Changes in Inflammatory and Contractile Protein Expression in Patients With Painful Bladder Syndrome/IC.

NCT00775281 | Completed

• 1 other identifier: KEK_146_05
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Interstitial cystitis (IC)/chronic pelvic pain syndrome (CPPS) is a clinical syndrome of pelvic pain and/or urinary urgency/frequency in absence of a specific cause such as bacterial infection or damage to the bladder. The pathogenetic mechanisms of IC/CPPS are as yet undefined and it is largely this lack of knowledge, which precludes a systematic therapeutic approach. Experimental evidence, including results from the animal models of cystitis and the knock-out mice, indicate a participation of tachykinin receptors, especially the NK1R, in neurogenic inflammation, which is considered an important element of the IC complex. However, there is very scant information about the molecular mechanisms of IC in humans, or of the types of receptors, which participate in neurogenic inflammation. Based on our molecular biological know-how and the clinical expertise, we propose to investigate the role of the tachykinin and bradykinin receptors and their signalling partners in CPPS and bladder dysfunction in humans.

Conditions

Overactive Bladder; Painful Bladder Syndrome; Chronic Pelvic Pain Syndrome; Cystitis, Interstitial

Keywords

Tachykinin receptors; Protein expression; Contractile proteins; Inflammatory proteins

Outcome Measures

Primary Outcomes (1)

• Receptor expression in disease states versus control

  at time of biospy

Study Arms (3)

1

2

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

university hospital clinic

You may qualify if:

• Clinical asymptomatic bladder function
• Clinical urgency frequency syndrome/ overactive bladder
• Clinical painful bladder syndrome/interstitial cystitis

You may not qualify if:

• Not able to understand patient information
• Other cause of symptoms
• Confusable diseases

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dept. of Urology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (10)

• Lilly JD, Parsons CL. Bladder surface glycosaminoglycans is a human epithelial permeability barrier. Surg Gynecol Obstet. 1990 Dec;171(6):493-6.

  PMID: 2244283 BACKGROUND

• Letourneau R, Pang X, Sant GR, Theoharides TC. Intragranular activation of bladder mast cells and their association with nerve processes in interstitial cystitis. Br J Urol. 1996 Jan;77(1):41-54. doi: 10.1046/j.1464-410x.1996.08178.x.

  PMID: 8653316 BACKGROUND

• Lowe EM, Anand P, Terenghi G, Williams-Chestnut RE, Sinicropi DV, Osborne JL. Increased nerve growth factor levels in the urinary bladder of women with idiopathic sensory urgency and interstitial cystitis. Br J Urol. 1997 Apr;79(4):572-7. doi: 10.1046/j.1464-410x.1997.00097.x.

  PMID: 9126085 BACKGROUND

• Chuang YC, Fraser MO, Yu Y, Chancellor MB, de Groat WC, Yoshimura N. The role of bladder afferent pathways in bladder hyperactivity induced by the intravesical administration of nerve growth factor. J Urol. 2001 Mar;165(3):975-9.

  PMID: 11176525 BACKGROUND

• Hohenfellner M, Nunes L, Schmidt RA, Lampel A, Thuroff JW, Tanagho EA. Interstitial cystitis: increased sympathetic innervation and related neuropeptide synthesis. J Urol. 1992 Mar;147(3):587-91. doi: 10.1016/s0022-5347(17)37314-7.

  PMID: 1538434 BACKGROUND

• Pang X, Marchand J, Sant GR, Kream RM, Theoharides TC. Increased number of substance P positive nerve fibres in interstitial cystitis. Br J Urol. 1995 Jun;75(6):744-50. doi: 10.1111/j.1464-410x.1995.tb07384.x.

  PMID: 7542136 BACKGROUND

• Pang X, Boucher W, Triadafilopoulos G, Sant GR, Theoharides TC. Mast cell and substance P-positive nerve involvement in a patient with both irritable bowel syndrome and interstitial cystitis. Urology. 1996 Mar;47(3):436-8. doi: 10.1016/S0090-4295(99)80469-5.

  PMID: 8633418 BACKGROUND

• Marchand JE, Sant GR, Kream RM. Increased expression of substance P receptor-encoding mRNA in bladder biopsies from patients with interstitial cystitis. Br J Urol. 1998 Feb;81(2):224-8. doi: 10.1046/j.1464-410x.1998.00507.x.

  PMID: 9488063 BACKGROUND

• Moskowitz MO, Byrne DS, Callahan HJ, Parsons CL, Valderrama E, Moldwin RM. Decreased expression of a glycoprotein component of bladder surface mucin (GP1) in interstitial cystitis. J Urol. 1994 Feb;151(2):343-5. doi: 10.1016/s0022-5347(17)34944-3.

  PMID: 8283520 BACKGROUND

• Saban R, Saban MR, Nguyen NB, Lu B, Gerard C, Gerard NP, Hammond TG. Neurokinin-1 (NK-1) receptor is required in antigen-induced cystitis. Am J Pathol. 2000 Mar;156(3):775-80. doi: 10.1016/S0002-9440(10)64944-9.

  PMID: 10702392 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

cold cut bladder biopsies

MeSH Terms

Conditions

Urinary Bladder, Overactive; Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cystitis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 17, 2008
• First Posted: October 20, 2008
• Study Start: October 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 27, 2010

Record last verified: 2010-04

Locations

CH (1)