Clinical trial NCT00999518: A Study To Investigate Tanezumab In Patients With Interstitial Cystitis/ Painful Bladder Syndrome
Official title: A PHASE 2B, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY EVALUATING THE EFFICACY AND SAFETY OF TANEZUMAB FOR THE TREATMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH INTERSTITIAL CYSTITIS/ PAINFUL BLADDER SYNDROME (IC/PBS).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cystitis, Interstitial
Keywords: Randomized double blind placebo-controlled parallel-group dose-range finding interstitial cystitis efficacy pain urinary symptoms safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-10-21
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In a previous study in patients with interstitial cystitis/ painful bladder syndrome (IC/PBS), tanezumab has shown to be efficacious in relieving the pain associated with IC/PBS, as well as some effect on reducing urinary urgency. Only one dose was studied, and tanezumab was well tolerated. In this study, the hypothesis being tested is that tanezumab will show efficacy at several doses on reducing pain with sufficient tolerability. Tanezumab's safety will also be assessed at different dose levels

Detailed description: This study was terminated on 16 November 2010 following a US FDA partial clinical hold for the tanezumab interstitial cystitis clinical study announced on 19 July 2010 for potential safety issues, and following a pre-planned interim analysis.

Eligibility criteria: Inclusion Criteria:

* Patients with interstitial cystitis/ painful bladder syndrome for more than 6 months with moderate to severe pain and a micturition frequency greater than 7 per day.
* Patients who have been on stable oral medicines for interstitial cystitis/ painful bladder syndrome for at least 3 months. Other therapies might need to be stopped.

Exclusion Criteria:

* Patients on certain recent treatments for interstitial cystitis/ painful bladder syndrome.
* Body mass index (BMI) of \>39 kg/m2.
* History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
* Patients with peripheral neuropathy.
* Patients with Type I or type II diabetes mellitus who have an HbA1c \> 8.0%.

Primary outcomes:
measure: Change From Baseline in Mean Average Daily Pain Score at Week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Change From Baseline in Mean Average Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
measure: Percentage of Participants Who Achieved At Least 30 Percent (%) and 50% Reduction in Mean Average Daily Pain Score
timeFrame: Week 8, 16
measure: Change From Baseline in Mean Worst Daily Pain Score at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
measure: Patient Global Assessment of Health Status Scores
timeFrame: Baseline, Week 2, 8, 16, 24
measure: Number of Participants With Global Response Assessment Scores
timeFrame: Week 8, 16, 24
measure: Number of Micturitions Per 24 Hours
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24
measure: Number of Nocturnal Micturitions Per 24 Hours
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24
measure: Number of Micturition-related Urgency Episodes Per 24 Hours
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24
measure: Participant's Urge to Urinate
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24
measure: Mean Voided Volume Per Micturition
timeFrame: Baseline, Week 4, 8, 12, 16, 20, 24
measure: O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) Score
timeFrame: Baseline, Week 2, 8, 16, 24
measure: Brief Pain Inventory-Short Form (BPI-sf) Score
timeFrame: Baseline, Week 8, 16, 24
measure: Number of Participants With Patient Global Satisfaction Assessment Scores
timeFrame: Week 8, 16, 24
measure: Number of Participants With Patient Global Preference Assessment Score
timeFrame: Week 8, 16, 24
measure: Number of Participants With Willingness to Re-use Medicine Assessment
timeFrame: Week 8, 16, 24
measure: Euro Quality of Life (EQ-5D) - Health State Profile Utility Score
timeFrame: Baseline, Week 8, 16, 24
measure: Painful Bladder/Interstitial Cystitis Quality of Life Questionnaire (PBIC-QoL) Total Score
timeFrame: Baseline, Week 2, 8, 16, 24
measure: Percentage of Participants Who Received Rescue Medication
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
measure: Number of Days of Rescue Medication Usage Per Week
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
measure: Number of Rescue Medication Doses Used Per Week
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
measure: Amount of Rescue Medication Taken Per Week
timeFrame: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
measure: Serum Total Nerve Growth Factor (NGF) Levels
timeFrame: Baseline, Week 1, 2, 8, 16, 24
Other outcomes:
measure: Number of Participants With Neurological Examination Findings
