Prostate CancerRESTORE-PCNCT07685249
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
A study testing Sex Therapy, Pelvic Floor Physical Therapy and Vacuum Erection Device (VED) in people with Prostate Cancer and Urinary Incontinence, run by Duke University at 1 site in United States.
Trial summary
This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Urinary Incontinence, Erectile Dysfunction
- What is being tested?
- Sex Therapy, Pelvic Floor Physical Therapy and Vacuum Erection Device (VED)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Nov 2029
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Biopsy-confirmed localized prostate adenocarcinoma.
- Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health.
- Initiating pelvic floor physical therapy as part of routine clinical care.
- Pre-treatment International Index of Erectile Function-5 (IIEF-5) score meeting the eligibility threshold, with or without aids, determined by medical record chart review (when documented within 4 months prior to index treatment) or collected post-treatment with participant recall anchored to the month prior to treatment. Eligibility threshold for the IIEF-5 is at or above 17.
- Able to read and understand English to complete patient-reported outcome measures.
- Ability to provide informed consent.
Who cannot join
- Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT.
- Recieved non-nerve-sparing treatment (when applicable).
- Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.
- Need for additional or secondary prostate cancer treatment during the intervention period.
- Documented cognitive impairment or impairment that would interfere with participation.
- Major psychiatric concern that would interfere with ability to consent or participate, such as schizophrenia, based on the medical record or treating clinician assessment.
- Inability to complete study video visits or questionnaires.
- History of prior local or systemic treatment for prostate cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
Michael W Willis, BA, 919-681-8437, michael.w.willis@duke.edu
Smrithi Divakaran, MPH, 919-681-7695, smrithi.divakaran@duke.edu
About this study
Official title: RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial
This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment.
All participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone.
Participants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.
Read the detailed description
This is a two-arm, parallel-group, randomized feasibility trial conducted at Duke University Health System. Eligible adult men treated for localized prostate adenocarcinoma with erectile nerve-sparing radical prostatectomy, radiotherapy, or cryoablation at Duke Health who are initiating pelvic floor physical therapy (PFPT) will be randomized 1:1 to PFPT plus sex therapy or PFPT alone. PFPT is delivered as part of routine clinical survivorship care. All enrolled participants will receive penile rehabilitation education and a vacuum erection device (VED) as part of standard PFPT, in addition to clinician-prescribed PDEi if applicable.
The sex therapy intervention is delivered by telehealth as 10 sessions of approximately 45 minutes over 6 months. Baseline assessment occurs after completion of localized treatment and before initiation of study-linked rehabilitation.
Patient-reported outcome measures will be collected at baseline and at 3, 6, 9, 12, 18, and 24 months post-baseline for feasibility of longer follow-up. Semi-structured qualitative interviews will be offered at 6 and 12 months post-baseline.
- Conditions
- Prostate Cancer, Urinary Incontinence, Erectile Dysfunction
- Being tested
- Sex Therapy, Pelvic Floor Physical Therapy, Vacuum Erection Device (VED)
- Keywords
- Pelvic Floor Physical Therapy, Sex Therapy, Penile Rehabilitation
- Medical subject headings
- Prostatic Neoplasms, Urinary Incontinence, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sex TherapyBehavioural
Telehealth sex therapy integrating psychoeducation, acceptance and commitment therapy strategies, and sensate focus skills; 10 sessions (~45 minutes) over 6 months delivered by a psychologist.
Pelvic Floor Physical TherapyBehavioural
Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.
Vacuum Erection Device (VED)Device
FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.
| Study group | Role | What they receive |
|---|---|---|
| PFPT + Sex Therapy | Experimental | Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED). Receives: Behavioral: Sex Therapy; Behavioral: Pelvic Floor Physical Therapy; Device: Vacuum Erection Device (VED) |
| PFPT Alone (Standard Care) | Active comparator | Standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED); no study-delivered sex therapy. Receives: Behavioral: Pelvic Floor Physical Therapy; Device: Vacuum Erection Device (VED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment feasibility as measured by number of participants recruited
Accrual rate will be used to assess feasibility of recruiting participants to the study target of 30 participants. This feasibility trial is designed to estimate key process parameters with precision rather than to test efficacy hypotheses
Measured: From initiation of recruitment to completion of accrual, up to 1 year
Enrollment feasibility, as measured by consent rate
Consent rate will be used to assess enrollment feasibility. This measure reflects the proportion of eligible participants who provide informed consent after screening and outreach.
