Prostate Cancer (Adenocarcinoma)NCT07693647
Evaluation of Pelvic Floor Function and Psychosocial Sequelae Following Radical Prostatectomy for Prostate Cancer
An observational study of Prostate Cancer (Adenocarcinoma) and Radical Prostatectomy, run by University of Valencia at 1 site in Spain.
Trial summary
This observational cross-sectional study aims to evaluate the effects of radical prostatectomy for prostate cancer on pelvic floor function and psychosocial well-being. The study will assess the prevalence and severity of urinary incontinence and erectile dysfunction, as well as their impact on quality of life, sexual… Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Radical Prostatectomy, Urinary Incontinence (UI)
- How many people
- 67 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult men who underwent radical prostatectomy for prostate cancer at least 12 months before enrollment. Participants will be recruited from the community through social media, institutional advertisements, patient networks, and snowball sampling. Eligible individuals will voluntarily contact the research team and, after providing electronic informed consent, will complete the study questionnaires online or, when necessary, through a structured telephone interview.
Who may be able to join
- Male participants aged 18 years or older. History of radical prostatectomy for prostate cancer, regardless of the surgical technique used.
- At least 12 months since radical prostatectomy. Able to understand the study information and provide electronic informed consent.
- Able to complete the questionnaires in Spanish, either independently or with the support of a structured telephone interview.
- Willing to participate voluntarily in the study.
Who cannot join
- Presence of comorbidities that may independently contribute to urinary incontinence or erectile dysfunction (e.g., neurological disorders or other relevant medical conditions).
- Severe cognitive or sensory impairment that prevents understanding the study procedures or completing the questionnaires.
- Refusal or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Urinary Incontinence, Erectile Dysfunction, and Psychosocial Outcomes Following Radical Prostatectomy for Prostate Cancer
This observational cross-sectional study aims to evaluate the effects of radical prostatectomy for prostate cancer on pelvic floor function and psychosocial well-being. The study will assess the prevalence and severity of urinary incontinence and erectile dysfunction, as well as their impact on quality of life, sexual health, self-esteem, and interpersonal relationships.
Adult men who underwent radical prostatectomy at least one year before enrollment will complete a series of validated questionnaires and provide demographic and clinical information through online surveys or telephone interviews. The study will also explore whether participants received pelvic floor physiotherapy before or after surgery and whether rehabilitation is associated with better functional and psychosocial outcomes. The findings may contribute to a better understanding of the long-term consequences of radical prostatectomy and help identify opportunities to improve patient care.
Read the detailed description
Radical prostatectomy is one of the most common curative treatments for localized prostate cancer. Although surgical techniques have improved over recent decades, urinary incontinence and erectile dysfunction remain among the most frequent long-term complications after surgery. These conditions may substantially affect patients' quality of life, sexual health, self-esteem, interpersonal relationships, and psychosocial well-being. Despite the availability of conservative pelvic floor rehabilitation strategies, access to and use of pelvic floor physiotherapy before and after surgery remain variable.
This observational cross-sectional study aims to evaluate the long-term effects of radical prostatectomy on pelvic floor function and psychosocial outcomes in men who underwent surgery at least one year before study participation. Data will be collected through validated patient-reported outcome measures and a structured questionnaire including sociodemographic, clinical, and treatment-related information.
Participants will be recruited through social media, institutional dissemination, patient networks, and snowball sampling. After providing electronic informed consent, participants will complete the study questionnaires either online or, when digital literacy is limited, through a structured telephone interview conducted by a trained researcher. No interviews will be audio-recorded, and all data will be pseudonymized before analysis.
The primary objectives are to evaluate urinary incontinence and erectile dysfunction after radical prostatectomy and to describe their psychosocial consequences. Secondary objectives include determining the proportion of patients who received information about pelvic floor physiotherapy, identifying the proportion who underwent pelvic floor rehabilitation before and/or after surgery, and exploring whether rehabilitation is associated with differences in functional and psychosocial outcomes. The study also aims to improve awareness of pelvic floor rehabilitation as part of the multidisciplinary management of prostate cancer survivors.
