Effect of Text Message Reminders on M-ISI Score After Prostate Surgery (TextMsgM-ISI)

University of Rochester

Status: Begins enrollment this month

Conditions: Benign Prostate Hyperplasia; Incontinence, Urinary Stress; Prostate Cancer

Treatments: Behavioral: Text message reminders

Study type: Interventional

Funder types: Other

Identifiers

NCT07071207

STUDY00009182

Details and patient eligibility

About

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.

Full 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).

Enrollment: 132 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 4 patient groups

Control group - LEP surgery patients

No Intervention group

Description:

Patients undergoing LEP surgery and standard of care discharge instructions to perform pelvic floor exercises

Intervention group - LEP surgery patients

Experimental group

Description:

Patient undergoing LEP surgery with text message intervention to perform pelvic floor exercises as described in the schedule of events

Treatment:

Behavioral: Text message reminders

Control group - RALP surgery patients

No Intervention group

Description:

Patients undergoing RALP surgery and standard of care discharge instructions to perform pelvic floor exercises

Intervention group - RALP surgery patients

Experimental group

Description:

Patient undergoing RALP surgery with text message intervention to perform pelvic floor exercises as described in the schedule of events

Treatment:

Behavioral: Text message reminders