Clinical effect of oxybutynin hydrochloride (1 mg/tablet)

The clinical efficacy of oxybutynin hydrochloride was studied on 21 patients with neurogenic bladder or unstable bladder complaining of urinary frequency, urgency and urgent incontinence. Oxybutynin hydrochloride (1 mg/tablet) was administered orally for 26.7 days, on average, 3 mg per day in 3 and 6 mg per day in 18 patients and the usefulness of this drug was assessed subjectively and objectively. Of 21 patients treated, 9 had neurogenic bladder and 10 had unstable bladder. Urinary frequency was normalized in 6 out of 16 (37.5%), urgency ceased in 6 out of 17 (35.7%) and urgent incontinence disappeared in 9 out of 14 (50%) patients. The mean volume at the first desire to void and the maximum cystometric capacity increased significantly on the cystometrogram after the administration of oxybutynin hydrochloride (p less than 0.01). Furthermore, the maximum vesical pressure decreased significantly (p less than 0.05). The maximum urinary flow rate increased slightly (p less than 0.1) and the residual urine volume significantly increased (p less than 0.05) after medication, although no changes were observed in tidal voiding volume or mean urinary flow rate. Of 20 patients, 9 showed improvement globally (45%), although no subjective or objective improvement was observed in 4 (20%) patients. Marked side effects were observed in 5 cases (two of acute urinary retention, each of increased urgency, residual urine and liver dysfunction), and side effects were seen in 10 of the 21 (47.6%) patients.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical study of terodiline hydrochloride for the treatment of urinary frequency and urinary incontinence, and its cardiovascular adverse effects]

We evaluated the effectiveness and side effects of terodiline hydrochloride in 109 patients with urinary frequency and urinary incontinence. The drug was administered at a dose of 24 mg once a day or 12 mg twice a day for 4 weeks. Symptoms such as urinary frequency and urinary incontinence were alleviated in 101 out of 109 patients (92.7%). Mild side effects such as thirst, dysuria, sense of residual urine, orthostatic hypotension and arrhythmia were observed in 9 out of 109 patients (8.2%). Side effects such as orthostatic hypotension and arrhythmia were observed on the 28th day or the 20th day of the administration, but these symptoms disappeared with discontinued use of this medicine. The results obtained from this study suggest that terodiline hydrochloride may be greatly useful for the patients with urinary frequency and urinary incontinence. But we must take account of the side effects such as orthostatic hypotension and arrhythmia.     

Long-term therapy with Robaveron tablet (KN-7) for urinary disturbance

Sixteen patients with benign prostatic hypertrophy (BPH, 5 cases) and neurogenic bladder (NB, 11 cases) were treated with Robaveron tablets (KN-7) containing an extract of swine prostate gland 20 mg/T. at the dose of 2 tablets t.i.d. for a long term of 6-33 months. Evaluation of drug efficacy and safety were based on decrease of residual urine, improvement of subjective symptoms, complaints of side effects and clinical laboratory tests recorded every three months. Significant decrease of residual urine rate and good improvement of various subjective symptoms such as difficulty in urination, pollakisuria, urinary incontinence, etc. were obtained and maintained. The overall effectiveness, rated as slightly improved or better on the final evaluation of these cases was 68.8%. No cases of side effects or abnormal changes in the laboratory tests directly due to the test drug were observed. Robaveron tablet is both safe and effective for the long-term therapy of urinary disturbance.     

Experience in the use of propiverine hydrochloride (P-4) for patients suffering from urinary frequency and/or incontinence

The clinical effectiveness and safety of propiverine hydrochloride (P-4, 20 mg tablet) were studied on 29 patients with nervous pollakisuria, neurogenic bladder or unstable bladder, whose chief complaints were urinary frequency and/or urinary incontinence. The clinical efficacy was "good" or better in 62.1% and "fair" or better in 86.2%. Patients' impressions were "good" or better in 79.3%. There were a total of 4 cases (13.8%) of adverse reactions, namely, two cases of decreased urinary stream, one dry mouth, and one dizziness. These reactions disappeared rapidly after the completion or discontinuance of drug administration, and therefore, did not constitute significant safety problems. The clinical efficacy in the treatment of subjective symptoms was 74.1% for diurnal pollakisuria, 50.0% for nocturnal pollakisuria, 83.3% for urinary incontinence and 69.0% for urgent feeling of micturition. For objective symptoms, P-4 increased significantly the volume of maximum desire to void (MDV); however it did not increase significantly the residual urine volume. The results of this study suggest that propiverine hydrochloride is very useful for the treatment of urinary frequency and/or incontinence.     

