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Trial record 51 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Microorganism in Overactive Bladder Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00883818
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : July 7, 2009
Information provided by:
Samsung Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: azithromycin, doxycycline Phase 4

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Detection and Treatment Benefit of Microorganism (Chlamydia Trachomatis, Mycoplasma Hominis, Ureaplasma Urealyticum) in Overactive Bladder Patients
Study Start Date : January 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Other Names:
  • azithromycin
  • doxycycline

Primary Outcome Measures :
  1. Percentage of positive cultures for M. hominis, U. urealyticum and C. trachomatis in women with OAB symptoms. [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Reduction rate in urinary frequency after treatment in women with positive culture at baseline. [ Time Frame: 2 weeks after treatment ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Women age of 20 ≤ and ≤ 80 years
  2. Symptoms of urinary frequency (≥8 micturitions per 24 hours) and urinary urgency (defined as a level of 3 to 5 in a 5 point urgency scale) at least one episode a day as verified by baseline micturition diary
  3. Symptoms of overactive bladder, including, urgency, frequency, and/or urinary urge incontinence for more than 3 months
  4. No proven ordinary bacteria on routine urine culture or gram stain
  5. Positive for one of Mycoplasma homonis, Ureaplasma Urealyticum and Chlamydia trachomatis on urethral or cervical swab

Exclusion Criteria:

  1. Neurogenic bladder
  2. Indwelling catheter
  3. PVR ≥ 150ml
  4. Interstitial cystitis
  5. History of radiation therapy on pelvic area or chemotherapy
  6. unable to record voiding diary
  7. Pregnancy
  8. Other reasons according to investigator's opinion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00883818

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Korea, Republic of
Inha University College of Medicine
Inchon, Korea, Republic of
Kangnam St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Asan Medical Center, Ulsan College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
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Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center

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Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center Identifier: NCT00883818     History of Changes
Other Study ID Numbers: 2006-12-027
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: July 7, 2009
Last Verified: June 2009
Keywords provided by Samsung Medical Center:
Overactive bladder
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms