Overactive BladderEarly Phase 1NCT07648290
Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
A Early Phase 1 study testing Macrobid® Capsules 100 mg and Standard Medical Care (SMC) in people with Overactive Bladder, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The primary objective of this study is to investigate whether providing a standing, take-home prescription for empiric Macrobid (self-start model) is superior to standard call-in/urgent care triage (triage model) among patients undergoing intradetrusor Botox®. Urinary tract infections. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Macrobid® Capsules 100 mg and Standard Medical Care (SMC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2026to 31 Mar 2028
- Phase
- Early Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients of all races and ethnicities aged 18 years and older.
- Diagnosis of Overactive Bladder (OAB) and/or Urge Urinary Incontinence (UUI).
- Scheduled to receive intradetrusor onabotulinumtoxinA (Botox®) for symptom management.
- Has decision making capacity to provide informed consent and comply with and follow study protocols.
- Ability to navigate a computer system independently
- Access to MyChart and email account
Who cannot join
- Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter.
- History of Severe Renal Impairment Cr/Cl - <60 ml/min 1.73m2
- History of recurrent UTIs (defined as >3x symptomatic UTIs in 12 months).
- Post-Void Residual (PVR) volume >150 mL.
- Active UTI at the time of procedure (procedure cancellation criteria).
- Patients currently on prophylactic antibiotics.
- Inability to provide informed consent.
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
Cleveland Clinic
Cleveland, Ohio, 44195
Ugochukwu Okoroafor, MD, 440-799-7739, okoroau@ccf.org
Shannon Wallace, MD
About this study
The primary objective of this study is to investigate whether providing a standing, take-home prescription for empiric Macrobid (self-start model) is superior to standard call-in/urgent care triage (triage model) among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Thus, the research team will compare Unplanned Healthcare Utilization, i.e. the frequency of triage calls, MyChart messages, Urgent Care visits, and Emergency Department visits related to urinary symptoms, between participants in the self-start intervention group and those in the triage control group. The team hypothesizes that patients in the "self-start" intervention group will demonstrate a lower frequency of healthcare utilization events when compared to those in the standard of care control.
Read the detailed description
Study Procedure and Intervention
Following enrollment and consent, participants will be randomized into two groups allocated 1:1 as follows:
- Intervention Group: Standing Prescription (Self-Start) + Sterile Urine Cup
- Control Group: Standard Triage Line.
Provider stratified block randomization (block size 4) will be implemented by REDCap randomization module on the day of participants scheduled procedure. At this point, each participant will be given a unique Study ID number to allow study coordinators to commence data abstraction from the EMR (EPIC) into REDCap.
All participants, regardless of randomization, will follow the current practice with provider specific antibiotic prophylaxis protocol as prescribed. Electronic medical record review will be performed by the study investigators to obtain relevant medical history, treatment plan and demographic information for each participant and transcribed into REDCap.
Arm 1: Intervention Group Following the procedure, participants will receive a standing prescription for oral Nitrofurantoin (Macrobid) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and discharge instructions. International treatment guidelines recommend short-course regimens for acute uncomplicated cystitis, usually 3-6 days of antibiotic therapy. This is supported by a Cochrane review of 15 studies, including 1644 elderly women, showing non-inferiority of short course regimen to a 7-14-day long course for treating uncomplicated cystitis in elderly women.
Participants will be provided with standard procedural discharge instructions. The standard procedural discharge instructions will be modified to include instructions on taking antibiotics as part of the study. A section for how to collect a sterile urine sample will also be included with their discharge instructions.
Participants will be instructed that if they experience specific UTI symptoms, they must:
- Collect a clean-catch midstream urine sample in the provided cup.
- Drop the sample at a Cleveland Clinic lab facility (a standing order for urine culture will be placed in the EMR).
- Initiate the antibiotic prescription after dropping off the sample.
UTI Symptoms are defined as dysuria, urinary frequency, urinary urgency and suprapubic pain. Participants with fever ≥100.4°F, flank pain, chills, or systemic symptoms will be instructed to seek immediate medical care and not self-start antibiotics. A member of the study team will monitor the results of the urine cultures for the intervention group. If a culture confirms a pathogen resistant to Macrobid, the participant will be contacted by a member of the team to discontinue Macrobid and initiate appropriate antibiotic therapy.
Arm 2: Control Group Participants will receive standard post-procedure discharge instructions which typically instruct participants to follow routine practice if a UTI is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic. Subsequent interactions with participants in control groups needing intervention (i.e UTI needing antibiotics) will be managed in relation to how care is sought. The research team will only observe participants' interactions with the health care system.
Follow-Up Participants will be monitored from the time of intradetrusor Botox® injection through 30 days post-procedure, corresponding to the highest risk window for post-procedural UTI and urinary retention.
Data collection will include:
- Survey assessment on Day 7 for possible symptoms of UTI and symptoms severity using Patient Global Impression of Severity (PGI-S)
- Survey assessment on Day 30 for possible symptoms of UTI, and symptoms severity using PGI-S and treatment satisfaction.
- EMR review for unscheduled UTI related visits or antibiotic prescriptions
- Telephone or secure MyChart portal messages. 7-days after the procedure is performed, each participant will receive the initial automated REDCap survey to assess for possible symptoms of a UTI and severity of symptoms using the Patient Global Impression of Severity (PGI-S). Symptoms of UTIs are defined as dysuria, urgency, suprapubic pain, fever and flank pain. Also included in the survey assessment with be two additional questions regarding timeline of symptoms and treatment initiation. This survey is easy to follow and will take no more than 5 minutes to complete.
At the end of the 30-day period, all participants will receive two surveys via automated REDCap to again assess for symptoms of UTI and severity using the PGI-S, and their level of satisfaction with their post-procedure care. Both surveys will take no more than 5 minutes to complete. Reminder emails to complete the surveys will be sent to participants no more than 2 times. Individual responses will be linked to the participants' unique ID number. All the data collection will be performed by the study investigators through electronic medical record review and stored in REDCap for up to 6 years after study closure.
- Conditions
- Overactive Bladder
- Being tested
- Macrobid® Capsules 100 mg, Standard Medical Care (SMC)
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macrobid® Capsules 100 mgDrug
Subjects will receive Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and standing lab orders for urine culture.
Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections.
Standard Medical Care (SMC)Other
Subjects will receive standard of care post-procedure discharge instructions which instruct the following if a urinary tract infection is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic.
| Study group | Role | What they receive |
|---|---|---|
| Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine Culture | Active comparator | Following the procedure, subjects will receive a standing prescription for oral Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and standing lab orders for urine culture and discharge instructions.
Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections. Receives: Drug: Macrobid® Capsules 100 mg |
| Standard Triage Line; Standard Medical Care (SMC) | Other | Subjects will receive standard post-procedure discharge instructions which typically instruct participants to follow routine practice if a UTI is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic. Receives: Other: Standard Medical Care (SMC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare utilization
Investigate whether providing a standing, take-home prescription for Nitrofurantoin (MACROBID), or other suitable prescription alternate detailed in the "arms and interventions section", is superior to SMC-triage care model call-in/urgent care among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Researchers will compare unplanned healthcare utilization, (the frequency of triage calls, MyChart messages, Urgent Care visits, ED visits, etc. related to urinary symptoms), between subjects in Self-Start arm (intervention) verses those who receive SMC.
Measured: Day of procedure to 30-days post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start31 Jul 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon Wallace, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648290
- Sponsor's protocol ID
- 26-430
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Start Triage Model for Post-Botox® Lower Urinary Tract Symptoms
- ClinicalTrials.gov ID
- NCT07648290
- Acronym / sponsor ID
- 26-430
- Conditions
- Overactive Bladder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 15 Jun 2026 (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 primary objective of this study is to investigate whether providing a standing, take-home prescription for empiric Macrobid (self-start model) is superior to standard call-in/urgent care triage (triage model) among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Thus, the research team will compare Unplanned Healthcare Utilization, i.e. the frequency of triage calls, MyChart messages, Urgent Care visits, and Emergency Department visits related to urinary symptoms, between participants in the self-start intervention group and those in the triage control group. The team hypothesizes that patients in the "self-start" intervention group will demonstrate a lower frequency of healthcare utilization events when compared to those in the standard of care control.
