Overactive Bladder Clinical Trial
Official title:
Detection and Treatment Benefit of Microorganism (Chlamydia Trachomatis, Mycoplasma Hominis, Ureaplasma Urealyticum) 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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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