CClinicalTrials.gg
CompletedNCT00883818Updated Jul 7, 2009

Microorganism in Overactive Bladder Patients

A Phase 4 interventional study of azithromycin, doxycycline in Overactive Bladder, sponsored by Samsung Medical Center. Completed at 3 sites in Korea, Republic of. Open to female participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-07-07.

Sponsored by Samsung Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
84
Allocation
Not applicable
Ages
20 Years to 80 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Overactive Bladder

Keywords

  • Overactive bladder
  • Mycoplasma
03

In context

Urinary Bladder, Overactive

855 studies on the registry are indexed under Urinary Bladder, Overactive; 125 are open to participants now.

This study's enrollment of 84 is above the median of 72 across 652 interventional studies indexed under Urinary Bladder, Overactive.

Browse Urinary Bladder, Overactive studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 80 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Antibiotics therapy

    Drug: azithromycin, doxycycline

Interventions

  • Drugazithromycin, 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

    Also known as: azithromycin, doxycycline

06

What researchers measure

Primary outcomes

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

    Time frame: Baseline

Secondary outcomes

  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

07

Study locations

3 sites
  • Inha University College of Medicine
    Inchon, Korea, Republic of
  • Kangnam St. Mary's Hospital, The Catholic University of Korea
    Seoul, 137-701, Korea, Republic of
  • Asan Medical Center, Ulsan College of Medicine
    Seoul, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00883818
Lead sponsor
Samsung Medical Center
First posted
Apr 20, 2009
Start date
Jan 2007
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Jul 7, 2009

Study contacts

Kyu-Sung Lee, Ph.D
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion