Improving Lower Urinary Tract Symptoms and Quality of Life in Patients with Benign Prostatic Hyperplasia
Background and Significance
By age of 60, nearly 30% of men experience Lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH)2,3, which alone incurs billions of dollars of cost in the U.S. health system4,5. Current treatment mode is the use of medication (e.g., alpha blockers and 5α-reductase inhibitors), but the 12-month adherence is only 29% among American men6,7 due to undesired side effects8. Unresolved LUTS are associated with increasing urinary retention, infection, hospital visit, healthcare cost, and worsening quality of life (QOL) of patients4,9,10.
The American Urologic Association (AUA) Practice Guideline11 recommends noninvasive intervention of lifestyle factors for mild and non-bothersome moderate-severe LUTS/BPH, but this behavioral approach, not only has limited armamentarium, but also has not been rigorously evaluated for LUTS/BPH, so testing is imperative12. More important, when conducted in the context of moderate to severe LUTS/BPH, this testing will ascertain whether a behavioral intervention can reduce LUTS that require medical treatment.
LUTS/BPH manifest in storage (e.g., urgency, frequency, nocturia), voiding (e.g., weak stream or straining), and post-micturition (e.g., dribbles) symptoms. The most bothersome symptom varies widely among individuals, posing a challenge to the behavioral intervention. We propose to test a new individualized behavioral approach to LUTS/BPH, which will (1) use selected behavioral techniques to treat most bothersome LUTS; (2) promote adherence to the learned behavioral techniques; and (3) utilize social support, particularly peer coaching, to empower behavioral changes17, 18. As patient adherence to the learned behavioral techniques increases, we expect to see reduced severity of LUTS, improved QOL, and lowered healthcare cost.
To this end, we propose to conduct a pilot study (n=30) first with specific aims to:
1. Estimate effect size of the differences among the three study groups in the severity of LUTS and QOL at 3- and 6-month (post-intervention) assessments after controlling for covariates.
- Hypothesis 1a: The two intervention groups will have less severity of LUTS, especially nocturia, and better QOL than the UC group at 3- and 6-month assessments.
- Hypothesis 1b: The PEER group is non-inferior to the SUPPORT group in reducing the severity of LUTS, especially nocturia, and improving QOL at 3- and 6-month assessments.
2. Collect preliminary data to explore possible mechanisms through which the interventions reduce the severity of LUTS and improve QOL after controlling for covariates
- Hypothesis 2a: Greater automaticity and self-efficacy are associated with greater adherence to the learned behavioral techniques.
- Hypothesis 2b: Greater adherence to the learned behavioral techniques is associated with the reduction in most bothersome LUTS such as nocturia, hence reducing the severity of LUTS (a 3-point reduction on IPSS) and improving QOL.
This pilot study uses an individualized approach to treat a person’s unique symptom condition and involves peer coaching to empower patient behavioral change for improving LUTS/BPH. The study will provide preliminary data to enable us to meet the request from a NIH review panel and significantly enhance our chance of winning NIH funding for this research program. It will help produce new knowledge about a treatment that centers on patient’s self-management of LUTS/BPH.
This will be a prospective, randomized, and controlled intervention study. About 30 eligible patients will be randomly assigned into three groups: (1) the educational training plus a support group (SUPPORT); (2) the educational training plus a support group and peer coaching (PEER); and (3) the standard care (SC), with 8 to 10 participants per group. The SUPPORT and PEER participants will learn behavioral techniques from attending a Health Education session. Thereafter, they will attend 6 monthly web-based group meetings. Additionally, the PEER participants will receive minimally 2 monthly contacts over 6 months from a peer coach. The SC participants will receive usual medical care without receiving behavioral training or any study intervention. The study participants will be assessed at baseline, 3 months (mid-intervention), and 6 months (post-intervention).
Inclusion criteria: (1) LUTS secondary to BPH by diagnosis, (2) presence of moderate to severe LUTS irrespective of bother (IPSS≥8) or medication, (3) age ≥ 45 according to the AUA guideline11, and (4) able to speak or understand English.
Exclusion criteria: (1) LUTS independent of BPH (e.g., neurogenic LUTS due to Parkinson’s or dementia, LUTS due to cancers, renal diseases, and bladder stones); (2) having a known medical history of urethral stricture, pediatric voiding dysfunction, and/or elimination disorder (e.g., severe constipation), chronic prostatitis, or bladder pain syndrome; (3) recurrent urinary tract infection; (4) uncontrolled diabetes, end-stage cardiac and respiratory failure; (5) a severe condition that requires immediate medical attention; (6) cognitive impairment that compromises the ability to follow study procedures; and (7) starting a surgical or minimally invasive procedure for LUTS during the study.