Detailed description
Study Procedure and Intervention
Following enrollment and consent, participants will be randomized into two groups allocated 1:1 as follows:
- Intervention Group: Standing Prescription (Self-Start) + Sterile Urine Cup
- Control Group: Standard Triage Line.
Provider stratified block randomization (block size 4) will be implemented by REDCap randomization module on the day of participants scheduled procedure. At this point, each participant will be given a unique Study ID number to allow study coordinators to commence data abstraction from the EMR (EPIC) into REDCap.
All participants, regardless of randomization, will follow the current practice with provider specific antibiotic prophylaxis protocol as prescribed. Electronic medical record review will be performed by the study investigators to obtain relevant medical history, treatment plan and demographic information for each participant and transcribed into REDCap.
Arm 1: Intervention Group Following the procedure, participants will receive a standing prescription for oral Nitrofurantoin (Macrobid) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and discharge instructions. International treatment guidelines recommend short-course regimens for acute uncomplicated cystitis, usually 3-6 days of antibiotic therapy. This is supported by a Cochrane review of 15 studies, including 1644 elderly women, showing non-inferiority of short course regimen to a 7-14-day long course for treating uncomplicated cystitis in elderly women.
Participants will be provided with standard procedural discharge instructions. The standard procedural discharge instructions will be modified to include instructions on taking antibiotics as part of the study. A section for how to collect a sterile urine sample will also be included with their discharge instructions.
Participants will be instructed that if they experience specific UTI symptoms, they must:
- Collect a clean-catch midstream urine sample in the provided cup.
- Drop the sample at a Cleveland Clinic lab facility (a standing order for urine culture will be placed in the EMR).
- Initiate the antibiotic prescription after dropping off the sample.
UTI Symptoms are defined as dysuria, urinary frequency, urinary urgency and suprapubic pain. Participants with fever ≥100.4°F, flank pain, chills, or systemic symptoms will be instructed to seek immediate medical care and not self-start antibiotics. A member of the study team will monitor the results of the urine cultures for the intervention group. If a culture confirms a pathogen resistant to Macrobid, the participant will be contacted by a member of the team to discontinue Macrobid and initiate appropriate antibiotic therapy.
Arm 2: Control Group Participants will receive standard post-procedure discharge instructions which typically instruct participants to follow routine practice if a UTI is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic. Subsequent interactions with participants in control groups needing intervention (i.e UTI needing antibiotics) will be managed in relation to how care is sought. The research team will only observe participants' interactions with the health care system.
Follow-Up Participants will be monitored from the time of intradetrusor Botox® injection through 30 days post-procedure, corresponding to the highest risk window for post-procedural UTI and urinary retention.
Data collection will include:
- Survey assessment on Day 7 for possible symptoms of UTI and symptoms severity using Patient Global Impression of Severity (PGI-S)
- Survey assessment on Day 30 for possible symptoms of UTI, and symptoms severity using PGI-S and treatment satisfaction.
- EMR review for unscheduled UTI related visits or antibiotic prescriptions
- Telephone or secure MyChart portal messages. 7-days after the procedure is performed, each participant will receive the initial automated REDCap survey to assess for possible symptoms of a UTI and severity of symptoms using the Patient Global Impression of Severity (PGI-S). Symptoms of UTIs are defined as dysuria, urgency, suprapubic pain, fever and flank pain. Also included in the survey assessment with be two additional questions regarding timeline of symptoms and treatment initiation. This survey is easy to follow and will take no more than 5 minutes to complete.
