Category
»
Primary study
Registry of Trials»ANZCTR
Year
»
2010
INTERVENTION: 1‐Patients in electrical stimulation (ES)group received pelvic muscle exercises(PMEs), plus ES that was provided with a (Sonopuls‐ 992992(ENRAF NONIU, Dimeq Bu, Holland) using a surface electrodes. Treatment time was set for 20 minutes , twice weekly for 12 weeks, after this time the device was automatically switched off, to ensure that each patient had same treatment duration. Stimulation parameters were 30 Hz (first 10 minutes) and 50 Hz (second 10 minutes) of biphasic square waves at 300 microseconds pulse duration and output current of 24 mA of maximum tolerable intensity was given. The Sites of electrode application were placed at 2nd and 3rd sacral outflow for 30 Hz, where the lateral border of each electrode placed over the posterior superior iliac crest, and the inside border located one finger width from the midline. For 50 Hz, the electrodes were placed to the symphysis pubis, one finger width either side of the midline. 2‐Patients in Biofeedback (BFB) group received PMEs and ES, additionally for 30 mniutes twice times weekly, for 12 weeks, and treated with BFB for 15 minutes twice weekly for 12 weeks using (Reactive Biofeedback, BEAC, Stradella, Italy) a 2‐channel electromyographic biofeedback apparatus, with one channel for perineal and the other for abdominal muscles and the signal received through surface electrodes. During the initial two to three sessions a strong emphasis was placed on the specificity of pelvic muscle contraction with minimum activity of abdominal muscles. During the following sessions, the exercises were designed to increase the power and endurance of the pelvic floor muscles. The patients performed these exercises while supine but later also when sitting or standing, and during normal daily activities. The PMEs in both group1 and 2 same as for the control group. electrical stimulation in undertaken by patient in biofeedback same as in electrical stimulation group except that duration is 30 minutes twice weekly CONDITION: radical prostatectomy Urinary incontinence PRIMARY OUTCOME: Urodynamic data ; Bladder volume at initial desire to void (ml) ; Maximum cystometric capacity (ml) ; Maximum flow rate (ml/sec) ; Detrusor pressure at maximum flow rate(cmH2O) ; Detrusor instability n(%) ; Bladder compliance n(%) ; Urodynamic evaluation included twin‐channel subtracted cystometry and pressure‐flow studies (UD 5000/5500 Dantec, Denmark), which allowed for simultaneous recording of intervesical and interurethral pressures . ; The patients assumed supine position, where the urethral catheter was inserted transurethrally, and the bladder was emptied. Rectal pressure was recorded via an intrarectal transducer. For filling cystometry a medium bladder filling rate of 50 ml/minute was used. Bladder stability was assessed during cough as a provocative test. For urethral pressure profilometry, the catheter was attached to an electronic catheter puller and withdrawn at a speed of 60 mm/minute with a perfusion rate of 2 ml/minute. Measurement was repeated with voluntary contraction of the external sphincter muscle to record maximal urethral pressure. One tablet of norfloxacin was given for antibiotic prophylaxis. ; Evaluation included determination of bladder volume at initial desire to void, maximal cystometric capacity, and detrusor pressure at maximum flow rate. Bladder compliance defined as a compliance of less than 12.5 mL/cm H2O, and detrusor instability were defined as involuntary detrusor contractions at pressures greater than 15 cm. H2O. SECONDARY OUTCOME: The self‐reported continence/ incontinence . The definition of urinary incontinence was according to the guidelines of the International continence society (ICS) where continence is defined as no need for wearing a pad (0 pads). INCLUSION CRITERIA: From July 2007 to February 2010 a total of 90 patients who underwent RRP, were recruited from the practice of four physicians at National Institute of Urology and Nephrology. The operation was performed by two urologists without any knowledge concerning the outcome of randomization procedure and the catheter was removed within 7‐10 days after surgery.
Epistemonikos ID: 1e60b17b48b769d9cd949d2e34bddcf2dbaa4d74
First added on: Aug 22, 2024