Incontinence, Urinary StressTextMsgM-ISINCT07071207
Effect of Text Message Reminders on M-ISI Score After Prostate Surgery
A study testing Text message reminders in people with Incontinence, Urinary Stress and Prostate Cancer, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Incontinence, Urinary Stress, Prostate Cancer, Benign Prostate Hyperplasia
- What is being tested?
- Text message reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
158 Sawgrass clinic; Suite 3100
Rochester, New York, 14620
About this study
Official title: Effect of Text Message Reminders on Michigan Incontinence Symptom Index Score After Prostate Surgery
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.
Read the 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).
- Being tested
- Text message reminders
- Medical subject headings
- Urinary Incontinence, Stress, Prostatic Neoplasms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message remindersBehavioural
daily 8am text messages reminding patients to perform Kegel exercises as per their standard-of-care post-operative discharge instructions.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Text message reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline until the participant reaches two successive M-ISI Pad Use Subdomain Scores of ≤ 2, assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start15 Sep 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incontinence, Urinary StressStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Quarrier, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071207
- Sponsor's protocol ID
- STUDY00009182
- Acronym
- TextMsgM-ISI
- Status last verified
- Nov 2025
- First submitted
- 7 Mar 2025
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Text Message Reminders on Michigan Incontinence Symptom Index Score After Prostate Surgery
- ClinicalTrials.gov ID
- NCT07071207
- Acronym / sponsor ID
- TextMsgM-ISI / STUDY00009182
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Text message remindersPatient undergoing LEP surgery with text message intervention to perform pelvic floor exercises as described in the schedule of events |
| 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 | Behavioral: Text message remindersPatient undergoing RALP surgery with text message intervention to perform pelvic floor exercises as described in the schedule of events |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message remindersdaily 8am text messages reminding patients to perform Kegel exercises as per their standard-of-care post-operative discharge instructions. | Behavioural | Intervention group - LEP surgery patients, Intervention group - RALP surgery patients |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message reminders in people with Incontinence, Urinary Stress and Prostate Cancer, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Austin Jackson ((585) 275-0126, Austin_jackson@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.