Urethral Stricture Disease

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Do you suffer from Urethral Stricture?

A urethral stricture is a narrowing of the urethra caused by scarring that obstructs the flow of urine as a result of inflammatory, ischemic or traumatic processes. If left untreated, the obstruction caused by a urethral stricture can lead to a reduced quality of life, bladder and kidney damage, and urinary tract infections in men.¹

Common symptoms of urethral stricture include:

  • Urinary Tract Infections (UTI’s)
  • Hesitancy when waiting for the stream of urine to begin
  • Weak or irregular flow
  • Straining to urinate
  • Painful urination
  • A sense of incomplete emptying
  • Dribbling after urination

If any of these describe your condition, talk to a Healthcare Provider about your Lower Urinary Tract Symptoms (LUTs)

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What causes Urethral Stricture Disease?

Common causes of urethral stricture include:

  • Medical procedures that involve inserting an instrument, such as an endoscope, into the urethra
  • Urinary tract infections (UTIs)
  • Latex reactions from Foley catheters
  • Irritation from Intermittent or long-term catheter use
  • Trauma or injury to the urethra or pelvis
  • BPH symptoms or previous surgery to remove or reduce an enlarged prostate gland
  • Cancer of the urethra or prostate
  • Sexually transmitted infections (STIs)
  • Radiation therapy

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A Breakthrough Treatment for Urethral Stricture Disease

For patients who have failed prior endoscopic management, 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.²

Until now, there has been no treatment for urethral stricture that provides ambulatory recovery, minimal complications and durable outcomes. Optilume® is the cost-effective alternative³ to recurrent endoscopic management, breaking the cycle of recurrent urethral stricture disease.4

Optilume® is:

Simple | Easily achieve relief

Safe | Proven on a difficult patient population4
In the ROBUST 1 and ROBUST 3 trials with patients who had received multiple prior dilations, there were:

  • No device-related serious complications4
  • Preservation of sexual function4

Durable | The breakthrough treatment to break the cycle


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How durable are the outcomes?

At three years, Optilume patients experienced a 176% improvement in urinary flow rate (Qmax), a 77% Freedom From Reintervation Rate (FFRI*) success rate, and a 65% decrease in International Prostate Symptom Score (IPSS) 4.*

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).²

*Includes worst observed value carried forward for subjects undergoing repeat intervention of the study stricture (i.e. clinical failures).
*Qmax = Maximum urinary flow
*FFRI = Freedom From Repeat Intervention (inc. self-catheterization)
*IPSS = International Prostate Symptom Score
*FCF = Failure Carried Forward

How is Urethral Stricture treated?

Intermittent self-catheterization
Some patients may attempt to manage urethral strictures by periodically inserting a catheter into their urethra to keep the scarred area from narrowing. This method can be painful and embarrassing, and requires a constant supply of catheters.

Standard Dilation
Typically, the first line of treatment for urethral strictures. Standard dilation is a procedure whereby a doctor can use either; rods of increasing diameters, or a non-drug coated dilation balloon, to stretch the urethral narrowing (stricture) without causing further injury. Many patients find this treatment a short-term solution.

Internal urethrotomy (DVIU) 
Published evidence indicates there is no significant difference between the success of standard balloon dilation and DVIU, at 24 months follow up for the treatment of urethral stricture.5

Urethroplasty involves surgical removal of the stricture and reconstruction of the urethra by performing an invasive, open surgical procedure. Sometimes this involves using a graft from the patient’s mouth. While urethroplasty may offer lasting results, this surgery often takes hours to complete and requires up to 8 weeks of recovery.  Furthermore, there are potential complications and side effects, including erectile dysfunction, curvature of the penis and stricture recurrence.6

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Additional Information

¹. Tritschler S, Roosen A, Füllhase C, Stief CG, Rübben H. Urethral stricture: etiology, investigation and treatments. Dtsch Arztebl Int. 2013;110(13):220-226. doi:10.3238/arztebl.2013.0220

²Elliott 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.

³Data on file

4Elliott 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

5Steenkamp JW, Heyns CF, de Kock ML. Internal urethrotomy versus dilation as treatment for male urethral strictures: a prospective, randomized comparison. J Urol 1997 Jan;157(1):98-101. PMID:8976225.

6Al-Qudah HS, Santucci RA. Extended complications of urethroplasty. Int Braz J Urol. 2005 Jul-Aug;31(4):315-23; discussion 324-5. doi: 10.1590/s1677-55382005000400004. PMID: 16137399.

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