Sexual DysfunctionNCT04544735
Improving Women's Function After Pelvic Radiation
A study testing Integrated Physical Therapy and Coping Skills Training in people with Sexual Dysfunction and Pelvic Floor Disorders, run by Duke University at 1 site in United States.
Trial summary
The purpose of the study is to develop and test an intervention combining physical therapy (PT) and coping skills training to improve women's sexual function after pelvic radiation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sexual Dysfunction, Pelvic Floor Disorders, Gynecologic Cancer
- What is being tested?
- Integrated Physical Therapy and Coping Skills Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2020to Dec 2027
- 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
- Diagnosis of non-metastatic gynecologic (cervical, endometrial, vaginal, vulvar), anal, rectal, or bladder cancer
- Completed pelvic radiation treatment within the last 5 years
- 18 years of age or older
- Able to speak/read English
- Able to give meaningful informed consent
- Diagnosis of non-metastatic gynecologic (cervical, endometrial, vaginal, vulvar), anal, rectal, or bladder cancer
Show all 10Show fewer
- Completed pelvic radiation treatment in the past 2 to 24 months
- 18 years of age or older
- Able to speak/read English
- Able to give meaningful informed consent
Who cannot join
- Major untreated or uncontrolled mental illness (e.g., schizophrenia)
- Unable to provide informed consent
- Medical Providers Participating in Intervention Development Interviews
- Eligibility Criteria:
- Oncology providers (e.g., radiation, medical, and surgical oncologists; nurses; advanced practice professionals) who provide care to women who receive pelvic radiation for gynecologic, anal, rectal or bladder cancers.
- Physical therapists with specialized certification in pelvic health or women's health physical therapy who provide care to patients in the outpatient setting.
Show all 9Show fewer
- Cancer Survivor User Testers
- Major untreated or uncontrolled mental illness (e.g., schizophrenia)
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27705
About this study
Official title: Integrated Physical Therapy and Coping Skills Training for Improving Women's Sexual Function After Pelvic Radiation
The purpose of the study is to develop and test an intervention combining physical therapy (PT) and coping skills training to improve women's sexual function after pelvic radiation.
Read the detailed description
Pelvic radiation, which is a critical component in the treatment of many gynecologic, bladder, rectal and anal cancers, often results in devastating and long-lasting sexual side effects. Vaginal changes following pelvic radiation include adhesions, agglutination, fibrosis, dryness, atrophy, and stenosis. Pelvic radiation-related sexual problems are often undertreated, resulting in poor symptom management and reduced quality of life. Rehabilitation programs including pelvic floor muscle training (PFMT) and vaginal dilator exercises may help minimize post-radiation vaginal changes and related sexual problems, but use of these rehabilitation strategies is inconsistent and infrequent in routine clinical practice. For many women, engaging in these rehabilitation strategies can be difficult and adherence is low (e.g.,1% to 35% for dilator use). Barriers to engaging in PFMT and dilator exercises include lack of information, pain, embarrassment, fear, and reliving invasive treatments. There is a critical need for interventions to help women access and engage in rehabilitation following pelvic radiation treatment. We propose to develop and pilot test a novel physical therapist delivered intervention to improve women's sexual function after pelvic radiation that integrates pelvic health physical therapy interventions (i.e., vaginal dilators, PFMT) and cognitive-behavioral based coping skills training for managing symptoms and improving treatment adherence. Pelvic health physical therapy interventions have demonstrated effectiveness for treating pelvic pain and sexual pain disorders. Coping skills training interventions have demonstrated benefits for reducing symptoms and improving treatment engagement.This study includes two phases: intervention development and pilot testing. For intervention development (months 1-6), qualitative data obtained from patient and healthcare provider interviews will be used to develop and refine the integrated PT and coping skills training intervention. Using information obtained in qualitative interviews, we will develop the intervention. In pilot testing (months 7-12), we will pilot the developed intervention with women who were treated with pelvic radiation. : The specific aims of this study are to: 1) develop and refine an integrated PT and coping skills training intervention based on qualitative data from interviews with cancer survivors, oncology providers, and pelvic health physical therapists; 2) pilot the developed intervention to examine its feasibility and acceptability; and 3) examine the patterns of change and relationships among outcome variables including vaginal changes, pelvic floor function, sexual function and satisfaction, and use of rehabilitation exercises.
