Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000975099
Ethics application status
Approved
Date submitted
5/11/2010
Date registered
12/11/2010
Date last updated
12/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Electrical Stimulation and Biofeedback on Urinary Incontinence after Radical Prostatectomy
Scientific title
Effect of Pelvic Floor Exercises, Electrical Stimulation and Biofeedback on Urinary Incontinence after Radical Prostatectomy: Single Blind Randomized Clinical Trial
Secondary ID [1] 253036 0
non
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary incontinence 258594 0
radical prostatectomy 258639 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258736 258736 0 0
Physiotherapy
Cancer 258779 258779 0 0
Prostate
Renal and Urogenital 258783 258783 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 257563 0
Rehabilitation
Comparator / control treatment
Patients randomized to PMEs group received verbal and written instructions about PMEs from a physiotherapist. After this introduction, each patient received intensive physiotherapy for 30 minutes, for two days weekly, and up to for 12 weeks. At the first treatment visit (1-8sessions)four exercises were performed assuming with the patient in the supine and hook-lying position. Exercise 1 was PMEs contraction with a posterior pelvic tilt. Exercise 2 was PMEs contraction with a bridging motion. Exercise three was PMEs contraction with adduction against a pillow between the knees. Exercise four was PMEs contraction with external rotation of hip against an 8-pound elastic exercise band. On the second treatment visit(9-16sessions); four PMEs exercises were performed assuming with the patient sitting on an inflatable exercise ball. Exercise one was PMEs contraction with a posterior pelvic tilting and rolling on the ball in the sagittal plan. Exercise two was PMEs contraction with a posterior pelvic tilting and rolling on the ball in the oblique plan. Exercise three was bouncing vertically and performing PMEs contraction at each ascending movement. Exercise four was PMEs contraction while rolling on the ball from sitting to stand for functional training with transfers. At the third treatment visit to the clinic917-24), we invited the patients to practice PMEs contraction only before any effort or activity that might induce incontinence (sneezing, coughing, or lifting a weight).
These set treatments were guided by the physical therapist. That encouraged the patients to perform four components of muscle function strength, endurance, speed, and control. Strength focused on recruiting as many muscle fibers as possible, maintaining the contraction at the optimum hold, while keeping the accessory muscles relaxed.
Initial contractions were of 5–10s with a 10–20s rest, with 12–20 repetitions. Endurance exercises focused on maintaining a muscle contraction at 50–60% of strength. The ‘hold’ time was 20–30s with an equal rest time, with six–eight repetitions. Speed was achieved by sets of quick repetitive contractions (5-10) in a 10-s span with a 20-s rest. Finally, purposeful control involved gradual recruitment to a maximal contraction and occurred in three stages, with a 5seconds hold at each stage and a slow release with a rest period of 15–30seconds.
Control group
Active

Outcomes
Primary outcome [1] 259601 0
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.
Timepoint [1] 259601 0
at baseline (six to 12 weeks post-surgery), and again after 12 weeks after enrollment in therapy,
Secondary outcome [1] 266306 0
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).
Timepoint [1] 266306 0
At six to 12 weeks postoperative, three and six months after starting the treatment were recorded

Eligibility
Key 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.
Minimum age
45 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 3020 0
Egypt
State/province [1] 3020 0
Country [2] 3021 0
Egypt
State/province [2] 3021 0

Funding & Sponsors
Funding source category [1] 258014 0
Self funded/Unfunded
Name [1] 258014 0
Mohammed taher ahmed omar
Country [1] 258014 0
Egypt
Primary sponsor type
Individual
Name
Mohammed Taher Ahmed Omar
Address
Faculty of physical therapy, cairo unversity,
17, Ahmed Elzyat street cairo, egypt102119
Country
Egypt
Secondary sponsor category [1] 257207 0
Individual
Name [1] 257207 0
Ashraf Hassan Mohammed
Address [1] 257207 0
Faculty of physical therapy, cairo unversity,
17, Ahmed Elzyat street cairo, egypt102119
Country [1] 257207 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260007 0
postgraudated and research councel in faculty of physical therapy
Ethics committee address [1] 260007 0
Faculty of physical therapy, cairo unversity,
17, Ahmed Elzyat street cairo, egypt, P.O.Box102119
Ethics committee country [1] 260007 0
Egypt
Date submitted for ethics approval [1] 260007 0
03/04/2007
Approval date [1] 260007 0
04/05/2007
Ethics approval number [1] 260007 0

Summary
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.
Trial website
Trial related presentations / publications
presented in the 22nd Saudi Urological conference
under title " Recent Advances in Urology,15-18-march 2010 at king faha culture center,riyadh, Saudi Arabia
Public notes

Contacts
Principal investigator
Name 31879 0
Address 31879 0
Country 31879 0
Phone 31879 0
Fax 31879 0
Email 31879 0
Contact person for public queries
Name 15126 0
Mohammed Taher Ahmed Omar
Address 15126 0
cuurent address
Facult of applied medical science, king saudi univeristy
12109, riyadh,11334
Country 15126 0
Saudi Arabia
Phone 15126 0
00966542115404
Fax 15126 0
Email 15126 0
[email protected]
Contact person for scientific queries
Name 6054 0
Mohammed Taher Ahmed Omar
Address 6054 0
cuurent address
Faculty of applied medical science, king saudi univeristy
12109, riyadh,11334
Country 6054 0
Saudi Arabia
Phone 6054 0
00966542115404
Fax 6054 0
Email 6054 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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