Effect of Text Message Reminders on M-ISI Score After Prostate Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Planning to undergo a radical prostatectomy (RALP) or laser enucleation of the prostate (LEP) procedure
Patient of URMC Urology
Adult male 18 years of age and older
Able to read, write, and speak in English (NOTE: due to limitations with questionnaire validation, only English-speaking subjects are permitted)
Disqualifiers
Less than 18 years of age
Unable to send and receive SMS texts
Unable to read, write, and speak English
Catheter dependency
Trial design
Design model
Parallel
Treatments tested in this trial
Text message reminders
Behavioraldaily 8am text messages reminding patients to perform Kegel exercises as per their standard-of-care post-operative discharge instructions.
Treatment groups
132 Participants
are divided into 4 treatment groupsGroup A: Control group - LEP surgery patientsNo intervention 0 interventions
Group B: Intervention group - LEP surgery patientsExperimental treatment 1 intervention
Group C: Control group - RALP surgery patientsNo intervention 0 interventions
Group D: Intervention group - RALP surgery patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to Recovery to Continence
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.
Time frame
From baseline until the participant reaches two successive M-ISI Pad Use Subdomain Scores of ≤ 2, assessed up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov