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Electrical Stimulation and Biofeedback on Urinary Incontinence after Radical Prostatectomy

Effect of Pelvic Floor Exercises, Electrical Stimulation and Biofeedback on Urinary Incontinence after Radical Prostatectomy: Single Blind Randomized Clinical Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000975099
Enrollment
90
Registered
2010-11-12
Start date
2007-07-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Urinary incontinence is one of the most distressing and significant post operative problems of radical retropubic prostatectomy (RRP) and negatively affects the quality of life Urodynamic data were obtained at baseline (six to 12 weeks post-surgery), and again after 12 weeks after enrollment in therapy, according to International Continence Society (ICS) standards. These evaluations were performed by urologists that were blinded to patient groups. 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.

Interventions

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 micr

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

Sponsors

Mohammed Taher Ahmed Omar
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
Male
Age
45 Years to 65 Years
Healthy volunteers
No

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.

Exclusion criteria

Exclusion criteria were; (1) previous bladder or prostate surgery, (2) prior urinary or fecal incontinence, (3) neurogenic and psychiatric disorders, (4) preoperative urinary tract complications, (5) radiotherapy, and use of anticholinergic drugs or any drugs that influence continence during the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026