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術直後に集中して行うTHPの5分間膀胱内注入療法は, 表在性膀胱癌の再発予防に対して安全かつ有効な治療方法と思われる, We conducted a prospective randomized controlled study on the prophylactic effects of short-term intravesical instillation of pirarubicin (THP) against recurrence to determine the effective administration schedule. All patients gave their informed consent. The subjects included bladder cancer patients who had pTa or pT1, and G1 or G2 cancer, and became tumor-free after transurethral resection of the bladder tumor (TUR-BT). After dissolving 30 mg of THP into 5 ml of distilled water, physiological saline was added to adjust the total volume to 50 ml, which was then instilled into the bladder, and was retained for 5 minutes. The schedule of instillation was for daily for 7 consecutive days from the day of TUR-BT and subsequently once a week for 10 weeks, 17 times in total for Group I, and once every two weeks for 6 months (12 times) starting 2 weeks after TUR and subsequently once a month until one year had passed after surgery (6 times), 18 times in total for Group II. The total number of cases was 69 (36 in Group I, 33 in Group II). The tumor-free ratios determined by the Kaplan-Meier analysis were 93.9% in Group I and 72.7% in Group II for one year, and 86.8% in Group I and 59.5% in Group II for two years. There was a statistically significant difference in the tumor-free ratios between the two groups by the generalized Wilcoxon test and the Log rank test (p = 0.0145 and 0.0107, respectively). Multivariated analysis using Cox's comparison hazard model produced p-values of 0.0002, 0.0007, 0.0009 and 0.0040 in the order of therapeutic mode, initial onset/recurrence, stage and number of tumor. Adverse events that forced discontinuation of the therapy for a while occurred in 4.3%. These results demonstrated that short-term intensive intravesical instillation of THP immediately after TUR-BT was a safe and effective therapy.

器質性インポテンス患者34名に対しAMSハイドロフレックスをインプラントして12週後, 1)満足度:非常に満足, 性交可能16例, 性交可能で満足13例, 性交可能でやや不満2例, 改善なし1例, 不明2例, 2)有用度:極めて有用20例, 有用11例, やや有用1例, 好ましくない1例, 判定不能1例, 3)副作用:海綿体膿瘍で抜去の1例, 平均19.2ヵ月中感染糜爛で抜去2例となった, The AMS Hydroflex penile prosthesis was implanted in 34 organic impotence patients between June 20, 1986 and Aug. 6, 1990. Patients ages ranged between 26 and 71 with an average of 50.5. The causes of impotences were; 17 cases of post-radical pelvic surgery, 7 cases of injury, 6 cases of diabetes and 4 of others. First evaluation was made after 12 weeks of implantation in terms of patient satisfaction with sexual intercourse and post operative complication. Sixteen patients (47.1%) were highly satisfied with intercourse, 13 (38.2%) satisfied with intercourse, 2 (5.9%) slightly dissatisfied even with successful intercourse, 1 (2.9%) with no improvement and 2 (5.9%) could not follow. Utility of the prosthesis, e.g. effectiveness and safety was; high utility in 20 (58.8%), good utility in 11 (32.4%), slight utility in 1 (2.9%), no favorable in 1 (2.9%) and no judgement in 1 (2.9%). The overall effectiveness and safety of the Hydroflex was demonstrated based on the above findings. Long term evaluation was made from the initial implantation of the device up to the termination of the trial with average of 19.2 months and was mentioned altogether.

Allylestrenol (ALE) and chlormadinone acetate (CMA) were administered to patients with prostatomegaly by the double-blind method, and a self-assessment questionnaire method developed by the authors was used to study the influence of these two antiandrogens on their sexual function. Each test drug was orally administered to 58 patients, in a daily dosage of 50 mg for 12 consecutive weeks. The questionnaires consisted of 6 categories each consisting of 5 questions, or 30 questions in total. The 6 categories were "sexual desire, " "erectile capacity" and "ejaculation, " which relate to the sexual function, and "living environment (including the frequency of sex), " "dysuria" and "dummy (personality)." Each question was graded into 0-10 points, and each patient was requested to circle the number which best described his status. The scores were compiled and statistically analyzed. Many patients were senile. Evaluable answers were obtained for 99 (85.3%) of the 116 patients. Factor analysis based on the preadministration scores confirmed the contents of the questionnaires to be appropriate for the objectives of the present study. Multiple regression analysis revealed a high correlation between the self-assessment scores and objective data (nocturnal penile tumescence values; NPT values) when dropout cases due to a decrease in the sexual function and non-replying cases were excluded. The self-assessment questionnaire method was concluded to be as useful an objective test method as the NPT measurement for examining the sexual function. Aggravation of the "frequency of urination during night" was conspicuous in the CMA group, and there was a significant difference (p less than 0.05) in this parameter between the two groups. Except for this parameter, dysuria was improved in both administration groups, and there was no significant difference in the efficacy of the two drugs. Both drugs tended to suppress overall sexual function, but the suppression was less severe in the ALE group. Especially the suppression was significantly (p less than 0.05) lower in the ALE group regarding the 3 parameters of "contact sexual arousal, " "contact erection" and "morning erection", which are included in the category of "sexual desire" or "erectile capacity." Also, suppression of "frequency of sex" and "intensity of sexual desire" tended to be lower in the ALE group at a level of significance of p less than 0.1. Regarding questions in the category of "ejaculation, " the incidence of non-replies was high in both groups, but its rate was higher in the CMA group.

