Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Prostatic Hyperplasia

Hyperplasia

Lower Urinary Tract Symptoms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

The Aquablation therapy is a minimally invasive, image-guided, heat-free robotic therapy delivered by the AQUABEAM Robotic System. During Aquablation therapy, the AQUABEAM Handpiece is inserted transurethrally into the prostatic urethra. The operating physician then utilizes cystoscopy in conjunction with transrectal ultrasound (TRUS) imaging for real time visualization. The AQUABEAM Robotic System utilizes high-velocity sterile saline waterjet to resect and remove the prostate tissue according to the operating physician's treatment plan.

Robotic Waterjet Treatment

Angela Lee

Pooja Talaty, MS MHA CCRP

Jennifer Penshorn, RN

Becky Lau

Aline Yacoubian

The goal of this clinical trial is to assess the performance and safety of the AQUABEAM Robotic System for the resection and removal of prostate tissue in patients experiencing lower urinary tract symptoms (LUTS) and are diagnosed with localized prostate cancer. Participants will go through baseline and follow up assessments up to 12 months.

PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs

Proportion (percentage) of participants with adverse events rated as related to the study procedure classified as Clavien-Dindo Grade 2 or higher or any Grade 1 event resulting in persistent disability (ejaculatory disorder, erectile dysfunction, or incontinence) evidenced through 3 months post-treatment.

PROCEPT BioRobotics

Urinary Bladder Neoplasms

Pain

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

A combination of two alkaloid, Protopine and Nuciferine

A combination of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®)

Protoves M1®

Francesco Chiancone

100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy (HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO TREATMENT). The aim of this study will be to analyse the role of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® instillations.

100 patients with bladder cancer whose underwent Hyperthermic Intravesical Chemotherapy (HIVEC®) will be randomized in two groups (Group A: PROTOVES M1 SYRUP, Group B: NO TREATMENT). The aim of this study will be to analyse the role of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®) in the prevention and the treatment of the low and mild grade adverse events related to the use of HIVEC® instillations.

At the baseline data on demographic and anthropometric features (age, weight, height, BMI), lifestyle characteristics (smoke, alcohol), any comorbidities (hypertension, diabetes mellitus, etc.) will be collected. All patients will be undergone to a clinical evaluation (comprised general, genital and urologic examination). Before starting the treatment, the following measurements will be collected: prostate volume by transrectal ultrasound, PSA, uroflowmetry (Qmax, Volume Voided, Post-Void Residual), IPSS (International Prostatic Symptoms Score) questionnaire, OverActive Bladder questionnaire-short form (OABq-SF) 6 and 13, patient perception of intensity of urgency scale (PPIUS), and visual analogue scale (VAS). PSA and IPSS will be investigated only in male pts. In addition, the patient impression of improvement will be assessed. Improvement will be evaluated with the Patient Global Impression of Improvement questionnaire (PGI-I), a validated tool to estimate the improvement or the deterioration associated to the treatment.

The primary endpoint was the evaluation of the efficacy of the therapy with Protoves-M1 in controlling of the irritative symptoms, including nocturia, urinary frequency, bladder pain, urgency and urge incontinence related to the chemo-hyperthermia treatment. The secondary endpoint evaluated was the influences of the treatment on the uroflowmetric parameters.

After 1 and 6 weeks of therapy all patients will be undergone to a clinical and instrumental evaluation : Uroflow-Qmax (ml/s), Uroflow-Volume voided (ml),Uroflow-RPM (ml), IPSS total, OAB-q SF 6, OAB-q SF 13, PPIUS, PGI-I, VAS scale will be collected.

Protoves M1® Syrup in Controlling Adverse Event During HIVEC® Instillations

The Role of Protopine Associated With Nuciferine (Protoves M1® Syrup) in Controlling Adverse Event During HIVEC® Instillations

The International Prostate Symptom Score (I-PSS) is based on the answers to some questions concerning urinary symptoms and one question concerning quality of life.

The OAB-q SF 6 is a questionnaire developed to evaluate the overactive bladder symptom and health-related quality of life.

The PPIUS is a questionnaire developed to evaluate the patient perception of intensity of urgency

PGI-I is a validated tool to estimate the improvement or the deterioration associated to the treatment.

Visual analogue scales (VAS) are 10-cm lines anchored at the ends by words that define the bounds of various pain dimensions.

Qmax (ml/s) is the maximum flow rate at uroflowmetry

Post-Void residual (ml) measures the amount of urine left in the bladder after urination.

Cardarelli Hospital

Assistant Medical Director, Principal Investigator

Wounds and Injuries

Infections

Hyperthermia

Hematuria

Fever

Tuberculosis

Non-Muscle Invasive Bladder Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Micronutrients

All Drugs and Chemicals

Silicon

BCG Vaccine

Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of self lubricated silicon tiemann 10 fr urinary catheter.

