Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Bladder, Overactive

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Lower Urinary Tract Symptoms

Urological Manifestations

All Drugs and Chemicals

Cholinergic Antagonists

Cholinergic Agents

Neurotransmitter Agents

Questionnaires, anticholinergic treatment, urodynamic study

Michael Vainrib, MD

Bladder carcinoma is the most common malignancy of the urinary tract. Approximately 75-85% of patients with bladder cancer present with a disease that is confined to the mucosa or submucosa. These categories are grouped as non-muscle-invasive bladder tumors(i.e. superficial tumors).

Bladder cancer is the fifth most common cancer in the United States, with an estimated 67,160 newly diagnosed cases and 13,750 deaths in the United States in 2007. The 5-year survival rate is 82% for all stages combined. The standard of treatment for patients with superficial bladder cancer is surgical transurethal resection (TUR) of tumors, with an 80% early success rate. However, nearly 70% of these patients will develop tumor recurrence, with 25% showing progression to muscle-invading disease, within 5 years with TUR.

It is therefore necessary to consider adjuvant therapy in all patients. The absolute risks of recurrence and progression do not always indicate the risk at which a certain therapy is optimal. The choice of therapy may be considered differently according to what risk is acceptable for the individual patient and the urologist.

Intravesical chemotherapy and immunotherapy are widely used as adjuvant therapies after TUR, to prevent recurrence and progression of superficial disease. Systemic therapy is typically reserved for higher stage, muscle-invading, or metastatic diseases. The urinary bladder is an ideal organ for regional therapy.

The urethra provides easy access of therapeutic agents to the urinary bladder. The presence of the specialized asymmetric unit membrane on the urothelium serves as a barrier and limits the absorption of molecules or particulates into the systemic circulation.

The rationale for intravesical therapy is to maximize the exposure of tumors located in the bladder cavity to therapeutics agents while limiting the systemic exposure and thereby limiting the host toxicities; the primary goal is to eradicate existing or residual tumors through direct cytoablation or immunostimulation. The unique properties of the urinary bladder render it a fertile ground for evaluating novel approaches to regional therapy, including local hyperthermia, co-administration of permeation enhancers, bioadhesive carriers, and gene therapy.

One of the developing treatments for high-risk superficial bladder cancers is the combination of intravesical chemotherapy and hyperthermia (HT), called chemohyperthermia (C-HT). The most common form of C-HT uses the Synergo HT system, in which local HT is administered via direct microwave irradiation of the urothelium by means of a 915-MHz intravesical microwave applicator. The target intravesical temperature is set between 41.8C and 44.8C and is measured by five thermocouples integrated in a 20-F treatment catheter. To avoid injury, the urethra is continuously cooled. Due to extensive global experience with its use and a significant amount of preclinical data demonstrating improved antineoplastic efficacy when heated, mitomycin C (MMC) is the most common intravesical chemotherapy agent used in conjunction with HT.

The most common adverse events during treatment were bladder spasms and bladder pain. Literature reports bladder spasms in 21.6% of patients, and bladder pain in 17.5%. Bladder spasms tended to occur more frequently with the prophylactic schedule, whereas pain was present equally in the prophylactic and ablative schedules but more commonly after the ablative schedule. In the first days following C-HT, storage LUTS (frequency, dysuria, urgency, nocturia) (25.6%) and hematuria (6.0%) are the most common adverse events. Most studies mention that these symptoms were mild and transient, resolving spontaneously within a few days of treatment. One study described severe cystitis complaints in three patients (16%), but other studies have not confirmed these adverse events. Two studies report the development of a contracted bladder and severe urinary incontinence after ablative C-HT. However, the possibility cannot be excluded that previous transurethral resection and intravesical chemotherapy might have contributed to this event.

Following the appearance of bothersome storage LUTS, patient should be managed by existing guidelines. Based on AUA/SUFU Diagnosis and Treatment of Overactive Bladder (Non-Neurogenic) in Adults Guidelines published in 2012 patients should be diagnosed, followed and treated according to the suggested algorithm.

In our study, we would like to assess the severity of OAB symptoms and their response to a standard OAB treatment according to AUA Guidelines for Non-neurogenic OAB as well as to assess urodynamic study variables in those who didn't respond to a standard medical treatment and bothered by their OAB symptoms.

Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment

Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment for Bladder Cancer

OAB-SS, OAB-Q, OAB-SQ - questionnaires Urodynamic study results in patients who will undergo the test

relationship between the answers in OAB-SS, OAB-Q, OAB-SQ - questionnaires, Urodynamic study results in patients who will undergo the test and type of Synergo protocol, number of treatments received, time of hyperthermia per treatment, bladder cancer stage at the beginning of Synergo treatment.

OAB-SS, OAB-Q, OAB-SQ - questionnaires and relationship to Urodynamic study results in patients who will undergo the urodynamic test

OAB-SQ - questionnaire and urodynamic study results

Meir Medical Center

Prostatic Neoplasms

Urination Disorders

Urological Agents

Solifenacin Succinate

Muscarinic Antagonists

Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate

Placebo

Sanjay Mehta, M.D.

