ProstatectomyNCT03714984
The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence
A study testing Pre operative exercise in people with Prostatectomy and Pelvic Floor Disorders, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Prostate cancer is the most common type of cancer between male population and urinary incontinence (UI) is the most common of long-term sequelae. Nowadays, robotic prostatectomy became the surgery standard but there is still discrepant results regards the incidence of UI and there is a lack of studies about the use of… Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Prostatectomy, Pelvic Floor Disorders
- What is being tested?
- Pre operative exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2018to 4 Dec 2023
- 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 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form
- Age >= 40 <= 70 years old
- Body mass Index <= 27
- Indication of robotic prostate surgery
- Tumor with clinical stage T1 and T2.
- Extracapsular Extension Score <= 3, measured with magnetic resonance before surgery.
Who cannot join
- Pathologic T3 tumor with radiotherapy indication
- Previous prostate surgery
- Previous urinary incontinence.
- Metabolic disorder
- Central or peripheral neurologic disorders
- Inability to understand informed consent or to carry out the rehabilitation protocol autonomously.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence in Patients Underwent Robotic Prostatectomy. A Randomized Clinical Trial
Prostate cancer is the most common type of cancer between male population and urinary incontinence (UI) is the most common of long-term sequelae. Nowadays, robotic prostatectomy became the surgery standard but there is still discrepant results regards the incidence of UI and there is a lack of studies about the use of pelvic floor rehabilitation in this population. Our study aims to assesses the efficacy of preoperative educational method in urinary incontinence after robotic prostatectomy.
Read the detailed description
Prostate cancer is the most common type of cancer between male population, with 161,300 new cases a year in the USA and an incidence of 10% in Italy. Since many years surgery is the treatment of choice, both at an early stage and in advanced cases, but involves side effects. From the post-operative problem presents in literature, urinary incontinence (UI) is the most common of long-term sequelae and significantly affects the quality of life and the psychological aspect in the post-surgical period. The incidence of UI after prostatectomy surgery varies between 0.8% and 87% in the first 3 and 6 months and between 5% and 44.5% after 1 year. This variability depends on the UI definition and the type of measurement used, which are not homogeneous among the various studies in the literature. Evaluations that are not objective make it difficult to compare the results obtained, thus creating discrepancies.
To date, robotic prostatectomy is becoming the gold standard for its recognized greater accuracy when compared with the open surgery and laparoscopic procedure, with a reduced learning curve for operators and giving better post-surgical results. Progress technological aspects, such as the three-dimensional vision of the operative field, the macroscopic magnification and better image resolution, have made the robotic procedure a less invasive surgery with better functional outcomes. Despite these factors, UI is still present and in the majority of cases management is not completely evidence based. Moreover there is not yet a definite consensus regarding the predictive factors (age, disease stage, body weight, prostate volume and other comorbidities) in the incidence of the UI.
When patients presents UI diagnoses, the conservative intervention through the pelvic floor rehabilitation is recommended in an attempt to reduce the impact of this complication. Muscle strengthening and pelvic floor awareness after surgery are used for years in clinical practice with results widely documented in the literature, but their effectiveness in the pre-operative period, especially if after robotic surgery, has not yet been sufficiently studied. Currently, there are discrepant results mainly due to the type of rehabilitative methodology applied and the time of beginning the preoperative treatment. Our study tries to evaluate, through an objective and reproducible measurement, the efficacy of a preoperative educational method in urinary incontinence after robotic prostatectomy.
- Conditions
- Prostatectomy, Pelvic Floor Disorders
- Being tested
- Pre operative exercise, Control Group
- Keywords
- Prostatectomy, Pelvic Floor Disorders, Robotic Surgical Procedures, rehabilitation
- Medical subject headings
- Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre operative exerciseOther
After randomization participants will be allocated in two groups. The educational pelvic floor intervention group will receive two months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction.
Control GroupOther
The control group will be just informed about the study protocol and will not receive any pre-operative intervention.
| Study group | Role | What they receive |
|---|---|---|
| Pre operative exercise | Experimental | The educational pelvic floor intervention group will receive one months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction. Patients and care giver will receive a daily exercise diary to fill at home and will be advised to follow the exercise program. Receives: Other: Pre operative exercise |
| Control group | Active comparator | The control group will be just informed about the study protocol and will not receive any pre-operative intervention. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported urinary continence
Continence (completely dry patient) will be defined as the sum of no urinary leakage reported by the patient in his bladder diary
Measured: 1,3,6 months and 1 year after surgery
Secondary outcomes (5)
The degree of urinary incontinence.
