Clinical trial NCT00499317: Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Official title: Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Prostatitis (CP)
Chronic Pelvic Pain Syndrome (CPPS)
Painful Bladder Syndrome (PBS)
Benign Frequency Syndrome (BFS)
Interstitial Cystitis
Keywords: Urgency
Frequency
Pelvic pain
Sexual dysfunction
Erectile dysfunction
Painful intercourse
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2007-07-11
Enrollment: 500
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We are collecting individuals with a diagnoses of CP/CPPS and their family members (with or without symptoms) from North America (United States and Canada). Preference is given to families with multiple affected individuals (males or females with IC/BPS/CPPS).

Brief summary: 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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital (BCH)
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Catherine Brownstein, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.