Gynecologic CancerNCT05769062
Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
A study testing Single digit pelvic exam in people with Gynecologic Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Single digit pelvic exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2023to 10 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Undergoing primary treatment for locally advanced cervical cancer with definitive, curative-intent chemoradiotherapy (chemotherapy must be a radiosensitizing platinum agent).
- At least 18 years of age.
- English speaker.
- Able to understand and willing to sign an IRB approved written informed consent document.
Who cannot join
- Received any form of pelvic radiation (excepting diagnostic studies).
- Currently taking and does not plan to take anti-estrogenic hormonal therapy.
- Diagnosis of interstitial cystitis/chronic bladder pain, irritable bowel syndrome, or inflammatory bowel disease.
- Currently being treated for a chronic non-cancer pain condition (treatment for pain after enrollment is acceptable).
- Inclusion Criteria - Retrospective Cohort (historical control)
- Received primary treatment for locally advanced cervical cancer with definitive, curative-intent chemoradiotherapy (chemotherapy must be a radiosensitizing platinum agent).
Show all 12Show fewer
- At least 18 years of age.
- Exclusion Criteria - Retrospective Cohort (historical control)
- Received any form of pelvic radiation (excepting diagnostic studies).
- Took anti-estrogenic hormonal therapy during treatment or in the 6 months following treatment.
- Diagnosis of interstitial cystitis/chronic bladder pain, irritable bowel syndrome, or inflammatory bowel disease at the start of treatment.
- Simultaneously treated for a chronic non-cancer pain condition at the start of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
The two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. The investigators hypothesize that an exam-based diagnostic tool will provide more information about the areas of injury related to pelvic radiation than patient-reported outcomes, and could be used in future studies of preventive strategies. An exam-based tool will also allow measurement of the pain dose-response to radiation treatment of specific areas, which could be excluded from radiation fields during treatment planning.
- Conditions
- Gynecologic Cancer
- Being tested
- Single digit pelvic exam
- Keywords
- cervical cancer, radiation, chemoradiation, pelvic floor muscle dysfunction, chronic pelvic pain
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single digit pelvic examProcedure or surgery
The exam takes approximately 5 minutes and uses a single digit to palpate the pelvic floor muscles, during which patients will rate pain on a scale of 0-10 at 5 paired locations.
| Study group | Role | What they receive |
|---|---|---|
| Single-digit pelvic exam | Experimental | * Patients will have a pelvic floor muscle exam performed by their gynecologic radiation oncologist prior to treatment, at treatment mid-point (after 3 weeks of treatment), at the end of treatment (after 6 weeks of treatment), and at a follow-up visit 6 months after the end of treatment. Patients will also complete the Pelvic Floor Impact Questionnaire 7 (PFIQ-7), Pelvic Floor Disability Index (PFDI-20), and the EORTC QLQ-CX24 at these time points.
* The patient will also undergo a standard of care MRI prior to starting treatment. Receives: Procedure: Single digit pelvic exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam
An exam will be considered positive for PFMD if pain at any examined site is reported as greater than or equal to four (>4) out of 10. The EORTC QLQ-CX2 contains 24 items scored 1-4 by frequency with which the patient experiences each. The minimum possible score is 24, and maximum 96, with higher scores indicating worse quality of life. The questionnaire will be considered positive if any vaginal, sexual, or genitourinary module question is rated 4 and otherwise will be analyzed as a continuous variable.
Measured: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
Comparison of patient-reported symptoms as measured by PFDI-20 compared to findings of single digit pelvic exam
An exam will be considered positive for PFMD if pain at any examined site is reported as >4 out of 10. The PFDI-20 includes 20 items in three domains and provides a scaled score of 0-100 indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire will be considered positive if the scaled score is greater than or equal to 16, indicating at least "moderate distress" and otherwise will be analyzed as a continuous variable.
