An Early Phase 1 interventional study of Macrobid® Capsules 100 mg and Standard Medical Care (SMC) in Overactive Bladder, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by The Cleveland Clinic · Early Phase 1, Interventional, and Supportive care
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.
Study Procedure and Intervention
Following enrollment and consent, participants will be randomized into two groups allocated 1:1 as follows:
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:
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:
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's planned enrollment of 260 is above the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Macrobid® Capsules 100 mg
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.
Other: Standard Medical Care (SMC)
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.
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.
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.
Time frame: Day of procedure to 30-days post procedure
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Mar 2028, 20 months after the start.
Of 30 phase 1 interventional studies under Urinary Bladder, Overactive, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 22. This study's planned 20 months is above that.
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Studies of the drug tested here: Nitrofurantoin