Jean-Marie Hervé

Electrovaporization of the Prostate with the Gyrus Device

PURPOSE To assess the efficacy and the safety of a new transurethral endoscopic device using bipolar electrocautery, the Gyrus system. This system permits rapid prostate tissue removal by endoscopic vaporization with little bleeding and no pad return using saline irrigation and therefore eliminating TURP syndrome. PATIENTS AND METHODS Forty-two patients (mean age 70; range 49-90 years) with symptomatic benign prostatic hyperplasia (BPH) without suspected cancer, confirmed by digital rectal examination and PSA tests, were treated between October 1998 and February 1999 with the Gyrus and evaluated at 1 and 3 months postoperatively by the International Prostate Symptom Score (IPSS) and maximum urinary flow rate. RESULTS No postoperative bleeding necessitating catheterization for postoperative retention occurred. The duration of the procedure was < or = 30 minutes in 12 patients, 30 to 60 minutes in 27 patients, and >60 minutes in 3 patients. The mean time of postoperative continuous bladder irrigation was 1.2 days (0.5-3 days). The mean catheterization time was 1.4 days (range 0.5-5 days). Urethral stricture requiring treatment occurred in two patients. Dysuria was reported by four patients (mild two, severe two). The postoperative hospitalization was a mean of 2.2 days. The mean peak flow rate increased from 7.9 to 19.7 mL/sec at 3 months, and the IPSS decreased from 16 to 9 at 3 months. CONCLUSION Our preliminary results with a bipolar electrode for electrovaporization of the prostate using the Gyrus suggest that it is a useful and safe endoscopic device. It appears to be an effective treatment for BPH; however, long-term results (i.e., 1-year follow-up) should be evaluated. This pilot series permits a comparative study with TURP to assess the benefits for patients and the health care system.

Urethral Recurrence of Transitional Cell Carcinoma of the Bladder

Objective: The management of the male urethra after cystectomy for bladder cancer continues to be a dilemma. Patients who undergo a cystectomy require either urinary diversion or bladder substitution. Therefore, the use of the urethra to ensure voiding is important. On the other hand, the probable risk of urethral carcinoma recurrence is generally estimated at approximately 10%. The aim of this study was to assess the predictive value of preoperative urethral biopsies, and of frozen sections during cystoprostatectomy, in patients with invasive bladder cancer. Methods: From 1982 to 1986, 118 male patients underwent a cystoprostatectomy for transitional cell carcinoma of the bladder. All patients underwent endoscopic latero-montanal biopsies 2 weeks preoperatively and urethral frozen cut section during radical prostatocystectomy. Results: Carcinoma was observed in 12 patients on both examinations. All patients underwent en bloc urethrectomy during cystectomy. In the remaining 106 patients, the frozen cut margin was negative (including 9 with positive latero-montanal biopsies), and these patients had the urethra preserved. After a 10-year minimum follow-up, no recurrence was observed in these patients with negative frozen cut section. No significant risk factors for urethral recurrence were found. Latero-montanal biopsies did not reveal a positive specificity, and this procedure was later abandoned in our institution (in 1986). Conclusions: The urethral frozen section was the only guideline used for simultaneously performing the urethrectomy. All male patients with negative frozen cut sections should be considered candidates for bladder substitution. A prophylactic urethrectomy is only indicated in patients with carcinoma (minimum carcinoma in situ) in the frozen urethral margin section during cystectomy.

Evaluation of Tension–Free Vaginal Tape Procedure

Introduction and Objectives: The aim of this study was to evaluate preliminary results of tension–free vaginal tape (TVT), a new surgical procedure, performed during the learning phase for the treatment of stress urinary incontinence. Material and Methods: One–hundred consecutive patients underwent surgery, between June 1998 and December 1999, by six different senior surgeons. Indications were socially annoying urinary stress incontinence which persisted after complete physical therapy education. Preoperative examination included a urodynamic evaluation program. Surgical procedure was performed according to Ulmsten technique under local, regional or general anaesthesia. Results were evaluated by self–evaluation questionnaire and the patients were followed for at least 1 year. Results: Perioperative complications were: 14 bladder injuries and one urethral perforation without sequelae (except prolonged bladder drainage up to 3 days). Postoperative complications were: 13 retentions including 3 persistent after 1 month. During the learning phase (50 first patients) bladder injuries, retention and dysuria were more frequent. Progressively, local anesthesia was abandoned while most of the 50 remaining patients had TVT performed under epidural anesthesia. Functional results were divided into 3 groups according to preoperative urethral closure pressure (UCP) and eventual concomitant prolapse repair (PR): (1) UCP >25 cm H2O no PR (59 patients): 39 were totally dry without any instability, 13 dry with de novo (4) or persistent (7) instability and 5 were moderately improved. (2) UCP <25 cm H2O no PR (25 patients): 11 were dry without instability, 5 dry with instability, 6 were improved and 4 failed. (3) PR (15 patients): 9 were dry, 4 were improved and 2 failed. For 2 patients a bladder erosion due to the tape occurred (7 and 11 months) after the TVT procedure. Conclusions: During the learning phase, bladder perforation (22%) and retention (20%) were much more frequent than previously reported. Nevertheless, our results confirm that TVT appears to be an efficient procedure: 97% of patients were cured or improved when UCP >25 cm H2O, 85% when UCP <25 cm H2O and 87% when a PR was associated.

