Prostate Cancer Patients Undergoing Radical ProstatectomyPhase 1/2AFPXNCT02233608
Advanced Pelvic Floor Training Program for Prostate Cancer Surgery
A Phase 1/2 study testing Advanced Pelvic Floor Muscle Exercise (APFX) in people with Prostate Cancer Patients Undergoing Radical Prostatectomy, run by University of Guelph-Humber at 1 site in Canada.
Trial summary
Radical prostatectomy is a common and effective treatment for prostate cancer but is associated with urinary incontinence that can persist for several months after surgery and significantly reduce quality of life. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer Patients Undergoing Radical Prostatectomy
- What is being tested?
- Advanced Pelvic Floor Muscle Exercise (APFX)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to 28 Sep 2017
- Phase
- Phase 1/2
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with localized prostate cancer (stage cT1-cT2) who have consented for radical prostatectomy (open retropubic, laparoscopic, robot-assisted laparoscopic)
- Between the the ages of 40 and 80 years
- Proficient in English
Who cannot join
- i) Diagnosed with a known neurological disease, autoimmune connective tissue disorder;
- ii) Have prior experience with pelvic floor training by a healthcare provider;
- iii) Have uncontrolled hypertension;
- iv) Have diagnosed COPD (Chronic Obstructive Pulmonary Disease) and/or chronic restrictive respiratory disease; or
- v) Have a history of inguinal herniation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Pilot Study of Conventional Versus Advanced Pelvic Floor Exercises to Treat Urinary Incontinence After Radical Prostatectomy
Radical prostatectomy is a common and effective treatment for prostate cancer but is associated with urinary incontinence that can persist for several months after surgery and significantly reduce quality of life. Studies have shown that routine performance of pelvic floor exercises after radical prostatectomy can aid in the recovery of urinary control; however, conventional pelvic floor exercises do not produce consistent results. Research indicates that incorporating other deep abdominal muscles can further activate the pelvic floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates' and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises with activation of supportive muscles. Our proposed study will be the first to test the effect of an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim of this study is to assess the feasibility of conducting a full-scale RCT of an advanced pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates, and Hypopressives techniques on urinary incontinence. Feasibility will be determined by measuring recruitment success, retention, outcome capture, and intervention adherence, tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate cancer in the advance pelvic floor training program will report greater improvement in urinary incontinence and health-related quality of life.
- Being tested
- Advanced Pelvic Floor Muscle Exercise (APFX)
- Keywords
- Prostate cancer, Radical prostatectomy, Pelvic floor muscle exercises, Pfilates, Hypopressives, Urinary Incontinence
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Pelvic Floor Muscle Exercise (APFX)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | The usual care group will receive generic pelvic floor muscle exercise (PMFX) instructions and demonstrations by the research coordinator at the initial post-operative time point. This will include instruction on how to engage the pelvic floor and specific PFMX prescription. Repetition volume will start at 20 repetitions per day during weeks 1-2; 60/day during weeks 3-4; and 90/day during weeks 5-6, and 100+/day for weeks 7-26. The total number of repetitions will be divided equally between rhythmic (contract and relaxed over one second) and sustained contractions (contract and hold for up to 10 seconds). |
| Advanced Pelvic Floor Exercise (APFX) | Experimental | Participants in this group will receive detailed week-by-week description of the program. The program progresses participants through stages of training every two weeks, starting the introduction of basic PFMX, and slowly incorporates Pfilates and Hypopressives exercises until week 8, where patients will maintain the final stage of training until week 26 or urinary incontinence is completely resolved. Receives: Behavioral: Advanced Pelvic Floor Muscle Exercise (APFX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Prior pelvic floor training trials in prostate cancer patients undergoing radical prostatectomy have observed recruitment rates of 21-70%. We will measure recruitment success through participant recruitment per week and record reasons for non-participation from those who inquire about the study and are eligible to participate but refuse.
Measured: When recruitment is complete (approximately 12 months after study initiation; October 2015)
Adherence to intervention group
Adherence to the two groups (standard pelvic floor exercises and advanced pelvic floor exercises) will be measured through a logbook that is included in their respective program manuals as well as a logbook completed by the research coordinator during the weekly telephone communications.
Measured: 26 weeks post-operatively
Study retention
Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.
