Urinary IncontinenceNCT05311267
Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
A study testing Action observation training in people with Urinary Incontinence, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Urinary incontinence (UI) is one of the most common side effects of radical prostatectomy (RP) and compromises men's quality of life. The first line treatment for urinary incontinence is the conservative approach of Pelvic Floor Muscle Training (PFMT) but, up to date, there seems to be no statistically significant… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Action observation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 15 Nov 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have undergone Robot-assisted Laparoscopic Prostatectomy with post-operative IU.
- Objectivity of recruitment and contraction of pelvic floor musculature (PP) at manual perineal testing.
Who cannot join
- Preoperative incontinence
- Pre-intervention radiotherapy
- Previous urogenital surgery beyond Robot-assisted Laparoscopic Prostatectomy.
- Concomitant presence of neurological, internal or musculoskeletal diseases that may affect functional or motor recovery.
- Less than 5 seconds of endurance in PP contraction
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Roberto Gatti, MSc
About this study
Urinary incontinence (UI) is one of the most common side effects of radical prostatectomy (RP) and compromises men's quality of life. The first line treatment for urinary incontinence is the conservative approach of Pelvic Floor Muscle Training (PFMT) but, up to date, there seems to be no statistically significant difference in the effectiveness of several proposed physiotherapy treatments.
Literature highlights the importance of also adding an educational component regarding the intentional contraction of the pelvic floor muscles (a skill termed "the Knack"). Moreover, in some studies, carried out on a sample of women, was introduced the use of virtual reality. This increased the adherence to treatment and showed an improvement in urinary continence. In addition to virtual reality, another intervention methodology used in physiotherapy is the one of Action Observation training (AOT) whose effectiveness has been proven both in sports and rehabilitation.
Read more
However, currently the effect of this innovative type of treatment has not yet been studied in men with UI following radical prostatectomy intervention.
The aim of this clinical study is to investigate the effectiveness of using AOT on urinary incontinence in subjects undergoing robotic radical prostatectomy.
- Conditions
- Urinary Incontinence
- Being tested
- Action observation training
- Keywords
- Robot-assisted Laparoscopic Prostatectomy, Action Observation Training, pelvic floor muscle training
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation trainingOther
Subject is asked to observe videos with motor contents
| Study group | Role | What they receive |
|---|---|---|
| AOT | Experimental | Participants who, in addiction to standard rehabilitation program after surgery (isometric exercises), underwent two training session of action observation therapy. Receives: Other: Action observation training |
| Control group | No intervention | Participants who received standard rehabilitation program after surgery. The control group, before performing the functional exercises watched two videos of different landscapes lasting 4 minutes each. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in continence using "24 hours pad test"
The primary outcome is to investigate if there is a difference in continence between the experimental and the control group at each physiotherapy session and compared to the baseline (T0).To quantify the extent of these losses, the weight of absorbent devices used by patients in the 24 hours prior to each evaluation will be measured.
Measured: Both groups will be evaluated 45 days after surgery (T0), 1-week after T0 (T1), 2 weeks after T0 (T2), 4 weeks after T0 (T4), 6 weeks after T0 (T6) and 8 weeks after T0 (T8), 3 months after T8 (T9).
Secondary outcomes (3)
Changes in urinary symptoms using International Prostatic Symptoms Score (IPSS)
The secondary objective is to investigate urinary symptoms using International Prostatic Symptoms Score (IPSS)
Measured: Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).
Changes in the quality of life using quality life index (QoL index) 0-6
The secondary objective is to investigate the quality of life using quality life index 0-6
Measured: Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).
Changes in urinary symptoms using International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
The secondary objective is to investigate urinary symptoms using International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Measured: Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Oct 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion15 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311267
- Sponsor's protocol ID
- 751
- Status last verified
- Apr 2022
- First submitted
- 11 Mar 2022
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation Training (AOT) in the Achievement of Urinary Continence in Men After Robot-assisted Laparoscopic Prostatectomy (RALP)
- ClinicalTrials.gov ID
- NCT05311267
- Acronym / sponsor ID
- 751
- Conditions
- Urinary Incontinence
- Keywords
- Robot-assisted Laparoscopic Prostatectomy, Action Observation Training, pelvic floor muscle training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 15 Nov 2022 (estimated)
- First posted
- 5 Apr 2022 (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.
