Prostate CancerNCT01996852
Improving Erectile Function and Quality of Life After Prostate Cancer Treatment
A study testing Cognitive-behavioral Meetings, sildenafil citrate and Vacuum Constriction Device in people with Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer. 144 patients and partners will participate in the study. The purpose of this study is to test a new treatment that combines a cognitive-behavioral intervention with medication and a vacuum constrictive device to treat ED. Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Following Simple Prostatectomy
- What is being tested?
- Cognitive-behavioral Meetings, sildenafil citrate and Vacuum Constriction Device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage I, II, and III prostate cancer
- Having completed definite treatment of localized prostate cancer (surgery or radiation);
- Presence of erectile dysfunction symptoms;
- Have a stable partner for six months who is willing to participate;
- Sexually active prior to cancer treatment (≥17 on the Sexual Health Inventory For Men- ("SHIM")).
- Prostatectomy with or without radiation for the pilot study patients only.
Who cannot join
- Receiving hormonal treatment;
- Cognitive impairment (≥5 on the Short Portable Mental Status Questionnaire (SPMSQ));
- Severe marital maladjustment that prevents a patient from benefiting from the proposed intervention (<85 on the Locke-Wallace Marital Adjustment Test);
- Taking nitrates of any kind;
- Congenital bleeding disorder or predisposition to priapism that is contraindicative to VCD use;
- Having untreated clinical depression and other psychotic mental disorders (e.g., bipolar, schizophrenia) (≥27 on the Center for Epidemiological Studies Depression Scale (CES-D)).
Show all 18Show fewer
- Patients taking any potent inhibitor of cytochrome P450 3A4 (e.g., ketoconazole, itraconazole, erythromycin, etc).
- Patients taking concomitant alpha-adrenergic blocking agents.
- Patients with a clinically significant abnormality on screening ECG (taken within 12 weeks) that in the opinion of the investigator/co-investigator may increase the patient's cardiovascular risk in this study.
- Patients with a history of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis).
- Patients with a history of severely impaired autonomic control of blood pressure.
- Patients with resting hypotension (BP < 90/50 mm Hg), or resting hypertension (BP > 170/110 mm Hg) at Screening.
- Patients with known hypersensitivity to Sildenafil or other ingredients of Sildenafil.
- Patients with retinitis pigmentosa.
- Patients with active peptic ulceration.
- Patients who have previously experienced non-arteritic ischemic optic neuropathy (NAION).
- Patients taking other phosphodiesterase Type 5 (PDE5) inhibitors.
- Patients taking Coumadin, Pradaxa or other blood thinner drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer. 144 patients and partners will participate in the study. The purpose of this study is to test a new treatment that combines a cognitive-behavioral intervention with medication and a vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic elements that enhance compliance with medical treatment and increase sexual activity through enhancement of the sensual pleasure of sex and partner support.
Read the detailed description
Erectile dysfunction (ED) is a common side effect of prostate cancer treatment. Existing medical treatment focuses on early penile rehabilitation, aiming to prevent penile shrinkage and preserve nerves and smooth muscles to facilitate erection return. It typically includes administration of phosphodiesterase type 5 inhibitor (PDE-5), application of vacuum constriction devices (VCD) or intracavernous injection immediately after prostate cancer treatment.
To evaluate the proposed intervention, a randomized, controlled longitudinal clinical trial will be conducted to examine the effect of this cognitive-behavioral intervention on early-stage prostate cancer patients with ED and their partners. The proposed study includes a pilot study, a randomized clinical trial (the main study) and data analysis. The study duration for main study participants is 10 months including one month of recruitment and baseline assessment, six months of intervention, and three months of follow-up. The study duration for pilot study participants is 7 months including one month of recruitment and baseline assessment plus six months of intervention.
The Pilot Study A pilot study will be conducted to develop and test the proposed study intervention over 12 months. The pilot study will recruit 36 early-stage prostate cancer patients and their partners. The 36 couples will be randomly assigned to three study arms: (1) standard medical treatment of ED (MED); (2) standard medical treatment of ED plus cognitive-behavioral intervention (MED+CBI); and (3) usual care (UC) in which the study participants will not receive any study intervention, but will continue with standard care that allows patient's request for ED treatment. The purpose to include the usual care group is to collect preliminary data to aid the estimation of intervention effect size, statistic power and sample size, and to compare the intervention outcome with the real world scenario in order to provide the justification for the inclusion or exclusion of the usual care arm in the main study. The pilot study participants will be assessed twice at baseline (T1) and 7 months (T2) only. Doppler Ultrasound of the penis will be performed at T1 and T2 to examine changes in the volume of penile blood flow in patients. Subjects are allowed to opt out of the Doppler Ultrasound test, because this pilot data is exploratory and five or more ultrasound tests per group are sufficient. Collecting and analyzing blood samples will be performed at T1 and T2 and subjects are allowed to opt out of this test as well. The blood sample will be collected in order to test transforming growth factor beta-1 (TGF-ß1) and to assess its relation to erectile function. The result will allow us to evaluate the intervention impact at molecular level and formulate a best possible intervention to ED.
The Main Study During a 4-year clinical trial study, 144 early-stage prostate cancer patients along with their partners will be randomly assigned to two study arms: (1) standard medical treatment of ED (MED) and (2) standard medical treatment of ED plus cognitive-behavioral intervention (MED+CBI). The MED includes administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump). The MED+CBI entails six in-person sessions and five telephone follow-ups over six months. The patients will be assessed on erectile function (EF), quality of life (QOL) and mood at baseline (T1), 7 months (T2) and 10 months (T3). The partners will be assessed on QOL and mood at T1, T2 and T3. Doppler Ultrasound of the penis will be performed at T1 and T2 to examine changes in the volume of penile blood flow among 50 patients who will be consecutively selected from the two study groups, with 25 per study arm.
The long-term primary goals of the study are to:
- Assess the effect of the new treatment on erection function, quality of life, and mood.
- Assess the treatment compliance and frequency of sexual activity of the new treatment.
- Investigate the mechanism in which the new treatment works.
The long-term secondary goals of the study are to:
- Assess the effect of the new treatment on the quality of life and mood of the patient's partner.
- Assess the changes in the volume of penile blood flow due to study treatments.
- Conditions
- Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Following Simple Prostatectomy, Erectile Dysfunction
- Being tested
- Cognitive-behavioral Meetings, sildenafil citrate, Vacuum Constriction Device
- Keywords
- Erectile dysfunction, ED, Prostate, Prostatectomy
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioral MeetingsBehavioural
The cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support.
Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review.
Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min.
sildenafil citrateDrug
Also called Viagra
100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed.
To increase external validity, participants will be given the choice of using Sildenafil in the study.
Vacuum Constriction DeviceDevice
Also called VCD, Pump
The medical treatment entails a 10-minute daily use of VCD (pump).
The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call.
| Study group | Role | What they receive |
|---|---|---|
| Standard ED Care | Active comparator | Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump) Receives: Drug: sildenafil citrate; Device: Vacuum Constriction Device |
| Standard ED Care + Cognitive-Behavioral Intervention | Experimental | standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings Receives: Behavioral: Cognitive-behavioral Meetings; Drug: sildenafil citrate; Device: Vacuum Constriction Device |
| Usual Care (UC) | No intervention | Study participants will not receive any study intervention, but will continue with standard care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erectile Function Improvement
Change in Total score in the International Index of Erectile Function (IIEF) between baseline and 10 months. The IIEF assesses male sexual function in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Higher scores indicate improved functioning.
Measured: 10 months after start of treatment
Change in Number of Erections
Change from baseline in the number of patients with a score of >=22 on the International Index of Erectile Function (IIEF). This score signifies the presence of erection.
Measured: 10 months after start of treatment
Erectile Function Improvement
Change in Total score in the International Index of Erectile Function (IIEF) between baseline and 7 months. The IIEF assesses male sexual function in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Higher scores indicate improved functioning.
Measured: 7 months after start of treatment
Change in Number of Erections
Change from baseline in the number of patients with a score of >=22 on the International Index of Erectile Function (IIEF). This score signifies the presence of erection.
Measured: 7 months after start of treatment
Secondary outcomes (9)
Sexual Quality of Life (QoL) Improvement
Change from baseline in the total score of the Sexual Quality of Life (male/female) scales. Higher scores indicate better quality of life.
Measured: 10 months after start of treatment
Change in Overall Quality of Life (QoL) Score
Change in the total score from baseline on the Short-Form-36 Health Survey (SF36) will be used to show changes in QoL. Higher scores indicate increased QoL. QOL in eight dimensions, including physical, role and social functioning, role limitations, and general physical and mental health.
Measured: 10 months after start of treatment
Improved Mood Score
Change from baseline in the sub-score from the 21-item Profile of Mood States (POMS) will be used to measure psychological adjustment to cancer. It will be used to measure depression, anxiety and anger. Higher scores indicate more mood disorder.
Measured: 10 months after start of treatment
Change in Treatment Compliance
Change from baseline in the number of patients compliant with treatment. Patients will be described as regular user, intermittent user, or drop out based on the information recorded in the patients Sex Diary over the previous seven days.
Measured: 10 months after start of treatment
Change in Frequency of Sexual Activity
Change from baseline in the mean value of sexual activities ((1) Sexual encounters; (2) Sexual simulation; (3) intercourse; and (ejaculation)) experienced by each participant over the previous seven days
Measured: 7 months after start of treatment
Change in Frequency of Sexual Activity
Change from baseline in the mean value of sexual activities ((1) Sexual encounters; (2) Sexual simulation; (3) intercourse; and (ejaculation)) experienced by each participant over the previous seven days
Measured: 10 months after start of treatment
Change in Treatment Compliance
Change from baseline in the number of patients compliant with treatment. Patients will be described as regular user, intermittent user, or drop out based on the information recorded in the patients Sex Diary over the previous seven days.
