DyspareuniaNCT06059586
Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
A study testing Pelvic health therapy and Dilator feasability in people with Dyspareunia and Pelvic Pain, run by Indiana University at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dyspareunia, Pelvic Pain, Sexual Dysfunction
- What is being tested?
- Pelvic health therapy and Dilator feasability
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jan 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer
- Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion
- Notes:
- Can have prior and/or current modalities of treatment to address diagnosis including surgery and chemotherapy
- Can receive radiation at any facility provided patient is able to perform Physical Therapy visits at IUH North/Schwarz Cancer Center
Who cannot join
- Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
- Not a candidate for curative radiation therapy per radiation oncologist's discretion
- Prior radiation therapy to the pelvis
- Women who are pregnant or nursing
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
IU Health West
Avon, Indiana, 46123
Nikki Barrow, 317-944-1242, nrbarrow@iu.edu
- Recruiting
IU Health Schwarz Cancer Center
Carmel, Indiana, 46032
John Spittler, 3172740771, ajspittl@iu.edu
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Sarah Dutkevitch, RN, 317-278-5618, sdutkevi@iu.edu
About this study
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.
Read the detailed description
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?
- Conditions
- Dyspareunia, Pelvic Pain, Sexual Dysfunction, Radiation Toxicity
- Being tested
- Pelvic health therapy, Dilator feasability
- Keywords
- vaginal dilator, pelvic health physical therapy
- Medical subject headings
- Dyspareunia, Pelvic Pain, Sexual Dysfunction, Physiological, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic health therapyBehavioural
Female Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education
Dilator feasabilityDevice
Patient Adherence to Vaginal Dilation Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Pelvic health Assessment and Intervention | Experimental | Not described Receives: Behavioral: Pelvic health therapy; Device: Dilator feasability |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 4 months
Secondary outcomes (3)
Average score on the Visual Pain Rating Scale.
Visual Analogue Pain Rating Scale 0-10
Measured: 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)
Measured: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Percentage of adherence to dilator use
Self-reported dilator adherence
Measured: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start16 Jan 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Namita Agrawal, Indiana University
- Investigators
- Namita Agrawal, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059586
- Sponsor's protocol ID
- CTO-IUSCCC-0772
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-Rehabilitation for Female Patients Undergoing Pelvic Radiotherapy
- ClinicalTrials.gov ID
- NCT06059586
- Acronym / sponsor ID
- CTO-IUSCCC-0772
- Conditions
- Dyspareunia, Pelvic Pain, Sexual Dysfunction, Radiation Toxicity
- Keywords
- vaginal dilator, pelvic health physical therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 16 Jan 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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?
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pelvic health Assessment and Intervention | Experimental | Behavioral: Pelvic health therapy, Device: Dilator feasability |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female
- ≥ 18 years old at the time of informed consent
- Ability to provide written informed consent and HIPAA authorization
- Primary diagnosis of cervical, vaginal, vulvar, uterine, or anal cancer
- Candidate for curative pelvic radiation with external beam, with or without brachytherapy, per radiation oncologist's discretion
Key exclusion criteria (4 listed)
- Major medical illnesses or psychiatric impairments, which in the investigator's opinion will prevent administration or completion of the protocol therapy and/or interfere with follow-up.
- Not a candidate for curative radiation therapy per radiation oncologist's discretion
- Prior radiation therapy to the pelvis
- Women who are pregnant or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic health therapyFemale Sexual Function Index (FSFI) and VAS Pain Scale Questionnaires, Physical Therapy Evaluation including Pelvic Floor Muscle Examination, Dilator Education | Behavioural | Pelvic health Assessment and Intervention |
| Dilator feasabilityPatient Adherence to Vaginal Dilation Questionnaire | Device | Pelvic health Assessment and Intervention |
Primary outcome
Feasability of implementation of pre-rehabilitation to radiotherapy
Time frame: Baseline
Recording the number of eligible patients for protocol that decline enrollment. The reason(s) for forgoing protocol intervention will be documented.
Feasability of implementation of pre-rehabilitation to radiotherapy
Time frame: Baseline
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.
Feasability of implementation of pre-rehabilitation to radiotherapy
Time frame: Baseline
The number of eligible patients identified, but not screened, for eligibility or not consented if eligible will be recorded.
Feasability of implementation of pre-rehabilitation to radiotherapy
Time frame: Baseline
The duration of time from initial clinical presentation to being offered information of clinical study will be recorded.
Feasability of implementation of pre-rehabilitation to radiotherapy
Time frame: Baseline to 6 weeks
The duration of time from enrollment on clinical study to being seen by physical therapy will be recorded.
Feasability of implementation of pre-rehabilitation to radiotherapy
Time frame: Baseline to 4 months
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.
3 secondary outcomes
Average score on the Visual Pain Rating Scale.
Time frame: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Evaluate female sexual function based on questionnaire responses
Time frame: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Percentage of adherence to dilator use
Time frame: 4 weeks, 6 weeks, 8 weeks, 12 weeks, and 16 weeks post radiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Namita Agrawal, MD principal investigator
Indiana University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic health therapy and Dilator feasability in people with Dyspareunia and Pelvic Pain, run by Indiana University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Namita Agrawal, MD ((317)944-2524, agrawaln@indiana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability of implementation of pre-rehabilitation to radiotherapy (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.