At the end of the 30-day period, all participants will receive two surveys via automated REDCap to again assess for symptoms of UTI and severity using the PGI-S, and their level of satisfaction with their post-procedure care. Both surveys will take no more than 5 minutes to complete. Reminder emails to complete the surveys will be sent to participants no more than 2 times. Individual responses will be linked to the participants' unique ID number. All the data collection will be performed by the study investigators through electronic medical record review and stored in REDCap for up to 6 years after study closure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine Culture | Active comparator | Drug: Macrobid® Capsules 100 mgFollowing the procedure, subjects will receive a standing prescription for oral Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and standing lab orders for urine culture and discharge instructions. Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections. |
| Standard Triage Line; Standard Medical Care (SMC) | Other | Other: Standard Medical Care (SMC)Subjects will receive standard post-procedure discharge instructions which typically instruct participants to follow routine practice if a UTI is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patients of all races and ethnicities aged 18 years and older.
- Diagnosis of Overactive Bladder (OAB) and/or Urge Urinary Incontinence (UUI).
- Scheduled to receive intradetrusor onabotulinumtoxinA (Botox®) for symptom management.
- Has decision making capacity to provide informed consent and comply with and follow study protocols.
- Ability to navigate a computer system independently
Key exclusion criteria (7 listed)
- Patients who currently perform Clean Intermittent Catheterization (CIC) or have an indwelling catheter.
- History of Severe Renal Impairment Cr/Cl - <60 ml/min 1.73m2
- History of recurrent UTIs (defined as >3x symptomatic UTIs in 12 months).
- Post-Void Residual (PVR) volume >150 mL.
- Active UTI at the time of procedure (procedure cancellation criteria).
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 |
|---|---|---|
| Macrobid® Capsules 100 mgSubjects will receive Nitrofurantoin (MACROBID) 100mg BID for 5 days (or a suitable alternative if resistant/allergic), a sterile urine cup and standing lab orders for urine culture. Suitable alternates for Nitrofurantoin (MACROBID) include: Trimethoprim/Sulfamethoxazole (BACTRIM) 100 mg twice a day for 5 days, Ampicillin-Sulbactam (AUGMENTIN) 500 mg twice a day for 5 days, Cephalexin (KEFLEX) 500 mg four times a day for 7 days, Ciprofloxacin (CIPRO) 500 mg twice a day for 7 days, or Cefexime (SUPRAX) 400 mg daily for 7 days. These medications prescribed as part of this study are clinically available Food and Drug Administration approved antibiotics for treating urinary tract infections. | Drug | Standing Prescription (Self-Start) + Sterile Urine Cup + Standing Lab Order for Urine Culture |
| Standard Medical Care (SMC)Subjects will receive standard of care post-procedure discharge instructions which instruct the following if a urinary tract infection is suspected: contact the nurse triage line, send a MyChart message to their providers office, or seek evaluation/treatment at an Urgent Care/Clinic. | Other | Standard Triage Line; Standard Medical Care (SMC) |
Primary outcome
Healthcare utilization
Time frame: Day of procedure to 30-days post procedure
Investigate whether providing a standing, take-home prescription for Nitrofurantoin (MACROBID), or other suitable prescription alternate detailed in the "arms and interventions section", is superior to SMC-triage care model call-in/urgent care among patients undergoing intradetrusor Botox®. Urinary tract infections. (UTIs) are the most common complication with intradetrusor Botox®, and patients have to call in to the triage line or present to a health care facility to be evaluated. Researchers will compare unplanned healthcare utilization, (the frequency of triage calls, MyChart messages, Urgent Care visits, ED visits, etc. related to urinary symptoms), between subjects in Self-Start arm (intervention) verses those who receive SMC.
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 3 Aug 2026.
- 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.
Shannon Wallace, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Macrobid® Capsules 100 mg and Standard Medical Care (SMC) in people with Overactive Bladder, run by The Cleveland Clinic 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 6 inclusion and 7 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 3 Aug 2026. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ugochukwu Okoroafor, MD (440-799-7739, okoroau@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare utilization (time frame: Day of procedure to 30-days post procedure). 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 3 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.