Erectile Dysfunction, Prostate Cancer, Urinary Incontinence
Conditions
Keywords
Pelvic Floor Physical Therapy, Sex Therapy, Penile Rehabilitation
Brief 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. 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.
Interventions
BEHAVIORALSex Therapy
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.
BEHAVIORALPelvic Floor Physical Therapy
Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.
DEVICEVacuum 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.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment feasibility as measured by number of participants recruited | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of sex therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised | 6 Months | 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." |
| Acceptability of pelvic floor physical therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised | 12 Months | 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." |
| Urinary symptoms and bother, as measured by the International Prostate Symptom Score with bother index/quality of life (IPSS with BI/QOL) | Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months | 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. |
| Erectile dysfunction as measured by the International Index of Erectile Function-5 (IIEF-5) | Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months | 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. |
| Sexual function and satisfaction as measured by the PROMIS Sexual Function and Satisfaction Male Brief Profile | Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months | 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. |
| General health status and utility as measured by the PROMIS-16 Profile v2.1 (PROPr) | Baseline and 12 Months | 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. |
| General health status and utility as measured by the PROMIS Global Health | Baseline and 12 Months | 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. |
| Depressive sympoms as measured by the Patient Health Questionnaire-8 scale | Baseline and 12 Months | 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). |
| Anxiety symptoms as measured by the Generalized Anxiety Disorder-7 scale | Baseline and 12 Months | 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. |
| Trauma-related symptoms as measured by Primary Care PTSD Screen | Baseline and 12 Months | 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. |
| Physical activity, as measured by the International Physical Activity Questionnaire | Baseline and 12 Months | 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. |
| Continence as measured by Continence Diary - Pad Count | Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months | 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. |
| Use of medications and sexual aids as measured by Medication and Sexual Aids Inventory and Use Log | Baseline, 3 Months, 6 Months, 9 Months, 12 Months, 18 Months, 24 Months | 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. |
| Adherence and Barriers to Adherence | Baseline and 12 Months | 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. |
| PDE5 inhibitor medication adherence, as measured by Screening Tool for AdheRence to medicineS (15-STARS ED) | Baseline, 3 Months, 6 Months, 9 Months, 12 Months | 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. |
| Sexual avoidance as measured by a Sexual Avoidance Questionnaire | Baseline and 12 Months | 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. |
| Sexual self-efficacy as measured by the Sexual Self-Efficacy Questionnaire | Baseline and 12 Months | 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. |
| Sexual satisfaction as measured by a Sexual Satisfaction Questionnaire | Baseline and 12 Months | 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. |
| Sexual dysfunction as measured by a Sexual Dysfunction Questionnaire | Baseline and 12 Months | 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. |
| Sexual health information and support needs | Baseline and 12 Months | 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. |
| Patient perceptions and opinions about guidelines | Baseline and 12 Months | Patient perceptions and opinions about guidelines will be assessed using 3 study-specific guideline perception items included in the questionnaire set. |
Countries
United States
Contacts
CONTACTMichael W Willis, BA
CONTACTSmrithi Divakaran, MPH
PRINCIPAL_INVESTIGATORRebecca A Shelby, PhD
Duke University
Outcome results
None listed