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NCT04323735 · ClinicalTrials.gov registry record · Phase 2

Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters

A Phase 2 study of Neurogenic Bladder, sponsored by Medstar Health Research Institute.

Recruiting
Registry status
Phase 2
Development phase
182
Enrollment target
1
Study location

NCT04323735: Recruiting Phase 2 study of Neurogenic Bladder, sponsored by Medstar Health Research Institute.

NCT04323735 is a Phase 2 study of Neurogenic Bladder that is actively recruiting participants, run by Medstar Health Research Institute. The registered enrollment target is 182 participants, above the 82-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (122% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04323735, a Phase 2 study of Neurogenic Bladder, is actively recruiting participants, sponsored by Medstar Health Research Institute.

RECRUITING
Registry status
Phase 2
Development phase
182 participants
Enrollment target
1
Study location

Study Summary

The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.

Primary Outcome

Will measure change in urinary symptoms for those that use an indwelling catheter. Higher score may mean worse outcomes. (local urine collection participants only)

Conditions Studied

Interventions

  • DRUG Culturelle 10 Billion CFU Capsule

Study Locations (1)

District of Columbia

  • MedStar National Rehabilitation Hospital - Washington D.C.

Trial Details

FieldValue
Enrollment Target 182 participants
Start Date 2020-01-10
Est. Completion 2026-09
Phase Phase 2
Medstar Health Research Institute

115 total trials

What NCT04323735 shows while recruiting

NCT04323735 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, above the 82-participant average among 16 other Neurogenic Bladder trials with a reported enrollment target (122% higher).

The record links to 1 condition, with Neurogenic Bladder appearing as the primary indexed condition, and to 1 intervention - of which Culturelle 10 Billion CFU Capsule is the first listed.

NCT04323735 reports a single indexed study location in District of Columbia.

Frequently Asked Questions

What is clinical trial NCT04323735 about?

NCT04323735 is a clinical study titled "Intravesical Lactobacillus for Urinary Symptoms Among People With NLUTD Who Use Indwelling Catheters". The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intrave...

What is the current status of trial NCT04323735?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 182 participants. The study started on 2020-01-10. Estimated completion is 2026-09.

What conditions does trial NCT04323735 study?

This clinical trial studies the following conditions: Neurogenic Bladder.

What interventions are being tested in trial NCT04323735?

The interventions under investigation include: Culturelle 10 Billion CFU Capsule (DRUG).

Who is sponsoring clinical trial NCT04323735?

This trial is sponsored by Medstar Health Research Institute, which has 115 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04323735 being conducted?

This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Neurogenic Bladder

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 NCT04323735's enrollment target sits among peer trials

182 2nd of 16 the highest of 16 other Neurogenic Bladder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neurogenic 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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Source: ClinicalTrials.gov NCT04323735, the US trial registry maintained by the National Library of Medicine. NCT04323735 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.