- Being tested
- Integrated Physical Therapy and Coping Skills Training
- Keywords
- Pelvic radiation, Sexual side effects, Pelvic health physical therapy, Cancer survivors, Intimacy dysfunction
- Medical subject headings
- Sexual Dysfunction, Physiological, Pelvic Floor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Physical Therapy and Coping Skills TrainingBehavioural
The proposed intervention will provide pelvic health physical therapy interventions including: education about vaginal moisturizers and lubricants, low back and hip assessment and instruction in accommodations (e.g., strategies for accommodating sexual position of choice), instruction in vulvar massage, instruction and facilitation of vaginal dilator use, and pelvic floor muscle training (PFMT) and exercises. Women will be given a set of vaginal dilators. Cognitive behavioral techniques that have been successfully used by physical therapists in prior intervention studies will be integrated into the PT intervention including breathing and relaxation techniques, guided imagery, systematic desensitization, cognitive restructuring techniques and coping thoughts, and problem solving
| Study group | Role | What they receive |
|---|---|---|
| Integrated Physical Therapy and Coping Skills Training | Experimental | The proposed intervention will will integrate two key components: pelvic health PT interventions (i.e., vaginal dilators, Pelvic Floor Muscle Training) and coping skills training for managing symptoms and improving treatment adherence. The intervention aims to improve women's sexual function after pelvic radiation Receives: Behavioral: Integrated Physical Therapy and Coping Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session Attendance
Treatment feasibility will be assessed by measuring the session attendance rate for each participant
Measured: Following completion of the intervention, up to 12 months
Attkisson & Zwick's Client Satisfaction Questionnaire
18 item questionnaire to measure and assess consumer satisfaction with health and human services.
Measured: 3 months post intervention
Secondary outcomes (6)
Sexual Vaginal Changes Questionnaire
27-item questionnaire to assess intimacy, sexual interest, sexual satisfaction, vaginal changes (lubrication, pain and bleeding) and sexual functioning
Measured: Baseline and 3 months post intervention
Australian Pelvic Floor Questionnaire
42 item questionnaire to assesses all pelvic floor symptoms including bladder, bowel and sexual function and prolapse symptoms
Measured: Baseline and 3 month post intervention
PROMIS Sexual Function and Satisfaction Measure Full Profile (Female)
27 item questionnaire to measure sexual function and satisfaction in female population with cancer in past 30 days
Measured: Baseline and 3 months post intervention
Generalized Anxiety Disorder Screener (GAD-7)
7-item questionnaire to assess symptoms of anxiety over the past two weeks
Measured: Baseline and 3 months post intervention
Patient Health Questionnaire Depression Screener (PHQ-9)
9-item questionnaire to asses depressive symptoms over the past two weeks
Measured: Baseline and 3 months post intervention
Adherence to Rehabilitation Strategies Scale
3 item questionnaire to assess adherence to rehabilitation strategies such as vaginal dilators, moisturizers, pelvic floor muscle exercises.
Measured: Baseline and 3 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start7 Oct 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Study is suspended due to lack of funds. Will resume as soon as funding is secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- More trials run by Duke 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544735
- Sponsor's protocol ID
- Pro00105435
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2020
- Last updated
- 8 Sep 2026
- 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 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Physical Therapy and Coping Skills Training for Improving Women's Sexual Function After Pelvic Radiation
- ClinicalTrials.gov ID
- NCT04544735
- Acronym / sponsor ID
- Pro00105435
- Keywords
- Pelvic radiation, Sexual side effects, Pelvic health physical therapy, Cancer survivors, Intimacy dysfunction
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is suspended due to lack of funds. Will resume as soon as funding is secured.
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Sep 2020 (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 the study is to develop and test an intervention combining physical therapy (PT) and coping skills training to improve women's sexual function after pelvic radiation.
