Post ProstatectomyNCT03755492
Initiative to Minimize Disparities in Postoperative Prostate Cancer Care
An observational study of Post Prostatectomy, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Einstein Healthcare Network in North Philadelphia serves a predominantly underserved medical community. The investigators routinely see patients who cannot afford absorbent pads after prostate surgery, which helps with quality of life secondary to urinary incontinence. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Post Prostatectomy
- What is being tested?
- Absorbent pad for urinary incontinence
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 20 Jul 2022
- Phase
- Observational
- 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
Study population: Males who reside in the health enterprise zone of north Philadelphia and are undergoing radical prostatectomy
Who may be able to join
- History of prostate cancer
- Scheduled for radical prostatectomy during a designated academic year
- Reside within Health Enterprise Zone (HEZ) of North Broad Street
- Median annual household income < $50,000
- Patient feels that they would struggle to afford absorbent pads and Tadalafil based on their annual income
- Patient must have no history of stress urinary incontinence prior to surgery
Who cannot join
- Patient's who do not meet the inclusion criteria above
- Patients who meet all inclusion criteria above, but do not want to use absorbent pads secondary to history of hypersensitivity/allergy to absorbent pads
- Patients with cognitive impairment will be excluded from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19141
About this study
Einstein Healthcare Network in North Philadelphia serves a predominantly underserved medical community. The investigators routinely see patients who cannot afford absorbent pads after prostate surgery, which helps with quality of life secondary to urinary incontinence. The investigators will provide absorbent pads to participants who would be unable to afford them. The investigators hypothesize that providing absorbent pads for 6 months will result in improved quality of life in regards to management of urinary incontinence after radical prostatectomy.
Read the detailed description
When detected early and managed with appropriate surgical treatment, such as radical prostatectomy, Prostate cancer prognosis is excellent, but recovery may be associated with significant transient impact on quality of life. This impact most often manifests in urinary domains, specifically, development of stress urinary incontinence. Several simple, low-cost but high-yield interventions may dramatically improve patient's postoperative quality of life. However, such interventions may be out of reach for patients from Health Enterprise Zones (HEZ) with limited funds. To make resources readily available for this patient population, the inclusion criteria will be prostatectomy patients of any age who reside within the designated North Broad street HEZ.
Stress urinary incontinence after prostatectomy is a source of major distress. Incontinence tends to improve over time with most patients regaining their urinary function. Symptomatic support with disposable absorbent pads/diapers for several months helps men effectively manage this side effect. While for most men the cost of the diapers is manageable, for men in HEZ this represents a significant financial burden on the patient and on caregivers. As a result, these patients often choose to remain home bound until they recover urinary control, preventing them from early return to employment and resulting in social isolation. The Healthcare Disparity SEED Grant will provide up to a 6-month supply of disposable absorbent pads/diapers to those patients meeting our inclusion criteria. Michigan Incontinence Symptom Index (M-ISI) questionnaires will be distributed to patients pre-operatively and during interval post-operative office visits to assess patient satisfaction with voiding function.
In addition to distributing M-ISI questionnaires, we will also distribute the Extended Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) to evaluate overall quality of life. This is a validated questionnaire capable of accurately assessing multiple domains of quality of life after prostate cancer treatment. Results of M-ISI and EPIC-CP scores will be compiled and analyzed to determine if intervention has resulted in measurable improvement between the treatment and control groups.
- Conditions
- Post Prostatectomy
- Being tested
- Absorbent pad for urinary incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbent pad for urinary incontinenceOther
6 month supply provided to patients as needed for urinary incontinence after radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Provided absorbent pads) | Patients will receive a 6 month supply (as needed) of absorbent pads for urinary incontinence. Receives: Other: Absorbent pad for urinary incontinence | |
| Group 2 (not provided absorbent pads) | Patients enrolled in the control arm will not receive absorbent pads. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan Incontinence Symptom Index (M-ISI)
Questionnaire to assess severity of urinary incontinence and how it influences a patient's quality of life. The questionnaire asks a total of 10 questions scaled 0 to 4. The 10 questions that make up the questionnaire cover bothersome lower urinary tract symptoms specific to stress urinary incontinence, urge urinary incontinence, how many pads patients are using to manage their incontinence, and how it is influencing their daily activities. Patients with higher scores have more severe and bothersome urinary incontinence.
Measured: 6 months after radical prostatectomy
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Questionnaire to help assess overall quality of life in patients with prostate cancer. This questionnaire is a 1-page, 16-item questionnaire that is designed to assess urinary incontinence, urinary irritation, bowel irritation, sexual health and hormonal health after prostate cancer surgery. Each domain is scored separately from a scale of 0 to 12. The minimum symptom score in each domain is a 0 and the maximum symptom score in each domain is a 12.