Effects of long-term administration of oxybutynin hydrochloride (KL007) for the treatment of neurogenic bladder and unstable bladder

The efficacy and safety of long-term administration of oxybutynin hydrochloride in patients with neurogenic bladder and unstable bladder, who complained of urinary frequency, urgency and incontinence, and whose bladder was proved to be uninhibited, reflex, and/or low compliant, were studied at the multi-center hospitals, and the following results were obtained. This study comprised 149 cases but 8 of them were excluded because of the incomplete protocol. Thus, 141 cases (104 neurogenic bladder patients, 33 unstable bladder patients and 4 others) were investigated. The daily dosage of Oxybutynin hydrochloride ranged from 1 to 18 mg, and averaged at 6.6 mg. Since a small daily dosage of 3 mg was administered in 32 cases to examine the minimum effective dosage of the drug, the low average dosage possibly resulted. The clinical optimal dosage seemed to be more than 6.6 mg. The average period of administration in all cases was 161.7 days (1-336 days), and the drug was discontinued in 46 cases (33.6%) on average 62.1 days (1-141 days). The rate of global improvement by this drug estimated at the time of completion was found to be 65.6% with excellent and good and 87.8% with excellent, good and fair. The efficacy of this drug was stable and not decreased during the long-term test period. As to the objective findings studied before, during and after the drug administration, cystometric bladder capacity was significantly increased both first desire to void and the total capacity. Voided volume and residual urine were also increased, but there was no change in the rate of residual urine. Side effects were observed in 37 (26.2%) of 141 cases, and mainly gastrointestinal signs such as dry mouth and constipation. Urological signs such as dysuria and urinary retention were experienced in 8 cases. Regarding the findings of laboratory tests, there were no abnormality except for small changes of some items in normal range. Six children who were younger than 15 years old were subjected to this study. The results of evaluation were similar to those obtained on adults and no side effects were observed. From these findings, oxybutynin hydrochloride is considered an effective and useful drug in patients suffering from neurogenic bladder and unstable bladder with over active bladder condition.     

The treatment of superficial bladder carcinoma with intravesical HPC-adriamycin and verapamil

A new form of hydroxypropylcellulose-adriamycin (HPC-ADM), which was supplemented with verapamil, a known calcium antagonist, in order to potentiate the antineoplastic effect of HPC-ADM, was synthesized and used for the treatment of superficial bladder carcinoma for clinical evaluation. The results are reported in this paper. A total of 23 patients who were treated for bladder carcinoma during a 2-year period (1987-1988) were subjected in this study. All patients were diagnosed cases of superficial bladder carcinoma as follows; Ta, 3 cases, T1, 18 cases and Tis, 2 cases. For the injection protocol, firstly HPC-ADM solution supplemented with verapamil was introduced into the urinary bladder via the urethra. After 2-3 weeks, the efficacy of the drug against the tumor was evaluated by cystoscope. Patients in whom the drug were found to be effective received increased administration of drug. In cases in whom the drug was found to be ineffective, different drugs for further treatment were adopted. The average frequency and amount of drug was 2.3 times and 45.2 mg, respectively. Complete responses achieved in 9 of 23 cases (39.1%). Of the 23 cases, 4 cases was with PR and 10 with NC. No cases were found to be with PD. Side effects were observed in 4 of the 23 cases (17.4%), however, severe side effects were not recognized. The important aspect in applying the method of intravesical therapy is that it makes enhanced antineoplastic potency possible with concomitant reduction of side effects and prevents the invasion of tumor.     

Effect of Robaveron tablet (KN-7) in the long-term therapy for urinary disturbances

Long-term therapeutic effect of Robaveron tablet (KN-7) was studied on 10 female patients of middle and old age with ptosis of urinary bladder and 9 patients with neurogenic bladder. The patients had mainly complained of such subjective symptoms as pollakisuria, difficulty of urination, sense of residual urine, lower abdominal discomfort and urinary incontinence. Robaveron tablet was administered at 2 tablets t.i.d. for 3-26 months. And the drug efficacy was evaluated by residual urine, cystometric findings and subjective symptoms. A significant decrease in the residual urine rate and a significant increase of pressure amplitude were obtained, and improvement of subjective symptoms was seen with an effective rate of about 70%. Overall effectiveness, rated slightly improved or better was 89.5%. No cases of side effects or abnormalities in laboratory tests were observed. Robaveron tablet is safe and effective for patients with urinary disturbance accompanied by ptosis of urinary bladder, as a myogenic disorder, as well as neurogenic bladder in the long-term therapy.     

