An observational study in Vaginal Stricture and Vaginal Stenosis, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-07-09.
Sponsored by University of California, San Diego · Observational
Radiation (RT) affects the vagina by narrowing, tightening and scarring, termed vaginal stenosis (VS). VS occurs in up to 88% of patients treated with radiation for cervical cancer. VS is not well characterized in measurements. There is a lack of understanding of how short and tight the vagina becomes after RT. This study will use specific measurements of the vagina during the routine physician physical exam after RT in the follow up periods: after RT, 3 months, 6 months, and 12 months using a plastic commercial dilator set and length and width measurements.
In addition, the study use a validated sexual health survey and a specific survey on vaginal dilation preferences to help stop VS after RT.
This single-arm pilot will enroll 12 subjects scheduled to receive radiotherapy or brachytherapy for gynecological cancers. The study will collect data from CT images, physical measurements, patient reported outcomes to develop a quantifiable generalizable metric for determining the severity of radiotherapy/brachytherapy induced vaginal stenosis.
The data will be used to inform the development of a novel personalized device for the treatment of vaginal stenosis.
108 studies on the registry are indexed under Radiation Injuries; 46 are open to participants now.
This study's planned enrollment of 12 is below the median of 105 across 41 observational studies indexed under Radiation Injuries.
Browse Radiation Injuries studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
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Female subjects over 18 years old, scheduled to receive radiotherapy and/or brachytherapy for the treatment of gynecological cancers.
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Patients diagnosed on imaging or biopsy with a synchronous primary malignancy (with the exception of DCIS of the breast, or early stage basal cell carcinoma of the skin)
a. transcription mediated amplification (TMA) or branched DNA testing.
1\. Patients with histologically confirmed newly diagnosed advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma): FIGO 2009 clinical stages IB2/IIA with positive para-aortic nodes, or FIGO 2009 clinical stages IIB/IIIB/IVA with positive pelvic or para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must be inferior to the T12/L1 interspace.
Other: UCSD Vaginal Dilator Questionnaire · Other: EORTC Sexual Health Questionnaire
14 question survey
22 question survey
Quantify radiation induced vaginal stenosis
acquire and integrate imaging and direct patient vaginal diameter measurements to characterize VS for the computer and benchtop models
Time frame: 1.5 years
Acquire Patients' Treatment Concerns and Preferences
Using a series of sexual and vaginal health questionnaires presenting an array of scaled (quantified) options we will determine patients' perceived flaws about current treatment and their preferences, and integrate them with the VS measurement results of Aim1 to guide modification and optimization of our soft balloon VS treatment system
Time frame: 1.5 years
Optimize and Validate Vaginal Stenosis Treatment System
Incorporating the multimodal vaginal stenosis measurements and patient preferences acquired in Aim 1, we will use computer modelling based on known vaginal wall properties to simulate and predict the long-term outcomes of balloon-driven, graded vaginal expansion to counteract VS. Benchtop experimentation will utilize an inflatable balloon-type device and 3D printed biomimetic stenosed vaginal phantoms to test the proposed treatment effect over various time periods emulating different stages of fibrotic stenosis. To directly test our working hypothesis results acquired from modeling will be compared statistically to benchtop data.
Time frame: 1 year
Plan to share: No
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University of California, San Diego