Name: Dasuni Chandrabhanu

Student ID: 2013521620023

Roll no. 13

Clinical case of evidence based medicine

Clinical case
64 year old Mr.Xiao has been having poor stream of urine and hesitancy for past 6 months.
When he was further questioned by the doctor, he revealed that he was unable to hold the urge to
pass urine and these symptoms were very cumbersome. No history of recurrent urinary tract
infections or episodes of acute retention of urine.
Physical examination revealed mildly enlarged prostate and other system examination normal.
He was given IPSS (International Prostate Symptom Score) questionnaire to evaluate the impact
towards the everyday life due to this problem. He got 15 points which was a moderate score that
requires treatment. Urinalysis showed no evidence of urinary tract infections/haematuria and
serum PSA was normal.

Results of investigations are more suggestive of benign prostatic hyperplasia. Urologist offered
three treatment options: monotherapy with alpha blockers, monotherapy with 5-alpha reductase
inhibitors and dual therapy with alpha blockers+ 5-alpha reductase inhibitors. Mr. Xiao is willing
to know the best medical therapy out of these without going into a surgery.

Step: 1 Formulating a clinical question

What is the best treatment modality that prevents future surgical interventions out of
monotherapies of each of alpha blockers and 5-alpha reductase and dual therapy of both in
patients with uncomplicated benign prostatic hyperplasia with significant impact to quality of
life?

Population- Patients with uncomplicated benign prostatic hyperplasia with significant impact to
quality of life

Interventions – Dual therapy with Alpha blockers + 5-alpha reductase

Comparison- Monotherapy with Alpha blockers and monotherapy with 5-alpha reductase

Outcome- prevention of future surgical interventions and other long term complications
Background

Benign Prostatic Hyperplasia(BPH) is a common chronic condition among adults between 40-80
that clinically presents with lower urinary tract symptoms(LUTS): nocturia, hesitancy, poor
stream, urgency, terminal dribbling, intermittency, sense of incomplete evacuation bladder. BPH
causes bladder outlet obstruction by spasm of the urethral muscles and mechanical compression
of the urethra due to the enlarged prostate.

Pathophysiology of BPH is very important in explaining the effectiveness of treatment

modalities.Yet the exact cause of BPH is unknown presence of Dihydrotestosterone(DHT) is
instrumental for the growth of prostate. DHT results from intra-prostatic conversion of
testosterone which is mediated by an enzyme 5-alpha reductase. Other than testosterone, other
mechanisms for BPH occurrence include stromal-epithelial interaction, growth factors, age
related change in estrogen-testosterone ratios and genetic factors.

Patients with symptoms of lower urinary tract should be evaluated using the AUA/IPSS
symptom score. The AUA/IPSS is a validated scoring system that is reproducible, accepted
internationally and used to both diagnose and evaluate the results of therapy. The questionnaire
consists of 7 questions that can be scored by assigning 0 to 5 to give a total maximum score of
35. Patients with scores ranging from zero to seven have mild symptoms and generally don’t
need treatment. Patients with scores ranging from 8 to 19 have moderate symptoms, and those
with scores ranging from 20 to 35 have severe symptoms. Treatment is recommended for those
patients who report moderate and severe symptoms when their symptoms are bothersome.

Patients with uncomplicated BPH must have a urinalysis and serum PSA (prostate specific
antigen).Urinalysis is important to document the presence of infection, hematuria, and renal
disease – all of which may be in the differential diagnosis of patients with BPH. Serum PSA is
indicated in all patients with BPH because patients may have concomitant prostate cancer.

Alpha blockers act by decreasing the bladder outflow obstruction by relaxation of smooth
muscles while 5-alpha reductase inhibitors act by preventing the formation DHT that leads to
proliferation of prostatic tissue so the size of prostate may decrease with the 5 alpha
reductase inhibitors.

Complications of BPH are acute retention of urine, recurrent urinary tract infections,
bladder stones etc. People with LUTS + bigger size prostates may need surgical
interventions such as TURP (Transurethral resection of prostate).
.Step 2: Search for evidence

 To answer questions about a therapeutic issue, we identify randomized controlled trials

(RCTs) of an experimental treatment or a control or standard treatment and subjects are
followed up forwardly for the outcome of interest

 Database:- PubMed
Step 3: Critical appraisal of the evidence

Validity of critical appraisal:-

• Is the patient’s group randomly assigned? Yes

• Is the method of distribution confidential? Yes

• Is the tracking complete? Yes

• Whether blinded? YeS

• Are there other treatments that are similar in addition to the treatment program? Yes

• Are the two groups similar in baseline at the beginning of treatment? Yes

Step 4: Apply the results

According to the study evidence, the long-term dual therapy with doxazosin( alpha blocker)and
finasteride (5-alpha reductase inhibitor) was safe and reduced the risk of overall clinical
progression of benign prostatic hyperplasia significantly more than did treatment with either drug
alone (monotherapy). Combination therapy and finasteride(5 alpha redutase) alone reduced the
long-term risk of acute urinary retention and the need for surgery.

Our patient vs the study scenario

According to the full text of study (https://www.nejm.org/doi/pdf/10.1056/NEJMoa030656)

Men >50 years of age with LUTS who had IPSS scores between 8-30 (moderate to severe
values and no past hx of prostatic surgery were recruited.

Our patient Mr.Xiao was 64 years old and had IPSS score of 15 with normal PSA value and no
past history of prostatic surgery. So results of this study is very much applicable to Mr. Xiao’s
condition as well.

Step 5: Evaluation after applying EBM

Mr.Xiao’s main concern is living a quality life without having complications like surgeries/acute
retention of urine etc. As we saw the results of above trial can be very much applicable to Mr.
Xiao’s scenario. So starting combination therapy with 5-alpha reductase(Finesteride) with alpha
blocker ( doxazosin) will meet the patient’s goal so is his satisfaction.

Using combined therapy is cost-effective since it decreses the possibility of invasive procedures
such as surgery/catherterizaton due to acute retention.
References

McConnell JD et al. The long-term effect of doxazosin, finasteride, and combination therapy on
the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003 Dec
18;349(25):2387-98. https://www.nejm.org/doi/pdf/10.1056/NEJMoa030656)