Measured: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
Comparison of patient-reported symptoms as measured by PFIQ-7 compared to findings of single digit pelvic exam
An exam will be considered positive for PFMD if pain at any examined site is reported as >4 out of 10. The PFIQ-7 includes 7 items each repeated across three domains and provides a scaled score and total score indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire does not have an established severity scale, and therefore will be analyzed as a simple continuous variable.
Measured: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
Secondary outcomes (7)
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using pelvic exam
Continuous variables of scales and total scores will be calculated for the exam at each time point and represented in spider-type plots. Results of the exam will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.
Measured: Through completion of follow-up (estimated to be 6 months)
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the EORTC QLQ-CX2 scores
Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.
Measured: Through completion of follow-up (estimated to be 6 months)
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFDI-20 scores
Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.
Measured: Through completion of follow-up (estimated to be 6 months)
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFIQ-7 scores
Continuous variables of scales and total scores will be calculated for the questionnaires at each time point and represented in spider-type plots. Results of the questionnaire will be analyzed using the thresholds described in the primary outcome measure, and frequencies of positive scores reported for each time point.
Measured: Through completion of follow-up (estimated to be 6 months)
Correlate radiation dose to pelvic floor structures with symptom severity by questionnaire (EORTC QLQ-CX2, PFDI-20, and PFIQ-7) and physical exam
Continuous variables of scales and total scores, as well as specific scores for radiation-exposed structures on exam, will be compared to dosimetric assessments of exposure of pelvic floor structures.
Measured: Through completion of follow-up (estimated to be 6 months)
Determine structure level radiation dose to complex functional pelvic structures
Standard dosimetric values will be calculated for each specific pelvic floor structure evaluated on exam.
Measured: Through completion of follow-up (estimated to be 6 months)
Frequency of pelvic floor muscle dysfunction symptoms in split-field IMRT patients compared to historical controls
Historical controls will be queried via chart review for dosimetric values in archived radiation treatment plans and compared to current gynecologic radiation standards. These patients will also undergo thorough chart review for subsequent diagnoses of pelvic floor-related disorders and compared to the diagnosis rate using the proposed screening tools in this study.
Measured: Through completion of follow-up (estimated to be 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start30 May 2023
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Why it stopped: Former PI left the institution so enrollment was closed early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Premal Thaker, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769062
- Sponsor's protocol ID
- 202209105
- Status last verified
- Oct 2025
- First submitted
- 16 Feb 2023
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Prevention of Pelvic Floor Dysfunction in Gynecologic Cancer Survivors
- ClinicalTrials.gov ID
- NCT05769062
- Acronym / sponsor ID
- 202209105
- Conditions
- Gynecologic Cancer
- Keywords
- cervical cancer, radiation, chemoradiation, pelvic floor muscle dysfunction, chronic pelvic pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Former PI left the institution so enrollment was closed early.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 15 Mar 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 two goals of this study are to establish a standardized method of assessing the pelvic floor for patients undergoing pelvic radiation and to determine the feasibility of inverse-RT planning using MRI to identify dosimetric constraints of the pelvic floor musculature for use in radiation planning. The investigators hypothesize that an exam-based diagnostic tool will provide more information about the areas of injury related to pelvic radiation than patient-reported outcomes, and could be used in future studies of preventive strategies. An exam-based tool will also allow measurement of the pain dose-response to radiation treatment of specific areas, which could be excluded from radiation fields during treatment planning.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-digit pelvic exam | Experimental | Procedure: Single digit pelvic exam* Patients will have a pelvic floor muscle exam performed by their gynecologic radiation oncologist prior to treatment, at treatment mid-point (after 3 weeks of treatment), at the end of treatment (after 6 weeks of treatment), and at a follow-up visit 6 months after the end of treatment. Patients will also complete the Pelvic Floor Impact Questionnaire 7 (PFIQ-7), Pelvic Floor Disability Index (PFDI-20), and the EORTC QLQ-CX24 at these time points. * The patient will also undergo a standard of care MRI prior to starting treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergoing primary treatment for locally advanced cervical cancer with definitive, curative-intent chemoradiotherapy (chemotherapy must be a radiosensitizing platinum agent).
