Efficacy of physiotherapy in post-prostatectomy urinary incontinence
| ISRCTN | ISRCTN48761809 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48761809 |
| Secondary identifying numbers | 2016 |
- Submission date
- 11/01/2017
- Registration date
- 13/01/2017
- Last edited
- 18/01/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Public
Facultad de Fisioterapia
Campus A Xunqueira s/n
Pontevedra
36005
Spain
| Phone | +34 (0)986 801 750 |
|---|---|
| m.soto@uvigo.es |
Study information
| Study design | Interventional single-centre randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN48761809_PIS_12Jan17.pdf |
| Scientific title | Effectiveness of a physiotherapy program in the treatment of urinary incontinence post-prostatectomy: a randomized controlled trial |
| Study objectives | The physical therapy program will improve the urinary incontinence in post-prostatectomy patients in three months. |
| Ethics approval(s) | Pontevedra-Vigo-Ourense Research Ethics Committee of the Health Department, 05/11/2014, ref: 2014/351 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2015 |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 134 patients (67 patients in each group) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/02/2015 |
| Date of final enrolment | 31/12/2017 |
Locations
Countries of recruitment
- Spain
Study participating centre
Vigo
36204
Spain
Sponsor information
University/education
Campus Lagoas Marcosende
Vigo
36310.
Spain
| Phone | +34 (0)986 812 000 |
|---|---|
| m.soto@uvigo.es | |
| Website | www.uvigo.es |
"ROR" |
https://ror.org/05rdf8595 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 12/01/2017 | 18/01/2017 | No | Yes |
Additional files
- ISRCTN48761809_PIS_12Jan17.pdf
- Uploaded 18/01/2017
Editorial Notes
18/01/2017: Participant information sheet added.
