Eric A. Hurtado

The safety and efficacy of ethylene vinyl alcohol copolymer as an intra-urethral bulking agent in women with intrinsic urethral deficiency.

Abstract The purpose of this post-marketing case-series is to report the short-term safety and effectiveness of ethylene vinyl alcohol (EVA) copolymer (TegressTM; C.R. Bard, Covington, GA, USA) in the treatment of intrinsic sphincter deficiency (ISD). The charts of all female patients who received ethylene vinyl alcohol (EVA) copolymer between 2005 and 2006 were reviewed for demographics, physical exam, urodynamic findings, outcomes and complications.Nineteen of twenty women who received EVA during this period completed follow-up. After an average of 1.4 injections, ∼58% of the patients had a complication related to the procedure with 37% experiencing urethral erosion. Of the patients, 10.5% reported at least a 50% subjective improvement in their symptoms. Intra-urethral bulking for the treatment of SID is meant to be minimally invasive and safe with minimal reports of complications. This series of 19 patients show significant percentage of patients experiencing serious complications with TegressTM. Additionally, TegressTM may be less efficacious than reported in the FDA trials, especially those with prior injections. A long-term prospective study needs to be performed in women with ISD before treatment can be recommended for general use by all gynecologists and urologists.

Large urethral prolapse formation after calcium hydroxylapatite (Coaptite) injection.

A 67-year-old woman who had failed two prior anti-incontinence surgeries presented with stress urinary incontinence and intrinsic sphincteric deficiency. Calcium hydroxylapatite (Coaptite®) was injected cystoscopically into the bladder neck and proximal urethra and resolved her incontinence. Seven months later, she presented with difficulty in voiding and a urethral mass. Physical examination revealed a large prolapse of the urethral mucosa obstructing the external urethral meatus. Surgical exploration revealed local migration of calcium hydroxylapatite particles from the site of injection (bladder neck and proximal urethra) to the distal urethra. The prolapsed urethral mucosa was incised and marsupialized. Improper injection techniques likely contributed to urethral prolapse in this complication. Meticulous attention to injection techniques is the key to treatment success of urethral bulking agents, particularly in patients who have a scarred/fixed urethra or have multiple urethral/vaginal surgeries.

Complications of ethylene vinyl alcohol copolymer as an intraurethral bulking agent in men with stress urinary incontinence.

OBJECTIVES To report the short-term safety and efficacy of ethylene vinyl alcohol (EVA) copolymer (Tegress; C.R. Bard, Inc., Covington, GA) in the off-label treatment of male stress urinary incontinence. METHODS We reviewed the charts of all adult male patients who received EVA copolymer between 2005 and 2006 for demographics, physical examination findings, urodynamic findings, outcomes, and complications. RESULTS A total of 17 of 18 men completed follow-up after receiving EVA during this time period. With an average of 1.4 injection sessions, 58.8% of patients experienced a complication related to the procedure, with 41.1% of these complications being urethral erosion of the material and 22% experiencing severe pain on injection. Subjective improvement of at least 50% was reported by 41.1% of patients. The mean follow-up period was 4.2 months. CONCLUSIONS Intraurethral bulking agents are meant to be a minimally invasive procedure with lower complication rates than alternatives such as the artificial urinary sphincter and male sling. The off-label use of EVA in men in this case series resulted in a significant complication rate. Urethral erosion was the most common complication causing dysuria, precluding further bulking in others, and resulting in loss of benefit with passage of material. In addition, EVA used in men may be less efficacious than the Food and Drug Administration data reported in women, especially with prior injectable therapy. In December 2006, EVA was voluntarily taken off the marketplace by CR Bard owing to reports from clinicians.

Rectal erosion of synthetic mesh used in posterior colporrhaphy requiring surgical removal

Treatment of pelvic organ prolapse with transvaginally placed synthetic mesh has recently increased. Several reports of complications have surfaced raising the overall question of safety regarding its use for vaginal prolapse repair. This case report describes a rectal erosion and dyspareunia that resulted from mesh placed into the posterior vaginal wall. A 47-year-old woman underwent a laparoscopic supracervical hysterectomy and a posterior repair with polypropylene mesh resulting in a rectal erosion. Despite removal of all of the mesh that could be excised rectally resulting in a healed rectal mucosa, the patient had persistent dyspareunia and pain requiring complete removal of the mesh using a vaginal approach. After surgery, the patient had resolution of all her symptoms. Further studies of transvaginally placed synthetic mesh need to be performed to determine its safety and efficacy.

Post hoc interpretation of urodynamic evaluation is qualitatively different than interpretation at the time of urodynamic study.

Intraobserver reliability of post hoc urodynamic interpretation is greater than interobserver reliability, attributable to interpreter bias. If post hoc interpretation is qualitatively similar to interpretation at the time of study by a urodynamicist in attendance (“live” interpretation), a similar intraobserver bias should be observed. We therefore evaluated the intra‐ and interobserver reliability of post hoc versus “live” interpretation.

