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Microorganism in Overactive Bladder Patients

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
azithromycin, doxycycline
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Mycoplasma

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Inha University College of Medicine
  • Kangnam St. Mary's Hospital, The Catholic University of Korea
  • Asan Medical Center, Ulsan College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Antibiotics therapy

Arm Description

Outcomes

Primary Outcome Measures

Percentage of positive cultures for M. hominis, U. urealyticum and C. trachomatis in women with OAB symptoms.

Secondary Outcome Measures

Reduction rate in urinary frequency after treatment in women with positive culture at baseline.
Changes in mean urgency episodes, PPBC scores, BFLUTS questionnaire and PPTB after treatment in women with positive culture at baseline.

Full Information

First Posted
April 16, 2009
Last Updated
July 5, 2009
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00883818
Brief Title
Microorganism in Overactive Bladder Patients
Official Title
Detection and Treatment Benefit of Microorganism (Chlamydia Trachomatis, Mycoplasma Hominis, Ureaplasma Urealyticum) in Overactive Bladder Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive bladder, Mycoplasma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotics therapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
azithromycin, doxycycline
Other Intervention Name(s)
azithromycin, doxycycline
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of positive cultures for M. hominis, U. urealyticum and C. trachomatis in women with OAB symptoms.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Reduction rate in urinary frequency after treatment in women with positive culture at baseline.
Time Frame
2 weeks after treatment
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women age of 20 ≤ and ≤ 80 years 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 Symptoms of overactive bladder, including, urgency, frequency, and/or urinary urge incontinence for more than 3 months No proven ordinary bacteria on routine urine culture or gram stain Positive for one of Mycoplasma homonis, Ureaplasma Urealyticum and Chlamydia trachomatis on urethral or cervical swab Exclusion Criteria: Neurogenic bladder Indwelling catheter PVR ≥ 150ml Interstitial cystitis History of radiation therapy on pelvic area or chemotherapy unable to record voiding diary Pregnancy Other reasons according to investigator's opinion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inha University College of Medicine
City
Inchon
Country
Korea, Republic of
Facility Name
Kangnam St. Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Asan Medical Center, Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Microorganism in Overactive Bladder Patients

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