Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528613
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
Real World Study in Greek Patients with BPH for Disease Control and QoL Under FDC Treatment with SolifenacinTamsulosin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Real World Study in Greek Patients with BPH for the Evaluation of Disease Control and QoL Under FDC Treatment with Solifenacintamsulosin
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KALLIRROI
Brief Summary:
Benign prostatic hyperplasia BPH is an age-related progressive condition of the prostate gland that results in an increase in prostate size
Although the normal prostate in adult men usually has a volume of 15-30 ml a value above 30 ml is usually considered enlarged However the threshold at which a prostate is considered enlarged has not been strictly defined and therefore for many physicians an enlarged prostate is a subjective finding on examination
BPH can only be defined histologically increase in the number of epithelial cells and stromal cells but in clinical practice it is characterized by lower urinary tract symptoms Lower Urinary Tract Symptoms LUTS The disease leads to increased pressure in the urethra causing resistance to urine flow known as Bladder Outlet Obstruction BOO This resistance can also lead to changes in bladder function caused by the obstruction such as overactivity of the bladder detrusor muscle or conversely reduced detrusor contractility BOO can present as LUTS infections or retention as well as other conditions
Lower urinary tract symptoms LUTS can be divided into storage irritant obstructive urinary and post-urinary symptoms and appear frequently causing intense discomfort reducing the quality of life LUTS are traditionally associated with bladder outlet resistance BOO most commonly when histologic BPH progresses through benign prostatic enlargement BPE to benign prostatic obstruction BPO
The European Urological Association EAU reports that lower urinary tract symptoms LUTS are a common problem in adult men with a significant impact on quality of life QoL Accordingly he suggests the use of the α1-blockermuscarinic receptor antagonist combination in men with moderate to severe storage symptoms voiding symptoms and PVR 150 ml in order to reduce the risk of acute urinary retention and relieve irritants storage symptoms leading to an improvement in the patients quality of life Given the small abundance of data for patients in Greece with BPH this study will evaluate the fixed combination of solifenacintamsulosin in terms of disease control and improvement of the quality of life of patients with BPH
Before enrolling in the study and before signing the consent form patients must have already received the drug with solifenacintamsulosin and then they are enrolled in the observational study where the physician applies hisher standard clinical practice
Although the normal prostate in adult men usually has a volume of 15-30 ml a value above 30 ml is usually considered enlarged However the threshold at which a prostate is considered enlarged has not been strictly defined and therefore for many physicians an enlarged prostate is a subjective finding on examination
BPH can only be defined histologically increase in the number of epithelial cells and stromal cells but in clinical practice it is characterized by lower urinary tract symptoms Lower Urinary Tract Symptoms LUTS The disease leads to increased pressure in the urethra causing resistance to urine flow known as Bladder Outlet Obstruction BOO This resistance can also lead to changes in bladder function caused by the obstruction such as overactivity of the bladder detrusor muscle or conversely reduced detrusor contractility BOO can present as LUTS infections or retention as well as other conditions
Lower urinary tract symptoms LUTS can be divided into storage irritant obstructive urinary and post-urinary symptoms and appear frequently causing intense discomfort reducing the quality of life LUTS are traditionally associated with bladder outlet resistance BOO most commonly when histologic BPH progresses through benign prostatic enlargement BPE to benign prostatic obstruction BPO
The European Urological Association EAU reports that lower urinary tract symptoms LUTS are a common problem in adult men with a significant impact on quality of life QoL Accordingly he suggests the use of the α1-blockermuscarinic receptor antagonist combination in men with moderate to severe storage symptoms voiding symptoms and PVR 150 ml in order to reduce the risk of acute urinary retention and relieve irritants storage symptoms leading to an improvement in the patients quality of life Given the small abundance of data for patients in Greece with BPH this study will evaluate the fixed combination of solifenacintamsulosin in terms of disease control and improvement of the quality of life of patients with BPH
Before enrolling in the study and before signing the consent form patients must have already received the drug with solifenacintamsulosin and then they are enrolled in the observational study where the physician applies hisher standard clinical practice
Detailed Description:
The only clearly defined risk factors for BPH are age and the presence of elevated androgens in the blood But there are other factors that can influence the prevalence of clinical disease such as metabolic syndrome diabetes obesity hypertension diet and heredity
Clinical BPH often occurs within the same family If one or more first-degree relatives have had BPH then a person is at greater risk of developing the disease The probability of developing BPH and the rates of occurrence and progression of LUTS increase significantly with age In a study of 278 men with an average age of 58 years it was shown that prostate volume increased at an average rate of 06ml per year
Although the severity of symptoms cannot be directly related to prostate volume having a large prostate volume is a risk factor for developing LUTS a larger prostate is associated with an increased risk of urinary retention
Data support that the metabolic syndrome may influence the natural course regarding the development of BPH and BOO Metabolic syndrome includes hypertension dyslipidemia glucose intolerance obesity and insulin resistance with compensatory hyperinsulinemia
In a meta-analysis it was shown that the obese the elderly patients with low HDL cholesterol values and patients with metabolic syndrome had a significantly higher total prostate volume
Diabetes mellitus as a cause of bladder dysfunction can manifest either as overactivity or as poor detrusor function Diet has been reported as a risk factor for the development of BPH High amounts of vegetables and soy products in the diet may explain the lower rate of BPH in Eastern compared to Western countries The association of alcohol diet and other lifestyle factors with obstructive uropathy was investigated in a cohort of 6581 Japanese-American men 846 of whom were later diagnosed with BPH after 17 years of follow-up Total alcohol intake was inversely associated with the risk of developing obstructive uropathy or BPH ie reduced risk of developing the disease
In the present study purpose is to evaluate the symptoms of the lower urinary tract in patients with BPH the International Prostate Symptom Score IPSS questionnaire will be used which is a modification of the AUA Symptom Index by adding a question that evaluates the quality of life in relation to the disease
Both the AUA index and the IPSS questionnaire although not specific for BPH prostate volume urine flow rate residual urine volume after voiding or bladder obstruction have been validated and are sufficiently sensitive for be used in symptom assessment and treatment selection Although the assessment of specific symptoms is necessary for the treatment outcome of LUTS due to BPH it is also important to have a simpler approach that addresses the patients perception of the severity and change of their symptoms
The Patient Global Impression of Severity PGI-S questionnaire assesses the patients overall impression of the severity of his condition due to BPH symptoms and is a record of perception of the patient in a simple valid and easily administered manner in clinical practice The Patient Global Impression of Change PGI-C is the questionnaire it assesses the patients overall impression of the change in their condition due to a treatment choice and is widely used in studies to assess chronic pain andor for the patients self-assessment of the overall improvement of a treatment
Clinical BPH often occurs within the same family If one or more first-degree relatives have had BPH then a person is at greater risk of developing the disease The probability of developing BPH and the rates of occurrence and progression of LUTS increase significantly with age In a study of 278 men with an average age of 58 years it was shown that prostate volume increased at an average rate of 06ml per year
Although the severity of symptoms cannot be directly related to prostate volume having a large prostate volume is a risk factor for developing LUTS a larger prostate is associated with an increased risk of urinary retention
Data support that the metabolic syndrome may influence the natural course regarding the development of BPH and BOO Metabolic syndrome includes hypertension dyslipidemia glucose intolerance obesity and insulin resistance with compensatory hyperinsulinemia
In a meta-analysis it was shown that the obese the elderly patients with low HDL cholesterol values and patients with metabolic syndrome had a significantly higher total prostate volume
Diabetes mellitus as a cause of bladder dysfunction can manifest either as overactivity or as poor detrusor function Diet has been reported as a risk factor for the development of BPH High amounts of vegetables and soy products in the diet may explain the lower rate of BPH in Eastern compared to Western countries The association of alcohol diet and other lifestyle factors with obstructive uropathy was investigated in a cohort of 6581 Japanese-American men 846 of whom were later diagnosed with BPH after 17 years of follow-up Total alcohol intake was inversely associated with the risk of developing obstructive uropathy or BPH ie reduced risk of developing the disease
In the present study purpose is to evaluate the symptoms of the lower urinary tract in patients with BPH the International Prostate Symptom Score IPSS questionnaire will be used which is a modification of the AUA Symptom Index by adding a question that evaluates the quality of life in relation to the disease
Both the AUA index and the IPSS questionnaire although not specific for BPH prostate volume urine flow rate residual urine volume after voiding or bladder obstruction have been validated and are sufficiently sensitive for be used in symptom assessment and treatment selection Although the assessment of specific symptoms is necessary for the treatment outcome of LUTS due to BPH it is also important to have a simpler approach that addresses the patients perception of the severity and change of their symptoms
The Patient Global Impression of Severity PGI-S questionnaire assesses the patients overall impression of the severity of his condition due to BPH symptoms and is a record of perception of the patient in a simple valid and easily administered manner in clinical practice The Patient Global Impression of Change PGI-C is the questionnaire it assesses the patients overall impression of the change in their condition due to a treatment choice and is widely used in studies to assess chronic pain andor for the patients self-assessment of the overall improvement of a treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None