We conducted a prospective randomized controlled study on the prophylactic effects of short-term intravesical instillation of pirarubicin (THP) against recurrence to determine the effective administration schedule. All patients gave their informed consent. The subjects included bladder cancer patients who had pTa or pT1, and G1 or G2 cancer, and became tumor-free after transurethral resection of the bladder tumor (TUR-BT). After dissolving 30 mg of THP into 5 ml of distilled water, physiological saline was added to adjust the total volume to 50 ml, which was then instilled into the bladder, and was retained for 5 minutes. The schedule of instillation was for daily for 7 consecutive days from the day of TUR-BT and subsequently once a week for 10 weeks, 17 times in total for Group I, and once every two weeks for 6 months (12 times) starting 2 weeks after TUR and subsequently once a month until one year had passed after surgery (6 times), 18 times in total for Group II. The total number of cases was 69 (36 in Group I, 33 in Group II). The tumor-free ratios determined by the Kaplan-Meier analysis were 93.9% in Group I and 72.7% in Group II for one year, and 86.8% in Group I and 59.5% in Group II for two years. There was a statistically significant difference in the tumor-free ratios between the two groups by the generalized Wilcoxon test and the Log rank test (p = 0.0145 and 0.0107, respectively). Multivariated analysis using Cox's comparison hazard model produced p-values of 0.0002, 0.0007, 0.0009 and 0.0040 in the order of therapeutic mode, initial onset/recurrence, stage and number of tumor. Adverse events that forced discontinuation of the therapy for a while occurred in 4.3%. These results demonstrated that short-term intensive intravesical instillation of THP immediately after TUR-BT was a safe and effective therapy.

The AMS Hydroflex penile prosthesis was implanted in 34 organic impotence patients between June 20, 1986 and Aug. 6, 1990. Patients ages ranged between 26 and 71 with an average of 50.5. The causes of impotences were; 17 cases of post-radical pelvic surgery, 7 cases of injury, 6 cases of diabetes and 4 of others. First evaluation was made after 12 weeks of implantation in terms of patient satisfaction with sexual intercourse and post operative complication. Sixteen patients (47.1%) were highly satisfied with intercourse, 13 (38.2%) satisfied with intercourse, 2 (5.9%) slightly dissatisfied even with successful intercourse, 1 (2.9%) with no improvement and 2 (5.9%) could not follow. Utility of the prosthesis, e.g. effectiveness and safety was; high utility in 20 (58.8%), good utility in 11 (32.4%), slight utility in 1 (2.9%), no favorable in 1 (2.9%) and no judgement in 1 (2.9%). The overall effectiveness and safety of the Hydroflex was demonstrated based on the above findings. Long term evaluation was made from the initial implantation of the device up to the termination of the trial with average of 19.2 months and was mentioned altogether.

Allylestrenol (ALE) and chlormadinone acetate (CMA) were administered to patients with prostatomegaly by the double-blind method, and a self-assessment questionnaire method developed by the authors was used to study the influence of these two antiandrogens on their sexual function. Each test drug was orally administered to 58 patients, in a daily dosage of 50 mg for 12 consecutive weeks. The questionnaires consisted of 6 categories each consisting of 5 questions, or 30 questions in total. The 6 categories were "sexual desire, " "erectile capacity" and "ejaculation, " which relate to the sexual function, and "living environment (including the frequency of sex), " "dysuria" and "dummy (personality)." Each question was graded into 0-10 points, and each patient was requested to circle the number which best described his status. The scores were compiled and statistically analyzed. Many patients were senile. Evaluable answers were obtained for 99 (85.3%) of the 116 patients. Factor analysis based on the preadministration scores confirmed the contents of the questionnaires to be appropriate for the objectives of the present study. Multiple regression analysis revealed a high correlation between the self-assessment scores and objective data (nocturnal penile tumescence values; NPT values) when dropout cases due to a decrease in the sexual function and non-replying cases were excluded. The self-assessment questionnaire method was concluded to be as useful an objective test method as the NPT measurement for examining the sexual function. Aggravation of the "frequency of urination during night" was conspicuous in the CMA group, and there was a significant difference (p less than 0.05) in this parameter between the two groups. Except for this parameter, dysuria was improved in both administration groups, and there was no significant difference in the efficacy of the two drugs. Both drugs tended to suppress overall sexual function, but the suppression was less severe in the ALE

