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NCT06706362 · ClinicalTrials.gov registry record · Phase 4
Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)
A Phase 4 study of Stress Urinary Incontinence, sponsored by Ohio State University.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 138
- Enrollment target
- 1
- Study location
NCT06706362: Recruiting Phase 4 study of Stress Urinary Incontinence, sponsored by Ohio State University.
NCT06706362 is a Phase 4 study of Stress Urinary Incontinence that is actively recruiting participants, run by Ohio State University. The registered enrollment target is 138 participants, below the 159-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (13% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06706362, a Phase 4 study of Stress Urinary Incontinence, is actively recruiting participants, sponsored by Ohio State University.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 138 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success rates if patients require temporary indwelling catheter versus intermittent self-catheterization (ISC).
Primary Outcome
Intervention (pre-operative oral antibiotics) and placebo groups will be compared for the risk of post-operative UTIs following urethral bulking procedures performed in the operating room. Patients who have symptoms, concerning for UTI during the immediate 6 week postoperative period will be asked to give a urine sample for culture. UTIs which are culture proven and symptomatic will be treated per individual provider preference. Positive urine cultures will be defined as cultures with greater t
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bactrim or Macrobid
Study Locations (1)
Ohio
- The Ohio State University Wexner Medical Center OB/GYN Female Pelvic Medicine and Reconstructive Surgery - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 138 participants |
| Start Date | 2025-09-15 |
| Est. Completion | 2027-10-15 |
| Phase | Phase 4 |
What NCT06706362 shows while recruiting
NCT06706362 is an interventional study that assigns participants to a tested intervention. The registered 138 participants enrollment target is mid-sized for trials with a published cap, below the 159-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (13% lower).
The record links to 1 condition, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06706362 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06706362 about?
NCT06706362 is a clinical study titled "Assessing the Utility of Prophylactic Antibiotics at Time of Urethral Bulking Using Bulkamid (Bulkamid Study)". The primary aim of this study is to assess the utility of prophylactic oral antibiotics at time of Bulkamid transurethral bulking to reduce the incidence of urinary tract infection (UTI) in the immediate postoperative period. The secondary aims of the study include assessing UTI rates and success ra...
What is the current status of trial NCT06706362?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 138 participants. The study started on 2025-09-15. Estimated completion is 2027-10-15.
What conditions does trial NCT06706362 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence.
What interventions are being tested in trial NCT06706362?
The interventions under investigation include: Placebo (DRUG), Bactrim or Macrobid (DRUG).
Who is sponsoring clinical trial NCT06706362?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06706362 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stress Urinary Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06706362's enrollment target sits among peer trials
138 13th of 35 higher than 23 of 35 other Stress Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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