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Prevention of Urinary Incontinence After Prostatectomy

Primary Purpose

Urinary Incontinence

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises
Sponsored by
Azienda Ospedaliero Universitaria Maggiore della Carita
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence focused on measuring Prostatectomy, Prostatic cancer, Urinary incontinence, Exercise, Electric stimulation therapy, Counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • men who will undergo radical prostatectomy for prostatic cancer

Exclusion Criteria:

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

Sites / Locations

  • SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early Rehabilitation

Counseling and home-based exercises

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Complete continence (PAD test 24 hours <10 cc)

Secondary Outcome Measures

PAD test 24 hours

Full Information

First Posted
September 21, 2009
Last Updated
September 21, 2009
Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita
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1. Study Identification

Unique Protocol Identification Number
NCT00982098
Brief Title
Prevention of Urinary Incontinence After Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Azienda Ospedaliero Universitaria Maggiore della Carita

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence
Keywords
Prostatectomy, Prostatic cancer, Urinary incontinence, Exercise, Electric stimulation therapy, Counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Counseling and home-based exercises
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises
Intervention Description
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).
Primary Outcome Measure Information:
Title
Complete continence (PAD test 24 hours <10 cc)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
PAD test 24 hours
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: men who will undergo radical prostatectomy for prostatic cancer Exclusion Criteria: previous urinary and/or faecal incontinence neurologic bladder previous pelvic surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Cisari, prof.
Organizational Affiliation
AUO "Maggiore della Carità" - Novara
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carlo Terrone, prof.
Organizational Affiliation
AUO "Maggiore della Carità" - Novara
Official's Role
Study Chair
Facility Information:
Facility Name
SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"
City
Novara
ZIP/Postal Code
28100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Prevention of Urinary Incontinence After Prostatectomy

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