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NCT03623880 · ClinicalTrials.gov registry record · NA
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 38
- Enrollment target
NCT03623880: Completed NA study, sponsored by Northwestern University.
NCT03623880 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 38 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03623880, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor disorders. Emotional distress is treatable using behavioral procedures, and effective treatment would increase women's emotional health and help to reduce urinary symptoms (e.g., incontinence, frequent urination). Women with pelvic floor disorders are often seen in the urogynecology clinic, which makes this setting ideal for offering additional interventions that may improve their quality of life. Unfortunately, many women with pelvic floor disorders may not receive effective behavioral treatment, such as cognitive behavior therapy, because urogynecologists and other medical professionals may not be aware of providers in their community who offer this treatment. The investigators will enhance treatment options by 1) providing evidence for an all-purpose cognitive-behavioral intervention (i.e., UP-CBT), 2) offering treatment in the urogynecology clinic, maximizing convenience, and 3) improving clinical outcomes for these patients. Specific Aims: 1. To demonstrate that UP-CBT is an effective form of therapy for women with lower urinary tract symptoms. 2. To use baseline characteristics in moderation analyses to determine which women will be most likely to have a good response to therapy. 3. To use mediation analyses to test a possible causal chain of events - Does treatment lead to lower anxiety, which in turn leads to fewer urinary symptoms?
Primary Outcome
Self-report measure of anxiety symptoms. Min T Score = 40.3; Max T Score = 81.6. Raw scores are summed, then converted to T Scores from a lookup table. Higher T scores represent a worse outcome (i.e., greater number of anxiety symptoms).
Interventions
- BEHAVIORAL Supportive Therapy
- BEHAVIORAL Unified Protocol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2018-09-03 |
| Est. Completion | 2020-12-10 |
| Phase | NA |
What the finished NCT03623880 record still lists
NCT03623880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Supportive Therapy is the first listed.
NCT03623880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03623880 about?
NCT03623880 is a clinical study titled "Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders". The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor disorders. Emotional distress is treatable using behavioral procedures, and effective treatment would increase women's ...
What is the current status of trial NCT03623880?
This trial is currently completed. It is a NA study. The enrollment target is 38 participants. The study started on 2018-09-03. Estimated completion is 2020-12-10.
What interventions are being tested in trial NCT03623880?
The interventions under investigation include: Supportive Therapy (BEHAVIORAL), Unified Protocol (BEHAVIORAL).
Who is sponsoring clinical trial NCT03623880?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03623880's enrollment target sits among peer trials
38 1538th of 2000 higher than 461 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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