Chronic Bladder Pain Syndrome in Women: Can Doxycycline Help? A Prospective Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital Inselspital, Berne
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01879930
First received: June 13, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

Chronic bladder pain syndrome is a chronic disabling disorder characterized by chronic pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urgency or frequency in the absence of an identifiable cause. Chronic bladder pain syndrome severely decreases an individual's quality of life and represents a significant financial burden to those affected by it. Currently, multifactorial pathogenesis is assumed including endocrine-involvement, pelvic floor muscle irregularities, immunologic aspects and chemical causes. Corresponding to the wide spectrum of presumptive triggers, a large number of therapeutic approaches are propagated, however most are associated with limited effectiveness. Thus, treatment of BPS is a challenge and the ideal therapy remains to be elucidated. Microorganisms such as Chlamydia trachomatis, Ureaplasma urealyticum and Mycoplasma genitalium remains a challenge so that these organisms may well be involved in the pathogenesis of chronic bladder pain syndrome. The investigators hypothesise that doxycycline orally for 4 weeks, including therapy of the sexual partner, can significantly relieve symptoms in women with chronic bladder pain syndrome


Condition Intervention Phase
Chronic Pelvic Pain Syndrome
Bladder Pain Syndrome
Drug: doxycycline
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Chronic Bladder Pain Syndrome in Women: Can Doxycycline Help? A Prospective, Randomised,Placebo-controlled, Double-blind Study

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • Change in the O'Leary-Sant IC symptom and problem index total score from baseline [ Time Frame: 4, 8 , 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of patient reported pain, urgency, frequency, functional bladder capacity documented in 72-hour pain and bladder diary, completed during the 3 days before the particular follow-up visit. [ Time Frame: 4, 8, 24 weeks ] [ Designated as safety issue: No ]
  • Changes in sexual function assessed by the Female Sexual Function Index (FSFI) at the time of the particular follow-up visit [ Time Frame: 4, 8, 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: doxycycline
Zadorin-100® (doxycycline), licence number Swissmedic: 43051 Legal holder: Mepha Pharma AG, Aesch/BL
Drug: doxycycline

Zadorin-100® (doxycycline), licence number Swissmedic: 43051 Legal holder: Mepha Pharma AG, Aesch/BL

Oral intake during study period (4 weeks) once in the morning and once in the evening

The masking of the agents is conducted using bordeaux-coloured, opaque hard-gelatine capsules (size 00) of the French company LGA. The hard-gelatine capsules are each filled with 1 unit Zadorin® 100

Other Name: Zadorin-100® (doxycycline), licence number Swissmedic: 43051
Placebo Comparator: placebo
Placebo Galepharm Composition: lactose monohydrate, ceolus PH 102, croscarmellose sodium, magnesiumstearat, manufacturer: Pharmacy Hotz, 8700 Küsnacht, Switzerland
Drug: placebo

Placebo Galepharm Composition: lactose monohydrate, ceolus PH 102, croscarmellose sodium, magnesiumstearat, manufacturer: Pharmacy Hotz, 8700 Küsnacht, Switzerland

Oral intake during study period (4 weeks) once in the morning and once in the evening

The masking of the agents is conducted using bordeaux-coloured, opaque hard-gelatine capsules (size 00) of the French company LGA. The hard-gelatine capsules are each filled with 1 unit placebo 100mg in the sham-group

Other Name: Placebo Galepharm

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Bladder pain / suprapubic pressure or discomfort for >6months
  • Urgency/urgency incontinence and/or frequency for >6months
  • Written informed consent (including confirmation that the partner will also be treated and that during the treatment period sexual intercourse is only allowed using condoms)

Exclusion Criteria

  • age < 18 years
  • Tetracycline allergy
  • Intake of a tetracycline in the last 3 months
  • pregnancy
  • breast feeding
  • bacterial cystitis in the last 4 weeks
  • urethral/vaginal/cervical/uterine and/or rectal cancer
  • chemical cystitis
  • tuberculous cystitis
  • benign or malignant bladder tumors
  • Lack of radiologic exclusion of pelvic pathology
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879930

Contacts
Contact: Fiona Burkhard, MD 0312 632 20 45 fiona.burkhard@insel.ch
Contact: Claudia Meissner, MD 031 632 20 45 claudia.meissner@insel.ch

Locations
Switzerland
Dep. of Urology, Bern University Hospital Recruiting
Berne, Switzerland, 3010
Contact: Fiona Burkhard, MD    031 632 20 45    fiona.burkhard@insel.ch   
Principal Investigator: Fiona Burkhard, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Fiona Burkhard Vice Chair urology dep. Inselspital
Study Chair: Claudia Meissner, MD Department of Urology, Inselspital Bern
  More Information

Publications:
Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01879930     History of Changes
Other Study ID Numbers: 075/08, 2148, 2012DR4157
Study First Received: June 13, 2013
Last Updated: September 8, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
randomized
placebo-controlled
double-blind study
doxycycline

Additional relevant MeSH terms:
Somatoform Disorders
Pelvic Pain
Syndrome
Cystitis, Interstitial
Mental Disorders
Pain
Signs and Symptoms
Disease
Pathologic Processes
Cystitis
Urinary Bladder Diseases
Urologic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on September 22, 2014