The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.

This is a randomized double blind placebo controlled flexible dose 12 week study. Following screening, subjects will receive their first dose of study medication following completion of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.

VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate

The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.

Astellas Pharma US, Inc.

Advanced Research Network

Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate

Total

Age, Continuous

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Early termination leading to small numbers of subjects analyzed.

Dr. Sanjay Mehta

Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).

Overall Study

Rare Diseases

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Acute Graft Versus Host Disease

1 tablet of 5 mg of succinate of Solifenacin will be administered each day for 3 months.

1 tablet of placebo of succinate of solifenacin will be administered each day for 3 months.

Succinate of Solifenacin

Placebo of Succinate of Solifenacin

Renaud de Crevoisier, MD

The purpose of this study is to determine whether Succinate of Solifenacin reduces the OverActive Bladder syndrome occurring during prostate irradiation.

A multicenter Phase III, randomized, double-blinded, parallel group placebo-controlled study.

2 groups:

* Control arm = pts. with placebo
* Experimental arm = pts. with Solifenacin succinate 5 mg - Vesicare® All patients with an OAB sub-score using the USP scale greater to 5 during prostate cancer radiotherapy will be included, receiving either a placebo or Solifenacin succinate (5mg) for duration of 3 months.

The randomization will be stratified on the radiotherapy dose (1 to 40 Gy or 40 to 70/80 Gy).

Screening:

For all patients, OAB items of the USP scale will be completed before each standard weekly assessment during prostate radiotherapy. Patients who reach an OAB sub-score greater to 5 will be addressed to an urologist in order to confirm absence of Qmax \< 10ml/sec at initial assessment, or post-void residual urine \> 100 milliliter (ml).

Inclusion \& treatment:

A week at most after pre-screening, patients will be randomized to receive either Vesicare®-5mg or a placebo. In both study arms, the treatment should be continued for 3 months.

Follow-up:

The radiation oncologist will perform patients' follow-up for the study at the treatment initiation, 6 weeks and 3 months after start of the treatment (Vesicare or placebo).

The questionnaires for the evaluation of OAB syndrome, acute urinary toxicity and quality of life should be completed for each follow-up visit. The voiding diary will be completed during 3 days before (or if not, 3 days after) all the evaluation times.

An urologist will perform an uroflowmetry and a post-voiding echography (or a bladder scan) before initiation of the treatment, and after 6 weeks of treatment.

Statistics and sample size PATIENTS ENROLMENT 70 patients will be included (considering 66 patients completing the full study) within 3 recruitment centers

Solifenacin Succinate for Treatment of Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer

Impact of Solifenacin Succinate for Treatment of Acute Irritative Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer

Score will be measured after study drug treatment initiation.

Center Eugene Marquis

Behaviors and Mental Disorders

Hypertrophy

Urinary Incontinence

Enuresis

Urinary Incontinence, Urge

Nocturnal Enuresis

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

Pathological Conditions, Anatomical

Patients diagnosed with prostate cancer, undergoing radical prostatectomy, with no overactive bladder (OAB) symptoms and without bladder outlet obstruction (BOO). 'Initial evaluation' before the surgery and follow up - 'Evaluation after 1,3,6,9,12 months'.

Patients diagnosed with prostate cancer, undergoing radical prostatectomy, with no overactive bladder (OAB) symptoms and with bladder outlet obstruction (BOO). 'Initial evaluation' before the surgery and follow up - 'Evaluation after 1,3,6,9,12 months'.

Patients diagnosed with prostate cancer, undergoing radical prostatectomy, with overactive bladder (OAB) symptoms and with bladder outlet obstruction (BOO). 'Initial evaluation' before the surgery and follow up - 'Evaluation after 1,3,6,9,12 months'.

Patients diagnosed with prostate cancer, undergoing radical prostatectomy, with overactive bladder (OAB) symptoms and without bladder outlet obstruction (BOO). 'Initial evaluation' before the surgery and follow up - 'Evaluation after 1,3,6,9,12 months'.

Healthy volunteer individuals aged 20-40. 'Initial evaluation' made only once.

Radical prostatectomy due to prostate cancer.

Radical prostatectomy

Initial evaluation

Evaluation after 1,3,6,9,12 months

Adam Ostrowski, MD

Tomasz A Drewa, Prof.

This study is designed to evaluate men before radical prostatectomy for the incidence of Overactive Bladder (OAB), as well as urge urine incontinence (UUI) development after the surgery. Patients will be evaluated for signs of OAB and for signs of Bladder Outlet Obstruction (BOO). Afterwards they will be divided into four observational groups. Follow up period is designed to be 12 months.

Radical prostatectomy remains the standard treatment in case of organ-confined and in selected cases of locally advanced prostate cancer. Radical prostatectomy consists of removing the prostate gland and seminal vesicles, ideally with negative surgical margins.

Most of the patients who present urinary incontinence after radical prostatectomy have stress urinary incontinence. However in some cases the post-surgical urinary incontinence is also due to urgency caused by overactive bladder development defined as urge urinary incontinence. Recent clinical observations suggest that men can also develop overactive bladder after radical prostatectomy.

