Daily text reminders to support pelvic floor exercises after prostate surgery
Effect of Text Message Reminders on Michigan Incontinence Symptom Index Score After Prostate Surgery
This trial will test whether daily text-message reminders help men recovering from prostate surgery keep up pelvic floor exercises and reduce urinary leakage compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Rochester Academic / other |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT07071207 on ClinicalTrials.gov |
What this trial studies
Men undergoing radical prostatectomy for prostate cancer or laser enucleation for benign prostatic hyperplasia at the University of Rochester will be enrolled and divided into two cohorts by procedure. Each cohort is split into an intervention arm that receives daily automated SMS reminders to perform pelvic floor exercises plus standard care and a control arm that receives standard care only. Urinary incontinence will be measured with the patient-reported Michigan Incontinence Symptom Index (M-ISI) and collected via SMS questionnaires. Outcomes will compare M-ISI scores between the reminder and control groups to see if reminders improve continence recovery.
Who should consider this trial
Good fit: Adult male patients of URMC Urology planning radical prostatectomy (RALP) or laser enucleation of the prostate (LEP), who read English, have a mobile phone that can receive SMS, and can provide informed consent.
Not a fit: Patients who cannot use SMS, do not read English, are catheter-dependent, or receive an artificial urinary sphincter or urethral sling during the study period are unlikely to receive benefit from the intervention.
Why it matters
Potential benefit: If successful, simple SMS reminders could speed recovery of urinary control and improve quality of life after prostate surgery.
How similar studies have performed: Text-message reminders have improved adherence in other pelvic-floor and chronic-disease settings, but direct evidence for reducing post-prostatectomy incontinence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rochester, New York
- 158 Sawgrass clinic; Suite 3100 — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Austin Jackson
- Email: Austin_jackson@urmc.rochester.edu
- Phone: (585) 275-0126
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.