Clinical study of ofloxacin (OFLX) on urinary tract infections

Fifty-three patients with urinary tract infections (UTI) were treated with Ofloxacin, a new oral synthetic antimicrobial agent, and its clinical efficacy was studied. Ofloxacin (600 mg/day) was administered to 35 patients with acute simple cystitis for more than three days, and to 17 patients with complicated UTI for more than five days except a case in which the treatment was interrupted for side effects. Acute simple cystitis: In ten cases meeting the criteria of UTI committee, overall effectiveness rate was 100%. All of the 26 strains isolated from 26 patients disappeared after the treatment. In all of acute simple cystitis cases, 94.3% were evaluated as excellent or as moderate by attending doctors. Complicated UTI: In 11 cases treated during five or seven days, 63.6% of patients showed improvement on pyuria. Seven out of nine strains isolated from seven patients disappeared. However, two strains of P. aeruginosa and P. cepacia persisted after the treatment. In all of the complicated UTI cases, 38.9% of patients were evaluated as excellent or as moderate by attending doctors. Some slight side effects were observed in four out of 53 cases. This study showed that Ofloxacin is effective against urinary tract infections.     

Clinical effects of oxybutynin hydrochloride on neurogenic bladder

Clinical effects of oxybutynin hydrochloride on lower urinary tract function at a dosage of 2 mg given orally three times daily (6 mg/day), were studied on 10 patients with neurogenic bladder by cystometry and measurement of residual urine. There was a significant increase, of about 34% in FDV, but no significant changes in MBV, or maximum voiding pressure of residual urine after administration. Urinary frequency, incontinence and urgency in subjective symptoms were decreased in patients given this drug. The effective rate (excellent and good) was 50% in global evaluation. Side effects were observed in 4 out of 10 patients; 3 had dry mouth and 1 had diarrhea. There were no serious side effects. These findings suggested that oxybutynin hydrochloride may be a useful drug for neurogenic bladder.     

Clinical studies of terodiline hydrochloride and clenbuterol hydrochloride for urinary frequency and incontinence]

The clinical effectiveness and safety of terodiline hydrochloride and clenbuterol hydrochloride were studied on 51 patients with neurogenic bladder, stress incontinence, unstable bladder and others, the chief complaints of which were urinary frequency or urinary incontinence. Overall improvement was graded as marked in 6 patients (11.8%), moderate in 20 patients (39.2%), slight in 11 patients (21.6%), unchanged in 13 patients (25.5%) and aggravated in one. The patients impression was "good" or better in 56.9%. There were a total of 13 cases (25.5%) of adverse reactions, namely, 7 cases of finger tremor, 3 cases of dry mouth and others. These reactions disappeared rapidly after the discontinuance of drug administration. The clinical efficacy in the treatment of subjective symptoms was 71.4% for urinary incontinence, 56.4% for diurnal pollakisuria. The examination of lower urethral functions demonstrated a significant (p less than 0.01) increase in bladder capacity at first desire and maximum desire to void. However, we found no significant increase in urethral clossure pressure. The findings of this study suggest that terodiline hydrochloride and clenbuterol hydrochloride are very useful for the treatment of urinary frequency and incontinence.     

The use of dimethyl sulfoxide in the treatment of intractable urinary frequency

Intravesical instillation of dimethyl sulfoxide (DMSO) was used in the treatment of patients with intractable urinary frequency due to chronic prostatitis, chronic cystitis, tuberculous contracted bladder and interstitial cystitis. Before the application of this therapy, all 4 patients were examined carefully to rule out cases of acute infectious diseases of the urinary tract, active urinary tuberculosis, neurogenic bladder and carcinoma in situ of the bladder. Three of the four patients achieved an excellent response both subjectively and objectively. In the United States, intravesical instillation of DMSO had already been established as the specific method in the treatment of interstitial cystitis and no side effects have been reported so far. Therefore, we recommend the use of intravesical instillation of DMSO more commonly in various forms of intractable urinary frequency.     

