114 Vaginal Surgery for Incontinence and Prolapse Figure 9.3. Traditional technique for sling placement. A: Retropubic space is entered laterally through the vaginal incision. B: Curved clamp passed through the retropubic space with direct finger guidance. C: Sling pulled up to the suprapubic incision by clamp (From Hinman F. Atlas of Urologic Surgery, 2nd ed., pp. 566–567. Copyright 1998, with permission from Elsevier.) Stress Urinary Incontinence Secondary to Intrinsic Sphincteric Deficiency 115 synthetic mesh to avoid the morbidity of fascial harvest, varying lengths of slings, from full- length to patch grafts, and different sites of fi xation for the sling, such as Cooper’s ligament, suprapubic or transvaginal pubic bone anchor fi xation, and passive fi xation by tissue adher- ence to the mesh within the retropubic space or obturator foramen. Currently there are no ran- domized trials comparing the different varia- tions of slings with respect to treatment of ISD. The choices of which sling material and which method of sling placement are at the discretion of the surgeon (130). For all types of SUI, urethral hypermobility, and ISD, autologous fascial pubovaginal slings are reported to have cure rates of 70% to 90% and cure/improved rates of 85% to 95% (15,16,18,23,24). Continence rates for patients with pure ISD appear to be slightly lower than that of patients with urethral hypermobility. With a mean follow-up of 22 months, Cross and colleagues (25) reported continence rates con- fi rmed by videourodynamics of 96% (43/45) in patients with preoperative urethral hypermobil- ity vs. 89% (65/73) in patients with preoperative ISD. With a mean follow-up of 51 months, Morgan and associates (16) reported continence rates of 91% for SUI due to urethral hypermobil- ity vs. 84% for SUI owing to ISD. Results of various sling procedures as treatment for SUI owing to ISD are noted in Table 9.2. Allograft/Xenograft Slings To decrease operative time and avoid the morbidity of autologous fascial harvest, the use of cadaveric allografts and xenografts has increased in recent years. The different nonau- tologous grafts are listed in Table 9.3 (26). These nonautologous grafts exhibit different elasticity and tensile strength. Kubricht et al (27) found that freeze-dried, gamma-irradiated cadaveric fascia lata had a tensile strength twice that of freeze-dried porcine small intestine submu- cosa. When comparing freeze-dried cadaveric fascia lata to solvent-dehydrated fascia lata, Lemer et al (28) found the solvent-dehydrated fascia to be signifi cantly stronger by tensiome- try. Although it is apparent that these grafts have different properties, it remains unclear which provides the best long-term results for sling surgery. Results using nonautologous grafts for sling surgery have been comparable to autologous slings with short- to intermediate-term follow- up. Brown and Govier (29) found a SUI cure rate of 74% and cured/improved rate of 93% with a mean follow-up of 12 months after freeze-dried cadaveric fascia lata sling, which was not signifi - cantly different from the 73% cured and 100% cured/improved after autologous slings at the same institution with mean follow-up of 44 months. In another comparison of allograft vs. Table 9.2. Results for suburethral sling series as treatment for ISD Sling Mean follow-up, % Type of sling Author, year (ref.) material n months (range) success Autologous Mason, 1996 (95) Rectus 63 12 (3–27) 94 Zaragoza, 1996 (23) Rectus 60 25 (11–34) 100 Barbalias, 1997 (96) Rectus 32 32 (30–38) 66 Hassouna, 1999 (98) Rectus 82 41 (6–96) 89 Kreder, 1996 (24) Rectus/FL 27 22 (9–32) 96 Haab, 1997 (81) Rectus/FL 37 48 (24–60) 73 Wright, 1998 (99) Rectus/FL 33 16 (15–28) 94 Richter, 2001 (100) Rectus/FL 57 42 (0.5–134) 84 Govier, 1997 (101) FL 30 14 (3–33) 70 Synthetic Barbalias, 1997 (97) PTFE 24 30 83 Staskin, 1997 (102) PTFE 122 24 88 Yamada, 2001 (103) PTFE 72 67 (50–75) 78 Morgan, 1985 (104) Marlex 208 >60 77 Rezapour, 2001 (40) TVT 49 48 86 Allograft Wright, 1998 (99) Cad FL 59 10 98 Ruiz, 2000 (105) Cad FL 105 18 93 FL, Fascia lata; PTFE, polytetrafluoroethylene; TVT, transvaginal tape. 116 Vaginal Surgery for Incontinence and Prolapse autologous sling with 2 years’ minimum follow- up, Flynn and Yap (30) found a cure rate of 71% and cured/improved rate of 84% with mean follow-up of 29 months in the allograft group vs. 77% cured rate and 90% cured/improved rate in the autologous sling group with mean follow- up of 44 months. The use of allograft in their series resulted in less postoperative pain and disability. A question that has been raised concerning the use of allografts in sling surgery is graft dura- bility. Although most allograft sling series report success rates comparable to autologous slings, the length of follow-up in the allograft series has been relatively short. Carbone and colleagues (31) reported disappointing results in 154 patients treated with freeze-dried cadaveric