Bulking Agents - Do they work for Men with Stress Incontinence?

Pete Health Guide April 30, 2009
  • A recent article published on IncontinenceNetwork provided information about using collagen injections to treat various forms of urinary incontinence. This peaked my interest because I have wanted to have this done to correct the stress incontinence that I have.

     

    My stress incontinence is caused by injuries to my bladder neck during a TURP (Transurethral Resection of the Prostate) three years ago. Most men who undergo a TURP will develop some form of incontinence.  Depending on extensive the TURP is, it can destroy  the muscle and tissue in the bladder neck.

     

    I have talked to my urologist on several occasions about the possibility of trying some of the bulking agents to correct this. When we first talked she seemed positive about trying it. However at a follow-up appointment she was not as enthusiastic. She indicate her reticence for the following reasons:

    • My stress incontinence is not severe enough to try a sling. (This is true.)
    • None of the bulking agents available today are FDA approved for use in men. This doesn't mean she can't use them. The Botox is also not approved by the FDA for urge incontinence.
    • There is little data on the efficacy of bulking agents in men. Some studies indicate it may be as low as 50%.
    • My bladder neck is so scarred from the TURP that she might not be able to inject it.

    Needless to say, I was very disappointed, particularly in light of the fact that one time she seemed to very willing to do it. She would do it if I requested, but felt that it would not be the right thing to do. I had to acquiesce to her opinion, in spite of my disappointment.

     

    I decided to do my research to accumulate some "ammunition" in case I had the courage to bring the subject up again. I spent a fair amount of time doing research on bulking agents for males. I have conversations or exchanged emails with Customer Support personnel at Boston Scientific, Uroplasty Inc., and C.R. Bard Company on the efficacy of their particular products for men with stress incontinence. These individuals were very helpful, even providing copies of clinical studies done for men.

     

    Men have two urinary sphincters, an internal one and an external one. The internal sphincter  is a continuation of the bladder detrusor muscle and is not under voluntary control. Its primary function is to prevent urine escaping during ejaculation. However, it does retain some tension and so contributes to male continence. Some sources indicate the internal sphincter may be more important for continence in males than the external sphincter. As stated above TURP or prostatectomy can damage or remove the muscles controlling this sphincter.

     

    Whether females have one or two sphincters depends on who you read. I have read some sources that indicate only one, others that indicate two, and still others the indicate a "long" one extending from the bladder neck to the voluntary pelvic muscles.

     

    In my case I developed both stress and urge incontinence.  I'm fortunate to have access to intravesical Botox (link) injections for my urge incontinence. However, Botox does not help with stress incontinence.

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    The "collagen" referred to in the article is just one many substances used for controlling stress incontinence. These substances are collectively referred to as "bulking agents." Among the many types are:

    • Tegress (formerly call Uryx): This product was originally produced by Genyx Medical, which has since been purchased by C.R. Bard. Bard discontinued this product in December, 2007. (I list it here because it is found when searching for information on bulking agents on the Internet.)
    • Durasphere: Comprised of carbon bead particles, this is produced by Carbon Medical Technologies.
    • Contigen: C. R. Bard. This is bovine glutaraldehyde cross-linked collagen.
    • Coaptite: Originally produced by Bioform Medical, it now markets Coaptite through Boston Scientific. This product is comprised of 100 micron spheres of calcium hydroxylapatite, a synthetic form of a natural material found in bones.
    • PTFE (Teflon) Paste: Marketed at "Polytef", it is currently not available in the US. Was used early on until it was discovered that some of the particles may migrate to other areas of the body, with unknown consequences.

    There are three techniques that are used:

    • Transurethral: A rigid cystoscope is inserted into the urethra and position just below the bladder neck. A needle is pass through the scope and through the urethral wall. The bulking agent is injected just below the urethral mucosa. The scope is rotated a two or three more times and the process repeated.
    • Periurethral: A rigid cystoscope is inserted into the urethra, but the bulking agent is injected from outside the urethral opening (meatus). There is small cleft between the meatus and the surrounding tissue above the vagina. A needle is inserted into this cleft and positioned using the view from the cystoscope as a guide for placement. Once the tip of needle is in satisfactory position, the bulking agent is inject. This process is repeated two or three more times around the periphery of the urethra. This procedure may require more anesthesia than transurethral, and is performed exclusively for women.
    • Antegrade: This is usually reserved for men with severe post-prostatectomy incontinence. The bladder is opened suprapubically and the bulking agent is inject from inside the bladder, adjacent to the bladder neck. This procedure is considered surgery and must be performed in the operating room with appropriate anesthesia and pain control.

    While the usual injection location is in the urethral mucosa of the bladder neck, some surgeons have had success injecting material below the bladder neck, sometimes as much as an inch or more.

     

    Bulking agents last usually from six months to year, although some people have gone longer than that. The bulking agents described above have FDA approval for use in women only. There is quite a bit of data on the efficacy of bulking agents for females, but not much on how well it works for males.

     

    Some studies indicate success rates for women of nearly 80%, depending on the bulking agent used. One study that compared Durasphere to collagen found an 80% success rate for Durasphere as compared to a 69% success rate for collagen. Other studies have found that collagen may be nearly as effective. Many of these bulking agents remain affective for at least 6 months, some for a year or more. However, clinical studies with male subjects do not achieve these rates.

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    So, unfortunately for me, my research supports my doctor's opinion!

     

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