- At least 18 years of age.
- English speaker.
- Able to understand and willing to sign an IRB approved written informed consent document.
Key exclusion criteria (12 listed)
- Received any form of pelvic radiation (excepting diagnostic studies).
- Currently taking and does not plan to take anti-estrogenic hormonal therapy.
- Diagnosis of interstitial cystitis/chronic bladder pain, irritable bowel syndrome, or inflammatory bowel disease.
- Currently being treated for a chronic non-cancer pain condition (treatment for pain after enrollment is acceptable).
- Inclusion Criteria - Retrospective Cohort (historical control)
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 |
|---|---|---|
| Single digit pelvic examThe exam takes approximately 5 minutes and uses a single digit to palpate the pelvic floor muscles, during which patients will rate pain on a scale of 0-10 at 5 paired locations. | Procedure or surgery | Single-digit pelvic exam |
Primary outcome
Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam
Time frame: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
An exam will be considered positive for PFMD if pain at any examined site is reported as greater than or equal to four (>4) out of 10. The EORTC QLQ-CX2 contains 24 items scored 1-4 by frequency with which the patient experiences each. The minimum possible score is 24, and maximum 96, with higher scores indicating worse quality of life. The questionnaire will be considered positive if any vaginal, sexual, or genitourinary module question is rated 4 and otherwise will be analyzed as a continuous variable.
Comparison of patient-reported symptoms as measured by PFDI-20 compared to findings of single digit pelvic exam
Time frame: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
An exam will be considered positive for PFMD if pain at any examined site is reported as >4 out of 10. The PFDI-20 includes 20 items in three domains and provides a scaled score of 0-100 indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire will be considered positive if the scaled score is greater than or equal to 16, indicating at least "moderate distress" and otherwise will be analyzed as a continuous variable.
Comparison of patient-reported symptoms as measured by PFIQ-7 compared to findings of single digit pelvic exam
Time frame: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment
An exam will be considered positive for PFMD if pain at any examined site is reported as >4 out of 10. The PFIQ-7 includes 7 items each repeated across three domains and provides a scaled score and total score indicating how much a patient is bothered by pelvic floor-related issues. The questionnaire does not have an established severity scale, and therefore will be analyzed as a simple continuous variable.
7 secondary outcomes
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using pelvic exam
Time frame: Through completion of follow-up (estimated to be 6 months)
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the EORTC QLQ-CX2 scores
Time frame: Through completion of follow-up (estimated to be 6 months)
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFDI-20 scores
Time frame: Through completion of follow-up (estimated to be 6 months)
Time course of pelvic floor dysfunction evolution over the course of treatment for cervical cancer using the PFIQ-7 scores
Time frame: Through completion of follow-up (estimated to be 6 months)
Correlate radiation dose to pelvic floor structures with symptom severity by questionnaire (EORTC QLQ-CX2, PFDI-20, and PFIQ-7) and physical exam
Time frame: Through completion of follow-up (estimated to be 6 months)
Determine structure level radiation dose to complex functional pelvic structures
Time frame: Through completion of follow-up (estimated to be 6 months)
Frequency of pelvic floor muscle dysfunction symptoms in split-field IMRT patients compared to historical controls
Time frame: Through completion of follow-up (estimated to be 6 months)
Results and safety
The study was stopped early (reason given: Former PI left the institution so enrollment was closed early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Premal Thaker, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single digit pelvic exam in people with Gynecologic Cancer, run by Washington University School of Medicine at 1 site 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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: Former PI left the institution so enrollment was closed early.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of patient-reported symptoms as measured by EORTC QLQ-CX2 compared to findings of single digit pelvic exam (time frame: Prior to starting treatment, at treatment mid-point (3 weeks after treatment), at end of treatment (after 6 weeks of treatment), and at 6 month follow-up visit after end of treatment). The study lists 3 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 15 Oct 2025.