NCT00675298

Brief Summary

Urologic pelvic pain syndrome (UCPPS), variably termed painful bladder syndrome/interstitial cystitis (PBS/IC) in females and chronic prostatitis/chronic pelvic pain syndrome in men (CP/CPPS), is a chronic, debilitating clinical syndrome presenting as severe pelvic pain with extreme urinary urgency and frequency in the absence of any known cause. The etiologic mechanisms underlying UCPPS are unknown, but recurrence, risks to siblings of affected individuals, concordance among monozygotic twins, and our own preliminary studies indicate a strong genetic contribution to the cause of UCPPS. The overall goal of this proposal is use novel approaches to understand the basis of UCPPS, to identify candidate genes containing mutations that result in UCPPS and determine how the different encoded proteins of these genes interact with one another in a common biological pathway. Ultimately, understanding how mutations in at least five different genes yield the symptoms of UCPPS should lead to improved diagnosis and possible therapies.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2008

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2014

Enrollment Period

5.4 years

First QC Date

May 7, 2008

Last Update Submit

February 2, 2017

Conditions

ProstatitisCystitis, InterstitialUrinary Bladder, OveractiveChronic Pelvic Pain SyndromePainful Bladder Syndrome

Keywords

ProstatitisCystitis, InterstitialUrinary Bladder, OveractiveChronic pelvic pain syndromePainful bladder syndromeUrgencyFrequency

Study Arms (5)

1

Men with chronic prostatitis/chronic pelvic pain syndrome

2

Women with painful bladder syndrome/interstitial cystitis

3

Children with overactive bladder

4

Bulgarian cohort with chronic prostatitis/chronic pelvic pain syndrome, painful bladder syndrome/interstitial cystitis and children with overactive bladder

5

Asymptomatic healthy controls

Eligibility Criteria

Age3 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Self-referred patients and subjects from a Bulgarian high-prevalence CPPS population

You may qualify if:

  • Have symptoms for at least 3 months within the preceding 6 months:
  • Pain in the pelvic area
  • Urinary frequency and/or
  • Urinary urgency and/or
  • Sexual dysfunction (erectile dysfunction)
  • Have CP/CPPS, IC, PBS, or BFS
  • Be willing to provide a saliva and urine sample
  • Agree to complete several brief questionnaires
  • Family of someone with CP/CPPS, PBS, IC or BFS
  • Live in the USA or Canada

You may not qualify if:

  • Major structural/anatomical urinary tract abnormalities
  • Underlying inborn or congenital conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jordan D Dimitrakoff

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

  • Dimitrakov J, Joffe HV, Soldin SJ, Bolus R, Buffington CA, Nickel JC. Adrenocortical hormone abnormalities in men with chronic prostatitis/chronic pelvic pain syndrome. Urology. 2008 Feb;71(2):261-6. doi: 10.1016/j.urology.2007.09.025.

    PMID: 18308097BACKGROUND

  • Dimitrakov J, Kroenke K, Steers WD, Berde C, Zurakowski D, Freeman MR, Jackson JL. Pharmacologic management of painful bladder syndrome/interstitial cystitis: a systematic review. Arch Intern Med. 2007 Oct 8;167(18):1922-9. doi: 10.1001/archinte.167.18.1922.

    PMID: 17923590BACKGROUND

  • Dimitrakov JD, Kaplan SA, Kroenke K, Jackson JL, Freeman MR. Management of chronic prostatitis/chronic pelvic pain syndrome: an evidence-based approach. Urology. 2006 May;67(5):881-8. doi: 10.1016/j.urology.2005.12.015. No abstract available.

    PMID: 16698346BACKGROUND

  • Dimitrakov JD. A case of familial clustering of interstitial cystitis and chronic pelvic pain syndrome. Urology. 2001 Aug;58(2):281. doi: 10.1016/s0090-4295(01)01138-4.

    PMID: 11489726BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Saliva and urine

MeSH Terms

Conditions

ProstatitisCystitis, InterstitialUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesCystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jordan D Dimitrakoff, MD, PhD

    Beth Israel Deaconess Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 7, 2008

First Posted

May 9, 2008

Study Start

January 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

February 3, 2017

Record last verified: 2014-02

Locations

US(1)