Patients with non muscle invasive bladder cancer undergoing intravesical instillation with the use of straight tipped latex foley 14 fr urinary catheter

The study compares the complications caused after the BCG intravesical instillation in patients treated for non invasive bladder cancer.The patients are divided into two groups one receiving IVI (intravesical Instillations) with the use of latex catheter while in the other silicone catheter is used.The two groups are compared in terms of fever, hematuria, LUTS and other complications following IVI.

Bladder cancer is the 9th most common diagnosed cancer according to 2021 statistics (4). It can be divided into muscle invasive (MIBC) and non muscle invasive bladder cancer (NMIBC) , based on the biopsy result after transurethral resection of the bladder tumor.In this research we will abide ourselves to the non muscle invasive bladder cancer.After the transurethral resection of bladder cancer, further management of this disease includes the intravesical instillation of chemotherapy or immunotherapeutic drugs.

The most commonly used drugs in our clinic is epirubicin and Bacillus Calmette Guerrin (BCG) for intravesical instillations.This research will focus on the use of intravesical instillations of BCG .Intravesical instillations of BCG are performed in patients with pTa/High Grade (HG), pT1/Low Grade(LG), pT1/HG and Carcinoma in Situ(CIS) tumors , while epirubicin is used in tumors pTa/LG.

The most common complications after intravesical instillation of BCG are either systemic (mycotic aneyrysms , tuberculosis, hepatitis, arthritis , spondylitis or ev enencephalitis) or are related to the urogenital system (cystitis, prostatitis which can be either tuberculous or bacterial, balanitis or tuberculous epididymitis) (3). The most common complications of the urinary system after the intravesical BCG instillation can appear as a combination of the lower urinary tract symptoms (LUTS) , macroscopic hematuria and fever (4).

There are researches that prove the superiority of silicon catheters for long term catheterization in terms of reduced urethral inflammation and consequently reduced LUTS (1,2). However, there is also an article that claims that latex urinary catheters that are coated with noble metals cause minimal LUTS compared with silicone catheters when used for short term catheterization (3). Nevertheless, there is not a comparative antegrade study for the use of different type of catheters for the intravesical instillation of BCG that proves the superiority of one catheter type over the other.

Purpose of this study The purpose of this study is the comparison of the symptoms arising from the use of two different types of urinary catheters (latex or silicon tiemann) during the intravesical instillation of BCG and the possible display of superiority of one of those catheter types.

Material and Methods This study is an antegrade comparative cohort study. In this are included patients of all age and genders. The patients were diagnosed with non muscle invasive bladder cancer after the transurethral resection of the bladder tumor and are undergoing intravesical BCG instillations after they get their biopsy results.They undergo either 6 weekly intravesical instillations in de novo diagnosed cancer or in 3 weekly instillations during the follow-up based on our clinic's protocol. The intravesical therapy begins 2-4 weeks after the surgery , since the patients has a negative urine culture. Another important condition is that the patient does not have macroscopic hematuria ,does not have fever or does not bleed during the catheter insertion.

The intravesical instillation is performed in the outpatient department of the 2nd University Urology Clinic in Sismanogleio Hospital ,Athens, Greece by three urologist J.M. ,T.B. and S.K.. Those three physicians use aseptic and non traumatic technique during the intravesical instillations (IVIs). For the IVIs either self lubricated silicon tiemann 10 fr urinary catheter or straight tipped latex foley 14 fr urinary catheter was used. The catheterization was done with the use of 2% xylocaine jelly in the urethra.The catheter was advanced slowly while the intravesical instillation was done slowly in a rate so that it was completed in 20-30 s.This technique was used by all the physicians.

The preparation and dilution of the drug used for the IVIs was done by the same trained nurses, under the same conditions for each case and is instilled as soon as it is ready.Before every insillation the physician asks the patient if he has symptoms since the previous instillation such as macroscopic hematuria, fever or LUTS. In case that one of those symptoms exists then the instillation is not performed.In case of hematuria ,instillation is postponed until this symptom disappears.In case of persisting LUTS until the the next instillation the patient receives antibiotic regimen based on urinary culture and continues with the instillation when the culture is negative. In case of fever above 38 celsius the patient undergoes an empiric antibiotic regimen with quinolones. If fever persists over 48 hours then the patient is reffered to an internist with subspecialisation in infectious medicine to exlude the possibility of systemic or urogenital tuberculous complication. The intravesical instillation regimen continues when the patient has no longer fever.

Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer

Complications in both groups- hematuria, fever, LUTS , systemic symptoms

National and Kapodistrian University of Athens

Doctor of Medicine

Urological Manifestations

Vasodilator Agents

Botulinum Toxins

Botulinum Toxins, Type A

abobotulinumtoxinA

incobotulinumtoxinA

Acetylcholine

Cholinergic Agents

Neurotransmitter Agents

A total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml).

BOTOX

Gusatavo E. Ayala, MD

This is a pilot study examining biological endpoints in men with localized prostate cancer who are scheduled to have radical prostatectomies and men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms (BPH/LUTS) following botulinum toxin type A (BoNT-A) injection. Patients will serve as their own controls by receiving BoNT-A injections into the right peripheral and transition zones and sham saline injections into the left peripheral and transition zones.

For the purposes of this study, patients are treated with the presentation of botulinum toxin type A which is marketed in the U.S. as BOTOX® by Allergan. BOTOX® is a purified neurotoxin complex supplied as a sterile, vacuum dried purified botulinum toxin type A, produced from fermentation of Clostridium botulinum type A.

A primary aim of this study is to determine the molecular effects of BoNT-A injection on human BPH tissues. While the majority of BoNT-A injections in humans target BPH in the transition zone, innervation is most abundant in the peripheral zone of the prostate where the majority of prostate cancers develop. In fact, recent studies have demonstrated the importance of neurogenesis and axogenesis in the spread of human prostate cancer. In addition, in vitro studies have shown that BoNT-A has antiproliferative effects on human prostate cancer cell lines.

Thus, a second aim of this proposal is to determine profile changes in high-grade prostatic intraepithelial neoplasia (HGPIN) and prostate cancer following BoNT-A injection into the peripheral zone. The investigators will also determine the effects of BoNT-A on the genetic profile of normal tissue. The investigators study population will be men with clinically localized prostate cancer. Men will be injected on one side in both their transition and peripheral zones with 100U BoNT-A (i.e. Botox®, Allergan, Inc.), respectively, one month prior to their scheduled radical prostatectomy. Sham saline injection of the other side of the prostate (transition and peripheral zones) will be used as an internal control. The investigators will inject the other lobe of the prostate with saline to account for any denervating effects of "wet needling." Patients will undergo radical prostatectomy without any changes to standard of care. The strategy has been used in the investigators Institution previously to determine the efficacy of gene therapy 22 and targeted drugs. However, and unlike the investigators previous neoadjuvant trials, the investigators will not power this study to look at the effects of Botox on biochemical recurrence free survival. This study only has biologic endpoints and no survival endpoints."

A third aim of the study will be to examine changes in vas deferens function following prostate treatment with BoNT-A. The investigators plan to harvest a 2.5 cm segment from the distal vas deferens on either side (i.e. Saline treated and BoNT-A treated) before entry into the prostate will be isolated and placed in oxygenated krebs solution for transport to the research laboratory.

Patients will have 3 visits to the clinic and two telephone calls during their participation in this study. The last visit is about 4 weeks after the injection.

BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)

H-25362: Effect of Botulinum Neurotoxin Type A Prostate Injections on Neurogenesis and Gene Profile Expression in Men With Localized Prostate Cancer and Lower Urinary Tract Symptoms/BPH (Protocol # 05-09-30-03)

The prostate tissue taken from each lobe will be compared to determine if the injection of BOTOX has effected the genetic profile.

Any changes to the vas deferens tissue after BOTOX injection, will be noted.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PRCT001 Aquablation theraPy Outcomes in pRostate Cancer patienTs	NCT06051942	Benign Prostati... Localized Prost...	Robotic Waterje...	- 80 Years	PROCEPT BioRobotics
Protoves M1® Syrup in Controlling Adverse Event During HIVEC® Instillations	NCT04148677	Bladder Cancer LUTS Pain	Protoves M1®	18 Years -	Cardarelli Hospital
Antegrade Observational Comparative Study for the Intravesical Instillation Therapy of Bacillus Calmette Guerin With the Use of Different Types of Urinary Catheters in Patients With Urinary Bladder Cancer	NCT05675176	Non-muscle-inva...	BCG	-	National and Kapodistrian University of Athens
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)	NCT01520441	Prostate Cancer Benign Prostati... Enlarged Prosta...	BOTOX	50 Years -	The University of Texas Health Science Center, Houston
BOTOX in Men With Prostate Cancer With Lower Urinary Tract Symptoms(LUTS)/Benign Prostatic Hyperplasia (BPH)	NCT01520441	Prostate Cancer Benign Prostati... Enlarged Prosta...	BOTOX	50 Years -	The University of Texas Health Science Center, Houston

Spots Global Cancer Trial Database for luts

Every month we try and update this database with for luts cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for luts

Every month we try and update this database with for luts cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for luts cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.