Prostate CancerNCT02558946
Physical Therapy for Men Undergoing Prostatectomy
A study testing Pelvic Floor Muscle Physical Therapy in people with Prostate Cancer and Urinary Incontinence, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to determine if pelvic floor muscle training with a physical therapist before and after surgery will improve health-related quality of life following robot-assisted radical prostatectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence, Pelvic Floor Physical Therapy
- What is being tested?
- Pelvic Floor Muscle Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2015to Jan 2025
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduling to undergo robot-assisted radical prostatectomy
- Patients willing and able to complete the EPIC questionnaire in its entirety
- Ability to provide informed consent
Who cannot join
- Previous prostate surgery
- Radiation treatment
- History of incontinence defined as any pad use for urinary leakage in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Methodist Hospital and IU Health University Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men with Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy
The purpose of this study is to determine if pelvic floor muscle training with a physical therapist before and after surgery will improve health-related quality of life following robot-assisted radical prostatectomy.
Read the detailed description
Goals of the present study will be to determine whether initiating pelvic floor muscle training preoperatively improves quality of life symptoms related specifically to urinary health following robot-assisted radical prostatectomy. Drawing definitive conclusions from past studies is challenging secondary to various inconsistencies including: variability of physical therapy intervention, poorly defined definitions of continence, as well as poorly defined quality of life measurements. Additionally, the vast majority of studies combined open and robotic prostatectomy increasing cohort heterogeneity and further blurring interpretation of results. The investigators' study will focus exclusively on patients undergoing robot-assisted radical prostatectomy. Standardized pelvic floor muscle therapy as well as clearly defined patient outcomes (ie: validated questionnaires) will be utilized to determine whether preoperative initiation of formal pelvic floor physical therapy can improve health-related quality of life following surgery.
In the era of robot-assisted radical prostatectomy does physical therapist initiated preoperative pelvic floor muscle training lessen the expected postoperative drop off in urinary related quality of life and/or improve patient's recovery of continence following surgery?
- Being tested
- Pelvic Floor Muscle Physical Therapy, Control Group
- 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.
Pelvic Floor Muscle Physical TherapyBehavioural
The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 1 week postoperative, and 4-6 weeks postoperative and will be coordinated with surgeon appointments to minimize any inconvenience and travel time.
Control GroupBehavioural
At the cancer consultation visit, subjects will be educated by the urologist or urology team member regarding surgical and postoperative expectations. At this time, subjects will be provided verbal instruction and written information regarding Kegel exercises. Subjects in the control group may decide the duration and frequency of home exercise performance.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Treatment Group | Active comparator | Written and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit. The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 7-10 days postoperative, and 4-8 weeks postoperative . Receives: Behavioral: Pelvic Floor Muscle Physical Therapy |
| Control Group | Active comparator | Written and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Comparison of post-op EPIC scores in the two study groups
Measured: 4 to 8 weeks post-op
Secondary outcomes (1)
Return to continence following surgery
Measured: Up to 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study start29 Jun 2015
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University Health
- Responsible party
- Principal investigator, Ronald Boris, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558946
- Sponsor's protocol ID
- 1501440753
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2015
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pelvic Floor Muscle Training May Improve Recovery of Continence in Men with Localized Prostate Cancer Undergoing Robot-Assisted Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT02558946
- Acronym / sponsor ID
- 1501440753
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana University Health
- Study start
- 29 Jun 2015 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 Sep 2015 (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.
The purpose of this study is to determine if pelvic floor muscle training with a physical therapist before and after surgery will improve health-related quality of life following robot-assisted radical prostatectomy.
Detailed description
Goals of the present study will be to determine whether initiating pelvic floor muscle training preoperatively improves quality of life symptoms related specifically to urinary health following robot-assisted radical prostatectomy. Drawing definitive conclusions from past studies is challenging secondary to various inconsistencies including: variability of physical therapy intervention, poorly defined definitions of continence, as well as poorly defined quality of life measurements. Additionally, the vast majority of studies combined open and robotic prostatectomy increasing cohort heterogeneity and further blurring interpretation of results. The investigators' study will focus exclusively on patients undergoing robot-assisted radical prostatectomy. Standardized pelvic floor muscle therapy as well as clearly defined patient outcomes (ie: validated questionnaires) will be utilized to determine whether preoperative initiation of formal pelvic floor physical therapy can improve health-related quality of life following surgery.
In the era of robot-assisted radical prostatectomy does physical therapist initiated preoperative pelvic floor muscle training lessen the expected postoperative drop off in urinary related quality of life and/or improve patient's recovery of continence following surgery?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Treatment Group | Active comparator | Behavioral: Pelvic Floor Muscle Physical TherapyWritten and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit. The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 7-10 days postoperative, and 4-8 weeks postoperative . |
| Control Group | Active comparator | Behavioral: Control GroupWritten and verbal information on performing Kegel exercises (exercises that aim to strengthen pelvic floor muscles) will be provided at the pre-op clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduling to undergo robot-assisted radical prostatectomy
- Patients willing and able to complete the EPIC questionnaire in its entirety
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Previous prostate surgery
- Radiation treatment
- History of incontinence defined as any pad use for urinary leakage in the past 6 months
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 |
|---|---|---|
| Pelvic Floor Muscle Physical TherapyThe treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 1 week postoperative, and 4-6 weeks postoperative and will be coordinated with surgeon appointments to minimize any inconvenience and travel time. | Behavioural | Physical Therapy Treatment Group |
| Control GroupAt the cancer consultation visit, subjects will be educated by the urologist or urology team member regarding surgical and postoperative expectations. At this time, subjects will be provided verbal instruction and written information regarding Kegel exercises. Subjects in the control group may decide the duration and frequency of home exercise performance. | Behavioural | Control Group |
Primary outcome
• Comparison of post-op EPIC scores in the two study groups
Time frame: 4 to 8 weeks post-op
1 secondary outcome
Return to continence following surgery
Time frame: Up to 12 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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 study testing Pelvic Floor Muscle Physical Therapy in people with Prostate Cancer and Urinary Incontinence, run by Indiana University at 1 site in United States.
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 3 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 4 Nov 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 United States. 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?
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?
• Comparison of post-op EPIC scores in the two study groups (time frame: 4 to 8 weeks post-op). 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 4 Nov 2024.