Detailed description
Pelvic radiation, which is a critical component in the treatment of many gynecologic, bladder, rectal and anal cancers, often results in devastating and long-lasting sexual side effects. Vaginal changes following pelvic radiation include adhesions, agglutination, fibrosis, dryness, atrophy, and stenosis. Pelvic radiation-related sexual problems are often undertreated, resulting in poor symptom management and reduced quality of life. Rehabilitation programs including pelvic floor muscle training (PFMT) and vaginal dilator exercises may help minimize post-radiation vaginal changes and related sexual problems, but use of these rehabilitation strategies is inconsistent and infrequent in routine clinical practice. For many women, engaging in these rehabilitation strategies can be difficult and adherence is low (e.g.,1% to 35% for dilator use). Barriers to engaging in PFMT and dilator exercises include lack of information, pain, embarrassment, fear, and reliving invasive treatments. There is a critical need for interventions to help women access and engage in rehabilitation following pelvic radiation treatment. We propose to develop and pilot test a novel physical therapist delivered intervention to improve women's sexual function after pelvic radiation that integrates pelvic health physical therapy interventions (i.e., vaginal dilators, PFMT) and cognitive-behavioral based coping skills training for managing symptoms and improving treatment adherence. Pelvic health physical therapy interventions have demonstrated effectiveness for treating pelvic pain and sexual pain disorders. Coping skills training interventions have demonstrated benefits for reducing symptoms and improving treatment engagement.This study includes two phases: intervention development and pilot testing. For intervention development (months 1-6), qualitative data obtained from patient and healthcare provider interviews will be used to develop and refine the integrated PT and coping skills training intervention. Using information obtained in qualitative interviews, we will develop the intervention. In pilot testing (months 7-12), we will pilot the developed intervention with women who were treated with pelvic radiation. : The specific aims of this study are to: 1) develop and refine an integrated PT and coping skills training intervention based on qualitative data from interviews with cancer survivors, oncology providers, and pelvic health physical therapists; 2) pilot the developed intervention to examine its feasibility and acceptability; and 3) examine the patterns of change and relationships among outcome variables including vaginal changes, pelvic floor function, sexual function and satisfaction, and use of rehabilitation exercises.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrated Physical Therapy and Coping Skills Training | Experimental | Behavioral: Integrated Physical Therapy and Coping Skills TrainingThe proposed intervention will will integrate two key components: pelvic health PT interventions (i.e., vaginal dilators, Pelvic Floor Muscle Training) and coping skills training for managing symptoms and improving treatment adherence. The intervention aims to improve women's sexual function after pelvic radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of non-metastatic gynecologic (cervical, endometrial, vaginal, vulvar), anal, rectal, or bladder cancer
- Completed pelvic radiation treatment within the last 5 years
- 18 years of age or older
- Able to speak/read English
- Able to give meaningful informed consent
Key exclusion criteria (9 listed)
- Major untreated or uncontrolled mental illness (e.g., schizophrenia)
- Unable to provide informed consent
- Medical Providers Participating in Intervention Development Interviews
- Oncology providers (e.g., radiation, medical, and surgical oncologists; nurses; advanced practice professionals) who provide care to women who receive pelvic radiation for gynecologic, anal, rectal or bladder cancers.
- Physical therapists with specialized certification in pelvic health or women's health physical therapy who provide care to patients in the outpatient setting.
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 |
|---|---|---|
| Integrated Physical Therapy and Coping Skills TrainingThe proposed intervention will provide pelvic health physical therapy interventions including: education about vaginal moisturizers and lubricants, low back and hip assessment and instruction in accommodations (e.g., strategies for accommodating sexual position of choice), instruction in vulvar massage, instruction and facilitation of vaginal dilator use, and pelvic floor muscle training (PFMT) and exercises. Women will be given a set of vaginal dilators. Cognitive behavioral techniques that have been successfully used by physical therapists in prior intervention studies will be integrated into the PT intervention including breathing and relaxation techniques, guided imagery, systematic desensitization, cognitive restructuring techniques and coping thoughts, and problem solving | Behavioural | Integrated Physical Therapy and Coping Skills Training |
Primary outcome
Session Attendance
Time frame: Following completion of the intervention, up to 12 months
Treatment feasibility will be assessed by measuring the session attendance rate for each participant
Attkisson & Zwick's Client Satisfaction Questionnaire
Time frame: 3 months post intervention
18 item questionnaire to measure and assess consumer satisfaction with health and human services.
6 secondary outcomes
Sexual Vaginal Changes Questionnaire
Time frame: Baseline and 3 months post intervention
Australian Pelvic Floor Questionnaire
Time frame: Baseline and 3 month post intervention
PROMIS Sexual Function and Satisfaction Measure Full Profile (Female)
Time frame: Baseline and 3 months post intervention
Generalized Anxiety Disorder Screener (GAD-7)
Time frame: Baseline and 3 months post intervention
Patient Health Questionnaire Depression Screener (PHQ-9)
Time frame: Baseline and 3 months post intervention
Adherence to Rehabilitation Strategies Scale
Time frame: Baseline and 3 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- 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.
Rebecca Shelby, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Physical Therapy and Coping Skills Training in people with Sexual Dysfunction and Pelvic Floor Disorders, run by Duke University 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 10 inclusion and 9 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: paused, as of the sponsor's last update on 8 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 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?
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?
Session Attendance (time frame: Following completion of the intervention, up to 12 months). The study lists 2 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 8 Sep 2026.