Microorganism in Overactive Bladder Patients

NCT00883818 | Completed Phase 4

• 1 other identifier: 2006-12-027
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

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.

Conditions

Overactive Bladder

Keywords

Overactive bladder; Mycoplasma

Outcome Measures

Primary Outcomes (1)

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

  Baseline

Secondary Outcomes (2)

• Reduction rate in urinary frequency after treatment in women with positive culture at baseline.

  2 weeks after treatment

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

  2 weeks after treatment

Study Arms (1)

Antibiotics therapy

EXPERIMENTAL

Drug: azithromycin, doxycycline

Interventions

azithromycin, doxycycline DRUG

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

Antibiotics therapy

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (3)

Inha University College of Medicine

Inchon, South Korea

Location

Kangnam St. Mary's Hospital, The Catholic University of Korea

Seoul, 137-701, South Korea

Location

Asan Medical Center, Ulsan College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Mycoplasma Infections

Interventions

Azithromycin; Doxycycline

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: April 20, 2009
• Study Start: January 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 7, 2009

Record last verified: 2009-06

Locations

KR (3)