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Prevention of Urinary Incontinence After Prostatectomy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00982098
Enrollment
110
Registered
2009-09-22
Start date
2007-02-28
Completion date
2009-11-30
Last updated
2009-09-22

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

Conditions

Urinary Incontinence

Keywords

Prostatectomy, Prostatic cancer, Urinary incontinence, Exercise, Electric stimulation therapy, Counseling

Brief summary

Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. In this study the investigators will compare the effect of an early rehabilitation programme (instruction of the patient, pelvic floor muscle training, electrical stimulation and biofeedback) versus instruction of the patient only. The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.

Interventions

PROCEDUREBioFeedback; 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).

Sponsors

Azienda Ospedaliero Universitaria Maggiore della Carita
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* men who will undergo radical prostatectomy for prostatic cancer

Exclusion criteria

* previous urinary and/or faecal incontinence * neurologic bladder * previous pelvic surgery

Design outcomes

Primary

MeasureTime frame
Complete continence (PAD test 24 hours <10 cc)12 months

Secondary

MeasureTime frame
PAD test 24 hours12 months

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026