Prostate CancerNCT04284020
Educational Program Plus Physiotherapy After Prostatectomy
A study testing Therapeutic educational program, PFMT and TTNS in people with Prostate Cancer and Side Effects, run by University of Alcala at 1 site in Spain.
Trial summary
Objective: to find out the effectiveness of therapeutic education program plus pelvic-perineal physical therapy in radical robotic prostatectomy men in terms of quality of life (QoL), urinary incontinence (UI), erectile dysfunction (ED) and muscle strength. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer, Side Effects
- What is being tested?
- Therapeutic educational program, PFMT and TTNS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men had undergone radical robotic prostate surgery.
- Men reading, understanding and freely signing an informed consent form.
Who cannot join
- Participants who had received adjuvant therapies (chemotherapy, radiotherapy) before pelvic-perineal physical therapy treatment.
- Men with a history of pelvic organ surgery.
- Men with chronic diseases that affects their quality of life.
- Participants with psychiatric or neurological problems.
- Postoperative men with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.
Trial locations and contacts
1 site in 1 country.
Cristina Romojaro-Pérez, PhD student contact
Cristina Romojaro-Pérez, PhD student contact
Spain1 site, 1 recruiting
- Recruiting
University of Alcalá. FPSM research group. HUPA
Alcalá de Henares, Madrid, 28805
María Torres-Lacomba, PhD, maria.torres@uah.es
Cristina Romojaro-Pérez, PhD student, cromojaroperez@gmail.com
About this study
Official title: Efficacy of Therapeutic Education After Radical Robotic Prostate Surgery: Randomized Clinical Trial
Objective: to find out the effectiveness of therapeutic education program plus pelvic-perineal physical therapy in radical robotic prostatectomy men in terms of quality of life (QoL), urinary incontinence (UI), erectile dysfunction (ED) and muscle strength.
Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned in two groups. Experimental group: training pelvic-perineal physical therapy plus lifestyle education. Control group: training in pelvic-perineal physical therapy only. In the 2 groups several physical therapy measurements will be undertaken: 1st before physical therapy treatment, 2nd, 3 th and 4th after 3, 6 and 12 months after initial measurement.
Read more
Study subjects: Post radical robotic prostatectomy men, which have not been already treated with adjuvant treatment and pelvic-perineal physical therapy, and after reading, understanding and freely signing an informed consent form.
Sample size: 84 subjects will be included (42 subjects per group). To have a statistical power of 90% to detect an average difference of 10 points between two groups in the change of quality of life according to the questionnaire validated in Spanish SF-12, assuming a standard deviation of the change of 20 points based on the study from Hou et al, establishing an alpha risk of 0.05, in a bilateral contrast and assuming a 10% of drops outs.
Data analysis: Separate analyzes of each variable collected in the two groups will be carried out. For continuous variables, means, medians, standard deviations and quartiles will be calculated, depending on the assumption or not, respectively, of the assumption of their normality previously determined with the Shapiro Wilk test (S-W). Qualitative variables will be described with absolute and relative percentage frequencies. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between measurements.
- Conditions
- Prostate Cancer, Side Effects
- Being tested
- Therapeutic educational program, PFMT, TTNS
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic educational programBehavioural
See arm/group descriptions
PFMTOther
Also called Pelvic floor muscle training
See arm/group descriptions
TTNSOther
Also called Transcutaneous tibial nerve stimulation
See arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Educational program & pelvic floor muscle training | Experimental | The educational strategy will consist of explaining a healthy lifestyle guide with videos, mobile apps and activities about the anatomy of the pelvic floor and the physiology of the pelvic organs. It will be recommended to avoid risk factors, such as gaining weight, high impact sports, constipation, smoking, or drinking too much caffeine and alcohol. They will also instruct in toilet habits.
The pelvic floor muscle training (PFMT) protocol will be applied. Participants will perform exercises with anal biofeedback, perineal and erectile dysfunction electrotherapy protocol and surface electromyography. They will perform PFMT in supine position, sitting, standing and walking. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30/40 minutes.
If the patients have overactive bladder symptoms they will perform transcutaneous tibial nerve stimulation (TTNS) protocol. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30 minutes. Receives: Behavioral: Therapeutic educational program; Other: PFMT; Other: TTNS |
| PFMT group | Active comparator | They will receive a basic behavioral educational strategy in the first session including pelvic anatomy and physiology, recommendations to avoid risk factors and toilet habits.
The PFMT protocol will be applied. Participants will perform PFMT exercises with anal biofeedback, perineal and erectile dysfunction electrotherapy protocol and surface electromyography. They will perform PFMT in supine position, sitting, standing and walking. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30/40 minutes.
If the patients have overactive bladder symptoms they will perform transcutaneous tibial nerve stimulation (TTNS) protocol. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30 minutes. Receives: Other: PFMT; Other: TTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QoL
It will be assessed by Short Form 12 (SF-12) Spanish version. The SF-12 consist in 12 items of 8 dimensions: 2 items about physical function, 1 item about social function, 2 items about physical role, 2 items about emotional role, 2 items about mental health, 1 item about vitality, 1 items about body pain, 1 item about general health. The 8 dimensions are scored from 0 (bad health) to 100 (optimal state of health).
Measured: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Change in UI
It will be assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) Spanish version.
The ICIQ-UI SF consist in 3 items (Frequency, Quantity and Impact) and 8 questions to identify the UI type. The 3 items are scored from 0 (no incontinence) to 21 (severe incontinence).
It will be assessed by 1 hour Pad Test. The Pad test consists in weigh a compress after being used under standardized conditions.
Measured: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Change in Prostatic Symptoms
It will be assessed by International Prostate Symptom Score (IPSS) Spanish version.
The IPSS consist of 6 items plus one about quality of life. The 6 items are scored from 1-7 (mild symptomatology), 8-19 (moderate symptomatology) to 20-35 (severe symptomatology).The item about quality of life is measured qualitatively.
Measured: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Change in Pelvic Floor Muscle Strength
The measuring consists of 4 factors: strength, relax, endurance and repeatability.
It will be measured with manometry (mmHg).
Measured: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Change in ED
It will be assessed by Short Questionnaire for Erectile Dysfunction (SQUED) Spanish version.
The SQUED consist of 3 items. The 3 items are scored from 0 (severe dysfunction) to 15 (no dysfunction).
Measured: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Assess adherence and satisfaction to treatment
It will be assessed by benefit, satisfaction and willingness to continue treatment questionnaire (BSD) Spanish version.
The BSD consist of 3 items: perception of the benefit, satisfaction with the treatment and willingness of the patient to continue with the treatment.
The 3 items are scored from 0 (no satisfaction and no adherence) to 10 (much satisfaction and adherence).
Measured: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Dec 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups: 1 experimental and 1 control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Romojaro Perez, University of Alcala
- Investigators
- Maria Torres-Lacomba, PhD, Study director, University of Alcalá. FPSM research group. HUPABeatriz Navarro-Brázalez, PhD, Study chair, University of Alcalá. FPSM research group. HUPA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284020
- Sponsor's protocol ID
- 4/2018
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Therapeutic Education After Radical Robotic Prostate Surgery: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04284020
- Acronym / sponsor ID
- 4/2018
- Conditions
- Prostate Cancer, Side Effects
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: to find out the effectiveness of therapeutic education program plus pelvic-perineal physical therapy in radical robotic prostatectomy men in terms of quality of life (QoL), urinary incontinence (UI), erectile dysfunction (ED) and muscle strength.
Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned in two groups. Experimental group: training pelvic-perineal physical therapy plus lifestyle education. Control group: training in pelvic-perineal physical therapy only. In the 2 groups several physical therapy measurements will be undertaken: 1st before physical therapy treatment, 2nd, 3 th and 4th after 3, 6 and 12 months after initial measurement.
Study subjects: Post radical robotic prostatectomy men, which have not been already treated with adjuvant treatment and pelvic-perineal physical therapy, and after reading, understanding and freely signing an informed consent form.
Sample size: 84 subjects will be included (42 subjects per group). To have a statistical power of 90% to detect an average difference of 10 points between two groups in the change of quality of life according to the questionnaire validated in Spanish SF-12, assuming a standard deviation of the change of 20 points based on the study from Hou et al, establishing an alpha risk of 0.05, in a bilateral contrast and assuming a 10% of drops outs.