timeFrame: Week 2, 8, 16, Week 24 or early termination
measure: Change From Baseline in Neuropathy Impairment Score (NIS) at Week 2, 8, 16 and 24
timeFrame: Baseline, Week 2, 8, 16, 24
measure: Body Temperature
timeFrame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
measure: Systolic and Diastolic Blood Pressure
timeFrame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
measure: Heart Rate
timeFrame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
measure: Respiratory Rate
timeFrame: Screening, Day 1 (1 hour pre-dose and post-dose), Week 1, 2, Week 8 (1 hour pre-dose and post-dose), Week 16, 24
measure: Electrocardiogram Parameters: RR, PR, QRS, QT and Corrected QT (QTcB and QTcF) Intervals
timeFrame: Screening, Day 1, Week 2, 8, 16, 24
measure: Electrocardiogram Parameter: Heart Rate
timeFrame: Screening, Day 1, Week 2, 8, 16, 24
measure: Post-void Residual (PVR) Volume
timeFrame: Screening, Week 2, 8, 16, 24
measure: Number of Participants With Urinalysis Abnormalities
timeFrame: Screening up to Week 24
measure: Number of Participants With Laboratory Test Abnormalities
timeFrame: Screening up to Week 24
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
timeFrame: Baseline up to 112 days after the last dose (up to Week 24)
measure: Number of Participants With Anti-Drug Antibody (ADA)
timeFrame: Baseline, Week 8, 16, 24
Locations:
city: Mobile
country: United States
facility: Alabama Orthopaedic Clinic
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Glendale
country: United States
facility: Canyon State Urology
state: Arizona
city: Phoenix
country: United States
facility: Elite Clinical Studies, LLC
state: Arizona
city: Phoenix
country: United States
facility: Urology Specialists, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Central Arizona Urologists
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Phoenix
country: United States
facility: Precision Trials, LLC
state: Arizona
city: Phoenix
country: United States
facility: Valley Radiologists (x-ray only)
state: Arizona
city: Phoenix
country: United States
facility: Valley Urologic Associates
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Medical Imaging
state: Arizona
city: Tucson
country: United States
facility: Radiology Limited (x-ray only)
state: Arizona
city: Tucson
country: United States
facility: Arizona Urologic Specialists
state: Arizona
city: Beverly Hills
country: United States
facility: Access Medical Imaging
state: California
city: Fresno
country: United States
facility: Urology Associates of Central California
state: California
city: Glendora
country: United States
facility: Citrus Valley Medical Research Inc.
state: California
city: Long Beach
country: United States
facility: Atlantic Urology Medical Group
state: California
city: Los Angeles
country: United States
facility: Institute for Advanced Urology
state: California
city: Murrieta
country: United States
facility: Tri Valley Urology Group
state: California
city: Murrieta
country: United States
facility: Valley Neurology
state: California
city: Signal Hill
country: United States
facility: Liberty Pacific Medical Imaging
state: California
city: Boulder
country: United States
facility: Boulder Medical Center, PC
state: Colorado
city: Longmont
country: United States
facility: Longmont Clinic, PC
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Farmington
country: United States
facility: Women's Health Specialty Care
state: Connecticut
city: New Britain
country: United States
facility: Grove Hill Clinical Research
state: Connecticut
city: New Britain
country: United States
facility: Urology Center of Grove Hill
state: Connecticut
city: Stamford
country: United States
facility: Brian J. Hines, MD
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Dover
country: United States
facility: Diagnostic Imaging (radiology only)
state: Delaware
city: Dover
country: United States
facility: Urology Associates of Dover
state: Delaware
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lake Worth
country: United States
facility: University Urologists
state: Florida
city: Naples
country: United States
facility: Specialists in Urology
state: Florida
city: New Port Richey
country: United States
facility: Advanced Urology Associates
state: Florida
city: New Port Richey
country: United States
facility: Excel Medical Imaging
state: Florida
city: New Port Richey
country: United States
facility: Urology Specialists of West Florida
state: Florida
city: Ocala
country: United States
facility: Advanced Imaging Center Incorporated
state: Florida
city: Ocala
country: United States
facility: Ocala Urology Specialists
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pinellas Park
country: United States
facility: Gateway Radiology (x-rays only)
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology, Inc.