Urinary incontinence (UI) is one of the most common side effects of radical prostatectomy (RP) and compromises men's quality of life. The first line treatment for urinary incontinence is the conservative approach of Pelvic Floor Muscle Training (PFMT) but, up to date, there seems to be no statistically significant difference in the effectiveness of several proposed physiotherapy treatments.
Literature highlights the importance of also adding an educational component regarding the intentional contraction of the pelvic floor muscles (a skill termed "the Knack"). Moreover, in some studies, carried out on a sample of women, was introduced the use of virtual reality. This increased the adherence to treatment and showed an improvement in urinary continence. In addition to virtual reality, another intervention methodology used in physiotherapy is the one of Action Observation training (AOT) whose effectiveness has been proven both in sports and rehabilitation.
However, currently the effect of this innovative type of treatment has not yet been studied in men with UI following radical prostatectomy intervention.
The aim of this clinical study is to investigate the effectiveness of using AOT on urinary incontinence in subjects undergoing robotic radical prostatectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOT | Experimental | Other: Action observation trainingParticipants who, in addiction to standard rehabilitation program after surgery (isometric exercises), underwent two training session of action observation therapy. |
| Control group | No intervention | –Participants who received standard rehabilitation program after surgery. The control group, before performing the functional exercises watched two videos of different landscapes lasting 4 minutes each. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have undergone Robot-assisted Laparoscopic Prostatectomy with post-operative IU.
- Objectivity of recruitment and contraction of pelvic floor musculature (PP) at manual perineal testing.
Key exclusion criteria (5 listed)
- Preoperative incontinence
- Pre-intervention radiotherapy
- Previous urogenital surgery beyond Robot-assisted Laparoscopic Prostatectomy.
- Concomitant presence of neurological, internal or musculoskeletal diseases that may affect functional or motor recovery.
- Less than 5 seconds of endurance in PP contraction
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 |
|---|---|---|
| Action observation trainingSubject is asked to observe videos with motor contents | Other | AOT |
Primary outcome
Changes in continence using "24 hours pad test"
Time frame: Both groups will be evaluated 45 days after surgery (T0), 1-week after T0 (T1), 2 weeks after T0 (T2), 4 weeks after T0 (T4), 6 weeks after T0 (T6) and 8 weeks after T0 (T8), 3 months after T8 (T9).
The primary outcome is to investigate if there is a difference in continence between the experimental and the control group at each physiotherapy session and compared to the baseline (T0).To quantify the extent of these losses, the weight of absorbent devices used by patients in the 24 hours prior to each evaluation will be measured.
3 secondary outcomes
Changes in urinary symptoms using International Prostatic Symptoms Score (IPSS)
Time frame: Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).
Changes in the quality of life using quality life index (QoL index) 0-6
Time frame: Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).
Changes in urinary symptoms using International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)
Time frame: Both groups will be evaluated 45 days after surgery (T0), 8 weeks after T0 (T8) or earlier in case of achievement of the primary goal in previous sessions (T1, T2, T4, T6), and 3 months after T8 (T9).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation training in people with Urinary Incontinence, run by Istituto Clinico Humanitas at 1 site in Italy.
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 5 Apr 2022. 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 Italy. 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 Roberto MSc Gatti (0282245610, Roberto.gatti@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in continence using "24 hours pad test" (time frame: Both groups will be evaluated 45 days after surgery (T0), 1-week after T0 (T1), 2 weeks after T0 (T2), 4 weeks after T0 (T4), 6 weeks after T0 (T6) and 8 weeks after T0 (T8), 3 months after T8 (T9).). 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 5 Apr 2022.