Effect of Text Message Reminders on M-ISI Score After Prostate Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Text message reminders.
- Who it may be relevant to
- Registry conditions: Incontinence, Urinary Stress, Prostate Cancer, Benign Prostate Hyperplasia. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Text Message Reminders on Michigan Incontinence Symptom Index Score After Prostate Surgery
Overview
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
- Behavioral Text message reminders
daily 8am text messages reminding patients to perform Kegel exercises as per their standard-of-care post-operative discharge instructions.
Primary outcome measures
- Time to Recovery to Continence [Time frame: From baseline until the participant reaches two successive M-ISI Pad Use Subdomain Scores of ≤ 2, assessed up to 12 months]
Eligibility criteria
Inclusion criteria
- 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)
- Has access to a mobile device capable of receiving automated text messages.
- Willing to receive text messages and to complete questionnaires via SMS text.
- Willingness to participate and able to provide informed consent.
Exclusion criteria
- Less than 18 years of age
- Unable to send and receive SMS texts
- Unable to read, write, and speak English
- Catheter dependency
- Has or plans to have Artificial Urinary Sphincter or Urethral Sling during the study period
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- 158 Sawgrass clinic; Suite 3100 — Rochester
Identifiers
NCT: NCT07071207 · STUDY00009182