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

NCT ID: NCT07071207

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-15

Study Completion Date

2028-05-01

Brief Summary

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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

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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).

Conditions

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Incontinence, Urinary Stress Prostate Cancer Benign Prostate Hyperplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group - LEP surgery patients

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group - LEP surgery patients

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

Group Type EXPERIMENTAL

Text message reminders

Intervention Type BEHAVIORAL

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

Control group - RALP surgery patients

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group - RALP surgery patients

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

Group Type EXPERIMENTAL

Text message reminders

Intervention Type BEHAVIORAL

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

Interventions

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Text message reminders

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Scott Quarrier

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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158 Sawgrass clinic; Suite 3100

Rochester, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Austin Jackson

Role: CONTACT

Phone: (585) 275-0126

Email: [email protected]

Other Identifiers

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STUDY00009182

Identifier Type: -

Identifier Source: org_study_id