Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Behaviors and Mental Disorders

Prostatic Neoplasms

Urinary Incontinence

Enuresis

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Maria Ervandian, MD

Helene Nørrelund

Michael Borre, Professor

Morten Høyer, Professor

The purpose of this study is to describe the urinary morbidity as a result surgery and radiation therapy, in patients treated for prostate cancer.

All the patients will undergo a Urodynamic examination to verify the grade of Urinary morbidity.

Introduction:

There is a little knowledge on long-term urinary morbidity in patients treated with radical prostatectomy (RP) and salvage radiotherapy (SRT). Both treatments are potentially curative for localized prostate cancer (PC). Improved long-term survival makes the awareness of late effects from radiotherapy important.

Purpose:

The purpose of this study was to access, late urinary morbidity in patients treated with SRT. The patients included in this study will have an urodynamic examination. The results from the urodynamic examination will help us with a better understanding of the different symptoms and their grade, after treatment with RP and SRT because of PC.

Materials and methods:

A total of 67 patients will be invited to participate in this urodynamic study. The patients will undergo a urodynamic examination, included biomechanical examination of urethra. The examination is a standard procedure at the department of Urology, Aarhus University hospital, Denmark.

The patients will, in relation to the urodynamics, have taken two blood samples. The blood samples, will later on, be used to detect some of the genetic reasons for morbidity after radiotherapy.

Endpoint:

The primary endpoint is the outcome of different parameters as a result of the urodynamic examination.

Perspective:

The perspective of this study is to help understanding the efficacy og morbidity of salvage radiotherapy. The investigators hope to get a better understanding of the mechanisms related to urinary morbidity.

Salvage Radiotherapy After Radical Prostatectomy

Changes in Bladder Function After Surgery and Radiation Therapy for Prostate Cancer

The patients load the water at a special flow toilet

Evaluation of biomechanical wall properties by measuring luminal cross-sectional area and pressure.

The bladder is filled with saline with a flow rate of 60 mL/minute.

To evaluate the uretal pressure profile. The water pump perfused saline at a flow rate of 1 mL, while the catheter. attached to an automatic pulling device, was pulled out of the urethra at 2 mm/s.

University of Aarhus

Uterine Cervical Neoplasms

Pelvic Floor Disorders

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Quality of Life

All Drugs and Chemicals

Reproductive Control Agents

Hormones

Follicle Stimulating Hormone

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Estradiol

Polyestradiol phosphate

Including four kinds of questionnaires: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3); EORTC QLQ-CX24; Eligibility Criteria (FSFI); and Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFIQ-7)

questionnaires survey

Urodynamic testing consists of important urodynamic parameters including:

Bladder capacity at the first void sense Bladder capacity at normal desire to void Bladder capacity at strong desire to void Qmax Qave Pves at Qmax Pdet at Qmax Cves at SDV Cdet at SDV Residual urine volume

Urodynamic testing

Rectum dynamics testing consists of important parameters of rectum activities

Rectum dynamics testing

Testing for ovarian reserve function consists of:

Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B

ovarian reserve function

Lei Li, M.D.

Lei Li, MD

This is prospective cohort study. All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. Before and after the major therapy (including at least radical hysterectomy and/or radiotherapy), the patients accept (1) the questionnaires survey about quality of life; (2) urodynamic testing; (3) rectum dynamics testing and (4) ovarian reserve function. The survival outcomes (disease-free survival and overall survival) will be supplemented as secondary objectives.

Peripheral blood samples for the testing of ovarian reserve function

Comprehensive Study on the Quality of Life in Cervical Cancer Patients

Comprehensive Study on the Quality of Life in Cervical Cancer Patients: A Prospective Cohort Study

Scores calculated from European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

Follicle-stimulating hormone tested in peripheral blood

Anti-mullerian hormone tested in peripheral blood

Bladder capacity at the first void sense tested by urodynamic testing

Bladder capacity at normal desire to void tested by urodynamic testing

Bladder capacity at strong desire to void tested by urodynamic testing

Maximun flow rate tested by urodynamic testing

Average flow rate tested by urodynamic testing

Bladder pressure at maximun flow rate tested by urodynamic testing

Detrusor pressure at maximun flow rate tested by urodynamic testing

Bladder compliance at strong desire to void tested by urodynamic testing

Detrusor compliance at strong desire to void tested by urodynamic testing

Residual urine volume tested by urodynamic testing

Anal sphincter pressure tested by rectum dynamic testing

Lei Li

Professor

Nocturnal Enuresis

Urination Disorders

Urologic Diseases

Lower Urinary Tract Symptoms

Urological Manifestations

Behavioral Symptoms

Elimination Disorders

Mental Disorders

Psychotic Disorders

All patients had investigated by retrograde cystography after LRP and were grouped according their bladder neck position: Level 0: bladder neck at or above the superior margin of the symphysis pubis (SMSP), Level -1: bladder neck at \<2 cm below SMSP, and Level -2: bladder neck at \>2 cm below SMSP.

bladder neck level on cystography

HannChorng Kuo, M.D.

