Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS), Painful Bladder Syndrome (PBS), Benign Frequency Syndrome (BFS). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) is a condition with several causes of which some remain unknown. It is believed that some types of CP may be genetic or passed down (inherited) from one generation to the next. In this study, we are collecting genetic material and medical information to try to determine if genetic factors play a role in CP/CPPS. We will be collecting DNA (from Blood/Saliva sample) and urine from each participant. Bladder tissue from affected individuals will also be collected. Individuals and families with CP/CPPS will be enrolled. Family members of an individual with CP/CPPS are eligible whether or not they also experience CP/CPPS symptoms.
Detailed description
We would like to determine if chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) has a genetic cause. We will be attempting to further describe the symptoms of CP/CPPS and to correlate them with changes in your genes. We will use several types of genetic testing; linkage analysis, whole exome sequencing and candidate gene studies. Each individual participant will be required to give a DNA sample (via Blood/Saliva), a urine sample and answer questionnaires. Affected participants will also be asked to provide a bladder sample from a clinical biopsy. All samples will be stored. Travel to Boston NOT required.
Primary outcome measures
- Participants With Candidate Disease-Causing Genetic Variant(s) Associated With CP/CPPS or IC/BPS [Time frame: From enrollment until completion of genetic analysis for the participant or family, up to 22 years.]
Eligibility criteria
Inclusion criteria
- 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, Interstitial Cystitis (IC), Bladder Pain Syndrome BPS, or Bladder Fasciculation Syndrome (BFS)
- Be willing to provide a blood/saliva, bladder tissue (from previous biopsy) and urine sample
- Agree to complete several brief questionnaires
- Family member of someone with CP/CPPS, BPS, IC or BFS
- Live in the USA or Canada
Exclusion criteria
- Major structural/anatomical urinary tract abnormalities
- Underlying inborn or congenital conditions which affect the urinary tract
- Surgery/chemotherapy in the pelvic area
- Bacterial cause to CP/CPPS or recurrent Urinary tract infections (UTI)
- Traumatic cause to CP/CPPS
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Family-based
Study locations
United States · 1 center
- Boston Children's Hospital (BCH) — Boston
Publications
- Propert KJ, Alexander RB, Nickel JC, Kusek JW, Litwin MS, Landis JR, Nyberg LM, Schaeffer AJ; Chronic Prostatitis Collaborative Research Network. Design of a multicenter randomized clinical trial for chronic prostatitis/chronic pelvic pain syndrome. Urology. 2002 Jun;59(6):870-6. doi: 10.1016/s0090-4295(02)01601-1. PMID 12031372
- Keay SK, Zhang CO. Abnormal Akt signalling in bladder epithelial cell explants from patients with interstitial cystitis/bladder pain syndrome can be induced by antiproliferative factor treatment of normal bladder cells. BJU Int. 2016 Jul;118(1):161-72. doi: 10.1111/bju.13457. Epub 2016 Mar 29. PMID 26919663
- 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 11489726
Identifiers
NCT: NCT00499317 · 04-11-160M · 91208