Allylestrenol (ALE) and chlormadinone acetate (CMA) were administered to patients with prostatomegaly by the double-blind method, and the effects of these antiandrogens on their sexual function were objectively compared. Each agent was orally administered to 58 patients in a dosage of 50 mg/day for 12 consecutive weeks. For the objective evaluation of the sexual function, nocturnal penil tumescence (NPT) was measured using an erectometer. For the subjective evaluation the conventional interview method was employed. The levels of hormones relating to sexual function were also determined. A decrease in NPT was noted in both the ALE and CMA groups, but the degree of the decrease was significantly smaller in the ALE group than in the CMA group (p less than 0.001). The results of the interview, revealed a large between the two drug groups; in the CMA group, marked worsening for all items. In the determination of hormones, levels of luteinizing hormone, follicle stimulating hormone, testosterone and estradiol were decreased in both drug groups, while the prolactin level was increased in both groups. The changes in the testosterone, estradiol and prolactin levels in the CMA group were significantly dominant compared with those in the ALE group. In addition, drop-out cases due to a decrease in the sexual function numbered 7 (12.1%) in the CMA group, while there were no such drop-out cases in the ALE group; the difference in the drop-out rate was thus significant. In conclusion, ALE's effects on the sexual function were concluded to be smaller than those of CMA.

39症例に対して4 mgを就寝前4週間経口投与し, きわめて有効であった, A clinical trial was performed with the tranquilizer Bromazepam on 39 patients undergoing diagnosis of psychogenic impotence, and the drug effect was evaluated according to the criteria based on our protocol. The protocol specifies 8 tests (1 for libido, 4 for erection, 2 for ejaculation, 1 for orgasm) which are scored according to an arbitrary logarithmic scoring system. At the end of the study the points made in the 8 tests were added to obtain the total score as the basis for evaluation of the overall drug effect. After treatment all tests showed an improvement, and the improvement in erection during masturbation, reflective erection, and condition of ejaculation was statistically significant. The total score also improved from 16.77 +/- 2.62 (mean +/- S.D.) before treatment to 11.42 +/- 1.96 after treatment, and the change was again statistically significant (P less than 0.05). The rate of satisfaction as a subjective symptom of improvement also increased from 25.38 +/- 4.40% to 39.10 +/- 4.53%. The results of the present study provide evidence to indicate that Bromazepam is beneficial for psychogenic impotence.

器質性インポテンスと混合型インポテンス患者計34名に対し, AMSペニールインプラントインフレータブル型モデル700をインプラントした.1)患者の満足度は, 非常に満足23例(67.7%), 満足7例(20.6%), やや不満3例(8.8%), 悪化1例(2.9%)であった.2)重度の合併症は2例に生じた.2例とも感染によるもので, 最終的には2例ともプロステーシスを抜去した.3)有用性の評価はきわめて有用26例(76.5%), 有用7例(20.6%), 好ましくない1例(2.9%)であった, The AMS 700TM & 700 CXTM penile prosthesis was implanted in 34 organic and mixed-type impotent patients between November, 1984 and July, 1988. The patients' ages ranged between 32 and 70, with an average age of 57.2. Twelve weeks after implantation, the prosthesis was evaluated in terms of patient satisfaction with sexual intercourse and postoperative complications. Twenty three patients (67.7%) were highly satisfied, 7 (20.3%) satisfied, 3 (8.8%) dissatisfied and 1 patient worsened (2.9%). Severe complication was found in two cases, both of them being complicated by infection; as a result the prosthesis was removed. Utility of the prosthesis, e.g. effectiveness and safety was; high utility in 26 cases (76.5%), moderate utility in 7 cases (20.6%), and no favorable in one case (2.9%). Thus, overall effectiveness and safety of the AMS 700 penile prosthesis, with its excellent cosmetic appearance upon implantation, were demonstrated by the above findings.

