NCT00982098

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

2.8 years

First QC Date

September 21, 2009

Last Update Submit

September 21, 2009

Conditions

Urinary Incontinence

Keywords

ProstatectomyProstatic cancerUrinary incontinenceExerciseElectric stimulation therapyCounseling

Outcome Measures

Primary Outcomes (1)

  • Complete continence (PAD test 24 hours <10 cc)

    12 months

Secondary Outcomes (1)

  • PAD test 24 hours

    12 months

Study Arms (2)

Early Rehabilitation

EXPERIMENTAL

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.

Procedure: BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercises

Counseling and home-based exercises

NO INTERVENTION

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.

Interventions

BioFeedback; Functional Electrical Stimulation; Pelvic Floor Muscle training exercisesPROCEDURE

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).

Early Rehabilitation

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men who will undergo radical prostatectomy for prostatic cancer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SC Medicina Fisica e Riabilitativa AUO "Maggiore della Carità"

Novara, 28100, Italy

Location

MeSH Terms

Conditions

Urinary IncontinenceProstatic NeoplasmsMotor Activity

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesProstatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Carlo Cisari, prof.

    AUO "Maggiore della Carità" - Novara

    STUDY DIRECTOR

  • Carlo Terrone, prof.

    AUO "Maggiore della Carità" - Novara

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

February 1, 2007

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

IT(1)