Clinical trial · Observational
Initiative to Minimize Disparities in Postoperative Prostate Cancer Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): COVID related impact on recruitment. Change in treatment (more effective surgical technique ) eliminated the studied side effect, thus making the intervention arm obsolete.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Post Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Absorbent pad for urinary incontinence | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group 1 (Provided absorbent pads)
- description
- Patients will receive a 6 month supply (as needed) of absorbent pads for urinary incontinence.
- interventionNames
- Other: Absorbent pad for urinary incontinence
- label
- Group 2 (not provided absorbent pads)
- description
- Patients enrolled in the control arm will not receive absorbent pads.
Primary outcomes (2)
- measure
- Michigan Incontinence Symptom Index (M-ISI)
- timeFrame
- 6 months after radical prostatectomy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. History of prostate cancer 2. Scheduled for radical prostatectomy during a designated academic year 3. Reside within Health Enterprise Zone (HEZ) of North Broad Street 4. Median annual household income \< $50,000 5. Patient feels that they would struggle to afford absorbent pads and Tadalafil based on their annual income 6. Patient must have no history of stress urinary incontinence prior to surgery Exclusion Criteria 1. Patient's who do not meet the inclusion criteria above 2. Patients who meet all inclusion criteria above, but do not want to use absorbent pads secondary to history of hypersensitivity/allergy to absorbent pads 3. Patients with cognitive impairment will be excluded from the study
References
Publications (3)
- BACKGROUNDSuskind 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. PMID 23945994
- BACKGROUNDChipman 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. PMID 24076307
- BACKGROUNDWagner 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. PMID 27475967