RECURRENCE, PROGRESSION AND SUCCESS IN STAGE TA GRADE 3 BLADDER TUMORS TREATED WITH LOW DOSE BACILLUS CALMETTE- GUERIN INSTILLATIONS

PURPOSE Bacillus Calmette-Guerin (BCG) therapy is considered to be an effective prophylactic and therapeutic agent for high risk superficial transitional cell carcinoma of the bladder. Nevertheless, in a select uncommon population of stage Ta grade 3 superficial lamina-free tumors the results of this treatment have not yet been well established. We evaluated recurrence and progression rates, and the success of BCG therapy in a population with stage Ta grade 3 transitional cell carcinoma of the bladder. MATERIALS AND METHODS Of the 605 patients treated at our institution from 1982 to 1996 for the histopathological diagnosis of primary bladder cancer 32 (5.3%) with stage Ta grade 3 noninvasive primary bladder tumor were treated with intravesical instillations of 75 mg. Pasteur strain BCG in 50 ml. saline weekly for 6 weeks. At a followup of 2 to 13 years (mean 58.4 months) patients were evaluated with urinary cytology, cystoscopy, transurethral resection and random mucosal biopsies. Recurrence, grade and stage progression, death and causality were analyzed. RESULTS Of the 32 patients 9 (28%) responded positively to BCG without recurrence, while disease recurred as stage Ta in 8 (25%) and T1 in 7 (22%), and progressed to muscle layer infiltration in 8 (25%). Four patients (12%) died of bladder cancer. The number of tumors at primary resection, gross examination, the mitotic index or an association with carcinoma in situ did not appear to be predictive factors of progression to muscle invasion. Urine cytology (I to II versus III to IV) appeared to correlate highly with progression and BCG response (p<0.001) with excellent sensitivity (1) but low specificity (0.67). CONCLUSIONS Our study demonstrates the high progression potential of stage Ta grade 3 tumors, since nearly 50% recurred and 25% progressed to invasive disease. These results may be closely compared with the results of previous trials of stage T1 grade 3 disease. We suggest that recurrence should be detected at an early stage using long-term followup with strict observance of the surveillance protocols during a minimum 5-year tumor-free period.

Correlation between p53 over expression and response to bacillus Calmette-Guerin therapy in a high risk select population of patients with T1G3 bladder cancer.

PURPOSE The aim of this study was to determine if p53 status, assessed before intravesical bacillus Calmette-Guerin (BCG) therapy, can predict clinical outcome in a high risk population of patients with stage T1, grade G3 bladder cancer and if it can be used to select patients responsive to therapy. MATERIAL AND METHODS After complete transurethral resection 35 patients with T1G3 bladder carcinoma received 6 weekly instillations of BCG and nonresponsive patients received a second course. After treatment cystoscopy and randomized biopsies of the bladder mucosa were performed. Pathologists had sufficient material to perform immunomarking in 25 cases using the peroxidase-antiperoxidase technique with antiprotein monoclonal antibody p53. The results were expressed in percentage of marked nuclei. We established 5% increment thresholds from 0 to 60%. Contingent tables were established, and chi-square and Fishers exact test were performed for each 5% threshold. RESULTS Median followup was 51.3 months (range 25 to 144). Of the 25 patients 8 (32%) did not respond to BCG therapy and 17 (68%) did. Immunomarkings were not statistically different between BCG responsive and nonresponsive patients for 0, 5, 10, 20, 35, 40, 45, 55 and 65 thresholds. Chi-square and Fishers exact test were 0.91 and 0.83, 0.40 and 0.20, 0.58 and 0.29, 0.96 and 0.81, 0.80 and 0.88, 0.67 and 0.73, 0.91 and 0.83, 0.80 and 0.38, 0.69 and 0.32, respectively. CONCLUSIONS Our results indicate that the percentage of p53 immunomarked cell cannot currently be used to predict clinical response to BCG therapy and, therefore, p53 over expression is not a viable indicator of T1G3 recurrence when using this treatment.

