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NCT00803270 · ClinicalTrials.gov registry record · Phase 4

Mixed Incontinence: Medical Or Surgical Approach?

A Phase 4 study, sponsored by Carelon Research.

Terminated
Registry status
Phase 4
Development phase
27
Enrollment target

NCT00803270: Clinical Trial Phase 4 study, sponsored by Carelon Research.

NCT00803270 is a Phase 4 study that was terminated before completion, run by Carelon Research. The registered enrollment target is 27 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00803270, a Phase 4 study, was terminated before completion, sponsored by Carelon Research.

TERMINATED
Registry status
Phase 4
Development phase
27 participants
Enrollment target

Study Summary

The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.

Primary Outcome

Composite measure defined as "much better" or "very much better" on Patient Global Impression of Improvement (PGI-I) and "normal" or "mild" on Patient Global Impression of Symptoms (PGI-S). PGI-I is a single item: "Circle the one answer that best describes your urinary tract condition now, compared to how it was before your incontinence treatment" with responses ranging from 1= "Very much better" to 7= "Very much worse." The PGI-S is a single item:; "Circle the one number that best describes how

Interventions

  • PROCEDURE Surgical
  • DRUG Non-Surgical Intervention

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2008-10
Est. Completion 2009-03
Phase Phase 4
Carelon Research

50 total trials

Why NCT00803270 stopped before completion

NCT00803270 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Surgical is the first listed.

NCT00803270 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00803270 about?

NCT00803270 is a clinical study titled "Mixed Incontinence: Medical Or Surgical Approach?". The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be...

What is the current status of trial NCT00803270?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 27 participants. The study started on 2008-10. Estimated completion is 2009-03.

What interventions are being tested in trial NCT00803270?

The interventions under investigation include: Surgical (PROCEDURE), Non-Surgical Intervention (DRUG).

Who is sponsoring clinical trial NCT00803270?

This trial is sponsored by Carelon Research, which has 50 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00803270's enrollment target sits among peer trials

27 1651st of 2000 higher than 346 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT00803270, the US trial registry maintained by the National Library of Medicine. NCT00803270 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.