|- candidate number||6313|
|- NTR Number||NTR1953|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-aug-2009|
|- Secondary IDs||080678 IWT|
|- Public Title||Influence of pre- and post-operative pelvic floor muscle exercises (PFME) on urinary incontinence after retropubic radical prostatectomy and robotic radical prostatectomy.|
|- Scientific Title||Influence of pre- and post-operative pelvic floor muscle exercises (PFME) on urinary incontinence after retropubic radical prostatectomy and robotic radical prostatectomy: a randomised controlled trial.|
|- hypothesis||1. Patients, starting with PFME before radical prostatectomy, have a shorter duration and a lower degree of post-operative urinary incontinence than patients who start with PFME after surgery;|
2. Patients, performing pre-operative PFME and PFME during catheter wearing, who develop urinary incontinence, will have a smaller amount of urine loss and urinary incontinence will be reduced more easily compared with patients receiving only exercises after catheter withdrawal;
3. Patients, who had a robotic radical prostatectomy, will restart sooner their pre-operative physical activity level than patients who had a retropubic radical prostatectomy;
4. Patients, who had a robotic radical prostatectomy, will regain urinary incontinence sooner than patients who had a retropubic radical prostatectomy.
|- Healt Condition(s) or Problem(s) studied||Urinary incontinence, Prostatic neoplasms, Pelvic floor muscle training (PFMT)|
|- Inclusion criteria||1. Patients who will have a retropubic radical prostatectomy or a robotic radical prostatectomy for localised or locally advanced prostate cancer in the University Hospital Gasthuisberg in Leuven;|
2. Patients who can participate in pelvic floor muscle training during the entire study period.
|- Exclusion criteria||1. Patients who refuse to participate in the study;|
2. Patients who are not able to perform PFME because of cognitive problems.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2009|
|- planned closingdate||31-mrt-2012|
|- Target number of participants||180|
|- Interventions||Before surgery (retropubic or robotic) the patient will be randomly assigned to the experimental group, starting PFME before surgery or to the control group, starting PFME after catheter withdrawal. |
The pelvic floor muscle training program consists of exercises of the pelvic floor manually controlled by the therapist and supplied with EMG biofeedback and electrostimulation in case of a weak pelvic floor. Every patient receives individual treatment on an outpatient basis once a week. Further the patient performs an exercise scheme independently at home.
|- Primary outcome||Duration and degree of urinary incontinence: All patients from the control group and from the experimental group are measured first preoperatively and then 1 month, 3 months, 6 months and 1 year after catheter withdrawal.|
|- Secondary outcome||1. At each measurement session pelvic muscle tone, strength, endurance and exhaustion are evaluated;|
2. Physical activity: pre-operatively, 1 month, 3 months, 6 months and 1 year after catheter withdrawal the patient fills in the 'physical activity and sports participation' questionnaire;
3. Erectile dysfunction: pre-operatively, 1 month, 3 months, 6 months and 1 year after catheter withdrawal the patient fills in the International Prostate Symptom Score (IPSS).
|- Timepoints||1. After 12 months, approximately 120 patients are measured preoperatively and have started their physiotherapeutic treatment;|
2. After 18 months, all patients are included in the study and started their physiotherapeutic treatment;
3. After 30 months all patients are being followed until one year after surgery. Data can be processed.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| Inge Geraerts|
|- CONTACT for SCIENTIFIC QUERIES|| Inge Geraerts|
|- Sponsor/Initiator ||Kath. Universiteit Leuven, Faculteit Bewegings- en Revalidatiewetenschappen|
(Source(s) of Monetary or Material Support)
|Institute for the Promotion of Innovation by Science and Technology in Flanders (IWT), Toegepast Biomedisch onderzoek met een primaire Maatschappelijke finaliteit (TBM)|
|- Brief summary||Prostate cancer is the most common cancer in men on this moment. Radical prostatectomy for localized prostate cancer was always done via retropubic (open) approach. However robotic prostatectomy becomes more and more the treatment of choice. Urinary incontinence and erectile dysfunction are the most embarrassing complications after prostatectomy. Pelvic floor muscle exercises can reduce incontinence and improve erectile function. The purpose of this study is to compare the complications of both surgeries and to evaluate the influence of pelvic floor muscle exercises given before catheter withdrawal. |
|- Main changes (audit trail)|
|- RECORD||12-aug-2009 - 11-okt-2009|