To investigate the relationship between post-operative bladder neck levels and urodynamic parameters and their effect on urinary incontinence after laparoscopic radical prostatectomy (LRP). Forty-eight consecutive patients undergoing LRP were retrospectively reviewed. All patients had investigated by retrograde cystography after LRP and were grouped according their bladder neck position: Level 0: bladder neck at or above the superior margin of the symphysis pubis (SMSP), Level -1: bladder neck at \<2 cm below SMSP, and Level -2: bladder neck at \>2 cm below SMSP. Urodynamic studies were carried out at baseline, 3 and 6 months post-operatively. Early recovery of urinary continence was defined as no urine leakage or only one pad/day used within 3 months after surgery. Demographic characteristics, changes of urodynamic parameters and continence outcomes were analyzed.

Laparoscopic radical prostatectomy (LRP) is effective in treating localized prostate cancer with good long-term oncological outcomes. Urinary incontinence, which is a bothersome complication with a negative effect on the patient's quality of life, remains a relevant problem after LRP, despite the improvements in the surgical technique. More than 80% of patients undergoing radical prostatectomy encounter urinary incontinence immediately after catheter removal, but the bladder condition can generally stabilize within two years after operation. Among the patients undergoing LRP, persistent urinary incontinence has been reported in 4-30% of patients, and further treatment is often required.

Definite evaluation for the voiding function has been recommended for patients with prolonged post-prostatectomy urinary incontinence (PPI). To improve quality of life after LRP, early recovery of urinary continence is an important concern for patients. Several studies have investigated the predictive factors of early recovery of urinary continence after prostatectomy, including the amount of urine loss after catheter removal, pelvic floor muscle function, a nerve-sparing technique, and the membranous urethral length loss ratio.

Other factors relating to the early recovery of urinary continence include post-operative anatomy of the lower urinary tract, such as the length of the membranous urethra and the level of the vesicourethral junction. However, there has been no consensus on the standard criteria that should be used to measure the structural changes, and the relationship between the urodynamic change and the anatomical morphology remains unclear. In this study, investigators study the relationship between the urodynamic parameters and the bladder neck levels after LRP, and their effects on the early recovery of urinary incontinence.

This study was a retrospective analysis. From 2011 to 2014, a total of 48 consecutive patients with localized prostatic cancer underwent LRP in single medical center by two experienced surgeons. Videourodynamic study was performed before operation (baseline) and at 3 and 6 months after operation. The Ethics Committee of the hospital approved this study and written informed consent was waived because the study was a retrospective analysis. The principles of Helsinki Declaration were followed throughout the study.

The urodynamic parameters were measured and recorded including first sensation of filling (FSF), maximum flow rate (Qmax), detrusor pressure at Qmax (PdetQmax), voided volume, cystometric bladder capacity (CBC), bladder compliance, post-void residual (PVR) volume, maximal urethral closure pressure (MUCP) and functional profile length (FPL). The urodynamic parameters were compared between baseline and different time-points after LRP.

The BN level was evaluated by retrograde cystography, which was routinely performed 7 to 14 days after LRP to evaluate the condition of anastomosis. The image was obtained anteroposteriorly after infusing 100-150 mL of contrast solution into the bladder while the patient was in standing position. The distance between the bladder neck and the superior margin of the symphysis pubis (SMSP) was then measured by the same urologist. The bladder neck level was graded on a three-point scale: a bladder neck level at or above the SMSP was marked as level 0, a bladder neck level with a distance less than 2 cm below the SMSP was marked as level -1, and bladder neck levels 2 or more cm below the SMSP was labeled as level -2.

The patient's urinary continence status was evaluated on direct visits and via questionnaires during follow-up periods at 3, 6, and 12 months post-operatively. Patients without urine leakage in their daily life and those who used only one pad per day for safety reasons without limitation in their daily activities were defined as "urinary continent". Otherwise, the patients were defined as "urinary incontinent". Regaining continence within 3 months after LRP was considered early recovery of urinary continence.

The data was collected retrospectively by chart review. The variables among continent and incontinent patients were evaluated by univariate analysis (t-test for continuous variables and Chi-square for categorical variables ). The ANOVA test was use to compare the urodynamic parameters between different BN levels. Statistical analysis was performed using SPSS 20.0 statistical software.

Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy

Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy: Bladder Neck Level and the Association With Urodynamic Parameters

No plan to share data with other researchers

Patients without urine leakage in their daily life and those who used only one pad per day for safety reasons without limitation in their daily activities at 3 months after laparoscopic radical prostatectomy were defined as "urinary continent"

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Salvage Radiotherapy After Radical Prostatectomy	NCT02597725	Prostate Cancer		50 Years - 90 Years	University of Aarhus
Comprehensive Study on the Quality of Life in Cervical Cancer Patients	NCT03967457	Quality of Life Cervical Cancer Urodynamics Rectum Dynamics Sex Dysfunction Pelvic Floor Di... Ovarian Reserve... Survivorship Disease-free Su... Overall Surviva...	questionnaires ... Urodynamic test... Rectum dynamics... ovarian reserve...	18 Years -	Peking Union Medical College Hospital
Salvage Radiotherapy After Radical Prostatectomy	NCT02597725	Prostate Cancer		50 Years - 90 Years	University of Aarhus
Salvage Radiotherapy After Radical Prostatectomy	NCT02597725	Prostate Cancer		50 Years - 90 Years	University of Aarhus
Predictor of Early Recovery on Urinary Continence After Laparoscopic Radical Prostatectomy	NCT03097367	Urinary Inconti...	bladder neck le...	40 Years - 90 Years	Buddhist Tzu Chi General Hospital

Spots Global Cancer Trial Database for urodynamics

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

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