Assesment of the degree of urinary incontinence based on a 24 hours pad test.
Measured: 1,3,6 months and 1 year after surgery
Quality of life instrument
Assesment of quality of life using the The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire.
Measured: 1,3,6 months and 1 year after surgery
Assesment of the post traumatic distress using the Impact of event Scale (IES).
Scale range from 0 to 4 with lower values representing better outcomes
Measured: 1,3,6 months and 1 year after surgery
Assesment of the individual resilience with the resilience scale for adults (RSA).
Scale range from 1 to 5 with lower values representing better outcomes
Measured: 1,3,6 months and 1 year after surgery
Assesment of the urinary status with the International Consultation on Incontinence (ICIQ) Questionnaire.
Summed of sub scales range from 0 to 3, 0 to 6 and 1 to 10. Minimum score of 1 and maximum score of 19, with lower values representing better outcomes
Measured: 1,3,6 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start15 Oct 2018
- Primary completion4 Dec 2019
- Study completion4 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ProstatectomyStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Superiority trial with 1:1 allocation ratio, randomized with two-arm parallel group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luiz Felipe Nevola Teixeira, PT, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714984
- Sponsor's protocol ID
- IEO 818
- Status last verified
- Jun 2023
- First submitted
- 18 Oct 2018
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fossati N, Di Trapani E, Gandaglia G, Dell'Oglio P, Umari P, Buffi NM, Guazzoni G, Mottrie A, Gaboardi F, Montorsi F, Briganti A, Suardi N. Assessing the Impact of Surgeon Experience on Urinary Continence Recovery After Robot-Assisted Radical Prostatectomy: Results of Four High-Volume Surgeons. J Endourol. 2017 Sep;31(9):872-877. doi: 10.1089/end.2017.0085. Epub 2017 Jul 21.
PubMed 28732186Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.
PubMed 20227168Moore KN, Valiquette L, Chetner MP, Byrniak S, Herbison GP. Return to continence after radical retropubic prostatectomy: a randomized trial of verbal and written instructions versus therapist-directed pelvic floor muscle therapy. Urology. 2008 Dec;72(6):1280-6. doi: 10.1016/j.urology.2007.12.034. Epub 2008 Apr 2.
PubMed 18384853Burgio KL, Goode PS, Urban DA, Umlauf MG, Locher JL, Bueschen A, Redden DT. Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial. J Urol. 2006 Jan;175(1):196-201; discussion 201. doi: 10.1016/S0022-5347(05)00047-9.
PubMed 16406909
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pre-operative Educational Pelvic Floor Intervention on Urinary Continence in Patients Underwent Robotic Prostatectomy. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03714984
- Acronym / sponsor ID
- IEO 818
- Conditions
- Prostatectomy, Pelvic Floor Disorders
- Keywords
- Prostatectomy, Pelvic Floor Disorders, Robotic Surgical Procedures, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 22 Oct 2018 (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.
Prostate cancer is the most common type of cancer between male population and urinary incontinence (UI) is the most common of long-term sequelae. Nowadays, robotic prostatectomy became the surgery standard but there is still discrepant results regards the incidence of UI and there is a lack of studies about the use of pelvic floor rehabilitation in this population. Our study aims to assesses the efficacy of preoperative educational method in urinary incontinence after robotic prostatectomy.
Detailed description
Prostate cancer is the most common type of cancer between male population, with 161,300 new cases a year in the USA and an incidence of 10% in Italy. Since many years surgery is the treatment of choice, both at an early stage and in advanced cases, but involves side effects. From the post-operative problem presents in literature, urinary incontinence (UI) is the most common of long-term sequelae and significantly affects the quality of life and the psychological aspect in the post-surgical period. The incidence of UI after prostatectomy surgery varies between 0.8% and 87% in the first 3 and 6 months and between 5% and 44.5% after 1 year. This variability depends on the UI definition and the type of measurement used, which are not homogeneous among the various studies in the literature. Evaluations that are not objective make it difficult to compare the results obtained, thus creating discrepancies.
To date, robotic prostatectomy is becoming the gold standard for its recognized greater accuracy when compared with the open surgery and laparoscopic procedure, with a reduced learning curve for operators and giving better post-surgical results. Progress technological aspects, such as the three-dimensional vision of the operative field, the macroscopic magnification and better image resolution, have made the robotic procedure a less invasive surgery with better functional outcomes. Despite these factors, UI is still present and in the majority of cases management is not completely evidence based. Moreover there is not yet a definite consensus regarding the predictive factors (age, disease stage, body weight, prostate volume and other comorbidities) in the incidence of the UI.