Complications of Tegress injections

Dear Editor, It was with great interest that we read the positive experience with ethylene vinyl alcohol (EVOH) as an intra-urethral bulking agent of Kuhn et al. [1]. In their article, no patients experienced urethral erosions, whereas our case series had an erosion rate of 37% [2]. Our study was criticized by the authors for not complying with the manufacturer’s recommendations (which is untrue) and thus resulted in an erosion rate higher than that reported in the study for Food and Drug Administration (FDA) approval. Specifically in our series, only four of the 19 patients received an additional 0.5 cc at only one injection site. Of these four patients, two patients experienced erosion. We were also criticized for performing injections until coaptation occurred. This statement was meant to reflect that we aborted injection of the contralateral side if good coaptation was achieved with bulking of the first injection site. In naïve patients, the stopping point with Tegress is not coaptation of the urethra as it is with true bulking agents such as collagen, Durasphere, Macroplastique, Deflux, and Coaptite. Very few of our patients were naïve (see below). This technique could potentially contribute to a decline in efficacy of the product though it should not affect the erosion rate. In our series, only one patient exceeded the manufacturer’s recommended total dose of 2 cc of EVOH. The patient who did receive a total of 2.5 cc at one injection session did not experience urethral erosion. One discrepancy that exists between our patient population and that in the study of Kuhn et al. is that only three of 19 patients in our series were naïve, meaning that they had never had any intra-urethral bulking agent. Since many of these patients had failed prior intra-urethral bulking agents, this may have led to a lower success rate. Kuhn et al. must be commended for their results with little complications. However, Kuhn et al. only performed cystoscopy for repeated injections in nine of 24 patients. It is possible that asymptomatic erosions were not discovered. Additionally, we reported a similar erosion rate of 41% in 17 male patients who also underwent EVOH injections [3]. If EVOH truly had such a low complication rate with good efficacy as reported by Kuhn et al. [1], then it is doubtful that C.R. Bard would have withdrawn it from the market voluntarily, as they did in December 2007.

Rodney A. Appell.

The field of Female Urology and Urogynecology has experienced a huge loss with the passing of Dr. Rodney Appell. Often, a physician is remembered by their contributions in a particular specialty. Many already know of his many publications in journals and textbooks. He was well known as an editor, his involvement with the NAFC and SUFU. He was an exceptional educator for many residents and fellows of which some have now become leaders in Urology and Urogynecology. For those who knew him well, he was much more. He was a man of integrity and brutal honesty. He was the person who was willing to take a stand for others. Whether it was for strangers being treated rudely by another passenger on a train or for his fellows caught in a political battle with university administration, he fought for what he believed was right and just. Everything he achieved was through his own merits and hard work. Many do not know that he did road construction during the summers to pay for medical school. To him, a half-day of work was from 6 AM to 6 PM. He had a strong belief in educating good surgeons and clinicians specifically in his area of focus of voiding dysfunction, incontinence, and pelvic organ prolapse. He happened to be one of the first Urologists to cross the specialty line by taking in Gynecologists as Fellows and training them in a Urology department. Prior to that, he taught the first Gynecologist to perform insertion of artificial urinary sphincters in women and later on men as well. We could elaborate on how much he taught us about surgery, clinical practice and urodynamics but this was just the academic aspect. For those who knew him best however, it was personal side that made him so unique. When you committed to him as a Fellow, he committed himself to you as a mentor in medicine and life. He was always ready to give advice about work and most importantly family. We learned of his sacrifices that he made that cost him precious time with his loved ones. He adored his sons, daughter-in-law, and his wife. We knew so much about them before we ever met them. When you earned his trust, you became a colleague and a friend where your input was expected and appreciated. His other loves included his dogs, fine restaurants, and the Houston Texans. He always had a good story from a fight breaking out on a salmon fishing trip to golfing with alligators (most involved many of the editors of prominent Urological journals). He had a great sense of humor with too many lines to quote, though often quoted by those who heard them. He also was generous with his time whether it was discussing physiology, research projects, or your spouse. He will be particularly missed by those of us fortunate enough to have been his Fellows. We owe him a great deal for his mentoring and friendship. He shaped us each uniquely as people and physicians which gave us the opportunity to obtain the careers that we currently have. Our hearts are with his family who loved him so very much. May he rest in peace and be remembered as a great physician, colleague, and friend.

Tolterodine: pharmokinetics, efficacy and safety

Tolterodine is a potent muscarinic antagonist for M1–M5 subtype receptors. Although nonselective, it has been shown to target the bladder preferentially over other organ systems. It is available in two forms; either as a 1 or 2 mg immediate-release formulation taken twice daily or a 2- or 4-mg extended-release formulation taken daily. In multiple trials, compared with other anticholinergic agents, it has been demonstrated to be effective in the treatment of adult females with an overactive bladder with and without urge incontinence, as well as in those with urge-predominant mixed incontinence. It is well tolerated and safe, with the extended-release formula demonstrating a lower frequency of adverse events, especially dry mouth.