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NCT07216456 · ClinicalTrials.gov registry record · NA

Vaginal Dilator Therapy After Pelvic Radiation

A NA study, sponsored by Duke University.

Not yet
Registry status
NA
Development phase
88
Enrollment target

NCT07216456: Clinical Trial NA study, sponsored by Duke University.

NCT07216456 is a NA study that has not yet begun recruiting, run by Duke University. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07216456, a NA study, has not yet begun recruiting, sponsored by Duke University.

NOT YET RECRUITING
Registry status
NA
Development phase
88 participants
Enrollment target

Study Summary

This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or sexual activity painful or difficult. Even though dilators are recommended, many women don't use them as often as needed. In this study, 88 participants will be randomly assigned to one of two groups: * One group will receive the new behavioral program, which includes support and strategies to help with regular dilator use. * The other group will receive written educational materials (enhanced usual care). The study will look at how often and how long participants use their dilators, and whether the program helps reduce symptoms like pain or emotional distress. Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months, plus short monthly check-ins. The goal is to see if the program is helpful and easy to use, and to prepare for a larger study in the future.

Primary Outcome

Feasibility will be determined by 1) greater than or equal to 80% of sessions completed and 2) attrition rate of less than or equal to 20%.

Interventions

  • BEHAVIORAL Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2027-08-01
Est. Completion 2030-04-30
Phase NA
Duke University

1,725 total trials

What is known before NCT07216456 opens enrollment

NCT07216456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 1 intervention - of which Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation is the first listed.

NCT07216456 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07216456 about?

NCT07216456 is a clinical study titled "Vaginal Dilator Therapy After Pelvic Radiation". This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or ...

What is the current status of trial NCT07216456?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 88 participants. The study started on 2027-08-01. Estimated completion is 2030-04-30.

What interventions are being tested in trial NCT07216456?

The interventions under investigation include: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation (BEHAVIORAL).

Who is sponsoring clinical trial NCT07216456?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07216456's enrollment target sits among peer trials

88 972nd of 2000 higher than 1,027 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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Source: ClinicalTrials.gov NCT07216456, the US trial registry maintained by the National Library of Medicine. NCT07216456 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.