Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Nervous System Diseases

Syndrome

Urinary Bladder Neoplasms

Malnutrition

Pain

Urinary Bladder, Neurogenic

Endometriosis

Urinary Bladder Diseases

Cystitis

Cystitis, Interstitial

Cystitis, Hemorrhagic

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Genital Diseases, Female

Genital Diseases

Neurologic Manifestations

Seven days of preoperative oral supplementation with an immune-enhanced oral nutrition

Immunonutrition: Oral Impact®, Nestlé Health Science, Switzerland.

IN will be administered as per manufacturer suggestion, i.e. three times a day during 7 days preoperatively. Oral Impact® is a powdered oral feed that provides 309 kcal/bag

Immunonutrition

Ilaria Lucca, MD

François Crettenand, MD

Bernhard Kiss, MD

Thomas Tawadros, PhD

The goal of this clinical trial research study is to evaluate the impact of preoperative oral immunonutrition (IN) on post-operative complications in patients undergoing a cystectomy.

As a secondary focus, this study will aim to develop a signature that would identify patients that would benefit the most from IN.

This is a multicentric (Swiss: N=3), prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers.

Despite standardized surgical technique and the development of new perioperative care protocols, cystectomy morbidity remains a serious challenge for urologists. Most common postoperative complications, such as infections, often lead to longer length of stay and worse survival. Malnutrition has been identified as an independent and modifiable risk factor for both mortality and morbidity. Immunonutrition (IN), containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids, aims to improve the nutritional status, immunological function and clinical outcome of surgical patients. Meta-analyses have demonstrated that preoperative IN reduces complications and length of hospital stay after major bowel surgery. Evidence-based data on preoperative oral IN support for cystectomy patients are lacking, which does not allow this treatment to be widely accepted, recommended, or reimbursed by health insurances in most European countries. Uncertainties also remain about the exact mechanism by which IN modulates the host immune response.

Complication rates after cystectomy range from 40-75%. Malnutrition has been identified as an independent and modifiable risk factor for both mortality and morbidity. To date, and in the last 20 years, no single intervention has allowed for a significant reduction in morbidity after cystectomy, which remains one of the highest in surgery. The present adequately powered multicenter RCT has the potential of changing current practice by recommending preoperative IN before cystectomy in case of positive results. If the present RCT demonstrates a benefit in administrating IN prior to cystectomy, urological guidelines will be modified accordingly to this new evidence. IN will then be recommended before cystectomy for the patient's benefit. The investigators truly believe that the proposed study is of high clinical importance with potential impact on perioperative urology guidelines.

Multicenter, prospective, controlled, pragmatic, parallel-group comparative study with block randomization stratified by centers

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy - A Multicenter Randomized Controlled Trial (INCyst Trial)

Long term overall and cancer-specific survival for bladder cancer patients

Assessment of the quality of life after surgery through a questionnaire (EORTC QLQ-C30)

Identification of biomarkers predictive of postoperative complications studying the patient's immune and microbiome signature: analysis of immune cells in the blood, analysis of the polyfunctionality of blood T cells, analysis of immune-related proteins in the urine and serum, microbiota analysis, expression of Argininosuccinate synthetase 1

Determination of infectious complications rate at 30 days after surgery (pneumonia, urinary tract infection, surgical site infection, sepsis, shock).

Determination of the Comprehensive Complication Index (CCI) at 30 and 90 days after surgery. The range is between 0 (no complication) to 100 (death).

Determination of the mortality rate at 30 and 90 days after surgery

Determination of the post-operative complication-free survival

Serum arginine levels will be assessed at enrolment (between Day -30 and Day -10) and at preoperative admission after intake of the allocated nutrition (Day -1) in all patients treated at Lausanne, CHUV.

Insel Gruppe AG, University Hospital Bern

Hôpital Riviera-Chablais, Vaud-Valais

Centre Hospitalier Universitaire Vaudois

MD, Principal Investigator

Behaviors and Mental Disorders

Rare Diseases

Urinary Incontinence

Teratoma

Enuresis

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Sacrococcygeal Teratoma

Sarah GARNIER

Sacrococcygeal teratomas are the most common neonatal tumors and require rapid and complete resection. Tumor nerve compression and pelvic surgical sequelae may lead to many and varied voiding disorders. Data concerning long-term vesico-sphincteric disorders are conflicting. Some studies find good functional results \[Cozzi et al., 2008; Draper et al., 2009\]. However other authors reveal neurologic bladder with detrusor sphincter dyssynergia \[Hambraeus et al., 2018\] and rise concerned about long-term renal function \[Khanna et al., 2019; Rehfuss et al., 2020\] even in the absence of clinical voiding disorders. Most of studies include young patients with other malformations such as anorectal malformations or dysraphisms which may impact the results. The main objective is to assess bladder dysfunction in children aged 6 to 18 years after isolated sacrococcygeal teratoma resection.

Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

Presence of voiding disorders will be assessed by the scale: Dysfonctional voiding scoring system

The Presence of defecation disorders will be assessed by the scale: Bristol stool scale

the Presence of secondary neurological bladder will be assessed by the uroflowmetry

University Hospital, Montpellier

Infections

Wounds and Injuries

Prostatic Neoplasms

Communicable Diseases

Spinal Cord Injuries

Urinary Tract Infections

Urinary Retention

Urination Disorders

Chronic Graft Versus Host Disease

Patients will use the Connected Catheter to empty the bladder during the course of treatment.

Connected Urinary Catheter

The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. It is a sterile, extended-use device that resides fully internally to the male lower urinary tract for an intended use life of up to 7 days per catheter.

Spinal Singularity has developed the Connected Catheter System to address several drawbacks of urinary catheters. The Connected Catheter is fully internal, indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization. Each subject will use the Connected Catheter for up to 35-40 days. This includes five device exchange appointments. The appointments are spaced 7 days apart and at each appointment the catheter will be replaced with a new one. Additionally, weekly follow-up will occur for 14 days following the final appointment after the subject discontinues use of study device and reverts to his original catheter.

Connected Catheter- Safety and Effectiveness Study

Evaluation of the Safety and Clinical Performance of the Gen 2 Connected Catheter - Wireless Urinary Prosthesis for Management of Chronic Urinary Retention

Rate of participants with successful voiding using the Connected Catheter as assessed by Post-Residual Volume (PVR) measurement via ultrasound

A subject is considered a responder to the treatment if a minimum of 80% of their PVR values met the following criteria

PVR is ≤ 50 mL OR PVR is ≤ baseline PVR with the standard of care catheter

Rate of participants treated with the Connected Catheter reported with a serious device related adverse event

Rate of Connected Catheter successfully inserted, anchored and removed

Rate of Connected Catheter valves sealed successfully

Rate of participants treated with the Connected Catheter with improved overall quality of life as measured by the SCI-QOL Survey and other surveys

Rate of participants treated with the Connected Catheter reported with a urinary tract infection

Rate of participants treated with the Connected Catheter that experience a lower urinary tract injury

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)	NCT05726786	Bladder Cancer Interstitial Cy... Painful Bladder... Neurogenic Blad... Hemorrhagic Cys... Endometriosis Bladder Disease	Immunonutrition	18 Years -	Centre Hospitalier Universitaire Vaudois
The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial)	NCT05726786	Bladder Cancer Interstitial Cy... Painful Bladder... Neurogenic Blad... Hemorrhagic Cys... Endometriosis Bladder Disease	Immunonutrition	18 Years -	Centre Hospitalier Universitaire Vaudois
Voiding Disorders in Children After Sacrococcygeal Teratoma Resection	NCT05182853	Sacrococcygeal ... Neurogenic Blad... Voiding Disorde...		6 Years - 18 Years	University Hospital, Montpellier
Connected Catheter- Safety and Effectiveness Study	NCT03843073	Urinary Retenti... Neurogenic Blad... Urologic Diseas...	Connected Urina...	18 Years -	Spinal Singularity

Spots Global Cancer Trial Database for neurogenic bladder