Rp Arora

Intravesicle gemcitabine in management of BCG refractory superficial TCC of urinary bladder—our experience

INTRODUCTION The incidence of bladder malignancy is increasing worldwide and the projected rise is 28% by 2010 for both sexes (according to the WHO). Though intravesical adjuvant therapy with bacillus Calmette-Guérin (BCG) is superior to any other immunotherapeutic/chemotherapeutic agent in reducing tumor recurrences and disease progression, its real efficacy remains controversial as one-third of the patients will soon develop BCG failure. Hence, there is a need for an alternative intravesical agent for treatment of BCG failure. Our aim is to study the efficacy, tolerability, and safety of intravesical gemcitabine in managing BCG refractory superficial bladder malignancy. MATERIAL AND METHODS Thirty-five BCG failure patients, 26 males and 9 females between 20 and 72 years of age were instilled 2000 mg of gemcitabine in 50 ml of normal saline intravesically 2 weeks post-tumor resection, for 6 consecutive weeks. Mean follow-up for 18 months with cystoscopy was done. RESULT Twenty-one patients (60%) showed no recurrences, 11 patients (31.4%) had superficial recurrences, while 3 patients (8.75%) progressed to muscle invasiveness. Average time to first recurrence was 12 months and to disease progression was 16 months. Adverse event was low and mild. Therapy was well tolerated. CONCLUSION Gemcitabine fulfills all requirements as an alternative agent in treating BCG failure patients with low adverse events, well tolerated, and highly effective in reducing tumor recurrences.

Photoselective vaporization of prostate vs. transurethral resection of prostate: A prospective, randomized study with one year follow-up

Objectives: To evaluate in a prospective, randomized study, the efficacy and safety profile of photoselective vaporization of prostate (PVP) using a 80W potassium titanyl phosphate (KTP) laser when compared to standard transurethral resection of prostate (TURP) in patients with lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE). Materials and Methods: Between February 2009 and August 2009, 117 patients satisfying the eligibility criteria underwent surgery [60 PVP{Group A}; 57 TURP{Group B}]. The groups were compared for functional outcome (both subjective and objective parameters), perioperative parameters and complications, with a follow up of one year. P value<0.05 was considered statistically significant. Results: The baseline characteristics of the two groups were comparable. Mean age was 66.68 years and 65.74 years, mean IPSS score was 19.98 and 20.88, mean prostate volume was 44.77 cc and 49.02 cc in Group A and B, respectively. Improvements in IPSS, QOL, prostate volume, Q max and PVRU at 12 months were similar in both groups. PVP patients had longer operating time, lesser perioperative blood loss, shorter catheterization time and a higher dysuria rate when compared to TURP patients. The overall complication rate was similar in the two groups. Conclusions: In patients with LUTS due to BPE, KTP-PVP is an equally efficacious alternative to TURP with durable results at one year follow up with additional benefits of lesser perioperative blood loss, lesser transfusion requirements and a shorter catheterization time. Long term comparative data is awaited to clearly define the role of KTP-PVP in such patients.

A prospective randomized comparison between early (<48 hours of onset of colicky pain) versus delayed shockwave lithotripsy for symptomatic upper ureteral calculi: a single center experience.

