Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Interstitial Cystitis Clinical Trial

— CP/CPPS  

Official title:

Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00499317
• Other study ID #: 04-11-160M
• Secondary ID: 91208
• Status: Recruiting
• Start date: January 15, 2007
• Est. completion date: December 31, 2026

Study information

• Verified date: August 2023
• Source: Boston Children's Hospital
• Contact: Elicia Estrella, MS, LCGC
• Phone: 617-919-4552
• Email: elicia.estrella[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Frequency Syndrome (BFS)
• Chronic Disease
• Chronic Pelvic Pain Syndrome (CPPS)
• Chronic Prostatitis (CP)
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Painful Bladder Syndrome (PBS)
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Locations

Country	Name	City	State
United States	Boston Children's Hospital (BCH)	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation