Periurethral Polytetrafluoroethylene Paste Injection in Incontinent Female Subjects: Surgical Indications and Improved Surgical Technique

Periurethral Polytetrafluoroethylene Paste Injection in Incontinent Female Subjects: Surgical Indications and Improved Surgical Technique

0022-5347/93/1492-0279$03.00/0 THE JOURNAL OF UROLOGY Copyright© 1993 by AMERICAN UROLOGICAL ASSOCIATION, INC. PERIURETHRAL POLYTETRAFLUOROETHYLENE P...

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0022-5347/93/1492-0279$03.00/0 THE JOURNAL OF UROLOGY Copyright© 1993 by AMERICAN UROLOGICAL ASSOCIATION, INC.

PERIURETHRAL POLYTETRAFLUOROETHYLENE PASTE INJECTION IN INCONTINENT FEMALE SUBJECTS: SURGICAL INDICATIONS AND IMPROVED SURGICAL TECHNIQUE RICHARD LOTENFOE, J. KEVIN O'KELLY, MOHAMED HELAL AND JORGE L. LOCKHART* From the Division of Urology, Department of Surgery, University of South Florida Health Sciences Center, H. Lee Moffitt Cancer and Research Institute and Tampa General Hospital, Tampa, Florida

ABSTRACT

We present the results with 2 techniques for periurethral polytetrafluoroethylene (Polytef) injection in 21 female subjects with type III stress urinary incontinence. The standard technique included the use of a stainless steel needle for injection, paste "sopping" and a Wolff, Storz or Lewy syringe as an injecting element. Postoperatively, no catheters were left indwelling and all patients were encouraged to urinate following recovery from the anesthesia. The modified technique included the use of a 14F angio-catheter for injection of the paste, paste heating and a Lewy syringe or Mentor gun as injector. Postoperatively, all patients were left with an indwelling suprapubic catheter for 3 to 5 days. A total of 27 injections was performed, including 9 with the standard technique and the last consecutive 18 with the modified technique. Average followup has been 11.4 months. Cure, improvement and no change rates from the preoperative condition were 11%, 22% and 67% with the standard technique and 39%, 17% and 44% with the modified technique, respectively. In the latter group 3 patients had received pelvic radiotherapy as definitive treatment for pelvic malignancies. The overall failure rate in patients with a stable detrusor was 42% compared to 75% in the group with bladder instability and low compliance. Advantages of the modified technique include avoidance in the formation of intraoper­ ative and postoperative fistulas, and easier handling and injection of the heated paste to achieve urethral compression. Improved short-term results with the modified technique indicate that a larger group of patients and long-term followup are essential requirements to determine the true efficacy of this technical modification. Based on these preliminary results, we now prefer the modified technique to the standard technique in the management of type III stress urinary incontinence. KEY WORDS:

urinary incontinence, polytetrafluoroethylene

Periurethral polytetrafluoroethylene (Polytef) injections have been used extensively in the management of male and f emale urinary incontinence.1' 2 At the University of Miami this technique has been used f or more than 20 years and at our institution we have injected polytetrafluoroethylene periure­ thrally and periureterally for 54 months. Periurethral injection has been used in men with post-prostatectomy urinary incon­ tinence, in female subjects with neurogenic bladders, sphincter insufficiency, different types of stress incontinence and recon­ structed urethras, and in children with sphincter insuffi­ ciency.3-8 Presently, we do not believe that this operation is a good substitute for the standard anti-incontinence techniques in female patients with clinical stress urinary incontinence and descended urethras (types I and II incontinence). Indications for injection include difficult clinical situations with sphincter insufficiency, such as women who have received pelvic radiation, urethras with structural damage and type III stress urinary incontinence.9 • 10 These patients usually demon­ strate disabling stress urinary incontinence, absent posterior urethral rotational descent, urethral fixation, scarring on pelvic examination and a persistently open bladder neck on bladder filling, which is visualized during video urodynamics.9 • 10 In a similar group that had failed previous corrective surgery we reported a success rate of 43.2% with the Stamey procedure, 50% with the modified Pereyra procedure and 94.6% with a Accepted for publication June 19, 1992. Read at annual meeting of Southeastern Section, American Urolog­ ical Association, Atlanta, Georgia, March 9-12, 1991. * Requests for reprints: Division of Urology, 12901 Bruce B. Downs Blvd., Tampa, Florida 33612.

combined cystourethropexy.11' 12 The combined cystourethro­ pexy adds plication of the posterior urethral ligaments behind the bladder neck to a needle suspension, and the combination of the 2 techniques facilitates and maintains urethral and bladder neck support.12 However, the initial high success rate of 94.6% with this operation diminished to 70% with longer followup. 13 Other alternatives for the management of type III incontinence primarily consist of producing urethral compres­ sion by a sling and the artificial urinary sphincter.14• 15 We report our surgical indications and results with the standard and modified techniques of injecting polytetrafluoroethylene periurethrally in female patients with disabling type III urinary stress incontinence. These patients were managed at a tertiary care medical center after they had undergone previous unsuc­ cessful surgical attempts to control the disease. PATIENTS AND METHODS

A total of 21 women between 8 and 87 years old (median age 55.5) underwent 28 periurethral polytetrafluoroethylene injec­ tions for type III stress urinary incontinence (table 1). These patients were followed for 3 to 44 months (median 11.4 months). All cases presented with type III incontinence accord­ ing to the classification of Green9 and McGuire et al.10 All women had undergone several anti-incontinence procedures that were successful in restoring an adequate repositioning of the urethra behind the bladder neck but failed to improve urinary incontinence. Two patients had also received pelvic radiotherapy, 3 had undergone urethral reconstruction (2 as part of an exstrophy closure) and 1 had had a stroke.

279

280

LOTENFOE AND ASSOCIATES TABLE 1. Patient population results Pt. No.-Age 1-58 2-58 3-51 4-14

Followup (mos.)

No. Injections

39 19

1 1 1 2

Failure Cure Failure Improved, failure

Standard X 2

18

2

Stable Stable Stable Low pressure instability

Modified Modified x 2 Modified Modified

17 3 15

1 2 1 1

Failure, improved Cure Failure, cure Cure Failure

Low compliance

Modified x 2

2

2

Improved, failure

Stable Stable Stable Stable Small capacity, instability Stable Low pressure instability

Standard, modified Standard, modified Modified Modified Modified

2 2 1 1 1

Failure Failure Cure Improved Failure

Modified Modified

10

1 1

Failure Failure

2

Stable Stable

Modified Modified

5 3

1 1

Improved Cure

3 3

Stable Low pressure instability

Modified Modified

3 3

1 1

Cure Cure

Injection Technique

Previous Procedures

Urodynamics

Cystourethropexy X 3 Cystourethropexy Cystourethropexy Cystourethropexy X 2, urethral reconstruction Cystourethropexy

Low pressure instability Stable Low pressure instability Stable

Standard Standard Standard Standard X 2

Stable

6-63 7-68 8-33 9-67

Cystourethropexy X 3 Cystourethropexy X 3 Cystourethropexy Radiation therapy for squamous cell Ca

10-67

Radiation therapy for Ca vagina, vaginal vesical fistula Cystourethropexy X 3 Cystourethropexy X 4 Cystourethropexy Cystourethropexy x 3 Cystourethropexy X 2

5-32

cervix

11-64 12-59 13-43 14-69 15-87 16-65 17-34 18-69 19-8 20-63 21-73

Cystourethropexy X Closure bladder exstrophy Cystourethropexy x Closure bladder exstrophy Cystourethropexy X Cystourethropexy X

3

Urodynamic investigation was done preoperatively in all patients. The lack of urethral function mitigates against the value of urethral profilometry, which is markedly decreased. 10 Of the patients 14 (67%) presented with a urodynamically stable detrusor function, 6 (29%) presented with bladder insta­ bility and 1 (5%) demonstrated a low compliant bladder. Cysto­ urethroscopy was performed in all patients to rule out associ­ ated intravesical disease and associated urethral pathological conditions, and to evaluate the anatomical configuration and position of the bladder neck. The standard technique for injection has been previously described by Politano. 2 The patient is placed in the lithotomy position, and is prepared and draped in a standard fashion (as for a cystoscopic procedure). The urethra is calibrated and cystourethroscopy is performed. Approximately 14 ml. polytet­ rafluoroethylene paste are injected at the 3 and 9 o'clock positions around the bladder neck area, using a stainless steel needle, which represents 2 tubes of paste (see figure). The highly viscous paste is placed in a glass container and is carefully sopped with water. Care should be taken to prevent

Lewy syringe with 14 gauge angio-catheter

7 12

Results

over-dilution of the paste, which would eliminate its consist­ ency and diminish its properties for urethral compression. The need for paste sopping is mainly to facilitate its injection through the syringe and needle. We used Wolff and Storz transurethral equipment or a Lewy syringe for injection of the paste. We performed 9 consecutive injections with this technique in 7 patients and then abandoned it because of an unacceptable number of failures. Analysis of these failures indicated techni­ cal problems related to a high incidence of paste leak into the bladder and/or urethra associated with difficulties during injec­ tion. Etiologically, the 7 patients had failed cystourethropexy, including 1 who had undergone a Young-Dees-Leadbetter ure­ thral reconstruction. Five patients presented with a stable bladder urodynamically and 2 had low pressure instability. With the modified technique the polytetrafluoroethylene tubes were placed in previously heated water for 3 to 5 minutes before use (instead of sopping the paste before injection). The paste was injected using a 14F angio-catheter at the 3 and 9 o'clock positions. This method allows easier injection of the paste and, with the needle removed and the silicone sheath remaining in place, puncture of the urethra or bladder base and subsequent iatrogenic fistula formation are avoided. These intraoperative perforations had been associated with postop­ erative paste leakage and the consequent loss of urethral compression. For injection we now prefer the Lewy syringe and we are investigating a new gun. Approximately 14 ml. paste are used with fairly equal distribution at both sides of the urethra, while an attempt is made to occlude the urethral lumen. At the end of the procedure and with the bladder filled to capacity, pressure is applied in the suprapubic area to observe if incon­ tinence occurs. We usually continue injecting paste until we cannot provoke stress incontinence (maximum amount of in­ jected paste in female subjects is 21 ml. or 3 tubes). We routinely leave a 16F Stamey suprapubic tube for 3 or 5 days to avoid paste distortion and displacement with voiding, and a loss of the initial urethral compression. The patient is discharged from the hospital the day of the surgery or the next morning. We have used the modified technique 18 times in 16 patients (table 1). In 2 patients both techniques were used. Among the

281

POLYTETRAFLUOROETHYLENE PASTE INJECTION FOR INCONTINENCE

16 patients treated with the modified technique 12 had failed cystourethropexy, 2 had received between 8,000 and rad to the pelvis for the management of uterine, vaginal or colonic carcinoma and 2 had had bladder exstrophy previously closed and urethral reconstruction. The procedure was considered a success if the patient was satisfied with the results. The patient was considered cured if there was no incontinence, an occa­ sional incontinent episode existed and improved, and/or incon­ tinence decreased markedly to wetting 2 or fewer pads within 24 hours. At physical examination these patients were conti­ nent under stress with a full bladder. The procedure was considered a failure if the patient was not satisfied with the results, they required more than 2 pads in a 24-hour period and/or incontinence was demonstrated during examination. Followup examinations were done 1 and 3 months postopera­ tively and then every 6 months. If a patient leaked urine after surgery, she was followed for at least 4 to 6 months expectantly since we have observed some late improvements after a period of postoperative incontinence. Urodynamic studies in the suc­ cess group were deemed unnecessary and have not been done. RESULTS

The success rate among 9 standard technique injections (including 1 cure and 2 improvements) was 33%, while 6 injections (67%) failed to improve the preoperative condition (table 2). The 3 patients cured or improved presented with a stable bladder while the 6 failures had detrusor stability (4) and low pressure instability (2). Using the modified technique 13 injections were performed in the pure cystourethropexy failure group, among which the success rate was 57% (8 injec­ tions, including 6 cures and 2 improvements). Five injections ( 36% ) did not change the preoperative clinical situation, in 2 patients (40%) who had early incontinence (less than 1 month postoperatively) and in 3 (60%) who had incontinence for more than 3 months postoperatively. Urodynamics demonstrated detrusor stability in 10 injected patients (5 cured, 2 improved, 3 failed) and low pressure instability with adequate capacity in 3 (1 cure, 2 failures). Of the 2 patients who received the modified technique and had had radiotherapy (between 8,000 and 10,000 rad) 1 with a low compliant bladder improved. The procedure failed in 2 patients who presented with low pressure instability (1 with a small capacity bladder) (table 2). Of the 2 patients who had undergone a bladder exstrophy closure in conjunction with urethral reconstruction (1 with a stable bladder and 1 with low pressure instability) 1 was cured and 1 remained unchanged from the preoperative condition. The overall group (with both techniques) included 27 injec­ tions for 16 stable bladders (7 cured, 2 improved, 5 failed), 5 bladders with low pressure instability and adequate capacity (1 cured, 4 failed), 1 bladder with low pressure instability and a small bladder capacity (failed) and 1 low compliant bladder (improved) (table Complications consisted of 1 case of urethral prolapse related to a sterile polytetrafluoroethylene abscess and l case of complete urethral obstruction requiring intermittent catheterization. There was no evidence of clinical migration of the polytetrafluoroethylene particles at followup of these patients. Surgical successes have not required anticho-

linergic medication postoperativelyo DISCUSSION

Polytetrafluoroethylene injections have been used exten­ sively for many years in the management of urinary inconti­ nence and to prevent vesicoureteral reflux; these 2 procedures have been popularized and pioneered respectively in this coun­ try by Politano et al. 1• 16 Surgical indications in a variety of clinical situations for the periurethral injection have already been reported. 3-7 Overall complications with this procedure have been minimal and, among the local problems: an occa­ sional perinea! abscess or urinary retention, as in our patients, is an infrequent occurrence. Migration of polytetrafluoroeth­ ylene particles has been demonstrated experimentally. 17 In 1 series an autopsy demonstrated a pulmonary granuloma dis­ covered as an incidental finding. Although pulmonary granu­ lomas due to polytetrafluoroethylene particle migration have been previously reported, in the aforementioned series and our own the event has not been clinically significant. 18• 19 Another feared complication, cancer transformation, has not been path­ ologically demonstrated. In 1 young woman a vaginal and uterine rhabdomyosarcoma developed 10 months following per­ iurethral polytetrafluoroethylene injection as definitive treat­ ment for urinary incontinence. 6 However, the cancerous lesion appeared at an anatomical location different from the area treated with polytetrafluoroethylene. To our knowledge, there are no published reports indicating malignant transformation. Politano and we have not observed this abnormality in any adult or child who was previously injected with periurethral polytetrafluoroethylene. The Food and Drug Administration has not yet approved the use of polytetrafluoroethylene paste in humans and, therefore, a special consent form indicating its investigational status with possible complications is essential before use. The management of type III female incontinence represents a therapeutic challenge. 9• 10 The presence of detrusor instability also could be responsible for a certain number of failures. Patients with small functional bladder capacities and high pressure instability should receive adjunctive therapy to the standard anti-incontinence techniques. 20 Surgeons prefer treat­ ing type III incontinence by placing autologous and prosthetic material compressing the bladder neck (slings, artificial urinary sphincter, combined cystourethropexy, polytetrafluoroethylene paste or collagen material). In a previous group of female patients presenting with different types of urinary incontinence and treated with periurethral polytetrafluoroethylene the over­ all success rate was 65%. 8 Factors associated failure in this included bladder urethra! scarring. diotherapy In our hands, the major technical limitations with the use of periurethral polytetrafluoroethylene were difficulties injecting the paste due to its consistency and the creation of a fistula with the injection needle. Paste sopping facilitates paste injec­ tion, and in female subjects the use of the Lewy syringe has also been extremely helpful. Paste preheating greatly facilitated the surgical injection of the paste and eliminated frustration caused by the inability to inject the paste adequately in the

TABLE 2

Technique

No. Pts.

No. Injections

Standard 7* Modified

16

9 18

* Two patients were treated later with the modified technique.

Results Etiology (No.) Cystourethropexy failures (all) Urethral reconstruction (1), stroke (1) Cystourethropexy failure (13) Radiation therapy (3) Exstrophy closure (2)

Cures

Improved

Failed

(%)

(%)

(%)

1 (11)

2 (22)

6 (67)

6 (46)

2 (15) 1 (33)

5 (38) 2 (66) 1 (50)

1 (50)

282

LOTENFOE AND ASSOCIATES

correct anatomical location. Another inconvenience was inad­ vertent perforation of the urethral wall or bladder base with the stainless steel needle. As a consequence of these iatrogenic fistulas incontinence developed late (days or weeks) following an initial episode of clinical dryness. These patients reported that the white paste was expelled with the urine and subsequent urinary incontinence appeared. We have avoided this compli­ cation with the use of an angio-catheter for injection instead of the stainless steel needle. Under cystoscopic control, the paste is carefully injected while the surgeon observes the ure­ thral wall apposition. Operative or delayed leakage of paste has not occurred, and we believe that with the modified technique we are allowing greater paste volume to remain periurethrally on a long-term basis. Results of the modified technique with a larger number of injections compare favorably with those previously obtained with the standard technique (56% versus 33%). A larger number of patients are required to establish the true statistical signifi­ cance of this difference. Results of the modified technique are similar to a previously reported series but in the latter group patients with types I and II incontinence had also been in­ cluded. 7• 8 Another significant finding represents the overall higher failure rate with both techniques (standard and modi­ fied) in patients with bladder instability when compared to those with stable bladders (75% versus 33.3%). Presently, we do not recommend these periurethral compressive injections for patients who have received pelvic radiotherapy as definitive treatment for malignancies or in patients presenting with high pressure instability. The use of a postoperative suprapubic tube for 3 to 5 days is an option to facilitate healing and hardening of the paste, and to avoid local displacement of the paste during voiding. This alternative is our personal choice and will require long-term evaluation. CONCLUSIONS

We present a modified periurethral polytetrafluoroethylene injection technique for use in female subjects with stress uri­ nary incontinence. Use of a 14F angio-catheter and appropriate injecting equipment (Lewy syringe or gun), heating the paste and leaving a suprapubic tube postoperatively have facilitated the surgical procedure. Our diminished incidence of postoper­ ative fistulization and paste leakage as well as the initially improved surgical results emphasize the value of these technical considerations for the periurethral polytetrafluoroethylene in­ jection procedure. REFERENCES