BACKGROUND AND PURPOSE The role of early/emergency shockwave lithotripsy (SWL) in symptomatic upper ureteral calculi has still not been established. We have performed a randomized comparison between early (<48 hours) vs delayed (>48 hours) SWL for symptomatic upper ureteral stones less than 1 cm to evaluate the feasibility, safety, and efficacy of early SWL in these patients. PATIENTS AND METHODS One hundred and sixty consecutive patients with a single radiopaque upper ureteral stone <1 cm, who presented with an episode of colicky pain and who were undergoing treatment between July 2008 and June 2009 in our department were included. The patients were hospitalized and randomized into two groups-group A: SWL was performed within 48 hours of onset of colicky pain (early SWL) using the electromagnetic lithotripter (Dornier Alpha Compact) along with analgesics and hydration therapy; group B: SWL was performed after 48 hours (delayed SWL) along with analgesics and hydration therapy. The statistical analysis was performed in two groups regarding the patient demographic profile, presence of hydronephrosis, time to stone clearance, success rates, number of sessions needed, auxiliary procedures, modified efficiency quotient (EQ), and complications. RESULTS Eighty patients were enrolled in each group. The mean stone size was 7.3 mm in group A vs 7.5 mm in group B (P = 0.52). The stone fragmentation rate was 88.75% in group A vs 91.2% in group B (P = 0.35). The overall 3-month stone-free rate was 86.3% (69/80) for group A vs 76.2% (61/80) for group B (P = 0.34). The mean time taken for stone clearance was significantly less in group A than in group B (10.2 days vs 21.1 days; P = 0.01). The number of sessions needed in group A were significantly less than in group B (1.3 vs 2.7; P = 0.01). The auxiliary procedure rate was also significantly lesser in group A than group B (16.3% vs 32.5%; P = 0.001). The modified EQ (in %) was 67.2 in group A vs 59.4 in group B (P = 0.21). The steinstrasse formation and requirement for percutaneous nephrostomy (PCN) were significantly less in group A (P:0.02 and P:0.01 respectively). CONCLUSIONS Early SWL (within 48 hours of onset of colicky pain) is feasible, safe, and highly efficacious in the management of symptomatic proximal ureteral stones <1 cm, resulting in a lesser requirement of number of SWL sessions, time taken for stone clearance, auxiliary procedure rate, and fewer complications in comparison with delayed SWL.

Role of botulinum toxin-A in management of refractory idiopathic detrusor overactive bladder: Single center experience

Background Overactive bladder (OAB) is a bothersome condition affecting the quality of life, financial constraint on the individual, and community. Anticholinergic drugs cannot be used for long term due to adverse side effects. Botulinum toxin has recently shown promising and encouraging result in management of OAB. Aim Aim was to study the safety, efficacy, tolerability, and duration of effect of 200 units of botulinum toxin in refractory idiopathic detrusor overactivity. Materials and Methods Thirty-nine female patients (average age of 52 years) clinically and urodynamically diagnosed as idiopathic OAB were injected 200 units of botulinum toxin-A mixed with 20 ml of normal saline, intradetrusally at the rate of 1 mL at each site for 20 such sites sparing the trigone and ureteric orifices. Follow up at 3rd, 6th, 9th, and 12th month with clinical and urodynamical questionnaire was done. Results There were 4 dropouts and 35 patients were evaluated, of which 30 patients (85.7%) showed improvement in clinical features like frequency, urgency, nocturia, and incontinence within 1 week of injection, which lasted for mean period of 7 months (varying from 6 to 9 months). Volume at first desire to void improved from median baseline of 104-204 ml and maximum cystometric capacity of bladder increased from mean baseline value of 205-330 ml. The detrusor pressure decreased by 49% from the baseline and postresidual urine volume increased by 30% of maximum cystometric capacity of bladder. There was no adverse effect on our patient. Conclusion Intradetrusor injection of Botox-A in management of refractory overactive idiopathic bladder is not only safe and well tolerated, but also very effective with practically no side effects.

Management of BCG non-responders with fixed dose intravesical gemcitabine in superficial transitional cell carcinoma of urinary bladder

Aims and Objectives: The incidence of bladder malignancy is increasing worldwide and the projected rise is 28% by 2010 for both sexes (WHO). Though intravesical adjuvant therapy with BCG is superior to any other immunotherapeutic/chemotherapeutic agent in reducing tumor recurrences and disease progression, its real efficacy remains controversial as one-third of the patients will soon become BCG failure. Hence there is a need for an alternative intravesical agent for treatment of BCG failure. Our aim was to study the efficacy, tolerability and safety of intravesical Gemcitabine in managing BCG-refractory superficial bladder malignancy. Materials and Methods: Thirty-five BCG failure patients, 26 males and nine females between 20-72 years of age were instilled with 2000 mg of Gemcitabine in 50 ml of normal saline intravesically two weeks post tumor resection, for six consecutive weeks. Mean follow-up was for 18 months with cystoscopies. Results: Twenty-one patients (60%) showed no recurrences, 11 patients (31.4%) had superficial recurrences while three patients (8.6%) progressed to muscle invasiveness. Average time to first recurrence was 12 months and to disease progression was 16 months. Adverse event was low and mild. Therapy was well tolerated. Conclusion: Gemcitabine fulfils all requirements as an alternative agent, in treating BCG failure patients with low adverse events, is well tolerated and highly effective in reducing tumor recurrences.