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute Incorporated
state: Florida
city: West Palm Beach
country: United States
facility: Midtown Imaging
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Medical Research Institute, LLC
state: Georgia
city: Alpharetta
country: United States
facility: Northside Hospital Radiology Services (x-ray only)
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Atlanta
country: United States
facility: MRI Imaging of Georgia
state: Georgia
city: Atlanta
country: United States
facility: MRI Imaging Of Georgia
state: Georgia
city: Decatur
country: United States
facility: Georgia Urology
state: Georgia
city: Evansville
country: United States
facility: Deaconess Clinic Downtown Research Institute
state: Indiana
city: Jeffersonville
country: United States
facility: Metropolitan Urology
state: Indiana
city: Newburgh
country: United States
facility: Deaconess Clinic Gateway Health Center Research Institute
state: Indiana
city: Noblesville
country: United States
facility: American Health Network (X-Ray only)
state: Indiana
city: Noblesville
country: United States
facility: Urology of Indiana, LLC
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic, Medical Imaging
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic, Urology
state: Iowa
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Diagnostics Imaging
state: Maryland
city: Annapolis
country: United States
facility: Anne Arundel Urology, PA
state: Maryland
city: Brighton
country: United States
facility: Alpha Clinical Research
state: Massachusetts
city: Fall River
country: United States
facility: Genesis Clinical Research and Consulting
state: Massachusetts
city: Grand Rapids
country: United States
facility: Grand Rapids Women's Health dba Female Pelvic Medicine and Urogynecology Institute of Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: HealthCare Midwest
state: Michigan
city: Kalamazoo
country: United States
facility: Rheumatology PC
state: Michigan
city: Kalamazoo
country: United States
facility: Beyer Research
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Hospitals - Royal Oak
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology, P.C.
state: Michigan
city: Edina
country: United States
facility: CRL Imaging Southdale (x-rays only)
state: Minnesota
city: Edina
country: United States
facility: Medical Advanced Pain Specialists Applied Research Center Incorporated
state: Minnesota
city: Southaven
country: United States
facility: Southeast Urology Network
state: Mississippi
city: Lincoln
country: United States
facility: Family Health Care Center (X-Ray)
state: Nebraska
city: Lincoln
country: United States
facility: Women's Clinic of Lincoln, P.C.
state: Nebraska
city: Albany
country: United States
facility: Capital Region Urological Surgeons
state: New York
city: Kingston
country: United States
facility: Benedictine Hospital
state: New York
city: Kingston
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: New York
country: United States
facility: University Urology Associates
state: New York
city: Poughkeepsie
country: United States
facility: DRA Imaging, PC (X-Rays Only)
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester, Department of Urology
state: New York
city: Salisbury
country: United States
facility: Crescent Medical Research
state: North Carolina
city: Salisbury
country: United States
facility: Salisbury Urological Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Tri-State Urologic Services PSC, Inc. dba The Urology Group
state: Ohio
city: Cofumbus
country: United States
facility: Central Ohio Urology Group
state: Ohio
city: Columbus
country: United States
facility: Columbus Urology Research, LLC
state: Ohio
city: Westerville
country: United States
facility: Premier Urology
state: Ohio
city: Oklahoma City
country: United States
facility: Legacy Clinical Research, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Planned Parenthood of Arkansas and Eastern Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma State University
state: Oklahoma
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Bala-Cynwyd
country: United States
facility: Urologic Consultants of Southeastern Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jeanes Hospital
state: Pennsylvania
city: Greer
country: United States
facility: Matrix Research, LLC
state: South Carolina
city: Greer
country: United States
facility: The Urology Group
state: South Carolina
city: Bristol
country: United States
facility: Bristol Urological Associates, PC
state: Tennessee
city: Bristol
country: United States
facility: TriCities Medical Research
state: Tennessee
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Knoxville
country: United States
facility: University Urology
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group
state: Tennessee
city: Memphis
country: United States
facility: The Neurology Clinic
state: Tennessee
city: Memphis
country: United States
facility: Southeast Urology Network
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Nashville
country: United States
facility: Access Clinical Trials, Inc (ACT)
state: Tennessee
city: Nashville
country: United States
facility: Center for Urological Treatment
state: Tennessee
city: Nashville
country: United States
facility: Diagnostic Health
state: Tennessee
city: Nashville
country: United States
facility: Swan and Brennan, Incorporated
state: Tennessee
city: Nashville
country: United States
facility: The Center for Reproductive Health
state: Tennessee
city: Houston
country: United States
facility: Mobley Research Center
state: Texas
city: Houston
country: United States
facility: Advances In Health, Inc.
state: Texas
city: Houston
country: United States
facility: St. Luke's Diagnostic and Treatment Center Kirby Glen
state: Texas
city: Houston
country: United States
facility: Centex Research, Inc.
