Condition category
Surgery
Date applied
11/01/2017
Date assigned
13/01/2017
Last edited
18/01/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A radical prostatectomy is an operation to remove the prostate gland in order to remove prostate cancer. The most common side effects of the operation are unintentional passing of urine (urinary incontinence) and problems with getting and keeping an erection (erectile dysfunction). This greatly reduces the patient’s quality of life. The aim of this study is to test a physiotherapy program for urinary incontinence three months after radical prostatectomy.

Who can participate?
Men aged over 18 who have undergone a radical prostatectomy and are experiencing incontinence and erectile dysfunction

What does the study involve?
Participants are randomly allocated to one of two groups. One group is treated with biofeedback pelvic floor training, a type of physical therapy that trains the brain and pelvic muscles to work together to tighten and relax the pelvic floor muscles. An anal electrode is used to record the activity of the pelvic floor muscles for 30 minutes. The patients also receive electrical stimulation for 15 minutes. The treatment lasts 45 minutes per day, 3 days per week. At home, patients also train their pelvic muscles through Kegel exercises throughout the day. The other group is treated according to the usual clinical practice, and an information sheet with Kegel exercises is provided after the operation. Both groups are assessed for incontinence, erectile dysfunction and quality of life at the start of the study and after 1 month, 2 months, 3 months (end of treatment), 6 months and 12 months.

What are the possible benefits and risks of participating?
The study will show whether physiotherapy can be used to treat urinary incontinence after prostatectomy. There is currently no standard treatment for this. Participants may benefit from an improvement in their urinary incontinence symptoms. The physiotherapy has no adverse effects. Sometimes it can cause discomfort due to the electrode being in the wrong position, but it can be fixed by adjusting the position of the electrode.

Where is the study run from?
Clínica Mercedes Soto (Spain)

When is the study starting and how long is it expected to run for?
January 2015 to December 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Mercedes Soto-González
m.soto@uvigo.es

Trial website

Contact information

Type

Public

Primary contact

Dr Mercedes Soto-González

ORCID ID

Contact details

Facultad de Fisioterapia
Campus A Xunqueira s/n
Pontevedra
36005
Spain
+34 (0)986 801 750
m.soto@uvigo.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016

Study information

Scientific title

Effectiveness of a physiotherapy program in the treatment of urinary incontinence post-prostatectomy: a randomized controlled trial

Acronym

Study hypothesis

The physical therapy program will improve the urinary incontinence in post-prostatectomy patients in three months.

Ethics approval

Pontevedra-Vigo-Ourense Research Ethics Committee of the Health Department, 05/11/2014, ref: 2014/351

Study design

Interventional single-centre randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Post-prostatectomy urinary incontinence

Intervention

Participants are assigned to the control group or intervention group through simple randomization. Doctors, patients and evaluators will not be blinded.

1. Intervention: Biofeedback is used for the pelvic floor training. An anal electrode records the activity of the pelvic floor muscles (30 minutes). Besides, the patients receive electrostimulation during 15 minutes. The treatment (biofeedback + electrostimulation) is 45 minutes per day (3 days per week). At home, patients train their pelvic muscles through Kegel exercises throughout the day.
2. Control: usual clinical practice. An information sheet with Kegel exercises is provided after the operation.

Patients are assessed at baseline, 1 month, 2 months, 3 months (end of treatment), 6 months and 12 months.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Loss of urine, measured using the 24 h Pad test and 1 h Pad test, at baseline, 1 month, 2 months, 3 months (end of treatment), 6 months and 12 months

Secondary outcome measures

1. Quality of life and incontinence, measured using the ICIQ-SF questionnaire at baseline, 1 month, 2 months, 3 months (end of treatment), 6 months and 12 months
2. Erectile dysfunction, measured using the International Index of Erectile Function (IIEF-5) at baseline, 1 month, 2 months, 3 months (end of treatment), 6 months and 12 months
3. Life habits, measured using a urinary diary at baseline, 1 month, 2 months, 3 months (end of treatment), 6 months and 12 months

Overall trial start date

01/01/2015

Overall trial end date

31/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Male patients intervened with radical prostatectomy
2. Incontinence (any loss of urine)
3. Erectile dysfunction, defined as a score under 21 in the International Index of Erectile Function (IIEF-5)
4. Over 18 years old

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

134 patients (67 patients in each group)

Participant exclusion criteria

1. Patients with neurological pathology (advanced Parkinson's, multiple sclerosis and disease with deterioration of cognitive or sensitive capacities or that course with muscle weakness)
2. Patients with serious disease processes such cancer, severe epoc, severe pulmonary hypertension
3. Patients with a pacemaker
4. Patients taking muscle relaxing medication
5. Patients with incotinence or erectile dysfunction with a score under 7 in the questionnaire IIEF-5 previous to the intervention

Recruitment start date

15/02/2015

Recruitment end date

31/12/2017

Locations

Countries of recruitment

Spain

Trial participating centre

Clínica Mercedes Soto
Emilia Pardo Bazán 29 Bajo
Vigo
36204
Spain

Sponsor information

Organisation

University of Vigo

Sponsor details

Campus Lagoas Marcosende
Vigo
36310.
Spain
+34 (0)986 812 000
m.soto@uvigo.es

Sponsor type

University/education

Website

www.uvigo.es

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Mercedes Soto-González (m.soto@uvigo.es)

Intention to publish date

31/12/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

18/01/2017: Participant information sheet added.