A comparative study of fixed dose of Tamsulosin with finasteride vs Tamsulosin with dutasteride in the management of benign prostatic hyperplasia

OBJECTIVE: The aim of this study was to compare the efficacy, safety and tolerability of Dutasteride vs Finasteride in a fixed dose combination, with a uro-selective a-blocker Tamsulosin, in the management of symptomatic BPH associated with LUTS. MATERIALS AND METHODS: 105 males between 40-80 years, clinically diagnosed as Benign prostatic hyperplasia (BPH) having a baseline evaluation of their IPSS, UFR, PSA, LFT, KFT, sex health, ultrasound of prostate and PVUV, were randomized to receive a fixed dose combination therapy of Tamsulosin (0.4 mg) with Finasteride (5 mg), vs Tamsulosin (0.4 mg) with Dutasteride (0.5 mg), daily for six consecutive months. Follow- up at the end of the 2nd, 4th, 8th, 12th and 24th week was done with IPSS, UFR, PSA, ultrasound of Prostate, PVUV and sex health. RESULTS: There were five dropouts, three from the Finasteride arm and two from Dutasteride arm, leaving a total of 100 patients for the final evaluation. Patients in both the groups showed improvement in their symptoms score and urine flow rate from the baseline, but those with the Dutasteride combination not only showed much better improvement in their symptoms score and urine flow, but were also relieved of their obstructive symptoms earlier (10-14 days) than seen in the Finasteride group (24-35 days). None of the patients had acute retention of urine (AUR) during the trial. The post void urine volume was decreased more in the Dutasteride group, than in patients with Finasteride. Sexual dysfunction incidence was same in both the groups. Approximately 50% reduction in the PSA level was seen in both the groups, while LFT did not show significant difference from the baseline, in either group. Both the drugs were well tolerated, with the patients good compliance and with no drop-out due to adverse effects. CONCLUSION : A combination of a-adrenergic blocker and 5-ARI is the best therapeutic option for medical management of BPH as it is safe, effective and well tolerated. A combination of Tamsulosin with Dutasteride results in early symptomatic relief and low PVUV, than seen with the Tamsulosin with Finasteride combination.

Analysis of the perioperative and five-year oncological outcome of two hundred cases of open radical cystectomy: A single center experience

OBJECTIVES We prospectively evaluated our perioperative and five-year oncological results of 200 cases of open radical cystectomy with urinary diversion, for formulating contemporary benchmarks, for future comparison of minimally invasive techniques. This is one of the largest prospective series reported from India of open radical cystectomy. MATERIALS AND METHODS Between 2004 and 2009, patients undergoing open radical cystectomy with urinary diversion, at our institution, were prospectively enrolled in the study. Data were recorded and analyzed statistically. RESULTS Two hundred patients were enrolled in the study. The mean age was 65.1 years. The patients undergoing ileal conduit and orthotopic neobladder were 159 (79.5%) and 41 (20.5%), respectively. The mean operating time was 275 minutes. The mean operating time for ileal conduit and orthotopic neobladder were 262 minutes and 288 minutes, respectively. The mean estimated blood loss was 690 ml. Blood transfusion was required in 37 (18.5%) patients. The mean hospital stay was 6.1 days. Major and minor complications were recorded in 16 (8%) and 31 (15.5%) patients, respectively. Perioperative mortality was recorded in only two (1.5%) patients. The pathologically organ-confined and non-organ-confined cases were 135 (67.5%) and 65 (32.5%), respectively. Thirty-three (16.5%) patients had pathologically confirmed lymph nodes. Median follow-up was 60.1 months. Local recurrence and distant metastases were recorded in 16 (8%) and nine (4.5%) patients, respectively. A five-year disease-free survival, cancer-specific survival, and overall survival were 75.5, 71.5, and 63.5%, respectively. CONCLUSIONS Open radical cystectomy has an acceptable perioperative morbidity and mortality, along with a favorable five-year oncological efficacy. Minimally invasive techniques need a long-term prospective comparison with this approach, before being accepted as a standard treatment for urinary bladder malignancy.