Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Hypertrophy

Neoplasm Metastasis

Pathological Conditions, Anatomical

Central Nervous System Depressants

All Drugs and Chemicals

Coagulants

Anesthetics

Anesthetics, Local

Hemostatics

Anesthetics, General

Terephthalic acid

TURP is an operation which can be performed under a general / regional anaesthetic. A cystoscope is passed into the urethra meatus, along the length of the urethra to the level of the prostate. The obstructing prostate lobes are resected using mono polar or bipolar energy to create a channel for improved urinary flow. Haemostasis is achieved by coagulation followed by insertion of a catheter for irrigation post procedure. Generally, patients stay for 1-2 nights post operatively. On the day of discharge the catheter is removed.

TURP

UroLift (Neotract) is a NICE-approved alternative to TURP that can be performed under local anaesthetic, sedation or general anaesthetic. The system comprises of two single-use components, a delivery device and an implant. The implant is made of a nitinol capsular tab, a polyethylene terephthalate monofilament and a stainless-steel end-piece. Again, a modified cystoscope is passed into the urethral meatus, along the length of the urethra to the level of the prostate. The delivery device deploys the implants into the prostate to 'pin' back the lobes of the prostate to create a channel for improved flow. Typically, 2-4 implants are used per procedure. Nine out of ten patients do not require a catheter post procedure

UroLift

Jai Seth

Kathie Wong

Miss Kathie Wong

Mark Brandon-Grove

Professor Nicholas James

Prostate cancer affects 1 in 8 men and in the UK approximately 14,000 men are treated with radiotherapy.

Around half of men diagnosed with prostate cancer will also have an enlarged prostate making it difficult to pass urine. When having radiotherapy, the prostate swells further which can lead to complete blockage of urine flow (urine retention), sepsis and kidney failure in severe cases. Radiotherapy itself can also cause urinary symptoms meaning that some patients can continue to have difficulty passing urine long after their cancer treatment finishes. Around a third of patients will need an operation to shrink their prostate before radiotherapy to prevent these possible short and long-term problems.

The standard operation is a transurethral resection of prostate (TURP). This involves cutting a channel through the prostate to improve urine flow.

This will be compared with a newer procedure known as UroLift. During UroLift, clips are inserted into the water pipe to pin back the prostate to widen the channel and improve urine flow. Which treatment is more acceptable to patients and gives better outcomes has never been tested before in men having radiotherapy for prostate cancer.

The study will help us to understand how the treatments impact on a patient's quality of life and understand what matters most to patients.

The results of this feasibility study will help us design a bigger study to assess TURP and UroLift in a larger group of patients across different hospitals. This research will help future patients make decisions about prostate cancer treatment choices that can affect their long-term well-being.

Prostate radiotherapy can cause lower urinary tract symptoms (LUTS) such as urinary frequency, difficulty starting a urine stream or feelings of incomplete emptying. 50% of men aged over 60 years may have pre-existing LUTS from bladder outflow obstruction (BOO) due to prostatic enlargement.

The short-term complications of untreated BOO in the context of prostate radiotherapy, although relatively rare, can be disastrous, leading to urinary retention, sepsis and renal failure. In the long-term, urinary symptoms and complications can continue to worsen. Patients with low flow rates pre-radiotherapy are at highest risk of urinary retention and are often offered transurethral resection of prostate (TURP) prior to radiotherapy. An urgent transurethral resection of prostate (TURP) either during or post radiotherapy may significantly disrupt the completion of the treatment and compromise outcomes, both oncological and functional. Case studies suggest that when patients undergo a TURP to treat prostate enlargement after radiotherapy, the risk of incontinence is much higher than surgery before radiotherapy. Therefore, for radiotherapy to safely go ahead, BOO due to an enlarged prostate must first be addressed. UroLift is a newer, minimally invasive alternative to TURP, approved by NICE for use in BPH and available in over 100 trusts nationally. A growing body of evidence including three meta-analyses supports its use in benign disease.

UroLift has not been trialled in patients undergoing prostate radiotherapy with coexisting LUTS. A subgroup analysis performed on retrospective data suggested that patients who had previously undergone prostate radiotherapy experienced symptom relief without an increase in adverse events.

The purpose of this trial is to produce a protocol for a randomised controlled evaluation of clinical and cost effectiveness of UroLift in comparison to TURP for men due to receive radiotherapy as treatment for prostate cancer. At the end of this study, we will understand whether such a trial is acceptable to all stakeholders, is methodologically robust and thus feasible. Furthermore, we will be able to report pilot findings for safety and efficacy

A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement

A Randomised Feasibility Study COmparing Urolift and Standard Transurethral Resection of Prostate Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement

We will evaluate whether it is possible to recruit patients to an RCT comparing standard treatment with a new treatment untested in the cancer arena

We will assess the proportion of patients who will complete the trial protocol

The Research Team will carry out 12 in-depth interviews. Using the Theoretical Framework of Acceptability(19), affective attitudes, burden, ethicality, intervention coherence, opportunity costs and perceived effectiveness will be assessed

The EPIC-50 is a validated questionnaire for measuring health related quality of life

The UCLA-PCI is a validated questionnaire for measuring health related quality of life

The ICIQ-UI is a validated questionnaire s a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence

The EQ-5D is a validated questionnaire for measuring health related quality of life

The CICS is a validated questionnaire for assessing illness-related couple communication

The PGI is a validated single item self reported scale to assess patient reported post-operative improvement in condition

The IPSS is a validated questionnaire for measuring the severity of urinary symptoms and overall quality of life

The FACT-P is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess for prostate-related symptoms. Each item is rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain. Total subscale score range for physical well-being domain is from 0 (worst response) to 28 (best response), where higher score indicate better quality of life.

collected and assessed for appropriateness, usability and completeness for both arms 3 months post radiotherapy treatment

30 day surgical morbidity rates will be collected with respect but not limited to infection, urinary retention and bleeding.