The Effect of Intravesical Mitomycin C on the Recurrence of Superficial (Ta–T1) Bladder Cancer. A Hungarian Multicenter Study

We evaluated the prophylactic efficacy of instillations of intravesical mitomycin C in 57 patients with primary superficial bladder cancer in a multicenter clinical trial. After complete transurethral resection of Ta–T1 G1–G2 transitional cell bladder carcinomas, patients were treated with mitomycin 40 mg/50 ml saline of 15 instillations for 12 months. Most of the complications were mild and transient but two patients dropped out of the trial because of moderate side effects. Fifty-one patients were evaluable. We observed tumour recurrences in six patients (11.8%) during a median follow-up of 44.5 months. The recurrences were treated by transurethral resection. There was no muscle invasive progression in the recurrences. Our investigations confirm the effectiveness of mitomycin C in the treatment of patients with superficial bladder cancer.     

Clinical effects of oxybutynin hydrochloride (Pollakis)--especially in the treatment of pollakisuria, urgency and urinary incontinence

The effects and the safety of oxybutynin hydrochloride were investigated in 52 patients, 17 male and 35 female, with the chief complaints of pollakisuria, urgency and urinary incontinence. Clinical responses to the drug were assessed mainly by the subjective symptoms of the patients. The diagnoses of these patients were neurogenic bladder in 17, unstable bladder in 16 and others in 19 patients. The average administration period was 66.8 days. The rate of global improvement (excellent and good) was 55% in the 2 mg dose given 3 times daily group, 68.2% in the 3 mg dose given 3 times daily group. Side effects, such as dry mouth, were observed in 2 of the 52 patients (3.8%), but no serious side effects were observed. The rate of global utility (remarkable and moderate) was 67.3%. These data indicate that oxybutynin hydrochloride seems to be useful and safe for the treatment of pollakisuria, urgency and urinary incontinence.     

两种方法行THP膀胱内灌注预防膀胱癌术后复发的疗效观察

目的：探讨膀胱癌术后大剂量吡喃阿霉素（THP）膀胱内灌注时保留时间对肿瘤复发和对人体安全性的差异。方法：将45例浅表性膀胱癌经尿道膀胱肿瘤电切术或膀胱部分切除术病人随机分对照组（24例）、观察组（21例），二术后2周开始应用THP（40mg/40ml）膀胱内灌注，观察组灌注后药物在膀胱内保留30min；对照组保留2h。结果：两组病人随访7－26个月，复发率比较，P＞0．05，差异无显著性意义；所有病人均能耐受THP膀胱内灌注；两组灌注后不同保留时间全身不良反应比较，均P＞0．05，差异无显著性意义；尿频、尿痛等膀胱刺激症和迟发性不良反应（尿道狭窄和前列腺炎）两组比较，P＜0．05，观察组明显低于对照组。结论：膀胱癌术后应用THP膀胱内灌注预防肿瘤复发效果显著，药物在膀胱内保留时间短，对膀胱、尿道刺激性小，不良反应少。     

Clinical effect of terodiline hydrochloride on nervous pollakisuria or irritative bladder

The clinical effect of terodiline hydrochloride (TD-758) was studied in 95 patients with nervous pollakisuria or irritative bladder. TD-758 was given per os randomly at a dose of 24 mg or 12 mg once a day for 4 weeks. The symptoms such as urinary frequency, urinary incontinence and sense of residual urine were improved in 74% of the patients taking 24 mg, and in 51% of the patients taking 12 mg. The difference was statistically significant. Side effects such as dry mouth, constipation and heart burn were observed in 15% of the patients in each group and were not serious. The results of this study indicate that TD-758 is useful for these patients and its optimal dosage is 24 mg once a day.     

Urodynamic verification of an overactive bladder is not a prerequisite for antimuscarinic treatment response

OBJECTIVE: To investigate the place of urodynamics in the evaluation of patients with symptoms of the overactive bladder by comparing the response to antimuscarinic therapy in those with and with no urodynamically verified symptoms. PATIENTS AND METHODS: In a prospective observational study, 356 female patients with urinary frequency (> or = 8 voids/24 h) and urgency, with or without urge incontinence, underwent cystometry. Patients were diagnosed with detrusor instability if there were spontaneous, uninhibited increases in detrusor pressure during bladder filling. All patients, regardless of urodynamic findings, were subsequently treated with oxybutynin 2.5 mg twice daily and bladder retraining. The outcome was evaluated as the change in urinary frequency and incontinence episodes after 6-8 weeks of treatment. RESULTS: Among 352 evaluable patients, 266 (76%) had detrusor instability on cystometry and the remainder did not. There was no significant between-group difference in mean age, urinary frequency or the number of incontinence episodes at presentation. Both groups improved equally well during oxybutynin and bladder retraining therapy; after 6-8 weeks there was no significant between-group difference for the mean change from baseline in urinary frequency or incontinence episodes. Tolerability profiles were comparable for the two groups. CONCLUSION: Patients with symptoms of an overactive bladder, but apparently normal urodynamic findings, respond equally well to antimuscarinic therapy as those with urodynamically verified symptoms. Such findings cast further doubt on the clinical validity of using invasive urodynamic procedures to characterize patients with irritative lower urinary tract symptoms before starting antimuscarinic therapy.     