- Conditions
- Prostate Cancer (Adenocarcinoma), Radical Prostatectomy, Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy
- Being tested
- No Interventions
- Keywords
- Prostate cancer, Radical prostatectomy, Urinary incontinence, Erectile dysfunction, Pelvic floor, Pelvic floor muscle training, Pelvic floor physiotherapy, Rehabilitation, Sexual health, Quality of life, Psychosocial outcomes
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Urinary Incontinence, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Men aged who underwent radical prostatectomy for prostate cancer | Men aged ≥18 years who underwent radical prostatectomy for prostate cancer at least one year before enrollment. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile dysfunction
Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5). Higher scores indicate better erectile function.
Measured: Baseline (single assessment)
Urinary incontinence severity
Urinary incontinence severity assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF). Higher scores indicate greater symptom severity and impact on quality of life.
Measured: Baseline (single assessment)
Secondary outcomes (9)
Prostate cancer-specific urinary symptoms and quality of life
Urinary symptoms and prostate cancer-specific quality of life assessed using the EORTC QLQ-PR25 questionnaire. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate Cancer Module (EORTC QLQ-PR25). Scores for each scale are transformed to a 0-100 scale. Higher scores indicate greater symptom burden for symptom scales and better functioning for functional scales.
Measured: Baseline (single assessment)
Sexual health
Sexual health assessed using the EORTC Sexual Health Questionnaire (EORTC SH22). Scores are transformed to a 0-100 scale. Higher scores indicate better sexual functioning for functional scales and worse symptoms or problems for symptom scales.
Measured: Baseline (single assessment)
Self-esteem and relationship outcomes
Self-esteem and relationship functioning assessed using the Self-Esteem and Relationship Questionnaire (SEAR).Total score ranges from 0 to 100, with higher scores indicating better self-esteem and relationship functioning.
Measured: Baseline (single assessment)
Health-related quality of life
Health-related quality of life assessed using the Short Form-36 Health Survey (SF-36). Scores for each domain range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline (single assessment)
Pelvic floor physiotherapy
Self-reported information regarding receipt of information about pelvic floor physiotherapy and participation in pelvic floor rehabilitation before and/or after radical prostatectomy.
Measured: Baseline (single assessment)
Comfort discussing urinary incontinence
Participant-rated comfort discussing urinary incontinence using a 10-point Likert scale (1 = very uncomfortable to 10 = very comfortable). Higher scores indicate greater comfort.
Measured: Baseline (single assessment)
Comfort discussing sexual health
Participant-rated comfort discussing sexual health using a 10-point Likert scale (1 = very uncomfortable to 10 = very comfortable). Higher scores indicate greater comfort.
Measured: Baseline (single assessment)
Perceived influence of social taboos
Perceived influence of social taboos on discussing urinary incontinence and sexual health assessed using a 10-point Likert scale (1 = no influence to 10 = very strong influence). Higher scores indicate greater perceived influence of social taboos.
Measured: Baseline (single assessment)
Honesty of questionnaire responses
Self-reported honesty when answering questionnaires assessed using a 10-point Likert scale (1 = not honest at all to 10 = completely honest). Higher scores indicate greater perceived honesty.
Measured: Baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noemi Moreno-Segura, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693647
- Sponsor's protocol ID
- Prostatectomy_ED
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Urinary Incontinence, Erectile Dysfunction, and Psychosocial Outcomes Following Radical Prostatectomy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT07693647
- Acronym / sponsor ID
- Prostatectomy_ED
- Conditions
- Prostate Cancer (Adenocarcinoma), Radical Prostatectomy, Urinary Incontinence (UI), Erectile Dysfunction Following Radical Prostatectomy
- Keywords
- Prostate cancer, Radical prostatectomy, Urinary incontinence, Erectile dysfunction, Pelvic floor, Pelvic floor muscle training, Pelvic floor physiotherapy, Rehabilitation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 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 observational cross-sectional study aims to evaluate the effects of radical prostatectomy for prostate cancer on pelvic floor function and psychosocial well-being. The study will assess the prevalence and severity of urinary incontinence and erectile dysfunction, as well as their impact on quality of life, sexual health, self-esteem, and interpersonal relationships.
Adult men who underwent radical prostatectomy at least one year before enrollment will complete a series of validated questionnaires and provide demographic and clinical information through online surveys or telephone interviews. The study will also explore whether participants received pelvic floor physiotherapy before or after surgery and whether rehabilitation is associated with better functional and psychosocial outcomes. The findings may contribute to a better understanding of the long-term consequences of radical prostatectomy and help identify opportunities to improve patient care.
