๐ฌIn plain words
What the trial is, and whether it could suit you
Specific Aim 1. To evaluate the efficacy of TNF antagonist action in BPH/LUTS Specific Aim 2. Define the consequences of TNF antagonist therapy on prostate tissue Specific Aim 3. Identify genetic predictors to stratify patients with differential response to TNF-antagonist therapy.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Male sex
* Age 45-80 years
* Diagnosed by physician with BPH
* Prostate volume โฅ 60mL
* IPSS โฅ 8
* Able and willing to complete questionnaires
* Able and willing to provide informed consent
* Able to read, write, and speak in English
* No prior treatment with TNF inhibitor (adalimumab, etanercept, infliximab, certolizumab, golimumab)
* No plans to move from study area in the next 6 months
Deferral Criteria:
* Microscopic hematuria without appropriate workup per AUA/Society of Urodynamics, Female Pelvic Medicine \& Urogenital Reconstruction (SUFU) Guidelines
* Positive urine culture
Exclusion Criteria:
* Female sex or intersex
* Age \< 45 or \> 80 years
* Being a prisoner or detainee
* Urinary retention with need for catheterization
* Gross hematuria
* Contraindication to treatment with adalimumab (e.g., presence of sepsis or active infection, active tuberculosis, Hepatitis B infection, invasive fungal infection, lymphoma, leukemia or other active malignancy, congestive heart failure, significant hematologic abnormality, allergy to adalimumab or its components, anti-drug antibodies, congestive heart failure)
* Diagnosis of autoimmune disease (rheumatoid arthritis, plaque psoriasis, ulcerative colitis, Crohn's disease, hidradenitis suppurativa, spondyloarthritis)
* Interstitial cystitis
* Pelvic or endoscopic genitourinary surgery within the preceding 6 months (not including diagnostic cystoscopy)
* History of lower urinary tract or pelvic malignancy including prostate cancer; history of pelvic radiation therapy
* Ongoing symptomatic urethral stricture
* Current chemotherapy or other cancer therapy
* Severe neurological or psychiatric disorder that would prevent study participation (e.g., bipolar disorder, psychotic disorder, Alzheimer's Disease)
* Current moderate or severe substance use disorder