CLINICAL TRIAL

Finasteride for Lower Urinary Tract Symptoms

Recruiting · 18+ · Male · Boston, MA

This study is evaluating whether MRI can be used to predict which patients with benign prostatic hyperplasia will respond to a drug.

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About the trial for Lower Urinary Tract Symptoms

Eligible Conditions
Prostate Hyperplasia · Hypertrophy · Prostatic Hyperplasia · Urinary Obstruction · Prostatic Diseases · Prostate Disease · Urologic Diseases · Hyperplasia · Prostate Hypertrophy · Lower Urinary Tract Symptoms · Prostate Pain · Urinary Tract Diseases · Benign Prostatic Hyperplasia (BPH)

Treatment Groups

This trial involves 2 different treatments. Finasteride is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Finasteride
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Finasteride
FDA approved

Side Effect Profile for Finasteride

Finasteride
Show all side effects
Rash
1%
Decreased libido
1%
Abdominal pain
0%
fulgurated skin lesions
0%
Palpitations
0%
Dizziness
0%
Cough
0%
Stent placement
0%
Urinary tract infection
0%
Dehydration
0%
Itch
0%
Syncope
0%
This histogram enumerates side effects from a completed 2017 Phase 4 trial (NCT01296672) in the Finasteride ARM group. Side effects include: Rash with 1%, Decreased libido with 1%, Abdominal pain with 0%, fulgurated skin lesions with 0%, Palpitations with 0%.

Eligibility

This trial is for male patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male (physiological);
Age ≥ 50;
Presence of lower urinary tract symptoms secondary to BPH;
Prostate size >40cc by digital rectal examination;
Undergoing clinically indicated prostate biopsy for elevated PSA.
You are eligible for treatment with 5ARI therapy. show original
You have no prostate nodule, tenderness or firmness. show original
You have a mildly elevated PSA level. show original
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Assessment of Finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Assessment of Finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Finasteride will improve 1 primary outcome in patients with Lower Urinary Tract Symptoms. Measurement will happen over the course of Assessment of Finasteride responsiveness through changes in urinary symptoms will be completed at 6 month intervals during clinic visits, and treatment efficacy will be determined after the first 12 months..

Finasteride treatment effect on lower urinary tract symptom improvement by urinary symptom score
ASSESSMENT OF FINASTERIDE RESPONSIVENESS THROUGH CHANGES IN URINARY SYMPTOMS WILL BE COMPLETED AT 6 MONTH INTERVALS DURING CLINIC VISITS, AND TREATMENT EFFICACY WILL BE DETERMINED AFTER THE FIRST 12 MONTHS.
Validated questions of the AUA Urinary Symptom Score will be used every 6 months to assess efficacy of Finasteride treatment in improving lower urinary tract symptoms in the patient population. Based on previous randomized trials, it will be determined whether the patient is responsive or resistant to the treatment dependent on changes in their AUA Urinary Symptom Score at the first 12 month mark. For patients who are resistant to Finasteride, other medical or surgical treatments will be offered, and the patients will be removed from the study.

Who is running the study

Principal Investigator
A. F. O.
Prof. Aria F. Olumi, MD
Beth Israel Deaconess Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can lower urinary tract symptoms be cured?

If LUTS is caused by BPH, patients should be informed about the lack of evidence for the hypothesis that LUTS can be cured and the increased potential risk of prostate cancer if the diagnosis of LUTS is made before prostate cancer is detected.

Anonymous Patient Answer

What is lower urinary tract symptoms?

LUTS are very common, with a frequency comparable to the general population. LUTS are associated with a lower quality of life in men. The most important LUTS are urgency, nocturia and incontinence related to all components of the IPSS.

Anonymous Patient Answer

How many people get lower urinary tract symptoms a year in the United States?

There are about 1.28 million American persons who have LUTS with the greatest burden on their lives occurring in those with mild LUTS and moderate to severe LUTS.

Anonymous Patient Answer

What are common treatments for lower urinary tract symptoms?

About one-third of men presenting with lower urinary tract symptoms could have urological treatment for a non-urinary cause. The most common treatments were medications, such as alpha-blockers. Many of these medications could worsen or lessen the men’s symptoms.

Anonymous Patient Answer

What causes lower urinary tract symptoms?

Female and male patients with LUTS exhibit different lifestyles. LUTS also differs depending on the patients' age; LUTS increases across all age groups until middle age, but men and women over the age of 70 report LUTS at higher rates than younger men and women.

Anonymous Patient Answer

What are the signs of lower urinary tract symptoms?

Patients with lower urinary tract symptoms often present with other symptoms, which may be underestimated. It is vital that gynaecologists take these into account when performing transvaginal pelvic examination in these patients.

Anonymous Patient Answer

How serious can lower urinary tract symptoms be?

Symptoms associated with lower urinary tract infection occur as common as urinary incontinence and occur more often when they are of moderate to severe intensity. Patients' attitudes towards lower urinary tract symptoms are a poor predictor of their impact as they do not necessarily recognize their impact on their daily functioning.

Anonymous Patient Answer

Have there been any new discoveries for treating lower urinary tract symptoms?

The diagnosis and treatment of lower urinary tract diseases does not improve after the introduction of new treatment modalities. Although treatment guidelines are usually considered, these are only published for select patients, not for the general population.

Anonymous Patient Answer

What does finasteride usually treat?

Finasteride has no effect on urinary symptoms. Finasteride may be useful for reducing the recurrence of prostate cancer when combined with androgen deprivation therapy. Patients may experience reduced urinary symptoms such as urgency and the urge/toilet incontinence without an increase of serious urinary side effects with finasteride.

Anonymous Patient Answer

What is finasteride?

Finasteride is a drug with multiple uses. On the one hand, it is marketed for its treatment of benign prostatic hyperplasia (BPH). BPH is characterized by a noncancerous growth of the prostate gland that causes urinary frequency, feeling of incomplete emptying, difficulty urinating, or an inability to get rid of urine, or to empty the bladder completely in a consistent way. On the other hand, finasteride is marketed for the treatment of adult male pattern hair loss. Hair will begin to thin as a result of androgens. The connection between hair shedding and men, especially baldness, has been well documented for thousands and millennia.

Anonymous Patient Answer

What is the average age someone gets lower urinary tract symptoms?

There is a strong association between age at baseline and subsequent risk of developing LUTS and BOO. As such, it appears that most people who develop LUTS suffer from symptoms earlier in their lives. This research can be used to help patients and their families to better manage their voiding dysfunction.

Anonymous Patient Answer

Is finasteride safe for people?

[Finasteride 20 mg once daily had no significant effect on the frequency of adverse effects in a study of people with lower urinary tract symptoms. A greater number of people treated with finasteride 20 mg reported experiencing a greater number of adverse effects than placebo-treated men (6.3% vs, 4.1%) or women (9.1% vs, 5.7%), and these effects were related to higher doses of finasteride used for men (finasteride 2.0 mg versus finasteride 20 mg for men, and finasteride 20 mg versus finasteride 2.0 mg for women (p<0.0001; relative dose ratios 10).

Anonymous Patient Answer
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