Data analysis: Separate analyzes of each variable collected in the two groups will be carried out. For continuous variables, means, medians, standard deviations and quartiles will be calculated, depending on the assumption or not, respectively, of the assumption of their normality previously determined with the Shapiro Wilk test (S-W). Qualitative variables will be described with absolute and relative percentage frequencies. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- two groups: 1 experimental and 1 control group
| Arm | Type | Receives |
|---|---|---|
| Educational program & pelvic floor muscle training | Experimental | Behavioral: Therapeutic educational program, Other: PFMT, Other: TTNSThe educational strategy will consist of explaining a healthy lifestyle guide with videos, mobile apps and activities about the anatomy of the pelvic floor and the physiology of the pelvic organs. It will be recommended to avoid risk factors, such as gaining weight, high impact sports, constipation, smoking, or drinking too much caffeine and alcohol. They will also instruct in toilet habits. The pelvic floor muscle training (PFMT) protocol will be applied. Participants will perform exercises with anal biofeedback, perineal and erectile dysfunction electrotherapy protocol and surface electromyography. They will perform PFMT in supine position, sitting, standing and walking. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30/40 minutes. If the patients have overactive bladder symptoms they will perform transcutaneous tibial nerve stimulation (TTNS) protocol. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30 minutes. |
| PFMT group | Active comparator | Other: PFMT, Other: TTNSThey will receive a basic behavioral educational strategy in the first session including pelvic anatomy and physiology, recommendations to avoid risk factors and toilet habits. The PFMT protocol will be applied. Participants will perform PFMT exercises with anal biofeedback, perineal and erectile dysfunction electrotherapy protocol and surface electromyography. They will perform PFMT in supine position, sitting, standing and walking. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30/40 minutes. If the patients have overactive bladder symptoms they will perform transcutaneous tibial nerve stimulation (TTNS) protocol. The intervention will last 5 weeks, 2 sessions per week. Each session will last 30 minutes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men had undergone radical robotic prostate surgery.
- Men reading, understanding and freely signing an informed consent form.
Key exclusion criteria (5 listed)
- Participants who had received adjuvant therapies (chemotherapy, radiotherapy) before pelvic-perineal physical therapy treatment.
- Men with a history of pelvic organ surgery.
- Men with chronic diseases that affects their quality of life.
- Participants with psychiatric or neurological problems.
- Postoperative men with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic educational programSee arm/group descriptions | Behavioural | Educational program & pelvic floor muscle training |
| PFMTAlso: Pelvic floor muscle trainingSee arm/group descriptions | Other | Educational program & pelvic floor muscle training, PFMT group |
| TTNSAlso: Transcutaneous tibial nerve stimulationSee arm/group descriptions | Other | Educational program & pelvic floor muscle training, PFMT group |
Primary outcome
Change in QoL
Time frame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
It will be assessed by Short Form 12 (SF-12) Spanish version. The SF-12 consist in 12 items of 8 dimensions: 2 items about physical function, 1 item about social function, 2 items about physical role, 2 items about emotional role, 2 items about mental health, 1 item about vitality, 1 items about body pain, 1 item about general health. The 8 dimensions are scored from 0 (bad health) to 100 (optimal state of health).
Change in UI
Time frame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
It will be assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence (ICIQ-UI) Spanish version. The ICIQ-UI SF consist in 3 items (Frequency, Quantity and Impact) and 8 questions to identify the UI type. The 3 items are scored from 0 (no incontinence) to 21 (severe incontinence). It will be assessed by 1 hour Pad Test. The Pad test consists in weigh a compress after being used under standardized conditions.
Change in Prostatic Symptoms
Time frame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
It will be assessed by International Prostate Symptom Score (IPSS) Spanish version. The IPSS consist of 6 items plus one about quality of life. The 6 items are scored from 1-7 (mild symptomatology), 8-19 (moderate symptomatology) to 20-35 (severe symptomatology).The item about quality of life is measured qualitatively.
Change in Pelvic Floor Muscle Strength
Time frame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
The measuring consists of 4 factors: strength, relax, endurance and repeatability. It will be measured with manometry (mmHg).
Change in ED
Time frame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
It will be assessed by Short Questionnaire for Erectile Dysfunction (SQUED) Spanish version. The SQUED consist of 3 items. The 3 items are scored from 0 (severe dysfunction) to 15 (no dysfunction).
Assess adherence and satisfaction to treatment
Time frame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.
It will be assessed by benefit, satisfaction and willingness to continue treatment questionnaire (BSD) Spanish version. The BSD consist of 3 items: perception of the benefit, satisfaction with the treatment and willingness of the patient to continue with the treatment. The 3 items are scored from 0 (no satisfaction and no adherence) to 10 (much satisfaction and adherence).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Romojaro-Pérez, PhD student contact
Cristina Romojaro-Pérez, PhD student contact
Maria Torres-Lacomba, PhD study director
University of Alcalá. FPSM research group. HUPA
Beatriz Navarro-Brázalez, PhD study chair
University of Alcalá. FPSM research group. HUPA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic educational program, PFMT and TTNS in people with Prostate Cancer and Side Effects, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Romojaro-Pérez, PhD student (cromojaroperez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in QoL (time frame: 4 measurements to evaluate: before physical therapy treatment, 3 months, 6 months and 12 months after initial measurement.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020; AzTrials last refreshed its copy on 27 Oct 2026.