Prostatic capsule- and seminal-sparing cystectomy for bladder carcinoma: initial results for selected patients.

To evaluate the oncological outcome and functional results of prostate‐sparing cystectomy (PSC), proposed for treating bladder cancer, used since 1999 in our institution in an attempt to preserve male sexuality and to increase continence after cystectomy.

Low-Dose BCG Instillations in the Treatment of Stage T1 Grade 3 Bladder Tumours: Recurrence, Progression and Success

The aim of this retrospective study was to evaluate the effects and results of low-dose bacillus Calmette-Guérin (BCG) therapy on a selective high-risk population of stage T1, grade 3 (G3) bladder tumours. Recurrence and progression were also analysed.Thirty-five consecutive patients presenting with T1 G3 tumours were treated with intravesical BCG. All patients underwent complete transurethral tumour resection. A course of BCG 75 mg Pasteur strain was begun 4 weeks after the first resection of the diagnosed tumour and continued for a 6-week period. At the end of treatment, a complete urological evaluation was routinely carried out: urine cytology test, cystoscopy with bladder biopsies randomly performed, and any recurrences were resected. In cases of abnormal cytology and/or recurrence an additional course of BCG was initiated, followed by the same tests. Follow-up examination and cystoscopy or fibroscopy were conducted every 3 months for 1 year, semiannually and annually thereafter.Median follow-up was 45 months (range 10–120); 7 patients (20%) did not respond to BCG instillations. Of these patients, 5 underwent cystectomy and in 2 patients the bladder was left in place in spite of recurrence because of age (+80 years). Twenty-eight patients (80%) responded positively, 24 after one single course of BCG, and 4 patients after two courses. During follow-up, recurrence was observed in 8 cases: stage T1 G3 in 4 patients, T1 CIS (carcinoma in situ) in 2 patients, Ta G2 and Ta G1 in 2 patients. Three of these patients were treated by cystectomy and the remaining patients with transurethral resection alone or combined with additional courses of BCG. Overall, 25 patients (71%) were considered free of tumour occurrence after low-dose BCG therapy. Ten patients underwent cystectomy (29%) or remained in occurrence and 2 patients died of the disease.These results can be closely compared to the results of other trials conducted on stage T1 G3 and BCG treatment, using a different dosage and BCG protocol therapy. BCG is an effective prophylactic and therapeutic agent for T1 G3 carcinoma of the bladder responders. The identification of these responders before beginning instillations still remains a challenge.

Extracorporeal shock wave therapy in the treatment of Peyronie’s disease: experience with standard lithotriptor (siemens-multiline)

OBJECTIVES To assess in a prospective study whether extracorporeal shock wave therapy (ESWT) using a standard radioscopic location lithotriptor is effective in the treatment of Peyronies disease. METHODS Fifty-four patients were included in this prospective study. Before and after treatment, the angulation was calculated by auto-photography. Pain severity was assessed by a visual analog pain scale. A self-evaluation questionnaire (International Index of Erectile Function) was used. All patients had symptoms (35 had pain during erection and 51 angulation greater than 20 degrees ). The mean disease duration was 16 months. The mean angulation before treatment was 48 degrees (range 10 degrees to 100 degrees ). Twenty-four patients had erectile dysfunction (questionnaire score less than 18). The Multiline Siemens lithotriptor was used. The plaque was located by palpation, and 1 mL of contrast agent was injected. Scopic visualization was used. Each patient received a minimum of one session of ESWT (3000 shock waves, 7 kJ) applied to a flaccid penis. RESULTS All patients completed the protocol. The tolerance and safety were excellent. Of the 35 patients with pain on erection, 31 (91%) noticed relief immediately after ESWT (mean reduction 2.9 on the visual analog pain scale) (P <0.00001). For 29 patients (53.7%), an improvement in angulation (greater than 10 degrees ) was observed, with a mean reduction of 31 degrees (P <0.001). For patients with erectile dysfunction, only 6 (25%) had an increased questionnaire score (greater than 4). Twenty-five patients thought the plaque was smoother. CONCLUSIONS ESWT with a standard lithotriptor (without the mobile arm) in Peyronies disease is a feasible, safe, and effective treatment for pain on erection and significantly improves the penile angle.

After Cystectomy, Is It Justified to Perform a Bladder Replacement for Patients with Lymph Node Positive Bladder Cancer?