Measured: From initiation of recruitment to completion of accrual, up to 1 year
Randomization feasibility
Randomization rate will be used to assess the proportion of consented eligible participants who are randomized in a 1:1 ratio to pelvic floor physical therapy (PFPT) plus sex therapy or PFPT alone.
Measured: From initiation of recruitment to completion of accrual, up to 1 year
Retention feasibility
Retention will be used to assess the proportion of randomized participants who remain in the study through the 12-month follow-up timepoint.
Measured: 12 months
Number of participants who complete study assessments
Assessment completion will be used to assess feasibility of longitudinal data collection across the planned study schedule. Scheduled patient-reported outcome assessments occur at baseline and during follow-up contacts.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Number of participants who participate in pelvic floor physical therapy (PFPT)
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes participation in PFPT.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Number of participants who participate in sex therapy
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes sex therapy participation in the intervention arm.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Number of participants who use recommended penile rehabilitation
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes recommended penile rehabilitation use patterns including vacuum erection device (VED) and PDE-5i use as measured via adherence logs.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Fidelity-monitoring feasibility
Fidelity-monitoring feasibility will be assessed using audio recording of sex therapy sessions and audit of a planned 20% sample of recordings using fidelity checklists.
Measured: During the 6-Month sex therapy intervention window
Secondary outcomes (21)
Acceptability of sex therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised
Participants assigned to sex therapy will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the sex therapy they are currently attending or have completed. The first 12 items assess agreement with statements related to therapy and therapist satisfaction on a 5-point scale from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks how much the treatment helped with the specific problem that led the participant to therapy, with response options ranging from "made things a lot better" to "made things a lot worse."
Measured: 6 Months
Acceptability of pelvic floor physical therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised
Participants in both arms will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to pelvic floor physical therapy. The first 12 items assess agreement with statements related to therapy and therapist satisfaction on a 5-point scale from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks how much the treatment helped with the specific problem or concern that led the participant to therapy, with response options ranging from "made things a lot better" to "made things a lot worse."
Measured: 12 Months
Urinary symptoms and bother, as measured by the International Prostate Symptom Score with bother index/quality of life (IPSS with BI/QOL)
The International Prostate Symptom Score with bother index/quality-of-life assessment is an 8-item measure that will be used to assess urinary symptoms and urinary-related bother. The first 7 questions assess symptom severity and scores may range from 1 to 35, where higher scores indicate higher symptom severity. The final question assesses urinary-related bother on a scale of 0 to 6, where a higher score indicates higher bother.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Erectile dysfunction as measured by the International Index of Erectile Function-5 (IIEF-5)
The International Index of Erectile Function-5 will be used to assess erectile function. At screening, if a pretreatment IIEF-5 is not available in the medical record, a screening IIEF-5 will be collected post-treatment with recall anchored to the month prior to treatment. Sum scores range from 5 to 25, where higher scores indicate higher erectile dysfunction.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Sexual function and satisfaction as measured by the PROMIS Sexual Function and Satisfaction Male Brief Profile
The PROMIS Sexual Function and Satisfaction Measure male brief profile is an 8-item measure used to capture sexual function, sexual satisfaction, and reasons for no sexual activity without requiring partner status. Scores range from 5 to 40, where higher scores indicate higher sexual function and satisfaction.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
General health status and utility as measured by the PROMIS-16 Profile v2.1 (PROPr)
PROMIS-16 Profile v2.1 (PROPr) is a 16-item measure used to assess general health status and utility. Scores range from 16 to 80, with higher scores indicating worse health status and utility.
Measured: Baseline and 12 Months
General health status and utility as measured by the PROMIS Global Health
PROMIS Global Health is a 10-item measure used to assess general health status and utility. The first 9 items are measured on a 5-point Likert scale, for sum scores of 9 to 45, where higher scores indicate better general health status. The 10th item asks respondents to rate their pain on average in the past 7 days on a 10-point scale, where 0 is no pain and 10 is the worst pain imaginable.
