Vaginal Dilator Therapy for Vaginal Stenosis

Overseen By Smrithi Divakaran, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Under 17, Pelvic floor therapy, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program to help women use vaginal dilators more regularly after pelvic radiation therapy. Vaginal dilators can prevent or treat vaginal narrowing (vaginal stenosis), which can make exams or sexual activity painful. Participants will be divided into two groups: one will receive a behavioral program with support and strategies, while the other will receive written information. The study aims to determine if the program improves consistent dilator use and reduces symptoms like pain or distress. Women who have undergone cancer-related pelvic radiation therapy and have been advised to use dilators may consider joining. As an unphased trial, this study offers participants the chance to contribute to innovative research that may enhance post-radiation care for women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this program is safe for improving engagement with vaginal dilator therapy?

Research has shown that vaginal dilators can help prevent or treat vaginal stenosis, a condition where the vagina narrows after pelvic radiation therapy, making exams or sexual activity painful. Although dilator use is generally recommended, many women do not use them regularly.

Studies have found that women who use vaginal dilators regularly have a lower risk of developing severe vaginal narrowing. For instance, one study found that 64% of women who consistently used dilators had a reduced risk of severe narrowing over five years. This suggests that using dilators is generally safe and can alleviate symptoms related to vaginal narrowing.

The treatment in this trial is a program designed to help women use dilators more consistently. This program includes activities like relaxation techniques and mindfulness to support regular use. As the program is educational and supportive, it is unlikely to pose safety concerns. Participants will receive materials and guidance to help them use dilators more effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve how women engage with vaginal dilator therapy after pelvic radiation, which is a common treatment for cancer survivors. Unlike standard approaches that typically offer basic written instructions, this trial uses a unique remote, behavioral intervention. It combines cognitive behavioral therapy techniques like progressive muscle relaxation and acceptance and commitment therapy practices such as mindfulness. This comprehensive approach could help women more effectively use dilators, potentially improving outcomes and quality of life after treatment.

What evidence suggests that this program is effective for improving engagement with vaginal dilator therapy?

Studies have shown that vaginal dilators can lengthen the vagina and relieve symptoms of vaginal stenosis, where the vagina is narrower than usual. Research indicates that women who use dilators regularly, especially after pelvic radiation, experience less pain and distress. In this trial, one group will join an educational program aimed at improving engagement with vaginal dilator therapy. This program includes coping strategies and psychoeducation to encourage more frequent use, with some participants using dilators several times a week. Increased use can lead to better outcomes, such as reduced discomfort during medical exams or sexual activity. Incorporating these practices into a regular routine can support self-care and readiness. ^{6 7 8 9 10}

Who Is on the Research Team?

Juliann Stalls, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for women who have undergone pelvic radiation therapy and may be at risk of vaginal narrowing (vaginal stenosis). Participants should be willing to use vaginal dilators and complete surveys throughout the study. Specific eligibility criteria are not provided, but typically include factors like age range, health status, and previous treatments.

Inclusion Criteria

Able to speak/read English

My cancer is in the anus, cervix, uterus, vagina, vulva, or bladder.

I am female.

Exclusion Criteria

Have a major/serious psychiatric concern (e.g., schizophrenia) as indicated by medical chart/medical provider

I am younger than 17 years old.

I am currently seeing a pelvic floor physical therapist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomly assigned to receive either a behavioral program or enhanced usual care to improve engagement with vaginal dilator therapy

9 months

Monthly check-ins (virtual)

Follow-up

Participants are monitored for changes in symptoms, emotional distress, and knowledge about dilator therapy

3 months

Surveys at 3, 6, and 9 months

What Are the Treatments Tested in This Trial?

Interventions

• Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation

Trial Overview The study is testing a new behavioral program designed to increase regular use of vaginal dilators compared with just receiving written educational materials. The aim is to see if the program improves adherence to using dilators and reduces symptoms associated with vaginal stenosis.

How Is the Trial Designed?

Group I: Improving Engagement with Vaginal Dilator Therapy after Pelvic Radiation Experimental Treatment 1 Intervention

A 6-session (45 minutes each) behavioral intervention will be delivered individually and remotely via videoconferencing. The intervention will be designed to improve engagement with vaginal dilator therapy among female cancer survivors who underwent pelvic radiation therapy. The intervention includes coping strategies from cognitive behavioral therapy (e.g., progressive muscle relaxation) and acceptance and commitment therapy (e.g., mindfulness), as well as psychoeducation (e.g., how to use dilators), to enhance engagement with vaginal dilator therapy.

Group II: Enhanced Usual Care Active Control 1 Intervention

Written materials will highlight the purpose of dilator therapy and how to use dilators (including frequency and duration).

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07216456

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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24088315

Can an Educational Intervention Improve Compliance With ... Our study findings indicated that our patients achieved a greater compliance of at least 2 to 3 times per week at 6 months than theirs in the intervention ...

3. ejoncologynursing.com ejoncologynursing.com/article/S1462-3889(25)00235-2/pdf

Journal Pre-proof Conclusion: Integrating vaginal dilator therapy into prehabilitation may enhance preparedness, promote self-care, and reduce distress during ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6822871/

Clinical and Psychological Outcomes of the Use of Vaginal ... The objective of this study was to evaluate the behaviour of the vaginal canal dimensions during the first 3 months after the end of the radiotherapy followed ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/01443615.2024.2317387

Full article: Effects of vaginal dilation therapy on ... To date, evidence has shown that vaginal dilation therapy (VDT) can help in increasing the vaginal length and in improving vaginal stenosis and the sexual ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8066324/

Pelvic Radiation Therapy Induced Vaginal Stenosis Within 24 months, the estimated risk of developing symptomatic VS was 16% at 55 Gy rectovaginal reference point dose, 20% at 65 Gy, 27% at 75 Gy ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S036030162401633X

Clinical Factors that Affect Patient-Reported Outcomes of ... Vaginal stenosis (VS) is a common sequela of pelvic radiotherapy (RT). Cellular injury results in shortening and/or narrowing of the vaginal ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03876860

An Enhanced Vaginal Dilator to Reduce Radiation-Induced ... This is a randomized control trial aimed to decreased radiation-induced vaginal stenosis in patients with endometrial or cervical cancer.

9. journals.lww.com journals.lww.com/md-journal/fulltext/2022/01280/vaginal_dilator_use_to_promote_sexual_wellbeing.46.aspx

Vaginal dilator use to promote sexual wellbeing after... At the vaginal examination performed 12 months after starting VD use, 47.2% of patients showed grade 1 VS and 30.2% showed grade 2, while 12 ...

10. redjournal.org redjournal.org/article/S0360-3016(24)03370-4/abstract

Association Between the Regular Use of Vaginal Dilators ... Of those, 565 (64%) reported regular dilation. This was associated with a significantly lower 5-year risk of vaginal stenosis G≥2 compared with ...