state: Texas
city: Murray
country: United States
facility: Rocky Mountain Neurological Associates
state: Utah
city: Murray
country: United States
facility: Salt Lake Surgical Center
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Regional Medical Center (X-rays only)
state: Utah
city: Salt Lake City
country: United States
facility: Salt Lake Research, PLLC
state: Utah
city: Salt Lake City
country: United States
facility: Western Urological Clinic, PC
state: Utah
city: Mountlake Terrace
country: United States
facility: Integrity Medical Research, LLC
state: Washington
city: Mountlake Terrace
country: United States
facility: Urology Northwest
state: Washington
city: Seattle
country: United States
facility: Marc Kirschner, MD
state: Washington
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
city: Abbotsford
country: Canada
facility: The Gateway 2
state: British Columbia
city: Barrie
country: Canada
facility: The Male/Female Health and Research Centre, Royal Court Medical Centre
state: Ontario
city: Kingston
country: Canada
facility: Centre for Applied Urological Research
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: Urology Associates / Urologic Medical Research
state: Ontario
city: Thunder Bay
country: Canada
facility: Anthony Skehan Medicine Professional Corporation
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Kouvola
country: Finland
facility: Kouvolan Laakariasema
city: Shatin
country: Hong Kong
facility: Department of Obstetrics & Gynaecology, Prince of Wales Hospital The Chinese University of Hong Kong
state: NEW Territories
city: Shatin
country: Hong Kong
facility: Department of Surgery, The Chinese University of Hong Kong
city: Fukuoka-shi
country: Japan
facility: Harasanshin Hospital, Urology
state: Fukuoka
city: Nakagyo-ku, Kyoto-shi
country: Japan
facility: Kyoto City Hospital, Urology
state: Kyoto
city: Arakawa-ku
country: Japan
facility: Tokyo Women's Medical University Medical Center East
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo University Hospital
state: Tokyo
city: Songpa-gu
country: Korea, Republic of
facility: Department of Urology, Asan Medical Center, University of Ulsan
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Korea University Anam Hospital
city: Bialystok
country: Poland
facility: SPZOZ Wojewodzki Szpital Zespolony im. Jedrzeja Sniadeckiego, Oddzial Urologii
city: Warszawa
country: Poland
facility: Conti Medica Sp. z o.o.
city: Warszawa
country: Poland
facility: Spoldzielnia Pracy Specjalistow Radiologow
city: Warszawa
country: Poland
facility: NZOZ Centrum Medyczne Wola
city: Warszawa
country: Poland
facility: Szpital Kliniczny Dzieciatka Jezus, Centrum Leczenia Obrazen
city: Bucuresti
country: Romania
facility: Dinu Uromedica SCM
state: Sector 4
city: Bucuresti
country: Romania
facility: Spitalul Clinic Prof. Dr. Th. Burghele
city: Pantelimon
country: Romania
facility: Centrul Medical Sf. Pantelimon
city: Moscow
country: Russian Federation
facility: Federal State Institution Scientific Research Institute of Urology of Rosmedtechnology
city: Moscow
country: Russian Federation
facility: Urology of Rosmedtechnology
city: Saint-Petersburg
country: Russian Federation
facility: Saint-Petersburg State Healthcare Institution City Hospital # 15/Department of Urology
city: St. Petersburg
country: Russian Federation
facility: SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava
city: St. Petersburg
country: Russian Federation
facility: SEIHPE St. Petersburg State Medical University n.a.I.P. Pavlov Roszdrava/Chair of Urology
city: Martin
country: Slovakia
facility: Martinska fakultna nemocnica
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Presov
country: Slovakia
facility: MILAB s.r.o.
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Clinica Del Remei - Instituto Medico Tecnologico
city: Barcelona
country: Spain
facility: Hospital Clinic I Provincial de Barcelona
city: Goteborg
country: Sweden
facility: Kliniska provningsenheten
city: Malmo
country: Sweden
facility: Medicinsk Rontgen (x-ray only)
city: Malmo
country: Sweden
facility: Center for Lakemedelsprovning Malmo
city: Koahsiung Hsien
country: Taiwan
facility: Chang Gung Medical Foundation - Kaohsiung/Department of Surgery
city: Taichung City
country: Taiwan
facility: Taichung Hospital, Department of Health, Executive Yuan
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital (X-Ray Only)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital/Department of Surgery
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.