Trans-MAPP II Study of Urologic Chronic Pelvin Pain

Interstitial Cystitis Clinical Trial

Official title:

Trans-MAPP Study of Urologic Chronic Pelvic Pain: Control Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898220
• Other study ID #: 825428
• Secondary ID: U01DK082316
• Status: Completed
• Start date: September 2016
• Est. completion date: June 2022

Study information

• Verified date: August 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Multidisciplinary Approach to the Study of Chronic Pelvic Pain (MAPP) Research Network has been established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) to focus on a broader approach to the study of Interstitial Cystitis (IC)/ Bladder Pain Syndrome (BPS) in men and women, and Chronic Prostatitis (CP)/Chronic Pelvic Pain Syndrome (CPPS) in men, than previously undertaken. Patients with IC or CP are being recruited for a new study called the "Trans-MAPP Study of Urologic Chronic Pelvic Pain: Symptom Patterns Study (SPS). This research study will recruit Control Participants to better understand the symptoms of individuals with some form of IC or CP. As with many chronic pain disorders, IC and CP are poorly understood, and treatment is often not helpful. The goal of this study is to better understand how pain is felt in people with IC or CP and the investigators hope that this study will lead to improvement in the treatment of IC and CP.

Description:

Urological Chronic Pelvic Pain Syndromes (UCPPS) are characterized by pelvic pain with concurrent urinary symptoms. Broadly, UCPPS comprise Interstitial Cystitis/Painful Bladder SyndromeBladder Pain Syndrome (IC/BPS) in men and women, and Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) in men. IC is a debilitating bladder disorder characterized by urinary urgency, frequency, and pain. The presentation of symptoms can be quite variable among patients, suggesting that IC is a multi-factorial syndrome with several proposed etiologies, some of which may be interrelated.1 BPS as defined by the International Continence Society, is "the complaint of suprapubic pain related to bladder filling, accompanied by other symptoms, such as increased daytime and night-time frequency, in the absence of proven urinary infection or other obvious pathology."2 BPS is a clinical description of disease based on the patient's symptoms, and does not depend on urodynamic or cystoscopic findings. These symptoms may be related to IC, although diagnostic criteria are still lacking for this entity, and the relationship between BPS and IC is not clear. After the initiation phase for the MAPP SPS Study, it became clear that many of the hypotheses being proposed required well-characterized healthy "normal" controls that lack urologic pain as well as other study related symptoms/conditions. This second phase is enriched with pre-defined subgroups and a longer follow-up period which will allow further investigation of clinical and biologic factors associated with worsening and/or improvement of reported urinary and non-urinary symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 2022
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant has signed and dated the appropriate Informed Consent document.
• Agreed to participate in ALL required study procedures (including Biospecimen collections, Neuroimaging, and Quantitative Sensory Testing).
• Gave permission for use of DNA for genetics studies.
• Gender recorded in Participant Registration module.
• Participant is at least 18 years of age.
• Participant is able to speak, read, and understand English.
• Participant reports a response of "0" (zero) on the pain, pressure or discomfort scale (SYM-Q, Question #1).
• Participant reports no chronic pain in the pelvic or bladder region, and reports no chronic pain in any other body region.
• Participant reports no urological symptoms that have been evaluated, but are still present.

Exclusion Criteria:

• Participant has an on-going symptomatic urethral stricture.
• Participant has an on-going neurological disease or disorder affecting the bladder or bowel fistula.
• Participant has a history of cystitis caused by tuberculosis, radiation therapy or Cytoxan/cyclophosphamide therapy.
• Participant has augmentation cystoplasty or cystectomy.
• Participant has an active autoimmune or infectious disorder (such as Crohn's Disease or Ulcerative Colitis, Lupus, Rheumatoid Arthritis, Multiple Sclerosis, or HIV).
• Participant has a history of cancer (with the exception of skin cancer).
• Participant has current major psychiatric disorder or other psychiatric or medical issues that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, etc.).
• Participant has severe cardiac, pulmonary, renal, or hepatic disease that in the judgment of the study physician would preclude participation in this study.
• Participant has had definitive treatment for acute epididymitis, urethritis, vaginitis.
• Participant has history of unevaluated hematuria, this will require the evaluation of a study physician to determine if this has been appropriately evaluated.
• Participant has had a cystoscopy with hydrodistention or kenalog injection.

Exclusion Criteria for Males Only:

• Diagnosis of unilateral orchalgia, without pelvic symptoms.
• History of transurethral microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon dilation, prostate cryo-surgery, or laser procedure.
• A prostate biopsy or transurethral resection of the prostate (TURP) within the last three months.

Exclusion Criteria for Females Only:

• Participant has a positive Urine pregnancy test.

Specimen Exclusion Criteria (Males and Females):

• Participant has a positive dipsticParticipant has a positive urine culture.

Fatigue Symptom Eligibility Criteria:

• Participant, for at least 3 months in the past year, has persistent fatigue not relieved with rest.
• Participant, for at least 3 months in the past year, has extreme fatigue following exercise or mild exertion.
• Participant, for at least 3 months in the past year, has impaired memory, concentration or attention. Exclusion Criteria - Urine test results: A clean-catch midstream urine specimen (VB2) will be obtained from all male and female participants during the initial and 6 month study visits, so that a urine dipstick analysis can be done for all participants, and a urine pregnancy test can be conducted for females of child bearing age excluding those who are post-menopausal and those with a history of hysterectomy.
• If participant has an abnormal dipstick urinalysis indicating abnormal levels of nitrites and/or occult blood, that in the opinion of the Principal Investigator warrants exclusion, participant will be ineligible for study participation at the initial visit and withdrawn from study participation. A positive dipstick at the 6 Month visit will also result in the participant being withdrawn.
• If participant has had a positive urine culture in the past 6 weeks, or currently has a midstream urine culture (VB2) (>100,000 CFU/ml), with a single uropathogen, the participant will be ineligible for the study at the initial visit, treated and withdrawn from study participation. A positive dipstick at the 6 Month visit will also result in the participant being treated and withdrawn. (Must be documented on Urine Culture Result - UCR form). We will keep all specimens and data collected from both eligible and in-eligible participants unless participant request that his/her data be destroyed, and not utilized for the study.

Related Conditions & MeSH terms

• Chronic Prostatitis
• Cystitis
• Cystitis, Interstitial
• Interstitial Cystitis
• Prostatitis

Locations

Country	Name	City	State
United States	University of Michigan, Ann Arbor	Ann Arbor	Michigan
United States	Northwestern University	Chicago	Illinois
United States	University of Iowa	Iowa City	Iowa
United States	University of California, Los Angeles (UCLA)	Los Angeles	California
United States	Washington University, St. Louis	Saint Louis	Missouri
United States	University of Washington, Seattle	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Severity Score	The outcome measures are the same scores which will be used to compare normal The scores for pain severity in healthy individuals with scores of those with a diseased state (i.e. individuals with UCPPS)	6 months
Primary	Urinary Severity Score	The outcome measures are the same scores which will be used to compare normal The scores for urinary severity in healthy individuals with scores of those with a diseased state (i.e. individuals with UCPPS	6 months