Improvement in baseline Urine flowmetry (measured by increased maximum flow rate)

Improvement in baseline Urine flowmetry (measured by post void residual)

Information on costs of the two interventions

Rate of re-operation for technical failure to reduce outflow obstruction

King's College London

St George's University Hospitals NHS Foundation Trust

Institute of Cancer Research, United Kingdom

North Cumbria University Hospitals NHS Trust

University College, London

City, University of London

Royal Marsden NHS Foundation Trust

Infections

Urinary Bladder Neoplasms

Communicable Diseases

Diarrhea

Prostatic Hyperplasia

Hyperplasia

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

Signs and Symptoms, Digestive

Prostatic Diseases

Genital Diseases

Genital Diseases, Male

Anti-Infective Agents

Antineoplastic Agents

Anti-Bacterial Agents

Levofloxacin

Ofloxacin

Antibiotics, Antitubercular

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

The control groups receives antimicrobial prophylaxis (AMP) as recommended by the guidelines.

Koenraad van Renterghem, PhD

To investigate the use of antibiotic prophylaxis in patients undergoing TURP and TURB. The investigators set up a prospective, randomized controlled trial in which (after exclusion of risk factors) patients will be randomized in receiving levofloxacin (Tavanic) orally or no antibiotics. The exclusion criteria for TURP are a pre-operative transurethral catheter or \> 100 urinary white blood cells in the pre-operative urine sample. The exclusion criteria for TURB are a pre-op catheter or clinical signs of infection.

Main objective:

To investigate the safety of omitting antibiotic prophylaxis in TURP (transurethral resection of the prostate) and TURB (transurethral bladder tumour resection) in patients without a pre-operative catheter or \> 100 WBC in the pre-operative urinary sample (TURP) or clinical signs of urinary infection (TURB).

Secondary objective:

To investigate post-operative bacteriuria after TURB and TURP in our population.

Principal inclusion criterium:

Patients undergoing TURP or TURB.

Primary exclusion criterium:

TURP: pre-operative catheter or \> 100 white blood cells in the pre- operative urinary sample.

TURB: pre-operative catheter or clinical signs of infection (fever, nyctalgia).

Primary endpoint:

Post-operative infection.

Secondary endpoint:

Post-operative bacteriuria.

Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)

A Prospective Study About the Safety of Omitting Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB): the prophylaxis001-trial

Urosepsis, fever (t°\> 38.5) or epididymitis.

Jessa Hospital

Urinary Retention

Genital Neoplasms, Male

In the REZUM arm, water vapour treatment is performed for all subjects under local anaesthesia.

Rezūm

In the TURP arm, all men will receive TURP operation under general or spinal anaesthesia

Peter Ka-Fung CHIU, FRCS, PhD

This is a randomized controlled trial using a non-inferiority design with the subjects randomized 1:1 to either water vapour thermal treatment (REZUM) arm or transurethral resection of prostate (TURP) arm.

Comparing Water Vapour Thermal Therapy (Rezūm) and TURP

A Randomized Controlled Trial Comparing Water Vapour Thermal Therapy (Rezūm) and TURP in Men With Benign Prostatic Hyperplasia in Refractory Urinary Retention

IPSS score ranging from 0-35 (the higher the worse)

Change in quality of life assessed by change in International Prostate QOL score (ranges from 0 to 6, the higher the worse)

It is assessed by maximum flow rate and post void volume in uroflowmetry

Measure the hours of in-patient hospitalisation

Percentage of patients with unplanned readmission

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement	NCT05840549	Prostate Cancer	TURP UroLift	-	Royal Marsden NHS Foundation Trust
Antibiotic Prophylaxis in Transurethral Prostate Resection (TURP) and Transurethral Bladder Tumour Resection (TURB)	NCT04212403	Urosepsis Bladder Cancer Prostate Hyperp... Antibiotic Resi... Antibiotic Resi... Antibiotic-asso... Antibiotic Toxi...	Levofloxacin	18 Years -	Jessa Hospital
A Study Comparing Urolift and TURP Ahead of Radiotherapy in Men With Urinary Symptoms Secondary to Prostate Enlargement	NCT05840549	Prostate Cancer	TURP UroLift	-	Royal Marsden NHS Foundation Trust
Comparing Water Vapour Thermal Therapy (Rezūm) and TURP	NCT05762198	Prostate Cancer	Rezūm TURP	50 Years - 80 Years	Chinese University of Hong Kong

Spots Global Cancer Trial Database for turp

Every month we try and update this database with for turp 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 turp

Every month we try and update this database with for turp 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 turp 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.