This study is designed to evaluate men before radical prostatectomy for the incidence of Overactive Bladder (OAB) and it's development after the surgery. Before surgery questionnaire assessment of lower urinary tract symptoms will be performed using International Prostate Symptom Score (IPSS) questionnaire. OAB symptoms will be analyzed using King's questionnaire, as well as using two different OAB symptom score (OABSS) designed by Blavis et al. and Homma et al. Each patient will have transabdominal ultrasonographic evaluation of the prostate and urinary bladder structure. Prostatic dimensions width (W), height (H), length (L) and volume will be recorded. The ultrasonography will be done in urinary bladder filling related to normal desire to void. Urinary bladder wall thickness (BWT) and detrusor muscle thickness (DWT) will be measured in sagittal plane in anterior bladder wall. The mean of three following measurements BWT and DWT will be obtained. The urinary bladder weight (UEBW: Ultrasound Estimated Bladder Weight) will be also estimated. After ultrasonography each patient will undergo uroflowmetry with post-void residual estimation.

On the results above 4 groups will be formed

Group 1 OAB (-) BOO (-)

Group 2 OAB (-) BOO (+)

Group 3 OAB (+) BOO (+)

Group 4 OAB (+) BOO (-)

The investigators will obtain detail information about the surgery (time, blood loss, histopathological outcome, nerve sparing, complications).

After the initial evaluation of the patients before surgery, the control evaluation is set on 1, 3, 6, 9, and 12 month after radical prostatectomy in groups 1-4 to define the lower urinary tract symptoms after radical prostatectomy related to pre-surgical patient clinical feature. During each of the following controls the investigator will not have the access to previously obtained data from the patient.

In addition, healthy volunteers aged 20 to 40 will be assigned as a control group.

Effects of Urinary Bladder Hypertrophy on Urge Urine Incontinence After Radical Prostatectomy

Could Urinary Bladder Hypertrophy Influence on Urge Urine Incontinence Development in Patients After Radical Prostatectomy: A Multi-center Study

The summary of all the results will be provided on ClinicalTrials.gov . Individual patient data may be provided after individual request to the extant needed for the requesting researcher.

Measuring the incidence of overactive bladder and urge urinary incontinence development after radical prostatectomy in patients - characterized by increased urinary wall thickness (changes of urinary bladder wall in ultrasound evaluation measured in sagittal section in millimeters).

Measurement: Bladder wall thickness, Detrusor Muscle thickness on each follow up visit.

Measuring the incidence of symptoms of overactive bladder and urge urinary incontinence development after radical prostatectomy in patients - characterized by changes found in OABSS survey (Questioners).

Measurement: OABSS survey on each follow up visit.

Defined as number of pads used per day during the follow up period.

Measurement: Number of pads, that patient claims he is using per day at the moment of each follow up visit.

The change of Maximal urine flow in the uroflowmetry test is a good predictor of the quality of urination. The change in Qmax will be observed after radical prostatectomy.

Measurement: Uroflowmetry on each follow up visit.

This outcome is designed to check whether and to what extent bladder volume (decreased) influences the development of OAB, worsens the continence and affects quality of life (QoL).

Measurement: Ultrasound measuring bladder capacity during normal desire on each follow up visit.

This outcome is designed to check how much incontinence and development of OAB affects the quality of life. King's Quality of Life Questioner will be assessed during each follow up visit.

Measurement: King's Quality of Life Questioner on each follow up visit.

This outcome is designed to check how much the surgery affects the quality of urination itself. IPSS questioner will be assessed during each follow up visit.

Measurement: IPSS on each follow up visit.

Measuring the incidence of overactive bladder and urge urinary incontinence development after radical prostatectomy in patients - characterized by calculated bladder weight (changes of calculated bladder weight in grams).

Measurement: Calculated Bladder weight on each follow up visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment	NCT01955408	Overactive Blad... Bladder Cancer Synergo	Questionnaires,...	18 Years -	Meir Medical Center
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment	NCT01955408	Overactive Blad... Bladder Cancer Synergo	Questionnaires,...	18 Years -	Meir Medical Center
VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate	NCT01777217	Over-Active Bla...	Solifenacin suc... Placebo	18 Years -	Advanced Research Network
Solifenacin Succinate for Treatment of Urinary Toxicity Occurring During Radiotherapy of Prostatic Cancer	NCT02805452	Overactive Blad...	Succinate of So... Placebo of Succ...	18 Years -	Center Eugene Marquis
Severity of Overactive Bladder Symptoms in Patients After Synergo Treatment	NCT01955408	Overactive Blad... Bladder Cancer Synergo	Questionnaires,...	18 Years -	Meir Medical Center
Effects of Urinary Bladder Hypertrophy on Urge Urine Incontinence After Radical Prostatectomy	NCT03061760	Prostate Cancer Urinary Inconti... Incontinence Prostatectomy Overactive Blad...	Radical prostat... Initial evaluat... Evaluation afte...	40 Years -	Collegium Medicum w Bydgoszczy

Spots Global Cancer Trial Database for overactive bladder