Measured: 6 months after radical prostatectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start1 Apr 2019
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Why it stopped: COVID related impact on recruitment. Change in treatment (more effective surgical technique ) eliminated the studied side effect, thus making the intervention arm obsolete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serge Ginzburg, MD, Albert Einstein Healthcare Network
- Investigators
- Serge Ginzburg, M.D., Study director, Einstein Healthcare Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755492
- Sponsor's protocol ID
- 5108
- Status last verified
- Jul 2022
- First submitted
- 3 Oct 2018
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The only time that individual participant data will be shared with other researchers is if it is requested and required by a reviewer of our research to aide with publication of our results
Publications
Suskind AM, Dunn RL, Morgan DM, DeLancey JO, McGuire EJ, Wei JT. The Michigan Incontinence Symptom Index (M-ISI): a clinical measure for type, severity, and bother related to urinary incontinence. Neurourol Urodyn. 2014 Sep;33(7):1128-34. doi: 10.1002/nau.22468. Epub 2013 Aug 14.
PubMed 23945994Chipman JJ, Sanda MG, Dunn RL, Wei JT, Litwin MS, Crociani CM, Regan MM, Chang P; PROST-QA Consortium. Measuring and predicting prostate cancer related quality of life changes using EPIC for clinical practice. J Urol. 2014 Mar;191(3):638-45. doi: 10.1016/j.juro.2013.09.040. Epub 2013 Sep 25.
PubMed 24076307Wagner AA, Cheng PJ, Carneiro A, Dovirak O, Khosla A, Taylor KN, Crociani CM, McAnally KC, Percy A, Dewey LE, Sanda MG, Chang P. Clinical Use of Expanded Prostate Cancer Index Composite for Clinical Practice to Assess Patient Reported Prostate Cancer Quality of Life Following Robot-Assisted Radical Prostatectomy. J Urol. 2017 Jan;197(1):109-114. doi: 10.1016/j.juro.2016.07.080. Epub 2016 Jul 27.
PubMed 27475967
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiative to Minimize Disparities in Postoperative Prostate Cancer Care
- ClinicalTrials.gov ID
- NCT03755492
- Acronym / sponsor ID
- 5108
- Conditions
- Post Prostatectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID related impact on recruitment. Change in treatment (more effective surgical technique ) eliminated the studied side effect, thus making the intervention arm obsolete.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 28 Nov 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.
Einstein Healthcare Network in North Philadelphia serves a predominantly underserved medical community. The investigators routinely see patients who cannot afford absorbent pads after prostate surgery, which helps with quality of life secondary to urinary incontinence. The investigators will provide absorbent pads to participants who would be unable to afford them. The investigators hypothesize that providing absorbent pads for 6 months will result in improved quality of life in regards to management of urinary incontinence after radical prostatectomy.
Detailed description
When detected early and managed with appropriate surgical treatment, such as radical prostatectomy, Prostate cancer prognosis is excellent, but recovery may be associated with significant transient impact on quality of life. This impact most often manifests in urinary domains, specifically, development of stress urinary incontinence. Several simple, low-cost but high-yield interventions may dramatically improve patient's postoperative quality of life. However, such interventions may be out of reach for patients from Health Enterprise Zones (HEZ) with limited funds. To make resources readily available for this patient population, the inclusion criteria will be prostatectomy patients of any age who reside within the designated North Broad street HEZ.
Stress urinary incontinence after prostatectomy is a source of major distress. Incontinence tends to improve over time with most patients regaining their urinary function. Symptomatic support with disposable absorbent pads/diapers for several months helps men effectively manage this side effect. While for most men the cost of the diapers is manageable, for men in HEZ this represents a significant financial burden on the patient and on caregivers. As a result, these patients often choose to remain home bound until they recover urinary control, preventing them from early return to employment and resulting in social isolation. The Healthcare Disparity SEED Grant will provide up to a 6-month supply of disposable absorbent pads/diapers to those patients meeting our inclusion criteria. Michigan Incontinence Symptom Index (M-ISI) questionnaires will be distributed to patients pre-operatively and during interval post-operative office visits to assess patient satisfaction with voiding function.
