Overactive BladderPhase 4NCT00883818
Microorganism in Overactive Bladder Patients
A Phase 4 study testing azithromycin, doxycycline in people with Overactive Bladder, run by Samsung Medical Center at 3 sites in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- azithromycin, doxycycline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2007to Dec 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Inha University College of Medicine
Inchon
Kangnam St. Mary's Hospital, The Catholic University of Korea
Seoul, 137-701
Asan Medical Center, Ulsan College of Medicine
Seoul
About this study
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.
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.
- Conditions
- Overactive Bladder
- Being tested
- azithromycin, doxycycline
- Keywords
- Overactive bladder, Mycoplasma
- Medical subject headings
- Urinary Bladder, Overactive, Mycoplasma Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin, doxycyclineDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics therapy | Experimental | Not described Receives: Drug: azithromycin, doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of positive cultures for M. hominis, U. urealyticum and C. trachomatis in women with OAB symptoms.
Measured: Baseline
Secondary outcomes (2)
Reduction rate in urinary frequency after treatment in women with positive culture at baseline.
Measured: 2 weeks after treatment
Changes in mean urgency episodes, PPBC scores, BFLUTS questionnaire and PPTB after treatment in women with positive culture at baseline.
Measured: 2 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Kyu-Sung Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883818
- Sponsor's protocol ID
- 2006-12-027
- Status last verified
- Jun 2009
- First submitted
- 16 Apr 2009
- Last updated
- 7 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Treatment Benefit of Microorganism (Chlamydia Trachomatis, Mycoplasma Hominis, Ureaplasma Urealyticum) in Overactive Bladder Patients
- ClinicalTrials.gov ID
- NCT00883818
- Acronym / sponsor ID
- 2006-12-027
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Mycoplasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 20 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antibiotics therapy | Experimental | Drug: azithromycin, doxycycline |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Neurogenic bladder
- Indwelling catheter
- PVR ≥ 150ml
- Interstitial cystitis
- History of radiation therapy on pelvic area or chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| azithromycin, doxycyclineAlso: azithromycin, doxycyclineazithromycin 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 | Drug | Antibiotics therapy |
Primary outcome
Percentage of positive cultures for M. hominis, U. urealyticum and C. trachomatis in women with OAB symptoms.
Time frame: Baseline
2 secondary outcomes
Reduction rate in urinary frequency after treatment in women with positive culture at baseline.
Time frame: 2 weeks after treatment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyu-Sung Lee, Ph.D principal investigator
Samsung Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing azithromycin, doxycycline in people with Overactive Bladder, run by Samsung Medical Center at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of positive cultures for M. hominis, U. urealyticum and C. trachomatis in women with OAB symptoms. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2009.