Measured: Baseline and 12 Months
Depressive sympoms as measured by the Patient Health Questionnaire-8 scale
The Patient Health Questionnaire-8 will be used to assess depressive symptoms and psychosocial context. The Patient Health Questionnaire-9 total score ranges from 0 to 27 (scores of 5-9 are classified as mild depression; 10-14 as moderate depression; 15-19 as moderately severe depression; ≥ 20 as severe depression).
Measured: Baseline and 12 Months
Anxiety symptoms as measured by the Generalized Anxiety Disorder-7 scale
The Generalized Anxiety Disorder-7 questionnaire will be used to assess anxiety symptoms and psychosocial context. The Generalized Anxiety Disorder-7 score ranges from 0 to 21, where a higher score indicates greater anxiety.
Measured: Baseline and 12 Months
Trauma-related symptoms as measured by Primary Care PTSD Screen
The Primary Care PTSD Screen for DSM-5 (PC PTSD-5) is a 5-item measure used to assess trauma-related symptoms and psychosocial context. Scores range from 0 to 5, where the score is a count of 'yes' responses to 5 yes or no questions about the impact of the trauma in the previous month.
Measured: Baseline and 12 Months
Physical activity, as measured by the International Physical Activity Questionnaire
The International Physical Activity Questionnaire (IPAQ) short form will be used to assess physical activity. The IPAQ is a seven-item questionnaire that assesses the amount of time participants have spent doing physical activity (e.g., moderate physical activities, vigorous physical activities, walking) in the last seven days.
Measured: Baseline and 12 Months
Continence as measured by Continence Diary - Pad Count
The Continence Diary - Pad Count will be used to assess pad use and continence patterns. Participants will record pad use for 7 typical days. Social continence is defined as 0 to 1 pad per day.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Use of medications and sexual aids as measured by Medication and Sexual Aids Inventory and Use Log
The Medication and Sexual Aids Inventory and Use Log will be used to track use of medications and sexual aids. The log captures whether items were used since the last survey, frequency, typical duration, and notes such as side effects, discomfort, bruising, and adjunct use.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Adherence and Barriers to Adherence
Study-specific adherence and barrier items will be used to understand what makes the rehabilitation program easier or harder to follow. Items address PFPT adherence and barriers, sex therapy adherence and barriers if assigned, and VED use adherence and barriers.
Measured: Baseline and 12 Months
PDE5 inhibitor medication adherence, as measured by Screening Tool for AdheRence to medicineS (15-STARS ED)
The 15-STARS ED is a 15-item self-report questionnaire used to assess adherence to phosphodiesterase type 5 inhibitor medication when prescribed by the treating clinician. Sum scores range from 0 to 14 with higher scores indicating lower adherence.
Measured: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Sexual avoidance as measured by a Sexual Avoidance Questionnaire
Sexual avoidance will be assessed using a 4-item sexual avoidance questionnaire. This measure asks respondents to indicate how often they have avoided partnered and unpartnered sexual activity, respectively, on a scale of 0 (Never) to 4 (Always or Almost Always). If a response other than 0 is provided, respondents will be asked to check all options that apply from a list of reasons why they have avoided that type of sexual activity.
Measured: Baseline and 12 Months
Sexual self-efficacy as measured by the Sexual Self-Efficacy Questionnaire
Sexual self-efficacy will be assessed using the 26-item Sexual Self-Efficacy Questionnaire. Participants indicate which activities they believe they can do and rate their confidence in being able to perform those activities on a 10 to 100 scale.
Measured: Baseline and 12 Months
Sexual satisfaction as measured by a Sexual Satisfaction Questionnaire
Sexual satisfaction will be assessed using the Sexual Satisfaction Questionnaire, a 4-item measure assessing respondents' agreement with 4 statements related to sexual satisfaction on a scale of 1 (Not at all) to 7 (Extremely). Higher scores indicate higher sexual satisfaction.
Measured: Baseline and 12 Months
Sexual dysfunction as measured by a Sexual Dysfunction Questionnaire
Sexual dysfunction will be assessed using a Sexual Dysfunction Questionnaire, a 4-item measure assessing respondents' agreement with 4 statements related to sexual dysfunction on a scale of 1 (Extremely) to 6 (None or Never). Higher scores indicate higher sexual dysfunction.