PURPOSE After cystectomy for bladder cancer, when pelvic lymph nodes are positive, bladder replacement remains controversial. The aim of this study was to evaluate the outcome of patients who underwent neobladder replacement despite bladder cancer metastasis to the regional lymph nodes. MATERIALS AND METHODS From 1981 to 1997, a total of 504 consecutive cystectomies for bladder cancer were performed at our institution. For 150 patients, pelvic lymphadenectomy were positive, nevertheless 71 patients underwent a neobladder replacement (50 N1 and 21 N2). The distribution of patients by clinical stage, according to the TNM 97 classification, was 4 T1, 14 T2, 32 T3 and 21 T4. No patient showed signs of metastasis on diagnosis. RESULTS Five-year disease specific survival rate of the entire group (71 patients) was 46%. With a mean follow-up of 8.3 years (3.2-20 years), 25 patients (35%) were alive and free of disease (72% with day continence), five patients were alive with recurrence (three bone metastasis, one chest metastasis and one with local recurrence), 41 patients died, (three non-cystectomy related). Of the 46 patients who recurred, a total of eight patients had local recurrence. For five patients, a severe dysfunction of the plasty appeared: two needed definitive bladder drainage until they died, one patient became totally incontinent, one patient needed a conversion of the plasty to Bricker ileal conduit. For the remaining patient the tumor involvement provoked recto-plasty-cutaneous fistula. All these five patients died in the 6 months after the plasty dysfunction appeared. CONCLUSIONS Although prognosis in bladder cancer metastasis to the regional lymph nodes has been reported to be poor, this study demonstrates that after cystectomy, it is justified to propose a neobladder replacement to well selected patients. Local recurrence only occurred in 11% of patients and there was no damage to enteroplasty function for nearly half of the patients, and considering benefit to the quality of life, orthotopic bladder substitution should be considered as the preferential diversion in this patient population.

Prognostic Value of MIB–1 Antibody Labeling Index to Predict Response to Bacillus Calmette–Guérin Therapy in a High–Risk Selected Population of Patients with Stage T1 Grade G3 Bladder Cancer

Purpose: Proliferation rate is an important determinant of bladder tumor progression. However, this factor has not yet been correlated to bacillus Calmette–Guérin (BCG) therapy response in a selected high–risk population of patients with stage T1 grade G3 bladder cancer. To assess the predictive value of the proliferation rate, an immunoreactivity test with monoclonal antibodies MIB–1 was carried out. The aim of this study was to evaluate the prognostic value of an MIB–1 labeling index by selecting a group of responsive patients prior to intravesical therapy.Materials and Methods: After complete transurethral resection, 35 patients with T1G3 bladder carcinoma received 6 weekly installations of BCG (intravesical Pasteur strain: 75 mg in 50 ml course of BCG therapy). After treatment a cystoscopy and randomized biopsies of the bladder mucosa were carried out and all recurrences were systematically resected. All tissue samples were fixed in Bouin’s solution, embedded in paraffin and stained with hematoxylin–eosin–safran. Pathologists had sufficient material to perform immunomarking in 25 patients using peroxidase–antiperoxidase (PAP) technique, with antiprotein monoclonal antibody MIB–1 (Immunotech, Marseilles, France) to study MIB–1 expression before BCG therapy. Consensus was obtained from three independent pathologists for all sections. The results were expressed in a percentage of marked nuclei. Ten percent increment thresholds were established from 10 to 60%. Contingency tables were established, χ2 (p1) and Fisher exact test (p2) were performed for each threshold of 10%.Results: Median follow–up was 57.3 months (range 25–144). Of the 25 patients, 8 (32%) did not respond to BCG therapy, 17 (68%) responded positively. With a 20% threshold, there was a statistical difference (p1 = 0.03, p2 = 0.04) between responder (R) and nonresponder (NR) patients. All the 7 patients with less than 20% of nuclear activity positively responded to BCG. At this threshold level, sensitivity was high but specificity low (positive predictive value = 0.44). If we consider other reactivity thresholds there were no statistical differences between R and NR patients (10%) threshold p1 = 0.13, p2 = 0.19; 30% p1 and p2 = 0.20; 40% p1 = 0.82, p2 = 0.61; 50% p1 = 0.57, p2 = 0.55).Conclusion: Our study indicates that the proliferation rate, assessed by MIB–1 immunoreactivity in Bouin’s solution–fixed primary tissue, could be a useful predictive marker of outcome in T1G3 bladder carcinoma. With a 20% reactivity cut–off, a negative MIB–1 immunomarking appears to predict a positive response to BCG instillations. However, on the other hand, MIB–1 is of limited clinical use because the low specificity of this test cannot predict failure and then select candidates for cystectomies.