1. Politano, V. A., Small, M. P., Harper, J. M. and Lynne, C. M.: Periurethral teflon injection for urinary incontinence. J. Urol., lll: 180, 1974. 2. Politano, V. A.: Periurethral teflon injection for urinary inconti-

nence. Urol. Clin. N. Amer., 5: 415, 1978. 3. Kaufman, M., Lockhart, J. L., Silverstein, M. J. and Politano, V. A.: Periurethral polytetraflouroethylene injection for post-pros­ tatectomy urinary incontinence. J. Urol., 132: 463, 1984. 4. Lewis, R. I., Lockhart, J. L. and Politano, V. A.: Periurethral polytetrafluoroethylene injection in incontinent female subjects with neurogenic bladder disease. J. Urol., 131: 459, 1984. 5. Vorstman, B., Lockhart, J. L., Kaufman M. and Politano, V. A.: Polytetrafluoroethylene injection for urinary incontinence in children. J. Urol., 133: 248, 1985. 6. Lockhart, J. L., Walker, R. D., Vorstman, B. and Politano, V. A.: Periurethral polytetrafluoroethylene injection following urethral reconstruction in female patients with urinary incontinence. J. Urol., 140: 51, 1988. 7. Lockhart, J. L.: Periurethral Po]ytef. J. Urol., part 2, 135: 50A, 1986. 8. Lockhart, J. L. and Sanford, E.: Periurethral Polytef and combined cystourethropexy for the management of difficult cases of uri­ nary incontinence. Prob!. Urol., vol. 4, No. 1, March 1990. 9. Green, T. H., Jr.: Development of a plan for the diagnosis and treatment of urinary stress incontinence. Amer. J. Obst. Gynec., 83: 632, 1962. 10. McGuire, E. J., Lytton B., Kohorn E. I. and Pepe, V.: The value of urodynamic testing in stress urinary incontinence. J. Urol., 124: 256, 1980. 11. Pow-Sa:ng, J. M., Lockhart, J. L., Suarez, A., Lansman, H. and Politano, V. A.: Female urinary incontinence; preoperative selec­ tion, surgical complications and results. J. Urol., 136: 831, 1986. 12. Lockhart, J. L., Ellis, G. F., Helal, M. and Pow-Sang, J. M.: Combined cystourethropexy for the treatment of type 3 and complicated female urinary incontinence. J. Urol., 143: 722, 1990. 13. Lotenfoe, R., O'Kelly, J. and Lockhart, J. L.: Combined cystou­ rethropexy and periurethral Polytef injection in the management of type III stress urinary incontinence. Presented at the 22nd Congress of the Societe International d'Urologie, Sevilla, Spain, November 4, 1991. 14. McGuire, E. J. and Lytton, B: Pubovaginal sling procedure for stress incontinence. J. Urol., 119: 82, 1978. 15. Scott, F. B., Bradley W. E. and Timm, G. W.: Treatment of urinary incontinence by implantable prosthetic sphincter. Urology, 1: 252, 1973. 16. Lynne, C. M. and Politano, V. A.: Periureteral teflon injection for vesicoureteral reflux. Program of annual meeting of American Urological Association, p. 164, abstract 292, 1983. 17. Malizia, A. A., Jr., Reiman, H. M., Myers, R. P., Sande, J. R., Barham, S. S., Benson, R. C., Jr., Dewanjee, M. K. and Utz, W. J.: Migration and granulomatous reaction after periurethral in­ jections of Polytef (teflon). J.A.M.A., 251: 3277, 1984. 18. Claes, H., Stroobauts, D., Van Meerbeek, J., Verbeken, E., Knockaert, D. and Baert, L.: Pulmonary migration following periurethral polytetrafluoroethylene injection for urinary incon­ tinence. J. Urol., 142: 821, 1989. 19. Mittleman, R. E. and Marraccini, J. V.: Pulmonary teflon granu­ lomas following periurethral teflon injection for urinary incon­ tinence. Letter to the Editor. Arch. Path. Lab. Med., 107: 611, 1983. 20. Lockhart, J. L., Vorstman, B. and Politano, V. A.: Anti-inconti­ nence surgery in females with detrusor instability. Neurourol. Urodynam., 3: 201, 1984.