Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2007-02-28
2009-11-30
Brief Summary
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The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early Rehabilitation
Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions.
After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).
Patients will be instructed to carry on exercises at home for the following 11 months.
BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises
After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).
Counseling and home-based exercises
Before surgery: 15 minutes pelvic floor muscle training and 15 minutes biofeedback, for 4 sessions.
After surgery: Patients will be instructed to carry on pelvic floor exercises at home for the year after prostatectomy.
No interventions assigned to this group
Interventions
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BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises
After surgery: physical therapist's assisted pelvic floor muscle biofeedback (15 min/day for 10 days), followed by patient's instruction for pelvic floor muscle training and home based exercised pelvic floor muscle for 10 days. Then pelvic floor muscle biofeedback (15 min/day for 10 days) and functional electrical stimulation of pelvic floor (30 min/day for 10 days).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* neurologic bladder
* previous pelvic surgery
18 Years
MALE
No
Sponsors
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Azienda Ospedaliero Universitaria Maggiore della Carita
OTHER
Responsible Party
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AUO "Maggiore della Carità"
Principal Investigators
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Carlo Cisari, prof.
Role: STUDY_DIRECTOR
AUO "Maggiore della Carità" - Novara
Carlo Terrone, prof.
Role: STUDY_CHAIR
AUO "Maggiore della Carità" - Novara
Locations
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SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"
Novara, , Italy
Countries
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Other Identifiers
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NO08974
Identifier Type: -
Identifier Source: org_study_id
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