Optilume for BPH in Arizona
Optilume® Urethral Drug Coated Balloon for the treatment of Anterior Urethral Stricture
A Safe, Simple and Durable Treatment for Urethral Stricture
Break the stricture cycle
The Optilume® urethral drug-coated balloon was developed in response to severe patient and physician dissatisfaction with current stricture solutions.
A Cutting Edge Solution to Solve the Dissatisfaction in Current Stricture Solutions
The Optilume® technology combines mechanical dilation for immediate symptomatic relief with local drug delivery to maintain urethral patency.
The semi-compliant balloon expands the tissue creating a mechanical balloon dilation effect rupturing the urethral mucosa and allowing direct, circumferential drug delivery to the exposed submucosa through micro-fissures across the length of the stricture.¹
Rapid uptake of the highly lipophilic drug, paclitaxel, limits hyperactive cell proliferation and the fibrotic scar tissue generation that results in stricture recurrence.
Providing Superior Results to Traditional Urethral Stricture Management
By combining simple and effective balloon dilation with localized delivery of a proven antiproliferative drug², the Optilume® technology provides superior results vs standard of care endoscopic management.³
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MKT-00546 [A]
How durable are the outcomes?
At 3 years, durability continued with 77% FFRI* ¹, with a 176% increase in Qmax* (Baseline 5.1, 3-year 14.1) and a 65% decrease in IPSS* (Baseline 25.2, 3-year 8.8). Qmax & IPSS are using FCF* rates – Includes worst observed value carried forward for subjects undergoing repeat intervention of the study stricture (i.e. clinical failures).
Simple | Easily achieve relief
Safe | Proven on a difficult patient population³
Durable | The breakthrough treatment to break the stricture cycle
For patients who have failed prior endoscopic treatment, today there is Optilume® — a breakthrough
urethral drug-coated balloon treatment that dilates the urethral lumen and delivers paclitaxel directly to
the stricture, significantly reducing the incidence of stricture recurrence.³
How Optilume® Works
The Optilume® procedure is similar to traditional mechanical dilation methods, making it simple to learn and perform. The semi-compliant balloon mechanically dilates and expands the urethral lumen, creating micro-fissures in the urothelium which facilitate circumferential drug delivery across the length of the urethral stricture. By combining simple and effective balloon dilation with localized delivery of a proven antiproliferative drug² – The Optilume® Urethral Drug Coated Balloon provides long-term relief from stricture recurrence¹.
¹Elliott SP, Virasoro R, Estrella R, et al. MP56-06 The Optilume Drug Coated Balloon for Recurrent Anterior Urethral Strictures: ROBUST I Clinical Study 3-year follow up, N = 43. J Urol 2021;206(3S):e971.
²Rosenfield K, Jaff MR, White CJ, et al. Trial of Paclitaxel-Coated Balloon for Artery Disease. NEJM 2015;372(2):145-53
³Elliott SP, Coutinho K, Robertson KJ, D’Anna R, Chevli K, Carrier S, Aube-Peterkin M, Cantrill CH, Ehlert MJ, Te AE, Dann J, DeLong JM, Brandes SB, Hagedorn JC, Levin R, Schlaifer A, DeSouza E, DiMarco D, Erickson BA, Natale R, Husmann DA, Morey A, Olsson C and Virasoro R, One-Year Results for the ROBUST III Randomized Controlled Trial Evaluating the Optilume Drug-Coated Balloon for Anterior Urethral Strictures, The Journal of Urology® (2021), doi: 10.1097/JU.0000000000002346
Manufactured by Urotronic, Inc. Please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. The Optilume DCB is indicated for use in patients with obstructive urinary symptoms associated with anterior urethral stricture. It is designed to be used in adult males for urethral strictures of ≤3cm in length. The Optilume DCB is contraindicated for patients with known hypersensitivity to paclitaxel or structurally related compounds and patients with urologic implants such as penile implants or artificial urinary sphincters. Paclitaxel may be present in semen after treatment with the Optilume DCB. The risks associated with paclitaxel in semen and the impact on sperm and spermatogenesis are unknown. Men should abstain or use a condom for 30 days and men with partners of child-bearing potential should use highly effective contraceptive and avoid fathering children for 6 months after treatment. Monitor for signs of anaphylaxis or hypersensitivity to paclitaxel. Potential risks can include, but are not limited to, the following: blood in the urine (hematuria), painful urination (dysuria), urinary tract infection (UTI), urinary retention, and stricture recurrence.
*List of treatments is not all inclusive.
Understanding Urethral Stricture Disease: Causes, Symptoms, and Treatment
Urethral stricture disease is a condition that affects the urethra, the tube that carries urine from the bladder out of the body. It involves the narrowing or blockage of the urethra, which can lead to various complications and discomfort for affected individuals. In this blog post, we will explain the causes, symptoms, diagnosis, and treatment options for urethral stricture disease.
What is Urethral Stricture Disease? 1,2,3
Urethral stricture disease occurs when the urethra becomes narrowed or obstructed, making it difficult for urine to pass through. This narrowing can occur anywhere along the length of the urethra, from the bladder to the tip of the penis in men, and from the bladder to the outside of the body in women. The condition can be either congenital (present at birth) or acquired (developed later in life).
Causes of Urethral Stricture Disease:1,2,3
There are several factors that can contribute to the development of urethral strictures, including:
- Trauma or injury to the urethra, such as from a pelvic fracture or straddle injury.
- Infections, particularly sexually transmitted infections (STIs) such as gonorrhea or chlamydia.
