Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Urinary Bladder Neoplasms

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Diurnal Enuresis

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Female Urogenital Diseases and Pregnancy Complications

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Anticonvulsants

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Mebeverine

Alverine

Parasympatholytics

Coloverin (Mebeverine hydrochloride 135 mg)

Coloverin

Placebo

Hassan Abol-Enein, MD

Ahmed Mosbah, MD

Ahmed Elhussein, MBBCH

Ahmed Elkarta, MBBCH

Mohamed Soltan, MBBCH

A randomized controlled trial to assess clinically the efficacy of the selective ileum spasmolytic mebeverine on daytime incontinence and nocturnal enuresis of orthotopic w-ileal neobladders and quality of life effect within 1 year post-surgery.

In appropriately selected patients an orthotopic neobladder (ONB) permits the elimination of an external stoma and preservation of body image without compromising cancer control after radical cystectomy. Voiding dysfunction (VD) following ONB can be divided into failure to empty bladder or failure to store urine. Failure to empty bladder by angulation of urethra is the most common cause. Failure to store urine can occur during daytime, night-time or both. VD that persists beyond 6 to 12 months warrants urodynamics evaluation to determine the cause and suggest plane of therapy. Voiding dysfunction has a detrimental impact on quality of life.

Among the various bowel segments studied, the ileum is ideal for ONB creation. A spherical reservoir, reconfigured from a de-tubularized ileal segment, offers the most desirable attributes like, adequate capacity, low intraluminal pressure, and good compliance. The patient of ONB reported 4-25% rate of clean intermittent self-catheterisation (CISC) for incomplete emptying. Daytime incontinence was present in 13% of patients. The rate of nocturnal incontinence is usually higher in the range of 15-40% in recent metanalysis. The success of ONB rely on detubularization of intestinal segment, sufficient capacity and proper configuration and position in the pelvis. Adequate capacity is achieved by using sufficient length, folding, and creation an ellipsoid or spherical configuration. The ONB should hold approximately 500 cc of urine at low pressure (at \< 15 cm H2O), empty completely (\< 100 cc urine), four to five times daily and allow the patient to sleep without awakening, while maintain normal body image

loss of the vesico-urethral reflex 'guarding reflex' in which increased urethral sphincter tone parallel to bladder distension, decreased patient vigilance during sleep resulting in reduced muscle tone and urethral closing pressure, decreased sensitivity of the membranous urethra after radical cystectomy, involuntary high-amplitude contractions of the reservoir secondary to bowel peristalsis and shifting of free water from the reservoir wall into the hyperosmolar urine are the main factor causing global and nocturnal polyuria in patient with ONB. Final, there is also evidence suggesting an increase in bowel activity during sleep. Maximum urethral closing pressure (MUCP) is the primary component responsible for daytime continence in patients with an ONB. However, Koraitim et al. suggest that nocturnal incontinence depends on three reservoir parameters: maximal contraction amplitude, baseline reservoir pressure at mid capacity, and MUCP.

Mebeverine is a derivative of reserpine, which has relatively specific effects on smooth muscle cells without atropine-like side effects in humans. It directly blocks voltage-operated sodium channels and inhibits intracellular calcium accumulation. It is three times more potent than papaverine in inhibiting the peristaltic reflex of the ileum.

Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders

Mebeverine For Daytime And Nocturnal Incontinence and After Orthotopic W-Ileal Neobladders - Assessment Of Efficacy And Quality Of Life Effect Within 1 Year Post-Surgery: A Randomized Controlled Study

meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)

Outcome Measure by standardized continence questionnaire

Outcome Measure by quality of life questionnaire

Outcome Measure by pressure change measurement in centimetre of water.

Mansoura University

Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator

Patients with orthotopic neobladder who met the inclusion criteria will be enrolled.Inclusion criteria :(1) being right-handed;(2) 3 months or more after operation;(3) No contraindications to fMIR examination;(4)Does not meet the relevant exclusion criteria.

Chunxiao Liu

Yuanxing Huang

Orthotopic sigmoid neobladder surgery is one of the ideal urinary diversion methods after radical cystectomy.In recent years, functional imaging studies have revealed brain regions related to urinary system function, but brain activity of lower urinary tract function in neobladder patients is still unclear.The aim of this study is to explore the brain activity of urination intention and self-controlled urination behavior in patients with orthotopic sigmoid neobladder by task-state functional magnetic resonance imaging (fMRI).

The Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.

Neuroimaging Study of Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.

Areas of the brain where excitation or inhibition occurs in fMRI images

Peak T values of activated or inhibited regions of the brain in fMRI images

Zhujiang Hospital

Professor;Chief Surgeon

Urologic Neoplasms

Urogenital Neoplasms

Urinary Bladder Diseases

new patients with bladder cancer scheduled for radical cystectomy and subsequent conduit diversion

new patients with bladder cancer scheduled for radical cystectomy and subsequent orthotopic neobladder

All eligible patients who agree to participate will be asked to fulfill three different validated health-related quality of life questionnaires (EORTC-QLQ-C30/BLM, FACT-BL and BCI) prior to surgery and at 3, 6, 12, 18 months postoperatively.

validated health-related quality of life questionnaires

Xiaoping Zhang, MD, PhD

Hangchuan Shi, MD

Xiaoping Zhang, MD,PhD

Xiang Li, MD

The aim of this study is to compare the health-related quality of life (HRQoL) between patients underwent conduit diversion and orthotopic neobladder after radical cystectomy. The investigators plan to use validated HRQoL questionnaires to learn about how the different urinary diversion operations affect the HRQoL of people living with bladder cancer. The findings from this study may help doctors and patients choosing the proper operation type.

Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders

A Prospective and Comparative Study of Health-related Quality of Life (HRQoL) in Patients With Conduit Diversion or Orthotopic Neobladder

The aim is to compare three various validated tools of HRQoL to study their relative contributions in accounting for variance in prediction of patient HRQoL.

The three validated tools of HRQoL are EORTC-QLQ-C30/BLM (The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire/bladder cancer module), FACT-BL (Functional Assessment of Cancer Therapy-Bladder cancer) and BCI (Bladder Cancer Index).

The two groups are conduit diversion group and orthotopic neobladder group.

Longitudinally learn about the changes of each individual patient HRQoL after urinary diversion and compare the changes of two groups, i.e. conduit diversion group and orthotopic neobladder group.

Supplement the assessment by interviewing the patients with some lab and image examinations, such as renal function tests, liver function tests, urine culture, urine cytology, chest radiography, ultrasound of kidney, ureter and bladder (KUB) etc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mebeverine For 1st Year Daytime And Nocturnal Incontinence After Orthotopic W-Ileal Neobladders	NCT03147599	Oncology Incontinence Incontinence, D... Incontinence, N... Bladder Cancer Orthotopic Neob...	Coloverin Placebo	18 Years -	Mansoura University
The Supraspinal Control of Lower Urinary Tract Function in Patients With Orthotopic Sigmoid Neobladder.	NCT05558111	Orthotopic Neob...		18 Years -	Zhujiang Hospital
Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders	NCT02174185	Bladder Cancer	validated healt...	18 Years -	Huazhong University of Science and Technology
Compare the Quality of Life Between Patients With Conduit Diversions or Orthotopic Neobladders	NCT02174185	Bladder Cancer	validated healt...	18 Years -	Huazhong University of Science and Technology

Spots Global Cancer Trial Database for orthotopic neobladder