Benign Prostate Hyperplasia, Incontinence, Urinary Stress, Prostate Cancer
Conditions
Brief summary
The purpose of this study is to compare post-prostatectomy incontinence via Michigan Incontinence Score Index in patients receiving daily text message reminders for pelvic floor exercises when compared to those not receiving text reminders.
Detailed description
This trial will be comprised of prostate cancer patients who have undergone a radical prostatectomy and benign prostate hyperplasia patients who have undergone a laser enucleation of the prostate. These two cohorts will each be split into an intervention and a control group. The purpose of this study is to evaluate post-prostatectomy incontinence via patient reported outcomes utilizing Michigan Incontinence Score Index in patients receiving daily text message reminders for pelvic floor exercises + standard of care (intervention group) compared to those receiving standard of care only (control group).
Interventions
BEHAVIORALText message reminders
daily 8am text messages reminding patients to perform Kegel exercises as per their standard-of-care post-operative discharge instructions.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Planning to undergo a radical prostatectomy (RALP) or laser enucleation of the prostate (LEP) procedure 2. Patient of URMC Urology 3. Adult male 18 years of age and older 4. Able to read, write, and speak in English (NOTE: due to limitations with questionnaire validation, only English-speaking subjects are permitted) 5. Has access to a mobile device capable of receiving automated text messages. 6. Willing to receive text messages and to complete questionnaires via SMS text. 7. Willingness to participate and able to provide informed consent.
Exclusion criteria
1. Less than 18 years of age 2. Unable to send and receive SMS texts 3. Unable to read, write, and speak English 4. Catheter dependency 5. Has or plans to have Artificial Urinary Sphincter or Urethral Sling during the study period 6. In the opinion of the investigator, the subject has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery to Continence | From baseline until the participant reaches two successive M-ISI Pad Use Subdomain Scores of ≤ 2, assessed up to 12 months | The time it takes for participants to recover continence, as defined by two successive M-ISI Pad Use Subdomain Scores of ≤ 2. The Pad Use Subdomain Score is determined by the sum of items Q7-8 from the M-ISI questionnaire, assessed as a time-to-event outcome. |
Countries
United States
Contacts
Primary ContactAustin Jackson
Outcome results
None listed