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

NCT07071207 | Recruiting DMC

• 1 other identifier: STUDY00009182
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Incontinence, Urinary Stress; Prostate Cancer; Benign Prostate Hyperplasia

Outcome Measures

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.

  From baseline until the participant reaches two successive M-ISI Pad Use Subdomain Scores of ≤ 2, assessed up to 12 months

Study Arms (4)

Control group - LEP surgery patients

NO INTERVENTION

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

Intervention group - LEP surgery patients

EXPERIMENTAL

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

Behavioral: Text message reminders

Control group - RALP surgery patients

NO INTERVENTION

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

Intervention group - RALP surgery patients

EXPERIMENTAL

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

Behavioral: Text message reminders

Interventions

Text message reminders BEHAVIORAL

daily 8am text messages reminding patients to perform Kegel exercises as per their standard-of-care post-operative discharge instructions.

Intervention group - LEP surgery patients; Intervention group - RALP surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

158 Sawgrass clinic; Suite 3100

Rochester, New York, 14620, United States

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Stress; Prostatic Neoplasms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Central Study Contacts

Austin Jackson

CONTACT

(585) 275-0126; Austin_jackson@urmc.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: July 17, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)