An interventional study of Pelvic health therapy and Dilator feasability in Dyspareunia, Pelvic Pain and Sexual Dysfunction, sponsored by Indiana University. Recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Indiana University · Not applicable, Interventional, and Supportive care
The purpose of this study is to examine the feasibility of adding pre-rehabilitation pelvic health physical therapy to standard of care radiation therapy treatment plan for female patients who have been diagnosed with cervical, vaginal, vulvar, uterine, or anal cancer and are a candidate for curative pelvic radiation with external beam. Participants will receive education on using a vaginal dilator for use during treatment and complete questionnaires looking at pain and sexual function.
Because of the increasing survivorship rate, there is a need for research addressing the post-treatment side effects of pelvic pain and dyspareunia, due to the significant impact these side effects have on patients' quality of life. Current best practice from trained pelvic health physical therapists for addressing dyspareunia and pelvic pain due to vaginal stenosis after radiation therapy, is vaginal dilation. Vaginal dilators are cone shaped durable medical equipment that are inserted into the vagina with lubricant, to assist in patency of the vaginal canal and stretching of the pelvic floor muscles.
The primary objective of this pilot clinical trial is to assess the feasibility of implementing a collaborative, coordinated, and multidisciplinary initiative between radiation oncology and pelvic health physical therapy to answer the following questions: 1) What are the barriers and facilitators to the implementation of a pre-rehabilitation service for gynecological and female anal cancer patients undergoing pelvic radiation and 2) What is the potential clinical value of adding pre-rehabilitative pelvic health services, with an emphasis on vaginal dilator education and use, to the gynecological and female anal cancer radiation setting, in collaboration with radiation oncology staff, as a means of reducing pelvic pain and dyspareunia?
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 20 is below the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Notes:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Pelvic health therapy · Device: Dilator feasability
Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education
Patient Adherence to Vaginal Dilation Questionnaire
Feasability of implementation of pre-rehabilitation to radiotherapy
Recording the number of eligible patients for protocol that decline enrollment. The reason(s) for forgoing protocol intervention will be documented.
Time frame: Baseline
Feasability of implementation of pre-rehabilitation to radiotherapy
The number of eligible patients that were not identified for protocol enrollment will be recorded and potential gaps in the screening process will be analyzed.
Time frame: Baseline
Feasability of implementation of pre-rehabilitation to radiotherapy
The number of eligible patients identified, but not screened, for eligibility or not consented if eligible will be recorded.
Time frame: Baseline
Feasability of implementation of pre-rehabilitation to radiotherapy
The duration of time from initial clinical presentation to being offered information of clinical study will be recorded.
Time frame: Baseline
Feasability of implementation of pre-rehabilitation to radiotherapy
The duration of time from enrollment on clinical study to being seen by physical therapy will be recorded.
Time frame: Baseline to 6 weeks
Feasability of implementation of pre-rehabilitation to radiotherapy
The number of Female Sexual Function Index questionnaires will be recorded as completed, incomplete or not attempted. Reasons for submitting incomplete questionnaires or not submitting a questionnaire will be recorded.
Time frame: Baseline to 4 months
Average score on the Visual Pain Rating Scale.
Visual Analogue Pain Rating Scale 0-10
Time frame: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Evaluate female sexual function based on questionnaire responses
Female Sexual Function Index questionnaires (Likert scale)
Time frame: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Percentage of adherence to dilator use
Self-reported dilator adherence
Time frame: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
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