Measured: Baseline and 12 Months
Sexual health information and support needs
A study-spcific Sexual Health Information and Support Needs questionnaire will be used to assess the importance of educational and supportive programming topics related to sexual health after prostate cancer treatment. Respondents will be asked to rate the importance of 12 related topics on a scale of 1 (Unimportant) to 5 (Very important). Respondents will also have the option to self-specify 'other' topics and rate the importance of those topics.
Measured: Baseline and 12 Months
Patient perceptions and opinions about guidelines
Patient perceptions and opinions about guidelines will be assessed using 3 study-specific guideline perception items included in the questionnaire set.
Measured: Baseline and 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca A Shelby, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685249
- Sponsor's protocol ID
- Pro00119667
- Acronym
- RESTORE-PC
- Status last verified
- Nov 2026
- First submitted
- 12 Jun 2026
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT07685249
- Acronym / sponsor ID
- RESTORE-PC / Pro00119667
- Conditions
- Prostate Cancer, Urinary Incontinence, Erectile Dysfunction
- Keywords
- Pelvic Floor Physical Therapy, Sex Therapy, Penile Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 6 Jul 2026 (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.
This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment.
All participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone.
Participants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.
Detailed description
This is a two-arm, parallel-group, randomized feasibility trial conducted at Duke University Health System. Eligible adult men treated for localized prostate adenocarcinoma with erectile nerve-sparing radical prostatectomy, radiotherapy, or cryoablation at Duke Health who are initiating pelvic floor physical therapy (PFPT) will be randomized 1:1 to PFPT plus sex therapy or PFPT alone. PFPT is delivered as part of routine clinical survivorship care. All enrolled participants will receive penile rehabilitation education and a vacuum erection device (VED) as part of standard PFPT, in addition to clinician-prescribed PDEi if applicable.
The sex therapy intervention is delivered by telehealth as 10 sessions of approximately 45 minutes over 6 months. Baseline assessment occurs after completion of localized treatment and before initiation of study-linked rehabilitation.
Patient-reported outcome measures will be collected at baseline and at 3, 6, 9, 12, 18, and 24 months post-baseline for feasibility of longer follow-up. Semi-structured qualitative interviews will be offered at 6 and 12 months post-baseline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFPT + Sex Therapy | Experimental | Behavioral: Sex Therapy, Behavioral: Pelvic Floor Physical Therapy, Device: Vacuum Erection Device (VED)Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED). |
| PFPT Alone (Standard Care) | Active comparator | Behavioral: Pelvic Floor Physical Therapy, Device: Vacuum Erection Device (VED)Standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED); no study-delivered sex therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Biopsy-confirmed localized prostate adenocarcinoma.
- Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health.
- Initiating pelvic floor physical therapy as part of routine clinical care.
- Pre-treatment International Index of Erectile Function-5 (IIEF-5) score meeting the eligibility threshold, with or without aids, determined by medical record chart review (when documented within 4 months prior to index treatment) or collected post-treatment with participant recall anchored to the month prior to treatment. Eligibility threshold for the IIEF-5 is at or above 17.
Key exclusion criteria (8 listed)
- Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT.
- Recieved non-nerve-sparing treatment (when applicable).
- Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.
- Need for additional or secondary prostate cancer treatment during the intervention period.
- Documented cognitive impairment or impairment that would interfere with participation.
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 |
|---|---|---|
| Sex TherapyTelehealth sex therapy integrating psychoeducation, acceptance and commitment therapy strategies, and sensate focus skills; 10 sessions (~45 minutes) over 6 months delivered by a psychologist. | Behavioural | PFPT + Sex Therapy |
| Pelvic Floor Physical TherapyRoutine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation. | Behavioural | PFPT + Sex Therapy, PFPT Alone (Standard Care) |
| Vacuum Erection Device (VED)FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device. | Device | PFPT + Sex Therapy, PFPT Alone (Standard Care) |
Primary outcome
Recruitment feasibility as measured by number of participants recruited
Time frame: From initiation of recruitment to completion of accrual, up to 1 year
Accrual rate will be used to assess feasibility of recruiting participants to the study target of 30 participants. This feasibility trial is designed to estimate key process parameters with precision rather than to test efficacy hypotheses
Enrollment feasibility, as measured by consent rate
Time frame: From initiation of recruitment to completion of accrual, up to 1 year
Consent rate will be used to assess enrollment feasibility. This measure reflects the proportion of eligible participants who provide informed consent after screening and outreach.
