Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment

NCT07685249 | Not Yet Recruiting

• 1 other identifier: Pro00119667
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Urinary Incontinence; Erectile Dysfunction

Keywords

Pelvic Floor Physical Therapy; Sex Therapy; Penile Rehabilitation

Outcome Measures

Primary Outcomes (9)

• 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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  6 Months

• Acceptability of pelvic floor physical therapy, as measured by the Satisfaction with Therapy and Therapist Scale-Revised

  12 Months

• 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

• 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

• 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

Other Outcomes (3)

• Acceptability of Intervention Measure (AIM)

  12 Months

• Intervention Appropriateness Measure (IAM)

  12 Months

• Feasibility of Intervention Measure (FIM)

  12 Months

Study Arms (2)

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).

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.

Behavioral: Pelvic Floor Physical Therapy; Device: Vacuum Erection Device (VED)

Interventions

Sex Therapy BEHAVIORAL

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.

PFPT + Sex Therapy

Pelvic Floor Physical Therapy BEHAVIORAL

Routine clinical survivorship care including pelvic floor assessment, exercises, behavioral strategies for urinary incontinence, and ongoing therapist-guided rehabilitation.

PFPT + Sex Therapy; PFPT Alone (Standard Care)

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.

PFPT + Sex Therapy; PFPT Alone (Standard Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence; Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Rebecca A Shelby, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael W Willis, BA

CONTACT

919-681-8437; michael.w.willis@duke.edu

Smrithi Divakaran, MPH

CONTACT

919-681-7695; smrithi.divakaran@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: July 6, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)