NCT00239824

Brief Summary

The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

2.2 years

First QC Date

October 14, 2005

Last Update Submit

July 15, 2016

Conditions

Urinary Incontinence

Keywords

urinary incontinencepelvic floor muscle trainingradical prostatectomyphysiotherapy

Outcome Measures

Primary Outcomes (1)

  • self reported continence (no need for wearing a pad)at 3 months

    One year

Secondary Outcomes (6)

  • Self reported time period from operation to continence.

    One year

  • 24 hours home pad test registering grams of urine

    One year

  • Pelvic floor muscle strength

    one year

  • Erectile dysfunction

    one year

  • Quality of life

    one year

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Strength training of the pelvic floor muscles with follow up instructions by a physiotherapist

Behavioral: Strength training of the pelvic floor musclesBehavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist

2

ACTIVE COMPARATOR

Strength training of the pelvic floor muscles without follow up instructions

Behavioral: strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapist

Interventions

Strength training of the pelvic floor musclesBEHAVIORAL

Group A followed a pelvic floor muscle exercise course consisting of intensive pelvic floor muscle training with follow up instructions (training group or DVD instructions)by a physiotherapist;3 x 10 contractions daily. Group B were instructed to train the pelvic floor muscles 3 x 10 contractions daily without follow up instructions by a physiotherapist.

Also known as: Physiotherapy, pelvic floor muscle training
1
strength training of the pelvic floor muscles with or without follow up instructions by a physiotherapistBEHAVIORAL
12

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer prostata operated (radical prostatectomy)
  • Incontinence after separation of catheter
  • Understands Norwegian language

You may not qualify if:

  • Drug/alcohol abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Services, St.Olavs Hospital, Trondheim University Hospital, Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (1)

  • Overgard M, Angelsen A, Lydersen S, Morkved S. Does physiotherapist-guided pelvic floor muscle training reduce urinary incontinence after radical prostatectomy? A randomised controlled trial. Eur Urol. 2008 Aug;54(2):438-48. doi: 10.1016/j.eururo.2008.04.021. Epub 2008 Apr 18.

    PMID: 18448233RESULT

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Physical Therapy Modalities

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 Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Siv Mørkved, PhD

    Clinical Services, St Olavs Hospital/ Dept.of Community Medicine and General Practice, Norwegian University of Science and Technology, Trondheim, Norway

    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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 17, 2005

Study Start

October 1, 2005

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

NO(1)