Randomization feasibility
Time frame: From initiation of recruitment to completion of accrual, up to 1 year
Randomization rate will be used to assess the proportion of consented eligible participants who are randomized in a 1:1 ratio to pelvic floor physical therapy (PFPT) plus sex therapy or PFPT alone.
Retention feasibility
Time frame: 12 months
Retention will be used to assess the proportion of randomized participants who remain in the study through the 12-month follow-up timepoint.
Number of participants who complete study assessments
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Assessment completion will be used to assess feasibility of longitudinal data collection across the planned study schedule. Scheduled patient-reported outcome assessments occur at baseline and during follow-up contacts.
Number of participants who participate in pelvic floor physical therapy (PFPT)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes participation in PFPT.
Number of participants who participate in sex therapy
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes sex therapy participation in the intervention arm.
Number of participants who use recommended penile rehabilitation
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Intervention exposure metrics will be used to assess feasibility of delivering and receiving the rehabilitation pathway. This includes recommended penile rehabilitation use patterns including vacuum erection device (VED) and PDE-5i use as measured via adherence logs.
Fidelity-monitoring feasibility
Time frame: During the 6-Month sex therapy intervention window
Fidelity-monitoring feasibility will be assessed using audio recording of sex therapy sessions and audit of a planned 20% sample of recordings using fidelity checklists.
21 secondary outcomes
Acceptability of sex therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised
Time frame: 6 Months
Acceptability of pelvic floor physical therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised
Time frame: 12 Months
Urinary symptoms and bother, as measured by the International Prostate Symptom Score with bother index/quality of life (IPSS with BI/QOL)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Erectile dysfunction as measured by the International Index of Erectile Function-5 (IIEF-5)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Sexual function and satisfaction as measured by the PROMIS Sexual Function and Satisfaction Male Brief Profile
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
General health status and utility as measured by the PROMIS-16 Profile v2.1 (PROPr)
Time frame: Baseline and 12 Months
General health status and utility as measured by the PROMIS Global Health
Time frame: Baseline and 12 Months
Depressive sympoms as measured by the Patient Health Questionnaire-8 scale
Time frame: Baseline and 12 Months
Anxiety symptoms as measured by the Generalized Anxiety Disorder-7 scale
Time frame: Baseline and 12 Months
Trauma-related symptoms as measured by Primary Care PTSD Screen
Time frame: Baseline and 12 Months
Physical activity, as measured by the International Physical Activity Questionnaire
Time frame: Baseline and 12 Months
Continence as measured by Continence Diary - Pad Count
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Use of medications and sexual aids as measured by Medication and Sexual Aids Inventory and Use Log
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months
Adherence and Barriers to Adherence
Time frame: Baseline and 12 Months
PDE5 inhibitor medication adherence, as measured by Screening Tool for AdheRence to medicineS (15-STARS ED)
Time frame: Baseline, 3 Months, 6 Months, 9 Months, 12 Months
Sexual avoidance as measured by a Sexual Avoidance Questionnaire
Time frame: Baseline and 12 Months
Sexual self-efficacy as measured by the Sexual Self-Efficacy Questionnaire
Time frame: Baseline and 12 Months
Sexual satisfaction as measured by a Sexual Satisfaction Questionnaire
Time frame: Baseline and 12 Months
Sexual dysfunction as measured by a Sexual Dysfunction Questionnaire
Time frame: Baseline and 12 Months
Sexual health information and support needs
Time frame: Baseline and 12 Months
Patient perceptions and opinions about guidelines
Time frame: Baseline and 12 Months
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 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer
Prostate Cancer (Diagnosis), ACP3
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.
Rebecca A 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 Sex Therapy, Pelvic Floor Physical Therapy and Vacuum Erection Device (VED) in people with Prostate Cancer and Urinary Incontinence, 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 7 inclusion and 8 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 6 Nov 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?
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 Michael W Willis, BA (919-681-8437, michael.w.willis@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment feasibility as measured by number of participants recruited (time frame: From initiation of recruitment to completion of accrual, up to 1 year). The study lists 9 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 6 Nov 2026.