Microbiomes of Pelvic Pain
CompletedNCT01738464
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This research study seeks to provide more insight as to how the microbiome affects or is affected by conditions causing chronic pelvic pain such as Interstitial Cystitis (IC), Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), Lower Urinary Tract Symptoms (LUTS), or Overactive bladder (OAB). Depression and many chronic pain disorders are often related and are poorly understood, and treatment is often not helpful. The goal of this study is to explain pelvic pain characteristics and causes by studying microbiomes of healthy people compared to people suffering from IC, CP/CPPS, LUTS, OAB, and Major depression.
Study details
- Official title
- Microbiomes of Pelvic Pain
- Conditions
- Interstitial Cystitis
- Chronic Prostatitis
- Chronic Pelvic Pain Syndrome
- Lower Urinary Tract Symptoms
- Overactive Bladder
- Major Depression
- Sponsor
- Northwestern University
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Start date
- 2012-06
- Primary completion
- 2023-07-07
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Any sex * Between the ages of 18 and 60 * Any ethnicity * Have provided informed consent * Physician diagnosis of interstitial cystitis/bladder pain syndrome (IC/BPS), interstitial cystitis/painful bladder syndrome (IC/PBS), chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), Lower Urinary Tract Symptoms, Overactive Bladder, or Major Depression. * Report symptoms of discomfort or pain in the pelvic or abdominal region of moderate severity for at least a three (3) month period within the last six (6) months, who have been currently diagnosed with major depression * Are healthy, age matched, controls. Exclusion Criteria: For IC/CPPS/LUTS/OAB * Evidence of facultative Gram negative or enterococcus with a value of ≥ 100,000 colony forming units (CFU)/milliliter in mid-stream urine (VB2) * Secondary chronic pain condition which would prevent a clear interpretation of the study results * A history of tuberculous cystitis, bladder cancer, carcinoma in situ, or urethral cancer; history of alcohol abuse, inflammatory bowel disease, pelvic radiation or systemic chemotherapy, intravesical chemotherapy, intravesical Bacillus Calmette-Guerin (BCG), active urethral stricture, ureteral calculi, urethral diverticulum, or neurological disease or disorder affecting the bladder or gut * Unlikely to be compliant due to unmanaged medical or psychological conditions, including neurological, psychological or speech/language problems that will interfere or prevent with their understanding of consent * Ability to comply with the protocol or ability to complete the study * Pregnant or Syndromes of Chronic Pelvic Pain (SCPP) symptoms are present only during menses * And if there was antibiotic use in the last 6 months For Depressed Patients: * Participant is in remission or has recovered from major depression, has substance abuse in the past 6 months, has been diagnosed with any bipolar or psychotic disorder, has been diagnosed with any severe cognitive impairment or dementia, history of cancer (with the exception of skin cancer), has current major psychiatric disorder or other psychiatric or medical comorbidities that would interfere with study participation (e.g. dementia, psychosis, upcoming major surgery, lupus, active heart failure, diabetes, etc., currently has a UTI and/or has had a positive urine culture in the past 6 weeks, and if there was antibiotic use in the last 3 months.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01738464