In addition to distributing M-ISI questionnaires, we will also distribute the Extended Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) to evaluate overall quality of life. This is a validated questionnaire capable of accurately assessing multiple domains of quality of life after prostate cancer treatment. Results of M-ISI and EPIC-CP scores will be compiled and analyzed to determine if intervention has resulted in measurable improvement between the treatment and control groups.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Provided absorbent pads) | – | Other: Absorbent pad for urinary incontinencePatients will receive a 6 month supply (as needed) of absorbent pads for urinary incontinence. |
| Group 2 (not provided absorbent pads) | – | –Patients enrolled in the control arm will not receive absorbent pads. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males who reside in the health enterprise zone of north Philadelphia and are undergoing radical prostatectomy
Key inclusion criteria (6 listed)
- History of prostate cancer
- Scheduled for radical prostatectomy during a designated academic year
- Reside within Health Enterprise Zone (HEZ) of North Broad Street
- Median annual household income < $50,000
- Patient feels that they would struggle to afford absorbent pads and Tadalafil based on their annual income
Key exclusion criteria (3 listed)
- Patient's who do not meet the inclusion criteria above
- Patients who meet all inclusion criteria above, but do not want to use absorbent pads secondary to history of hypersensitivity/allergy to absorbent pads
- Patients with cognitive impairment will be excluded from 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 |
|---|---|---|
| Absorbent pad for urinary incontinence6 month supply provided to patients as needed for urinary incontinence after radical prostatectomy | Other | Group 1 (Provided absorbent pads) |
Primary outcome
Michigan Incontinence Symptom Index (M-ISI)
Time frame: 6 months after radical prostatectomy
Questionnaire to assess severity of urinary incontinence and how it influences a patient's quality of life. The questionnaire asks a total of 10 questions scaled 0 to 4. The 10 questions that make up the questionnaire cover bothersome lower urinary tract symptoms specific to stress urinary incontinence, urge urinary incontinence, how many pads patients are using to manage their incontinence, and how it is influencing their daily activities. Patients with higher scores have more severe and bothersome urinary incontinence.
Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)
Time frame: 6 months after radical prostatectomy
Questionnaire to help assess overall quality of life in patients with prostate cancer. This questionnaire is a 1-page, 16-item questionnaire that is designed to assess urinary incontinence, urinary irritation, bowel irritation, sexual health and hormonal health after prostate cancer surgery. Each domain is scored separately from a scale of 0 to 12. The minimum symptom score in each domain is a 0 and the maximum symptom score in each domain is a 12.
Results and safety
The study was stopped early (reason given: COVID related impact on recruitment. Change in treatment (more effective surgical technique ) eliminated the studied side effect, thus making the intervention arm obsolete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Background: PubMed 23945994Suskind AM, Dunn RL, Morgan DM, DeLancey JO, McGuire EJ, Wei JT. The Michigan Incontinence Symptom Index (M-ISI): a clinical measure for type, severity, and bother related to urinary incontinence. Neurourol Urodyn. 2014 Sep;33(7):1128-34. doi: 10.1002/nau.22468. Epub 2013 Aug 14.
- Background: PubMed 24076307Chipman JJ, Sanda MG, Dunn RL, Wei JT, Litwin MS, Crociani CM, Regan MM, Chang P; PROST-QA Consortium. Measuring and predicting prostate cancer related quality of life changes using EPIC for clinical practice. J Urol. 2014 Mar;191(3):638-45. doi: 10.1016/j.juro.2013.09.040. Epub 2013 Sep 25.
- Background: PubMed 27475967Wagner AA, Cheng PJ, Carneiro A, Dovirak O, Khosla A, Taylor KN, Crociani CM, McAnally KC, Percy A, Dewey LE, Sanda MG, Chang P. Clinical Use of Expanded Prostate Cancer Index Composite for Clinical Practice to Assess Patient Reported Prostate Cancer Quality of Life Following Robot-Assisted Radical Prostatectomy. J Urol. 2017 Jan;197(1):109-114. doi: 10.1016/j.juro.2016.07.080. Epub 2016 Jul 27.
- Individual participant dataSharing planned: No. The only time that individual participant data will be shared with other researchers is if it is requested and required by a reviewer of our research to aide with publication of our results
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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.
Serge Ginzburg, M.D. study director
Einstein Healthcare Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Prostatectomy, run by Albert Einstein Healthcare Network 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 6 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: stopped early, as of the sponsor's last update on 21 Jul 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 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?
The study was stopped early (reason given: COVID related impact on recruitment. Change in treatment (more effective surgical technique ) eliminated the studied side effect, thus making the intervention arm obsolete.). 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?
Michigan Incontinence Symptom Index (M-ISI) (time frame: 6 months after radical prostatectomy). The study lists 2 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 NCT03755492, which also lists 3 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 21 Jul 2022.