Detailed description
Radical prostatectomy is one of the most common curative treatments for localized prostate cancer. Although surgical techniques have improved over recent decades, urinary incontinence and erectile dysfunction remain among the most frequent long-term complications after surgery. These conditions may substantially affect patients' quality of life, sexual health, self-esteem, interpersonal relationships, and psychosocial well-being. Despite the availability of conservative pelvic floor rehabilitation strategies, access to and use of pelvic floor physiotherapy before and after surgery remain variable.
This observational cross-sectional study aims to evaluate the long-term effects of radical prostatectomy on pelvic floor function and psychosocial outcomes in men who underwent surgery at least one year before study participation. Data will be collected through validated patient-reported outcome measures and a structured questionnaire including sociodemographic, clinical, and treatment-related information.
Participants will be recruited through social media, institutional dissemination, patient networks, and snowball sampling. After providing electronic informed consent, participants will complete the study questionnaires either online or, when digital literacy is limited, through a structured telephone interview conducted by a trained researcher. No interviews will be audio-recorded, and all data will be pseudonymized before analysis.
The primary objectives are to evaluate urinary incontinence and erectile dysfunction after radical prostatectomy and to describe their psychosocial consequences. Secondary objectives include determining the proportion of patients who received information about pelvic floor physiotherapy, identifying the proportion who underwent pelvic floor rehabilitation before and/or after surgery, and exploring whether rehabilitation is associated with differences in functional and psychosocial outcomes. The study also aims to improve awareness of pelvic floor rehabilitation as part of the multidisciplinary management of prostate cancer survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men aged who underwent radical prostatectomy for prostate cancer | – | Other: No InterventionsMen aged ≥18 years who underwent radical prostatectomy for prostate cancer at least one year before enrollment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult men who underwent radical prostatectomy for prostate cancer at least 12 months before enrollment. Participants will be recruited from the community through social media, institutional advertisements, patient networks, and snowball sampling. Eligible individuals will voluntarily contact the research team and, after providing electronic informed consent, will complete the study questionnaires online or, when necessary, through a structured telephone interview.
Key inclusion criteria (4 listed)
- Male participants aged 18 years or older. History of radical prostatectomy for prostate cancer, regardless of the surgical technique used.
- At least 12 months since radical prostatectomy. Able to understand the study information and provide electronic informed consent.
- Able to complete the questionnaires in Spanish, either independently or with the support of a structured telephone interview.
- Willing to participate voluntarily in the study.
Key exclusion criteria (3 listed)
- Presence of comorbidities that may independently contribute to urinary incontinence or erectile dysfunction (e.g., neurological disorders or other relevant medical conditions).
- Severe cognitive or sensory impairment that prevents understanding the study procedures or completing the questionnaires.
- Refusal or inability to provide informed consent.
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 |
|---|---|---|
| No InterventionsNo intervention | Other | Men aged who underwent radical prostatectomy for prostate cancer |
Primary outcome
Erectile dysfunction
Time frame: Baseline (single assessment)
Erectile function assessed using the International Index of Erectile Function-5 (IIEF-5). Higher scores indicate better erectile function.
Urinary incontinence severity
Time frame: Baseline (single assessment)
Urinary incontinence severity assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI SF). Higher scores indicate greater symptom severity and impact on quality of life.
9 secondary outcomes
Prostate cancer-specific urinary symptoms and quality of life
Time frame: Baseline (single assessment)
Sexual health
Time frame: Baseline (single assessment)
Self-esteem and relationship outcomes
Time frame: Baseline (single assessment)
Health-related quality of life
Time frame: Baseline (single assessment)
Pelvic floor physiotherapy
Time frame: Baseline (single assessment)
Comfort discussing urinary incontinence
Time frame: Baseline (single assessment)
Comfort discussing sexual health
Time frame: Baseline (single assessment)
Perceived influence of social taboos
Time frame: Baseline (single assessment)
Honesty of questionnaire responses
Time frame: Baseline (single assessment)
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 13 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma) and Radical Prostatectomy, run by University of Valencia at 1 site in Spain.
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 4 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 13 Jul 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 Spain. 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?
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?
Erectile dysfunction (time frame: Baseline (single assessment)). 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 13 Jul 2026.