fascia lata and transvaginal bone anchor fi xa- tion. They found a high SUI recurrence rate of 38% within 1 year and attributed these early failures to cadaveric allograft degeneration based on fi ndings at reoperation. Fitzgerald and asso- ciates (32) noted that upon reoperating on freeze-dried cadaveric fascial sling failures, the slings had undergone some form of degenera- tion or autolysis, and in some cases the sling could not be identifi ed. Elliot and Boone (33) found no evidence of rapid graft degeneration following solvent-dehydrated cadaveric fascia lata sling, with a 96% cured/improved rate using 12 months as the minimum follow-up. After per- forming over 400 sling procedures using solvent- dehydrated cadaveric fascia lata, the authors have noted no evidence of rapid graft degenera- tion as well. When comparing the various mate- rials used in sling surgery after 12 weeks of subcutaneous implantation in the rabbit model, Dora et al (34) found that human cadaveric fascia and porcine xenografts showed a marked decrease (60–89%) in tensile strength and stiff- ness, whereas polypropylene mesh and autolo- gous fascia did not differ in tensile strength from baseline. With intermediate-term out- comes using nonautologous grafts for sling surgery reported in most series as comparable to that of autologous slings, the signifi cance of these fi ndings is not known. Another concern with the use of allografts has been the risk of disease transmission. Measures used to prevent disease transmission in tissue allografts include donor screening and a multi- step tissue sterilization process. Despite these measures, the presence of intact DNA material has been reported (35). Another potential concern is for the transmission of prion disease, such as Creutzfeldt-Jakob disease. Prions are protein molecules that can resist conventional means of sterilization. Although there is a theo- retical risk, to date there have been no reported cases of disease transmission with the use of cadaveric allografts in continence surgery. Synthetic Slings In recent years the use of synthetic mesh slings has gained popularity. Many of the early mesh slings, such as Marlex, Mersilene, silicone, and Protogen (Boston Scientifi c, Natwick, MA), were shown to have increased complication rates, such as urethral and vaginal erosions requiring mesh removal (18,36,37). In 1996 Ulmsten and associates (38) introduced the tension-free vaginal tape (TVT) procedure as a sling proce- dure performed with local anesthetic using a loosely woven polypropylene mesh. This sling Table 9.3. Allograft and xenograft materials used in sling surgery Sling material Trade name (manufacturer) Processing technique Cadaveric allografts Fascia lata FasLata (CR Bard, Inc., Murray Hill, New Jersey) Freeze-dried, gamma irradiated Suspend (Mentor, Santa Barbara, CA) Solvent-dehydrated, gamma-irradiated Decellularized dermis Duraderm (CR Bard, Inc., Murray Hill, New Jersey) Freeze-dried Alloderm (LifeCell Corp., Branchburg, NJ) Freeze-dried Acellular dermal matrix Repliform (Boston Scientific, Natick, Freeze-dried Massachusetts) Urogen (American Medical Systems, Inc., Gamma-irradiated Minnetoka, MN) Xenografts Acellular porcine dermis Dermatrix (Advanced UroScience, Saint-Paul, MN) Pelvicol (CR Bard, Inc., Murray Hill, New Jersey) Acellular matrix from Stratasis (Cook Urological, Bloomington, porcine small intestine IN) submucosa Fortaflex (Organogenisis, Canton, MA) Stress Urinary Incontinence Secondary to Intrinsic Sphincteric Deficiency 117 aims to re-create the pubourethral ligament and support of the suburethral vagina, by its placement at the mid-urethra without tension, and does not require suture fi xation. It. With follow-up out to 5 years in some series, the success rates are similar to that of autologous slings (39,40), and the previous problems of mesh erosion have been minimal. Modifi cations to the TVT procedure include the Suprapubic arc (AMS; Minnetouka, MN) procedure, where needle passage for sling placement is performed from the suprapubic incisions down to the vagina, and the newer transobturator slings, in which there is no retropubic needle passage and the ends of the mesh sling are brought through the obturator foramen on either side. Early results using a transobturator technique are promising. Delorme and associates (41) reported 91% cured and 100% cured/improved rates for all types of SUI using the transobturator technique (TOT) in 32 patients with a minimum follow-up of 12 months (mean 17 months). In a prospective randomized trial comparing 1-year outcomes of TVT (31 patients) to transobturator suburethral sling (30 patients), deTayrac et al (42) found comparable cure rates, 84% for TVT vs. 90% for TOT, with signifi cantly lower operat- ing times, 15 minutes vs. 27 minutes, and lower incidence of intraoperative bladder injuries, 0 vs. 10%, in the TOT group. Further discussion on mid-urethral slings is provided in Chapter 10. Bone-Anchored Slings Another method for securing the suburethral sling by transvaginal pubic bone anchor fi xa- tion has been described (43). Advantages of using transvaginal bone anchors include the ability to perform a sling procedure completely transvaginally without retropubic needle passage, minimal postoperative pain, and a consistent, stable point of fi xation. Nonautolo- gous allograft or synthetic sling materials are employed, obviating the need for fascial harvest. The theoretical disadvantage of bone anchor fi xation is the potential for osseous complica- tions, such as osteitis pubis or osteomyelitis. Results for the treatment of SUI using bone anchor slings have been variable. As stated pre- viously, Carbone and associates (31) experienced a high early failure rate using freeze-dried cadav- eric fascia lata. In a later report on their experi- ence with transvaginal bone anchor gelatin-coated Dacron sling, they reported a 95% cured/ improved rate for SUI, but patients with signifi - cant ISD were excluded from this study (44). Giberti and Rovida (45) reported on 63 patients receiving gelatin-coated Dacron bone anchored slings. With 17 months mean follow-up, the cured rate was 82% and the cured/improved rate was 91%, but they noted that all of the patients with preoperative ISD failed. In the authors’experience using solvent- dehydrated, nonfrozen cadaveric fascia lata with bone anchor fi xation in 330 patients with a mean follow-up of 25 months (maximum follow-up of 63 months), the cured rate for all types of SUI was 59% and the cured/improved rate was 80%. When comparing those patients in our series who had ISD preoperatively to those who did not, with Intrinsic sphincteric defi ciency (ISD) defi ned as VLPP < 50, the failure rate was 24% vs. 18%, respectively. This difference was not statistically signifi cant. Complications of Suburethral Slings The most common complication of suburethral sling procedures is voiding dysfunction/inade- quate bladder emptying requiring intermittent catheterization or suprapubic catheterization drainage to avoid urinary retention. These symptoms are usually transient and resolve within the fi rst week postoperatively. Prolonged urinary retention >3 months postoperatively has been reported to occur 2% to 10% in most sling series, with a procedure to loosen an obstructing sling or formal urethrolysis being required in 1% to 5%. Another common cause of postoperative mor- bidity following sling surgery is urinary urgency/ urge incontinence. De novo urinary urgency has been reported to occur in 5% to 30% of patients, and de novo urge incontinence has been reported in up to 10% of patients. The etiology of these symptoms is not clear, but may include an unmask- ing of undiagnosed preoperative detrusor overac- tivity, a direct effect of increased bladder outlet resistance on detrusor function, or denervation from surgical dissection. These symptoms are usually transient in the absence of overt bladder outlet obstruction, and respond well to anticho- linergic therapy and behavioral modifi cation/bio- feedback. Interestingly, many patients who suffer from mixed urinary incontinence preoperatively have resolution of their urge incontinence follow- ing sling surgery. Schrepferman and associates (46) reported that after pubovaginal sling, 118 Vaginal Surgery for Incontinence and Prolapse preoperative urge symptoms resolved in 91% of patients with low pressure (<15 cmH 2 O) detrusor instability preoperatively, in 32% of patients with sensory instability (no unstable detrusor contrac- tions) preoperatively, and in 28% of patients with high pressure (>15 cmH 2 O) detrusor instability preoperatively. In the authors’ experience, after transvaginal suburethral sling, 35% of patients with preoperative urge incontinence have persis- tent urge incontinence postoperatively. Injury to the urethra or bladder may occur dur- ing suburethral sling surgery. Patients who have had previous retropubic or anti-incontinence operations are at increased risk. With careful dissection, these complications can usually be avoided. It is important that any injury to the bladder or urethra during sling surgery is identi- fi ed with intraoperative cystoscopy to prevent the subsequent morbidities of erosion, fi stula forma- tion, or infection. If a small, uncomplicated ure- thral injury occurs in a patient with healthy urethral tissues, it can be repaired primarily in layers and the sling operation can be completed followed by urethral catheter drainage. If the ure- thral injury is more extensive or the patient has poor tissues, such as those with previous radia- tion, it is prudent to repair the urethra, augment the repair with a Martius graft, and postpone sling placement until healing has occurred. If a bladder injury occurs during sling passage, on the side of the injury, the sling is pulled back down into the vaginal incision and sling passage is repeated. The surgeon may choose to provide continuous bladder drainage by suprapubic tube or urethral catheter for 2 to 7 days postoperatively depending on the degree of injury. Some infrequent, but potentially serious com- plications have been reported with the mid-ure- thral polypropylene procedures that pass the sling blindly through the retropubic space. Because the vaginal and suprapubic dissections are limited and passage of the sling through the retropubic space is performed without direct guidance, major vascular injuries (47), bowel perforations (48–50), and seven deaths have been reported by the manufacturer, six of which were due to unrecognized bowel injury (51). Kobashi and Govier (49) noted a mean decrease in hematocrit level of 7.1% on the fi rst postop- erative day following the SPARC procedure, and 4 of 140 patients (2.9%) required blood transfu- sions postoperatively. When using bone anchors for sling fi xation, concern has been raised about the potential for osseous complications. In our 5-year experience of over 400 transvaginal bone anchor slings using solvent-dehydrated cadaveric fascia lata (52), we reported two cases of postoperative osteitis pubis that resolved within 3 months with conservative treatment, no cases of osteomyeli- tis, and no bone anchors have required removal. Infectious osseous complications experienced previously with suprapubic bone anchor fi xation for suspension procedures (53) have not been experienced with transvaginal techniques. Injectable Bulking Agents As an alternative to open surgery, injectable bulking agents have become a common therapy for SUI owing to ISD. The purpose of this form of therapy is to increase the volume or bulk within the proximal urethral wall, between the external sphincter and bladder neck, thereby compressing the urethral mucosa into the lumen and providing better coaptation, thus increas- ing outfl ow resistance (Figure 9.4). Historically, bulking agents have not been used to treat ure- thral hypermobility, as it provides no external support to return the bladder neck or proximal urethra to their normal anatomic position. The fi rst reported periurethral injection therapy was reported in 1938, when Murless (54) injected sodium morrhuate (a sclerosing agent) through the anterior vaginal wall in an attempt to obtain scarring of the periurethral tissues to achieve continence. Subsequently, Quackles (55) injected paraffi n wax transperineally and Sachse (56) injected Dondren (a sclerosing agent). In these early experiences, results were not opti- mistic and signifi cant complications, such as pulmonary embolism and urethral sloughing, were reported. In the last 30 years, with the development of more suitable materials for injection, like polytetrafl uoroethylene (PTFE) (57), glutaraldehyde cross-linked collagen (58), and carbon-coated zirconium beads (59), this minimally invasive therapy has seen increas- ingly widespread use. Indications The ideal candidate for injectable therapy has been described as one with diminished urethral function (ISD), a well-supported urethra, and normal bladder function (60). Despite the Stress Urinary Incontinence Secondary to Intrinsic Sphincteric Deficiency 119 general perception that injectable bulking therapy should be used to treat isolated ISD, several series have included patients with and without urethral hypermobility and have reported no signifi cant difference in outcomes (61–64). Patients with comorbidities that are prohibitive of, or who refuse, more invasive surgery are good candidates for injectable therapy, as well as those patients with recurrent SUI and a well-supported urethra after a previ- ous anti-incontinence operation. In a randomized controlled trial comparing collagen vs. open surgery (modifi ed Burch, sub- urethral sling, or bladder neck suspension) as fi rst-line treatment for SUI, Collet and associates (65) found that at 12 months follow-up, collagen was 53% successful vs. 72% success in the surgi- cal group, with success being defi ned as 24-hour pad test <2.5 g. They additionally noted no statistical difference between the groups with respect to improvement in quality of life or patient satisfaction, whereas complications were signifi cantly less frequent and severe in the col- lagen group. Prior to conducting the trial, a large survey of urologists and gynecologists revealed that a 20% difference in results would be accept- able for considering bulking therapy as fi rst-line treatment for SUI. Techniques of Injection Prior to performing a proximal urethral bulking procedure, the patient should have sterile urine and be taught how to perform self-catheteriza- tion in the event that urinary retention occurs in the early postoperative period. The proce- dure may be performed in the offi ce setting with local anesthetic (topical and injectable lido- caine), or in an ambulatory surgical center or operating room if intravenous sedation is preferred by the patient or the surgeon. Two techniques for injection have been described: transurethral and periurethral. The authors routinely perform bulking procedures under monitored sedation, providing optimal patient comfort while avoiding patient movement during needle placement and injection, using the periurethral technique, which avoids mucosal disruption and bulking agent extru- sion through the injection site. Faeber and colleagues (66) compared transurethral to peri- urethral injection techniques and found no sig- nifi cant difference in continence outcomes, complications, or number of injections per patient, but did note that a signifi cantly higher volume of collagen was injected when the procedure was performed periurethrally. For transurethral injection the patient is placed in the lithotomy position and a 12-degree, blunt-tipped cystoscope with an injection needle port is introduced into the patient’s urethra. A syringe of the desired bulking agent is attached to the needle and the needle is primed. The scope is positioned at the mid-urethra, and rotated for needle placement at the 4 o’clock position. The needle is advanced with the bevel toward the urethral lumen, and the urethral mucosa is Figure 9.4. Anatomy and cystoscopic views of the bladder neck and urethra. (Courtesy of Carbon Medical Technologies, Inc., St. Paul, MN, with per- mission.) A: Open bladder neck prior to injection of bulking material. B: Coaptation of the bladder neck and proximal urethra after injection. 120 Vaginal Surgery for Incontinence and Prolapse punctured at a 45-degree angle until the bevel of the needle is covered (Figure 9.5A). Keeping the needle in place the scope is re-angled back paral- lel with the urethra, and the needle is advanced 1 to 2 cm so that the tip is located in the submu- cosa of the proximal urethra. The bulking mate- rial is injected with consistent, moderate thumb pressure on the plunger (Figure 9.5B). With correct needle placement, the fl ow should be even and smooth. Viewed cystoscopically, the urethral mucosa should rise as the material is introduced. Injection is continued until the resulting submucosal bleb has crossed the midline. If circumferential closure is not obtained from the initial injection site, the procedure is repeated at the 8 o’clock position. The objective is to obtain complete coaptation of the urethral mucosa when viewed cystoscopically with the irrigation on. Care should be taken not to advance the cystoscope proximal to the mid- urethra once injection is initiated, so that mucosal disruption is avoided. The bladder may be drained by passing a well-lubricated, 10-French red rubber catheter. For the periurethral technique, the patient is placed in lithotomy position and the cystoscope is introduced into the bladder. With the scope held in the neutral position, parallel to the fl oor, the periurethral groove is identifi ed approxi- mately 0.5 to 1 cm lateral to the meatus. An 18- gauge, 1.5-inch, angled needle is attached to a syringe fi lled with normal saline or lidocaine that will be used for hydrodissection. The needle is then inserted at the 3 o’clock position in the urethral groove and advanced 2 to 3 cm, keeping the needle hub parallel to the scope (Figure 9.6A). The 15-degree angle of the needle guides the tip into the correct submucosal plane. To verify placement, the cystoscope is withdrawn to the mid-urethra and the needle tip is wiggled, causing tenting of the overlying urethral mucosa. Hydrodissection is performed by injecting 1 to 2 cc of fl uid. A mucosal bleb should be visualized during hydrodissection if the needle is in the correct position. If no bleb is seen, the needle should be withdrawn and repositioned. With correct needle placement confi rmed, the needle is held in place while switching the syringe to one fi lled with bulking material. The material is injected under direct cystoscopic visualization as previously described with transurethral injec- tion (Figure 9.6B). Once an adequate amount of material has been delivered, a fi gure-of-eight absorbable suture is placed around the needle puncture site in the urethral groove. The suture is tied down as the needle is removed to prevent extrusion of bulking material and bleeding from the puncture site. Bulking Agents Currently, the ideal bulking agent has not been found. The ideal agent should be hypoal- lergenic, biocompatible, nonimmunogenic, noncarcinogenic, and durable without biodeg- radation or migration (67). Other important considerations for bulking agents include ease Figure 9.5. Transurethral injection technique. (Courtesy of Carbon Medical Technologies, Inc., St Paul, MN, with permission.) A: Needle puncture at the mid-urethra, at a 45-degree angle. B: Needle advanced submucosally, parallel to the urethra, to the proximal urethra for injection. Stress Urinary Incontinence Secondary to Intrinsic Sphincteric Deficiency 121 of injection (agents that require higher pres- sures to inject, have higher extravasation rates), requirement for specialized injection equip- ment, need for preparation or special handling of the material before injection, and cost. A list of approved and investigational injectable agents is found in Table 9.4. Presently, autolo- gous fat, cross-linked collagen, and carbon- coated beads are the only Food and Drug Administration (FDA)-approved bulking agents for the treatment of SUI owing to ISD in the United States. Autologous Fat In 1989, the periurethral injection of autologous fat was fi rst reported by Gonzalez et al (68). Using a liposuction technique, subcutaneous fat was harvested from the anterior abdominal wall, washed to remove debris, and injected using a transurethral technique. Autologous fat has the advantages of being biocompatible, readily available, and inexpensive. The primary disadvantage of using autologous fat as a bulking agent appears to be poor durability related to a high rate of resorption. Within 6 months, 50% to 60% volume loss of free fat grafts has been demonstrated by magnetic reso- nance imaging (69). This rapid resorption rate is thought to be a result of inadequate neovas- cularity to the central portion of the graft and destruction of the normal adipocyte architec- ture during the retrieval and washing process (70,71). Other available bulking agents have been shown to be more effective for the Figure 9.6. Periurethral injection technique. (Courtesy of Carbon Medical Technologies, Inc., St Paul, MN, with permission.) A: Needle puncture in the groove lateral to the urethral meatus. B: With needle placement confirmed, bulking material is injected. Table 9.4. Currently available and investigational injectable bulking agents Agent Trade name Company Approval status Autologous fat Bovine cross-linked collage Contigen Bard, Covington, GA FDA approved 1993 Carbon-coated zirconium beads Durasphere Boston Scientific, Boston, MA FDA approved 1999, no longer available Graphite-coated zirconium beads Durasphere EXP Boston Scientific, Boston, MA FDA approved 2003 PTFE (Teflon) Urethrin Mentor, Santa Barbara, CA Approved in Canada/Europe Silicone Macroplastique Uroplasty, Minneapolis, MN FDA trials ongoing Dimethylsulfoxide and ethylene Uryx Genyx Medical Inc., FDA submission vinyl alcohol copolymer San Diego, CA Hyaluronic acid and dextranomer Zuidex Q-med, Uppsala, Sweden FDA trials ongoing microspheres Calcium hydroxyapatite Coaptite Bioform, Franksville, WS FDA trials ongoing FDA, Food and Drug Administration; PTFE, polytetrafluoroethylene. 122 Vaginal Surgery for Incontinence and Prolapse treatment of female SUI, making the use of autologous fat less desirable. Cross-Linked Collagen Glutaraldehyde cross-linked (GAX)-collagen is derived from bovine dermis, purifi ed into an acellular derivative, enzymatically treated to eliminate antigenicity, and fi nally cross-linked with glutaraldehyde for resistance to host col- lagenases (72). More than any other bulking agent, there have been numerous studies looking at the effi cacy and safety of collagen as treat- ment for female SUI. Because collagen is well tolerated with proven safety, it is currently the most widely used injectable bulking agent. Pre- operative skin testing must be performed as a 4% allergy rate has been reported. Once injected, there is minimal host infl ammatory response and no migration (134). Graphite-Coated Zirconium Beads Durasphere EXP is a synthetic bulking agent composed of graphite-coated zirconium beads that are suspended in a water-based carrier. This material is nonreactive, nonantigenic (no skin test is required), and nonbiodegradable, making it the authors’ agent of choice for bladder neck injection. Durasphere EXP is similar to its predecessor, Durasphere (carbon- coated zirconium beads), with two exceptions: it is not visualized on plain radiographs, and the particle size is slightly smaller (90–212 μm). There was one prior report of possible carbon- coated zirconium bead migration to local and regional lymph nodes, as evidenced on x-rays obtained 3 months after injection (73). These patients suffered no resultant sequelae, and tissue examination was not performed to confi rm that what was seen on the postopera- tive radiographs was indeed particles that had migrated. Polytetrafl uoroethylene (PTFE, Tefl on) Polytetrafl uoroethylene is a colloidal suspen- sion of microparticles varying in size, the majority of which are <50 μm. It is commonly used as a urethral bulking agent in Europe and Canada, but has never gained approval in the United States due to safety concerns. Because of the small particle size, a propensity for migra- tion has been noted to local and distant sites with resultant foreign-body granulomatous reaction (74,75). Polytetrafl uoroethylene is locally reactive as well with cases of urethral granuloma formation, urethral fi brosis, and periurethral abscess reported (76). Claes and associates (77) reported a case of febrile alveo- litis believed to be attributed to pulmonary par- ticle migration after PTFE for SUI. Other than this case, signifi cant clinical sequelae of PTFE particle migration have not been reported. An additional drawback to PTFE as an inject- able therapy for SUI is the high viscosity of the substance, making it more diffi cult to inject. A high-pressure injection syringe or gun is neces- sary for agent delivery. The pressures required to inject PTFE increase the risk of injection site extrusion and/or urethral mucosal disruption during placement. Silicone Macroplastique is composed of silicone mic- roparticles, ranging in size from 50 to 300 μm, suspended in a water-soluble carrier. Its use was fi rst reported in 1992 (78). Like PTFE, with a portion of the particles being <70 μm in size, migration of silicone particles has been demon- strated (79). Unlike PTFE, there is no granulo- matous reactive response to silicone particles. Owing to the uncertain etiologic role of silicone in the development of collagen vascular disor- ders, and the implant’s propensity to migrate after injection, approval for this agent in the United States is not imminent. Dimethylsulfoxide (DMSO) and Ethylene Vinyl Alcohol Copolymer Uryx is an injectable solution that was origi- nally developed as an embolic agent for the treatment of vascular anomalies. When this solution contacts body tissues or fl uid, the DMSO diffuses away from the copolymer, resulting in precipitation of a soft, solid mass. Studies have demonstrated that Uryx is biocom- patible and nonmigratory, without signifi cant adverse reactions in human studies for embolic purposes (80). This substance is currently undergoing trials for FDA approval as a ure- thral bulking agent. Stress Urinary Incontinence Secondary to Intrinsic Sphincteric Deficiency 123 Hyaluronic Acid and Dextranomer Microspheres This substance was approved in the United States for subureteric injection for the treatment of vesicoureteral refl ux in 2001. Both constitu- ents, cross-linked dextran and hyaluronic acid, are biocompatible and biodegradable. Tolera- bility and safety have been demonstrated in the pediatric population. Presently, trials evaluat- ing the effi cacy and durability of dextranomer as a bulking agent for the treatment of SUI are ongoing (129). Calcium Hydroxyapatite This is a synthetic injectable consisting of hydroxyapatite spheres, 75 to 125 μm in size, suspended in a gel of sodium carboxylmethyl- cellulose. Calcium hydroxyapatite is naturally found in bone and teeth, and has been used safely for orthopedic and dental procedures for many years. The microspheres do not migrate, and are biocompatible, nonimmunogenic, and nonantigenic. This substance can be visualized radiographically. The effi cacy and durability of calcium hydroxyapatite as a urethral bulking agent is currently in clinical trials. Results Published continence results of various injectable agents are found in Table 9.5. Inject- able agents have attained sufficient conti- nence improvement to be declared a success (by varying definitions) by the evaluating physicians 60% to 80% of the time at varying lengths of follow-up. Strict continence, defined as no urinary leakage (not uniformly reported in published series), is achieved in the minority of patients after injectable therapy, with rates in the 20% to 50% range typically reported. With the exception of autologous fat, which has been shown to have poor efficacy durability (81), the results of the various agents have been comparable. All of the available agents may require more than one injection to achieve initial success, and subsequent injections later to maintain the continence improvement. The only large randomized, controlled trial comparing bulking agents, carbon-coated zirco- nium beads to collagen, was published by Light- ner and associates (59). At 12 months’ follow-up, they showed a modestly superior cure/improved continence rate in the Durasphere group, but this difference was not statistically signifi cant. In a recent follow-up study of this cohort (82), Table 9.5. Continence results for the different injectable bulking agents Injectable No. Mean Mean no. of % % Author, year (ref.) material of pts. follow-up injections Cured (C) Improved (I) % Failed Trockman, 1995 (106) AF 32 6 1.6 12 44 44 Haab, 1997 (81) AF 45 7 1.7 13 30 57 Collagen 22 7 1.9 24 62 14 Winters, 1995 (107) Collagen 160 24 NR (1–3) 50 28 22 Monga, 1995 (61) Collagen 60 24 1.6 48 20 32 Richardson, 1995 (108) Collagen 42 46 2 40 43 17 Herschorn, 1996 (62) Collagen 187 22 2.5 23 52 25 Homma, 1996 (109) Collagen 78 24 1.9 7 65 28 Smith, 1997 (110) Collagen 94 14 2.1 38 29 33 Swami, 1997 (111) Collagen 111 39 NR 25 40 35 Corcos, 1999 (112) Collagen 48 48 2.2 30 40 30 Politano, 1982 (113) PTFE 51 6 1.8 51 20 29 Lopez, 1993 (114) PTFE 128 31 1.3 54 19 27 Herschorn, 2000 (115) PTFE 46 12 2 30 41 29 Lightner, 2001 (59) Carbon 61 12 1.7 80% (C/I) 20 Collagen 68 12 1.6 69% (C/I) 31 Harriss, 1996 (116) Silicone 40 36 1 40 18 42 Barranger, 2000 (117) Silicone 21 24 1 19 29 52 Radley, 2001 (118) Silicone 56 19 NR (1–3) 20 41 39 Tamanini, 2003 (119) Silicone 21 12 1.4 38 29 33 Mayer, 2001 (120) Coaptite 10 12 1.7 70% (C/I) 30 Stenberg, 2003 (121) Dextranomer 16 >60 NR 56% (C/I) 44 [...]... prospective randomized trial comparing tension-free vaginal tape and transobturator suburethral tape for surgical treatment of stress urinary incontinence Am J Obstet Gynecol 2004;190:602–608 Kobashi KC, Mee SL, Leach GE A New technique for cystocele repair and transvaginal sling: the cadaveric prolapse repair and sling (CaPS) Urology 2000 ;56 (suppl 6A):9–14 129 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 ... Steele DJ, Radomski SB Follow-up of intraurethral collagen for female stress urinary incontinence J Urol 1996; 156 :13 05 1309 130 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 Vaginal Surgery for Incontinence and Prolapse Steele AC, Kohli N, Karram MM Periurethral collagen injection for stress incontinence with and without urethral hypermobility Obstet Gynecol 2000; 95: 322–331 Bent AE, Foote J,... be informed about the risk and carefully monitored for obstruction symptoms after surgery Vaginal Surgery for Incontinence and Prolapse with prolapse repair It allows minimally invasive surgery to be used in stress urinary incontinence to restore the physiologic and anatomic conditions of continence, as far as possible The first operative and postoperative results after more than a year of follow-up... Collagen injection therapy for female intrinsic sphincteric deficiency J Urol 1997; 157 :12 75 1278 Swami S, Batista JE, Abrams P Collagen for female genuine stress incontinence after a minimum 2-year follow-up Br J Urol 1997;80: 757 –760 Corcos J, Fournier C Periurethral collagen injection for the treatment of female stress urinary incontinence: 4-year follow-up results Urology 1999 ;54 :8 15 818 Politano VA Periurethral... avoids damage to the urethra and bladder and, for this reason, makes cystoscopy unnecessary However, the long-term safety of this type of tape is not known, particularly in relation to changes in the synthetic material and changes in bladder and urethral functioning caused by the tape, such as voiding disorders and bladder overactivity 133 134 Vaginal Surgery for Incontinence and Prolapse Epigastric artery... series and case reports J Urol 2001;1 65: 19 75 1978 Murless BC The injection treatment of stress incontinence J Obstet Gynaecol Br Emp 1938; 45: 521 52 4 Quackles R Deux incontinences après adenomectomie gueries par injection de paraffine dans le perinee Acta Urol Belg 1 955 ;23: 259 –262 Sachse S Treatment of urinary incontinence with sclerosing solutions: indications, results, complications Urol Int 1963; 15: 2 25 229... urethra is to grasp the tape at its middle with Babcock forceps so as to create a small, 5- mm-long tape loop As described above, traction is exerted on the distal ends of the tape, avoiding compression of the urethra 138 Vaginal Surgery for Incontinence and Prolapse Figure 10 .5 The TVT-O technique The tape is introduced in the obturator hole from the vaginal incision After an incision is made beneath the... female stress urinary incontinence in the new millennium Urol Clin North Am 2002;29 :55 9 57 4 Pannek J, Brands FH, Senge T Particle migration after transurethral injection of carbon-coated beads for stress urinary incontinence J Urol 2001;166:1 350 – 1 353 Malizia AA, Reiman HM, Myers RP, et al Migration and granulomatous reaction after periurethral injection of polytef (Teflon) JAMA 1984; 251 :3277–3281 Mittleman... C, Rezapour M Seven year follow up of the tension free vaginal tape procedure for treatment of urinary incontinence Obstet Gynecol 2004;104:1 259 –1262 Ward KL, Hilton P, UK and Ireland TVT Trial Group A prospective multicenter randomized trial of tensionfree vaginal tape and colposuspension for primary urodynamic stress incontinence: two-year follow-up Am J Obstet Gynecol 2004;190(2):324–331 Cody J, Wyness... Injectable silicone macroparticles: a new treatment for female stress incontinence J Urol 1992;147:280A Henly DR, Barrett DM, Weiland TL, et al Particulate silicone for use in periurethral injections: local tissue effects and search for migration J Urol 19 95; 153 : 2039–2043 Lylyk P, Vinuela F, Vinters HV, et al Use of a new mixture for embolization of intracranial vascular malformations Preliminary experimental . incon- tinence. J Urol 1996; 156 :13 05 1309. 130 Vaginal Surgery for Incontinence and Prolapse 63. Steele AC, Kohli N, Karram MM. Periurethral collagen injection for stress incontinence with and. resolution of their urge incontinence follow- ing sling surgery. Schrepferman and associates (46) reported that after pubovaginal sling, 118 Vaginal Surgery for Incontinence and Prolapse preoperative. bladder neck and proximal urethra after injection. 120 Vaginal Surgery for Incontinence and Prolapse punctured at a 4 5- degree angle until the bevel of the needle is covered (Figure 9.5A). Keeping