ulsan College of Medicine|
|Seoul, Korea, Republic of|
|Kangnam St. Mary's Hospital, The Catholic University of Korea|
|Seoul, Korea, Republic of, 137-701|
|Principal Investigator:||Kyu-Sung Lee, Ph.D||Samsung Medical Center|