Effects of TNF Blockade on Human BPH/LUTS
Benign Prostatic Hyperplasia (BPH)
About this trial
This is an interventional basic science trial for Benign Prostatic Hyperplasia (BPH)
Eligibility Criteria
Inclusion Criteria: Male sex Age 50-75 years Diagnosed by physician with BPH Prostate volume ≥ 80mL IPSS ≥ 8 Scheduled for BPH surgery (prostatic urethral lift, water vapor thermal therapy, transurethral resection of prostate, laser vaporization or enucleation, robotic waterjet treatment, or simple prostatectomy) 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 < 50 or > 75 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
Sites / Locations
- NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
adalimumab
Placebo
adalimumab 40 mg every 2 weeks
placebo injection (saline) every 2 weeks.