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

NCT01879930 | Terminated Phase 4 DMC

• 3 other identifiers: 075/0821482012DR4157
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pelvic Pain Syndrome; Bladder Pain Syndrome

Keywords

randomized; placebo-controlled; double-blind study; doxycycline

Outcome Measures

Primary Outcomes (1)

• Change in the O'Leary-Sant IC symptom and problem index total score from baseline

  4, 8 , 24 weeks

Secondary Outcomes (2)

• 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.

  4, 8, 24 weeks

• Changes in sexual function assessed by the Female Sexual Function Index (FSFI) at the time of the particular follow-up visit

  4, 8, 24 weeks

Study Arms (2)

doxycycline

ACTIVE COMPARATOR

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

Drug: doxycycline

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

doxycycline DRUG

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

Also known as: Zadorin-100® (doxycycline), licence number Swissmedic: 43051

doxycycline

placebo DRUG

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

Also known as: Placebo Galepharm

placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Urology, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

Related Publications (5)

• van de Merwe JP, Nordling J, Bouchelouche P, Bouchelouche K, Cervigni M, Daha LK, Elneil S, Fall M, Hohlbrugger G, Irwin P, Mortensen S, van Ophoven A, Osborne JL, Peeker R, Richter B, Riedl C, Sairanen J, Tinzl M, Wyndaele JJ. Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal. Eur Urol. 2008 Jan;53(1):60-7. doi: 10.1016/j.eururo.2007.09.019. Epub 2007 Sep 20.

  PMID: 17900797 BACKGROUND

• Burkhard FC, Blick N, Hochreiter WW, Studer UE. Urinary urgency and frequency, and chronic urethral and/or pelvic pain in females. Can doxycycline help? J Urol. 2004 Jul;172(1):232-5. doi: 10.1097/01.ju.0000128698.93305.2e.

  PMID: 15201781 RESULT

• Temml C, Wehrberger C, Riedl C, Ponholzer A, Marszalek M, Madersbacher S. Prevalence and correlates for interstitial cystitis symptoms in women participating in a health screening project. Eur Urol. 2007 Mar;51(3):803-8; discussion 809. doi: 10.1016/j.eururo.2006.08.028. Epub 2006 Aug 30.

  PMID: 16979286 RESULT

• Leppilahti M, Tammela TL, Huhtala H, Auvinen A. Prevalence of symptoms related to interstitial cystitis in women: a population based study in Finland. J Urol. 2002 Jul;168(1):139-43.

  PMID: 12050508 RESULT

• O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.

  PMID: 9146003 RESULT

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Fiona Burkhard

  Vice Chair urology dep. Inselspital

  PRINCIPAL INVESTIGATOR

• Claudia Meissner, MD

  Department of Urology, Inselspital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 18, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 5, 2015

Record last verified: 2015-03

Locations

CH (1)