Therapeutic drug for the treatment of micturition disorders

Details Therapeutic drug for the treatment of micturition disorders Therapeutic drug for the treatment of micturition disorders

2000-07-05

2001-12-11

Gitomer, Ralph (Department: 1623)

Drug, bio-affecting and body treating compositions

Designated organic active ingredient containing

Ester doai

C514S599000, C514S788000, C514S741000, C514S869000, C514S968000, C514S826000

Reexamination Certificate

active

06329428

ABSTRACT:

TECHNICAL FIELD
The present invention relates to a therapeutic drug for treating diseases of the lower urinary tract system, including those of the bladder and prostate, which can cause micturition disorders. The invention also relates to a therapeutic drug for micturition disorders accompanying these diseases.
BACKGROUND ART
Micturition disorder is a term which collectively refers to micturition-related pathological conditions, encompassing dysuria, pollakiuria, miction pain, and urinary incontinence.
Dysuria generally refers to a state where smooth urination is disturbed. Typical symptoms include: delay between the desire to void and the initiation of micturition; thin stream of urine, time for voiding prolonged; post-micturition dribble; conscious exertion of abdominal pressure needed to initiate voiding; and sense of residual urine remaining in the bladder immediately after urination. A special form of dysuria is urinary retention, which refers to a state in which voluntary micturition is disturbed and is characterized by retention of urine. Causes of urinary retention are broadly divided into (1) those attributed to neurological factors, including incoordination of the bladder smooth muscle and detrusor-sphincter dyssynergia, and (2) those attributed to organic factors, such as prostate-associated diseases, bladder neck sclerosis, and urethral stricture. Until today, however, the causes have not yet clearly elucidated and current theory holds that neurological changes and organic changes are closely related to each other. Thus, in order to formulate a remedy, studies should be directed not only at localized anatomy, but at the entire urinary system, including the bladder, the prostate, and the external sphincter (see
Medicine Journal
, vol. 33, S-1, 193-197 (1997).
Pollakiuria refers to a pathological condition in which frequency of urination rises to an abnormally high level. Frequency varies greatly from day to day among healthy individuals, and therefore, it is difficult to demarcate clearly. However, as a rough yardstick, frequency of more than ten times during the day and more than 2 times at during sleeping hours is regarded to be pollakiuria. Pollakiuria is sometimes accompanied by miction pain.
Miction pain is a pain felt along the urethra during micturition. Patients may experience this pain only at the initial or the final stage of voiding.
Urinary incontinence refers to a pathological condition where there is an involuntary letting of urine. There are several types of urinary incontinence: overflow incontinence where although the bladder is filled with urine normal micturition is inhibited and urine eventually overflows when a condition of urinary retention is reached; urge incontinence in which patients cannot suppress voiding once they have the desire to micturate; stress incontinence where incontinence occurs only when abdominal pressure is elevated; and true incontinence in which the bladder can no longer hold urine due to, for example, a dysfunction of the urethral sphincter. Urinary incontinence is often accompanied by pollakiuria.
Causes of micturition disorders include (1) disturbance of the nerves which control the bladder/urethral sphincter, which is attributed to, for example, spinal injuries, cerebrospinal tumors, cerebrospinal vascular disorders, myelitis, multiple sclerosis, Parkinson's disease, spinal meningoceles, radical surgery for uterine cancer, and radical surgery for colon cancer; (2) stimulation of the bladder membrane due to lesions in the bladder wall or inflammation or fibrosis of the muscle layers of the bladder, caused by cystitis, prostatitis, calculus at the lower end of the ureter, bladder cancer, etc. (3) injuries of the urethral sphincter; (4) obstructive lesions in the urethra attributed to prostatic hypertrophy. prostatic cancer, bladder neck sclerosis, or urethral stricture. Therapies for micturition disorders focus firstly on the treatment of underlying disorders/diseases. However, when such treatment is impossible, symptomatic treatment is usually attempted.
Among the above-mentioned causal disorders/diseases, diseases of the lower urinary tract system, such as lesions in the bladder wall or urethral obstructive lesions, such as cystitis, prostatitis, prostatic hypertrophy, bladder neck sclerosis, obstructive lesions, are intractable, and therefore there is a strong need for the development of effective pharmaceuticals.
Cystitis refers to infectious or non-infectious inflammation which primarily arises in the bladder membrane and submucosal tissue. In some cases, cystitis invades muscle layers. Generally, cystitis is divided into acute and chronic forms on the basis of clinical progress. Depending on the presence or absence of obstructive diseases in the lower urinary tract, cystitis is further classified into simple cystitis and complex cystitis. Generally, simple cystitis proceeds acutely and responds well to antimicrobial drugs. In contrast, complex cystitis proceeds chronically and often does not respond well to antimicrobial drugs, and is thus sometimes referred to as intractable cystitis. Intractable cystitis includes interstitial cystitis, hemorrhagic cystitis, bacterial intractable cystitis, and eosinocytic cytitis (see
Medicine Journal
, vol. 31, No. 3, 81-84 (1995)).
Interstitial cystitis is a disease of the bladder in which the present complaints (PC) include pain in the lower abdomen due to repletion of the bladder (bladder pain), pollakiuria, urinary urgency, or dysuria. These can be accompanied by complaints of a mental nature, including sensations of incomplete urination, malaise, depression, and anxiety, but are not accompanied by infection or peculiar pathological findings. In 1987, the National Institutes of Health (USA) provided guidelines—although thought to be incomplete—or diagnosing interstitial cystitis. According to the guidelines, causes of this disease, which have not been completely elucidated, include disturbance of the lymphatic system; chronic infection; disturbance of the nervous system; mental disorder; autoimmune disease; angiitis; toxic factors in the urine; compromised bladder defensemechanisms; and mast cells (
Clinical Urology
, Vol. 52, No. 9, 635-640, August, 1998). In the United States, about 500,000 patients currently suffer from interstitial cystitis and the American Urological Association includes in each of its conferences special sessions presenting the results of research into interstitial cystitis. The prevalence of interstitial cystitis is higher in women. Such female patients have difficulty in working and not infrequently become targets for firing and are subjected to sexual harassment. In Japan also, there may be many victims of interstitial cystitis. However, significant numbers of undiagnosed victims may be hidden among patients who complain of pollakiuria, in view that universal standards for diagnosis have not yet been established.
Current therapy for interstitial cystitis includes hydrodistention therapy; and drug therapy by use of drugs such as antidepressants, anti-histaminic agents, steroids, dimethyl sulfoxide (DMSO), and heparin. In hydrodistention therapy, the bladder is expanded through hydraulic pressure, and abatement is observed in approximately 50-60% of cases. However, after completion of the therapy, the condition may become aggravated in 2-3 weeks or may recur in 4-12 months. In such cases, the therapy must be repeated. Antidepressants elevate the patient's pain threshold and induce sleep. However, such drugs do not treat the underlying pollakiuria. Anti-histaminic agents have been used because it is believed that the development of interstitial cystitis is related to mast cells. However, it is accepted that these agents used alone rarely control the condition and must be used in combination with other therapies. Steroids, which are used for a comparatively large number of patients in Japan, are not drugs of first choice in Europe and the United States. This is because the optimum dose and administration duration of steroids have not been fu

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