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NCT01642277 · ClinicalTrials.gov registry record · Phase 2
Bacterial Genomic Sequencing in Overactive Bladder
A Phase 2 study of Overactive Bladder, sponsored by Loyola University.
- Completed
- Registry status
- Phase 2
- Development phase
- 134
- Enrollment target
- 1
- Study location
NCT01642277: Completed Phase 2 study of Overactive Bladder, sponsored by Loyola University.
NCT01642277 is a Phase 2 study of Overactive Bladder that has completed, run by Loyola University. The registered enrollment target is 134 participants, below the 205-participant average among 46 other Overactive Bladder trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01642277, a Phase 2 study of Overactive Bladder, has completed, sponsored by Loyola University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 134 participants
- Enrollment target
- 1
- Study location
Study Summary
No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown that female urine, even in the absence of culture evidence of bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine and sequenced to identify bacterial species present in urine. From this the investigators can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a difference in the bacterial communities in the urine of women who respond to Solifenacin, a drug used to treat OAB, versus those that do not.
Primary Outcome
Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.
Conditions Studied
Interventions
- DRUG Solifenacin
Study Locations (1)
Illinois
- Loyola University Chicago Health Sciences Division - Maywood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 134 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-08 |
| Phase | Phase 2 |
What the finished NCT01642277 record still lists
NCT01642277 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 205-participant average among 46 other Overactive Bladder trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 1 intervention - of which Solifenacin is the first listed.
NCT01642277 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01642277 about?
NCT01642277 is a clinical study titled "Bacterial Genomic Sequencing in Overactive Bladder". No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown t...
What is the current status of trial NCT01642277?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 134 participants. The study started on 2012-07. Estimated completion is 2014-08.
What conditions does trial NCT01642277 study?
This clinical trial studies the following conditions: Overactive Bladder.
What interventions are being tested in trial NCT01642277?
The interventions under investigation include: Solifenacin (DRUG).
Who is sponsoring clinical trial NCT01642277?
This trial is sponsored by Loyola University, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01642277 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT01642277's enrollment target sits among peer trials
134 20th of 46 higher than 27 of 46 other Overactive Bladder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Overactive Bladder 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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