We treated 53 patients for male infertility with TSUMURA - Hachimijiogan given as a daily dose of 7.5 g for 144 days on the average. The sperm density was improved by administration to 10 X 10(6)/ml or more in 22 patients (41.5%) and lowered to 10 X 10(6)/ml or more in only 2 patients (3.8%). The sperm motility was improved by 10% or over in 29 patients (54.7%) as compared with 5 patients (9.4%) in whom it was lowered by 10% or more. The sperm motile efficiency index ( SMEI ) was improved in 40 (75.5%) of the 53 patients. Statistically significant differences were noted in the improvement in sperm density, sperm motility and SMEI . By contrast, there was no difference in semen volume, sperm morphology or sperm agglutination between the pre- and post- treatment periods. During the period of treatment, the wives of 4 patients (7.5%) conceived children. These results suggest that TSUMURA - Hachimijiogan is effective for male infertility to a certain extent and that clinical trials on its use for male infertility may be meaningful.

TKT-100, a high-unit kallidinogenase preparation, was orally given to 21 patients who had male sterility, at the daily dose of 6 tablets for 3 to 4 months. As a result, sperm density was increased in 14 of the patients (66.7%), sperm motility was improved in 17 (31.0%), and the sperm motility efficiency index (SMEI) was raised in 16 (76.2%). A modification of the Eliasson Score was used for bulk measurement of seminal quality. The score was improved in 16 of the patients (76.2%). Impregnation was successful in 4 patients (19.0%). These results suggest that TKT-100 is effective for treating substantial male sterility.

TKT-100, a high-unit kallidinogenase preparation, was orally given to 21 patients who had male sterility, at the daily dose of 6 tablets for 3 to 4 months. As a result, sperm density was increased in 14 of the patients (66.7%), sperm motility was improved in 17 (31.0%), and the sperm motility efficiency index (SMEI) was raised in 16 (76.2%). A modification of the Eliasson Score was used for bulk measurement of seminal quality. The score was improved in 16 of the patients (76.2%). Impregnation was successful in 4 patients (19.0%). These results suggest that TKT-100 is effective for treating substantial male sterility.

A clinical trial was performed with the tranquilizer Bromazepam on 39 patients undergoing diagnosis of psychogenic impotence, and the drug effect was evaluated according to the criteria based on our protocol. The protocol specifies 8 tests (1 for libido, 4 for erection, 2 for ejaculation, 1 for orgasm) which are scored according to an arbitrary logarithmic scoring system. At the end of the study the points made in the 8 tests were added to obtain the total score as the basis for evaluation of the overall drug effect. After treatment all tests showed an improvement, and the improvement in erection during masturbation, reflective erection, and condition of ejaculation was statistically significant. The total score also improved from 16.77 +/- 2.62 (mean +/- S.D.) before treatment to 11.42 +/- 1.96 after treatment, and the change was again statistically significant (P less than 0.05). The rate of satisfaction as a subjective symptom of improvement also increased from 25.38 +/- 4.40% to 39.10 +/- 4.53%. The results of the present study provide evidence to indicate that Bromazepam is beneficial for psychogenic impotence.

We treated 53 patients for male infertility with TSUMURA - Hachimijiogan given as a daily dose of 7.5 g for 144 days on the average. The sperm density was improved by administration to 10 X 10(6)/ml or more in 22 patients (41.5%) and lowered to 10 X 10(6)/ml or more in only 2 patients (3.8%). The sperm motility was improved by 10% or over in 29 patients (54.7%) as compared with 5 patients (9.4%) in whom it was lowered by 10% or more. The sperm motile efficiency index ( SMEI ) was improved in 40 (75.5%) of the 53 patients. Statistically significant differences were noted in the improvement in sperm density, sperm motility and SMEI . By contrast, there was no difference in semen volume, sperm morphology or sperm agglutination between the pre- and post- treatment periods. During the period of treatment, the wives of 4 patients (7.5%) conceived children. These results suggest that TSUMURA - Hachimijiogan is effective for male infertility to a certain extent and that clinical trials on its use for male infertility may be meaningful.

The AMS 700TM & 700 CXTM penile prosthesis was implanted in 34 organic and mixed-type impotent patients between November, 1984 and July, 1988. The patients' ages ranged between 32 and 70, with an average age of 57.2. Twelve weeks after implantation, the prosthesis was evaluated in terms of patient satisfaction with sexual intercourse and postoperative complications. Twenty three patients (67.7%) were highly satisfied, 7 (20.3%) satisfied, 3 (8.8%) dissatisfied and 1 patient worsened (2.9%). Severe complication was found in two cases, both of them being complicated by infection; as a result the prosthesis was removed. Utility of the prosthesis, e.g. effectiveness and safety was; high utility in 26 cases (76.5%), moderate utility in 7 cases (20.6%), and no favorable in one case (2.9%). Thus, overall effectiveness and safety of the AMS 700 penile prosthesis, with its excellent cosmetic appearance upon implantation, were demonstrated by the above findings.