Comparative double-blind trial of KN-7 tablet and Robaveron injection in the treatment of neurogenic bladder

The clinical effectiveness, safety and usefulness of KN-7 tablet as a new oral application of the prostatic extract, on urinary dysfunction of neurogenic bladder were compared with those of Robaveron injection by the double-blind test method. In the study, 2 tablets t.i.d. and a shot of intramuscular injection 1 ml a day were given successively for 3 weeks. A total of 233 cases were reported from 37 facilities belonging to the KN-7 Clinical Research Group. Some of them were excluded or dropped out. The number of cases used for analysing the effectiveness, safety and usefulness were 214, 232 and 215, respectively. There was no bias between the two groups with a significant homogeneity in the background. In the overall clinical effectiveness, the effective rate including excellent, moderate and slightly effective was 76.9% with KN-7 and 77.4% with Robaveron. In the clinical usefulness, the rate of usefulness of slightly useful or above was 75.0% with KN-7 and 75.7% with Robaveron. There was no significant difference between the two groups in the clinical effective and useful rates at a significant level of 5%. Side effects were observed in 1 of the 114 (0.9%) patients given KN-7 and 8 of the 118 (6.8%) patients given Robaveron. The incidence of adverse reactions with KN-7 was significantly lower than that with Robaveron. Based on the results, it was concluded that KN-7 tablets, 2 tablets t.i.d., would be as effective and useful as a Robaveron injection 1 ml daily and safer than the latter in the treatment of neurogenic bladder.     

Clinical experience with T-2588 in complicated urinary tract infections

The clinical effectiveness and safety of T-2588 were evaluated in 21 patients with complicated urinary tract infections. Six hundred mg of T-2588 per day was administered orally in three divided doses for 14 days. The results were excellent in 7 cases (33.3%), moderate in 8 cases (38.1%) and poor in 6 cases (28.6%), and the effectiveness rate was 71.4%. The effectiveness rates of the single infection group and mixed infection group were 91.7% and 44.4%, respectively. The overall bacteriological eradication rate obtained was 77.1%, and those of gram-positive cocci and gram-negative rods were 62.5% and 81.5%, respectively. None of the 21 cases, had any significant side effects and abnormal laboratory findings. From the above results, T-2588 is considered to be a useful antibiotic in the treatment of complicated urinary tract infections.     

Clinical evaluation of long-term administration of terodiline hydrochloride for the treatment of patients with pollakisuria and incontinence

We evaluated the effectiveness and side effects of long-term administration of terodiline hydrochloride in patients with chief complaints of pollakisuria or incontinence or both due to unstable bladder or neurogenic bladder associated with uninhibited contraction. The dose was 24 mg once daily. The symptoms such as pollakisuria and incontinence improved in 31 out of 41 patients (76%). Mild side effects were observed in 12 out of 47 patients (26%), which were thirst, dizziness, dysuria, urticaria and gastrointestinal symptoms. An increasing tendency of both maximum desire to void and compliance (p less than 0.10), and significant difference in maximum static pressure (p less than 0.05) were observed on urodynamic examinations before and after administration of this medicine. The results obtained from this study suggest that terodiline hydrochloride may be greatly recommended for patients with such symptoms as pollakisuria and incontinence.     

Study of clinical efficacy and safety of long-term cinoxacin therapy of chronic urogenital organ infection

Thirty-five patients with chronic simple and complicated urogenital organ infections were treated with 400 mg/day Cinoxacin for 60 to 284 days. The effects were judged according to improvements of subjective symptoms, bacteriuria and pyuria before and after the complete administration. Overall clinical efficacy in 35 cases with urogenital organ infections was estimated as excellent: 54%, good: 26%, poor: 17%, and effectiveness rate: 80%. The clinical effectiveness rate in 12 cases of chronic simple urinary tract infection was 100%, and in 14 cases of chronic complicated urinary tract infections was 64%, and in 6 cases of chronic prostatitis the rate of effectiveness was 83%. No recurrence was observed during the treatment. No side-effects or toxicity were seen. Accordingly long-term Cinoxacin therapy seems to be useful in preventing recurrence in chronic infections encountered in the department of urology.