- Inflammation or irritation of the urethra, often due to conditions such as urethritis or balanitis.
- Medical procedures involving the urethra, such as catheterization or urethral surgery.
- Radiation therapy for prostate cancer or other pelvic cancers.
Symptoms of Urethral Stricture Disease: 1,2,3
The symptoms of urethral stricture disease can vary depending on the severity of the condition but may include:
- Difficulty starting urination or maintaining a steady stream.
- Weak urine flow.
- Frequent urination or a feeling of incomplete emptying of the bladder.
- Urinary retention (inability to urinate).
- Urinary tract infections (UTIs).
- Pain or discomfort during urination. 7. Blood in the urine (hematuria).
Diagnosis: 1,2,3
Diagnosing urethral stricture disease typically involves a combination of medical history evaluation, physical examination, and diagnostic tests. These may include:
- Uroflowmetry: A test to measure the flow rate and pattern of urine during urination.
- Cystoscopy: A procedure in which a thin, flexible tube with a camera (cystoscope) is inserted
into the urethra to visually inspect the inside of the urethra and bladder. - Retrograde urethrography: A special X-ray procedure that uses contrast dye to visualize the
urethra and identify any narrowing or blockages. - Urinalysis and urine culture: Tests to evaluate for signs of infection or other abnormalities in
the urine.
Treatment: 1,2,3
Treatment options for urethral stricture disease depend on the severity of the condition and may include:
- Dilation: A procedure in which a series of increasingly larger tubes or dilators are inserted into the urethra to widen the narrowed area.
- Urethrotomy: A minimally invasive procedure in which a small incision is made in the narrowed portion of the urethra to widen it.
- Urethroplasty: A surgical procedure to reconstruct or repair the narrowed portion of the urethra using tissue grafts or flaps.
- Urinary catheterization: In some cases, a catheter may be temporarily inserted into the
urethra to relieve urinary retention or facilitate urine drainage. - Medications: Antibiotics may be prescribed to treat any underlying infections, while alphablockers or other medications may be used to help relax the muscles of the urethra and improve urine flow.
- Optilume® Balloon Treatment: Optilume is an effective alternative to traditional endoscopic stricture treatments, offering minimally invasive, immediate relief4. Optilume works by inhibiting new scar tissue growth that often recurs after dilations or direct visual internal urethrotomy.
Conclusion:
Urethral stricture disease is a challenging condition that can significantly impact a person’s quality of life. Early diagnosis and appropriate treatment are essential for managing the symptoms and preventing complications. If you experience any symptoms of urethral stricture disease, it’s important to seek medical attention promptly to receive a proper evaluation and personalized treatment plan.
Evolution of Treatment Paths for Urethral Stricture Disease: From Traditional Approaches to Innovative Solutions like Optilume® Balloon Treatment
Urethral stricture disease has long been a challenging condition to manage, requiring various interventions to address the narrowing or blockage of the urethra effectively. Over time, the treatment landscape for urethral strictures has evolved significantly, from traditional surgical approaches to the emergence of minimally invasive techniques like Optilume® balloon treatment. In this article, we’ll explore the evolution of treatment paths for urethral stricture disease, highlighting the role of Optilume® balloon treatment in reshaping the management paradigm.
Traditional Approaches:
Historically, the treatment of urethral strictures has relied on traditional surgical interventions, including:
- Dilation: Mechanical dilation involves the gradual stretching of the narrowed urethral segment using a series of progressively larger instruments or dilators. While effective in some cases, dilation may be associated with a risk of tissue trauma and stricture recurrence.
- Urethrotomy: Urethrotomy entails the incision or cutting of the narrowed portion of the urethra using a surgical instrument called a urethrotome. This procedure aims to widen the stricture and improve urine flow but may be limited by the risk of scar tissue formation and stricture recurrence.
- Urethroplasty: Urethroplasty is a surgical reconstruction procedure that involves excising the narrowed segment of the urethra and reconstructing it using tissue grafts or flaps. While urethroplasty offers durable results, it is more invasive and may require a longer recovery period.
Emerging Technologies:
In recent years, advancements in medical technology have led to the development of innovative treatments for urethral stricture disease, including:
- Optilume® Balloon Treatment: Optilume® represents a novel approach to treating urethral strictures by combining controlled dilation with drug coating technology. During the procedure, a specially designed balloon catheter is inserted into the narrowed urethral segment and inflated to dilate the stricture gently. Additionally, the balloon catheter releases a therapeutic agent directly into the stricture site, aiming to reduce inflammation and promote tissue healing. Optilume® offers the advantage of being minimally invasive, with potential benefits such as shorter recovery times and reduced risk of complications compared to traditional surgical interventions1.
Clinical Efficacy and Future Directions:
Preliminary studies and clinical trials have shown promising results with Optilume® balloon treatment for urethral stricture disease. These studies have demonstrated improvements in urinary flow rates, reductions in stricture recurrence rates, and overall symptomatic relief in treated patients1 . However, further research and long-term follow-up are needed to establish the efficacy and safety profile of Optilume® conclusively.
Conclusion:
The evolution of treatment paths for urethral stricture disease reflects ongoing efforts to improve patient outcomes and quality of life. While traditional surgical approaches remain valuable in certain cases, innovative technologies like Optilume® balloon treatment offer new possibilities for minimally invasive and targeted interventions. As research in this field continues to advance, the future holds promise for further refining treatment strategies and enhancing the management of urethral stricture disease.