An interventional study of Sex Therapy and Pelvic Floor Physical Therapy in Prostate Cancer, Urinary Incontinence and Erectile Dysfunction, sponsored by Duke University. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Duke University · Not applicable, Interventional, and Supportive care
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.
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.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ten 45-minute telehealth sex therapy sessions over 6 months plus standard pelvic floor physical therapy and penile rehabilitation education (including provision of VED).
Behavioral: Sex Therapy · 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.
Behavioral: Pelvic Floor Physical Therapy · Device: Vacuum Erection Device (VED)
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.
Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.
FDA-cleared manual vacuum pump provided to all participants with education in safe use for penile rehabilitation; not evaluated as an investigational device.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During the 6-Month sex therapy intervention window
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."
Time frame: 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."
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)
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.
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)
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.
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
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.
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)
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 Months
Acceptability of Intervention Measure (AIM)
The Acceptability of Intervention Measure will be completed by interventionists, providers, and research staff based on their experience delivering or supporting the study. Four items are rated on a 5-point agreement scale from "Completely disagree" to "Completely agree."
Time frame: 12 Months
Intervention Appropriateness Measure (IAM)
The Intervention Appropriateness Measure will be completed by interventionists, providers, and research staff based on their experience delivering or supporting the study. Four items are rated on a 5-point agreement scale from "Completely disagree" to "Completely agree."
Time frame: 12 Months
Feasibility of Intervention Measure (FIM)
The Feasibility of Intervention Measure will be completed by interventionists, providers, and research staff based on their experience delivering or supporting the study. Four items are rated on a 5-point agreement scale from "Completely disagree" to "Completely agree."
Time frame: 12 Months
Plan to share: No
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