Measured: 26 weeks post-operative
24-hour Pad Test for Urinary Leakage
A 24-hour pad test will be used to measure urinary incontinence by assessing the quantity of urine lost in one day. A urinary leakage pad is measured after a 24-hour period and compared to the unused pad weight and is used to most accurately assess the severity of urinary incontinence.
Measured: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
Pelvic Floor Strength
Digital rectal examination of pelvic floor strength by a specially trained pelvic floor physiotherapist will be conducted. Pelvic floor strength will be graded on the Modified Oxford Scale.
Measured: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26, weeks post-operatively
Secondary outcomes (5)
Quality of Life
Prostate specific quality of life will be measured using the Functional Assessment of Cancer Treatment-Prostate (FACT-P) and the Patient-Oriented Prostate Utility Scale (PORPUS).
Measured: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operative
3-Day Bladder Diary for Urinary Incontinence
The bladder diary is a standard instrument for self-reporting voiding patterns. Items include fluid intake, frequency of toilet voids, episode of urine loss, number of pads used, and activity during event for the three-day period. Bladder diaries are widely used in clinical trials assessing urinary incontinence after radical prostatectomy.
Measured: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Self-Reported Urinary Incontinence, Prostate Symptoms, and Erectile Function
Urological symptoms are assessed using the International Prostate Symptom Score (IPSS). Additional, a single item regarding leaking urine and bladder control from the PORPUS will be used to evaluate incontinence. Erectile function will be assessed using the 5-item International Index of Erectile Function scale (5-IIEF).
Measured: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Body Composition
Body composition will be assessed via bioelectrical impedance analysis, height, weight, waist and hip circumference, and body mass index.
Measured: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Physical Activity
Physical activity level will be measured wight he 3-item Godin Leisure Time Exercise Questionnaire - Leisure Score Index (GLTEQ-LSI).
Measured: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startJan 2015
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer Patients Undergoing Radical ProstatectomyStudies 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Guelph-Humber
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, University Health Network, Toronto
- Responsible party
- Principal investigator, Daniel Santa Mina, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233608
- Sponsor's protocol ID
- D2014-20
- Acronym
- AFPX
- Status last verified
- Oct 2017
- First submitted
- 3 Sep 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Santa Mina D, Au D, Alibhai SM, Jamnicky L, Faghani N, Hilton WJ, Stefanyk LE, Ritvo P, Jones J, Elterman D, Fleshner NE, Finelli A, Singal RK, Trachtenberg J, Matthew AG. A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol. BMC Urol. 2015 Sep 16;15:94. doi: 10.1186/s12894-015-0088-4.
PubMed 26377550
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of Conventional Versus Advanced Pelvic Floor Exercises to Treat Urinary Incontinence After Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02233608
- Acronym / sponsor ID
- AFPX / D2014-20
- Keywords
- Prostate cancer, Radical prostatectomy, Pelvic floor muscle exercises, Pfilates, Hypopressives, Urinary Incontinence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of Guelph-HumberUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, University Health Network, Toronto
- Study start
- Jan 2015
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 8 Sep 2014 (estimated)
- 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.
Radical prostatectomy is a common and effective treatment for prostate cancer but is associated with urinary incontinence that can persist for several months after surgery and significantly reduce quality of life. Studies have shown that routine performance of pelvic floor exercises after radical prostatectomy can aid in the recovery of urinary control; however, conventional pelvic floor exercises do not produce consistent results. Research indicates that incorporating other deep abdominal muscles can further activate the pelvic floor making it stronger than by activating the pelvic floor alone. Specifically, 'Pfilates' and 'Hypopressives' are two new techniques that combine traditional pelvic floor exercises with activation of supportive muscles. Our proposed study will be the first to test the effect of an advanced pelvic floor exercise training program that includes Pfilates and Hypopressives to treat urinary incontinence following radical prostatectomy. Our primary aim of this study is to assess the feasibility of conducting a full-scale RCT of an advanced pelvic floor exercise training program, including standard pelvic floor exercises, Pfilates, and Hypopressives techniques on urinary incontinence. Feasibility will be determined by measuring recruitment success, retention, outcome capture, and intervention adherence, tolerance, and safety. We hypothesize men under going radical prostatectomy for prostate cancer in the advance pelvic floor training program will report greater improvement in urinary incontinence and health-related quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –The usual care group will receive generic pelvic floor muscle exercise (PMFX) instructions and demonstrations by the research coordinator at the initial post-operative time point. This will include instruction on how to engage the pelvic floor and specific PFMX prescription. Repetition volume will start at 20 repetitions per day during weeks 1-2; 60/day during weeks 3-4; and 90/day during weeks 5-6, and 100+/day for weeks 7-26. The total number of repetitions will be divided equally between rhythmic (contract and relaxed over one second) and sustained contractions (contract and hold for up to 10 seconds). |
| Advanced Pelvic Floor Exercise (APFX) | Experimental | Behavioral: Advanced Pelvic Floor Muscle Exercise (APFX)Participants in this group will receive detailed week-by-week description of the program. The program progresses participants through stages of training every two weeks, starting the introduction of basic PFMX, and slowly incorporates Pfilates and Hypopressives exercises until week 8, where patients will maintain the final stage of training until week 26 or urinary incontinence is completely resolved. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men with localized prostate cancer (stage cT1-cT2) who have consented for radical prostatectomy (open retropubic, laparoscopic, robot-assisted laparoscopic)
- Between the the ages of 40 and 80 years
- Proficient in English
Key exclusion criteria (5 listed)
- i) Diagnosed with a known neurological disease, autoimmune connective tissue disorder;
- ii) Have prior experience with pelvic floor training by a healthcare provider;
- iii) Have uncontrolled hypertension;
- iv) Have diagnosed COPD (Chronic Obstructive Pulmonary Disease) and/or chronic restrictive respiratory disease; or
- v) Have a history of inguinal herniation
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 |
|---|---|---|
| Advanced Pelvic Floor Muscle Exercise (APFX) | Behavioural | Advanced Pelvic Floor Exercise (APFX) |
Primary outcome
Recruitment
Time frame: When recruitment is complete (approximately 12 months after study initiation; October 2015)
Prior pelvic floor training trials in prostate cancer patients undergoing radical prostatectomy have observed recruitment rates of 21-70%. We will measure recruitment success through participant recruitment per week and record reasons for non-participation from those who inquire about the study and are eligible to participate but refuse.
Adherence to intervention group
Time frame: 26 weeks post-operatively
Adherence to the two groups (standard pelvic floor exercises and advanced pelvic floor exercises) will be measured through a logbook that is included in their respective program manuals as well as a logbook completed by the research coordinator during the weekly telephone communications.
Study retention
Time frame: 26 weeks post-operative
Retention will be assessed by measuring attrition throughout the intervention period and at each assessment.
24-hour Pad Test for Urinary Leakage
Time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
A 24-hour pad test will be used to measure urinary incontinence by assessing the quantity of urine lost in one day. A urinary leakage pad is measured after a 24-hour period and compared to the unused pad weight and is used to most accurately assess the severity of urinary incontinence.
Pelvic Floor Strength
Time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26, weeks post-operatively
Digital rectal examination of pelvic floor strength by a specially trained pelvic floor physiotherapist will be conducted. Pelvic floor strength will be graded on the Modified Oxford Scale.
5 secondary outcomes
Quality of Life
Time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operative
3-Day Bladder Diary for Urinary Incontinence
Time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Self-Reported Urinary Incontinence, Prostate Symptoms, and Erectile Function
Time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Body Composition
Time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 week post-operatively
Physical Activity
Time frame: At baseline, approximately 1 week prior to surgery, and 2, 6, 12, 26 weeks post-operatively
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 26 Oct 2017.
- Derived from this study: PubMed 26377550Santa Mina D, Au D, Alibhai SM, Jamnicky L, Faghani N, Hilton WJ, Stefanyk LE, Ritvo P, Jones J, Elterman D, Fleshner NE, Finelli A, Singal RK, Trachtenberg J, Matthew AG. A pilot randomized trial of conventional versus advanced pelvic floor exercises to treat urinary incontinence after radical prostatectomy: a study protocol. BMC Urol. 2015 Sep 16;15:94. doi: 10.1186/s12894-015-0088-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Advanced Pelvic Floor Muscle Exercise (APFX) in people with Prostate Cancer Patients Undergoing Radical Prostatectomy, run by University of Guelph-Humber at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 26 Oct 2017. 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 Canada. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recruitment (time frame: When recruitment is complete (approximately 12 months after study initiation; October 2015)). The study lists 5 primary outcomes in all. 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 NCT02233608, which also lists 1 linked publication.
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 26 Oct 2017.