When patients presents UI diagnoses, the conservative intervention through the pelvic floor rehabilitation is recommended in an attempt to reduce the impact of this complication. Muscle strengthening and pelvic floor awareness after surgery are used for years in clinical practice with results widely documented in the literature, but their effectiveness in the pre-operative period, especially if after robotic surgery, has not yet been sufficiently studied. Currently, there are discrepant results mainly due to the type of rehabilitative methodology applied and the time of beginning the preoperative treatment. Our study tries to evaluate, through an objective and reproducible measurement, the efficacy of a preoperative educational method in urinary incontinence after robotic prostatectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Superiority trial with 1:1 allocation ratio, randomized with two-arm parallel group
| Arm | Type | Receives |
|---|---|---|
| Pre operative exercise | Experimental | Other: Pre operative exerciseThe educational pelvic floor intervention group will receive one months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction. Patients and care giver will receive a daily exercise diary to fill at home and will be advised to follow the exercise program. |
| Control group | Active comparator | Other: Control GroupThe control group will be just informed about the study protocol and will not receive any pre-operative intervention. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form
- Age >= 40 <= 70 years old
- Body mass Index <= 27
- Indication of robotic prostate surgery
- Tumor with clinical stage T1 and T2.
Key exclusion criteria (6 listed)
- Pathologic T3 tumor with radiotherapy indication
- Previous prostate surgery
- Previous urinary incontinence.
- Metabolic disorder
- Central or peripheral neurologic disorders
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 |
|---|---|---|
| Pre operative exerciseAfter randomization participants will be allocated in two groups. The educational pelvic floor intervention group will receive two months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction. | Other | Pre operative exercise |
| Control GroupThe control group will be just informed about the study protocol and will not receive any pre-operative intervention. | Other | Control group |
Primary outcome
Change in self-reported urinary continence
Time frame: 1,3,6 months and 1 year after surgery
Continence (completely dry patient) will be defined as the sum of no urinary leakage reported by the patient in his bladder diary
5 secondary outcomes
The degree of urinary incontinence.
Time frame: 1,3,6 months and 1 year after surgery
Quality of life instrument
Time frame: 1,3,6 months and 1 year after surgery
Assesment of the post traumatic distress using the Impact of event Scale (IES).
Time frame: 1,3,6 months and 1 year after surgery
Assesment of the individual resilience with the resilience scale for adults (RSA).
Time frame: 1,3,6 months and 1 year after surgery
Assesment of the urinary status with the International Consultation on Incontinence (ICIQ) Questionnaire.
Time frame: 1,3,6 months and 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 28732186Fossati N, Di Trapani E, Gandaglia G, Dell'Oglio P, Umari P, Buffi NM, Guazzoni G, Mottrie A, Gaboardi F, Montorsi F, Briganti A, Suardi N. Assessing the Impact of Surgeon Experience on Urinary Continence Recovery After Robot-Assisted Radical Prostatectomy: Results of Four High-Volume Surgeons. J Endourol. 2017 Sep;31(9):872-877. doi: 10.1089/end.2017.0085. Epub 2017 Jul 21.
- Background: PubMed 20227168Centemero A, Rigatti L, Giraudo D, Lazzeri M, Lughezzani G, Zugna D, Montorsi F, Rigatti P, Guazzoni G. Preoperative pelvic floor muscle exercise for early continence after radical prostatectomy: a randomised controlled study. Eur Urol. 2010 Jun;57(6):1039-43. doi: 10.1016/j.eururo.2010.02.028. Epub 2010 Mar 1.
- Background: PubMed 18384853Moore KN, Valiquette L, Chetner MP, Byrniak S, Herbison GP. Return to continence after radical retropubic prostatectomy: a randomized trial of verbal and written instructions versus therapist-directed pelvic floor muscle therapy. Urology. 2008 Dec;72(6):1280-6. doi: 10.1016/j.urology.2007.12.034. Epub 2008 Apr 2.
- Background: PubMed 16406909Burgio KL, Goode PS, Urban DA, Umlauf MG, Locher JL, Bueschen A, Redden DT. Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial. J Urol. 2006 Jan;175(1):196-201; discussion 201. doi: 10.1016/S0022-5347(05)00047-9.
- 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.
Luiz Felipe Nevola Teixeira, PT principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre operative exercise in people with Prostatectomy and Pelvic Floor Disorders, run by European Institute of Oncology 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 17 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported urinary continence (time frame: 1,3,6 months and 1 year after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03714984, which also lists 4 linked publications.
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 17 Apr 2024.