Measured: 7 months after start of treatment
Sexual Quality of Life (QoL) Improvement
Change from baseline in the total score of the Sexual Quality of Life (male/female) scales
Measured: 7 months after start of treatment
Change in Overall Quality of Life (QoL) Score
Change in the total score from baseline on the Short-Form-36 Health Survey (SF36) will be used to show changes in QoL. Higher scores indicate increased QoL. QOL in eight dimensions, including physical, role and social functioning, role limitations, and general physical and mental health.
Measured: 7 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: Premature terminated at institution request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Zhang, MD, Principal investigator, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996852
- Sponsor's protocol ID
- CASE14812
- Other IDs
- 05-12-05C
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2013
- Last updated
- 10 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Erectile Function and Quality of Life After Prostate Cancer Treatment
- ClinicalTrials.gov ID
- NCT01996852
- Acronym / sponsor ID
- CASE14812
- Conditions
- Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction Following Simple Prostatectomy, Erectile Dysfunction
- Keywords
- Erectile dysfunction, ED, Prostate, Prostatectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Premature terminated at institution request
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, University Hospitals Cleveland Medical Center
- Study start
- Jul 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Posted 10 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study of erectile dysfunction (ED) in men diagnosed with prostate cancer. 144 patients and partners will participate in the study. The purpose of this study is to test a new treatment that combines a cognitive-behavioral intervention with medication and a vacuum constrictive device to treat ED. This new treatment consists of multiple therapeutic elements that enhance compliance with medical treatment and increase sexual activity through enhancement of the sensual pleasure of sex and partner support.
Detailed description
Erectile dysfunction (ED) is a common side effect of prostate cancer treatment. Existing medical treatment focuses on early penile rehabilitation, aiming to prevent penile shrinkage and preserve nerves and smooth muscles to facilitate erection return. It typically includes administration of phosphodiesterase type 5 inhibitor (PDE-5), application of vacuum constriction devices (VCD) or intracavernous injection immediately after prostate cancer treatment.
To evaluate the proposed intervention, a randomized, controlled longitudinal clinical trial will be conducted to examine the effect of this cognitive-behavioral intervention on early-stage prostate cancer patients with ED and their partners. The proposed study includes a pilot study, a randomized clinical trial (the main study) and data analysis. The study duration for main study participants is 10 months including one month of recruitment and baseline assessment, six months of intervention, and three months of follow-up. The study duration for pilot study participants is 7 months including one month of recruitment and baseline assessment plus six months of intervention.
The Pilot Study A pilot study will be conducted to develop and test the proposed study intervention over 12 months. The pilot study will recruit 36 early-stage prostate cancer patients and their partners. The 36 couples will be randomly assigned to three study arms: (1) standard medical treatment of ED (MED); (2) standard medical treatment of ED plus cognitive-behavioral intervention (MED+CBI); and (3) usual care (UC) in which the study participants will not receive any study intervention, but will continue with standard care that allows patient's request for ED treatment. The purpose to include the usual care group is to collect preliminary data to aid the estimation of intervention effect size, statistic power and sample size, and to compare the intervention outcome with the real world scenario in order to provide the justification for the inclusion or exclusion of the usual care arm in the main study. The pilot study participants will be assessed twice at baseline (T1) and 7 months (T2) only. Doppler Ultrasound of the penis will be performed at T1 and T2 to examine changes in the volume of penile blood flow in patients. Subjects are allowed to opt out of the Doppler Ultrasound test, because this pilot data is exploratory and five or more ultrasound tests per group are sufficient. Collecting and analyzing blood samples will be performed at T1 and T2 and subjects are allowed to opt out of this test as well. The blood sample will be collected in order to test transforming growth factor beta-1 (TGF-ß1) and to assess its relation to erectile function. The result will allow us to evaluate the intervention impact at molecular level and formulate a best possible intervention to ED.
The Main Study During a 4-year clinical trial study, 144 early-stage prostate cancer patients along with their partners will be randomly assigned to two study arms: (1) standard medical treatment of ED (MED) and (2) standard medical treatment of ED plus cognitive-behavioral intervention (MED+CBI). The MED includes administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump). The MED+CBI entails six in-person sessions and five telephone follow-ups over six months. The patients will be assessed on erectile function (EF), quality of life (QOL) and mood at baseline (T1), 7 months (T2) and 10 months (T3). The partners will be assessed on QOL and mood at T1, T2 and T3. Doppler Ultrasound of the penis will be performed at T1 and T2 to examine changes in the volume of penile blood flow among 50 patients who will be consecutively selected from the two study groups, with 25 per study arm.
The long-term primary goals of the study are to:
- Assess the effect of the new treatment on erection function, quality of life, and mood.
- Assess the treatment compliance and frequency of sexual activity of the new treatment.
- Investigate the mechanism in which the new treatment works.
The long-term secondary goals of the study are to:
- Assess the effect of the new treatment on the quality of life and mood of the patient's partner.
- Assess the changes in the volume of penile blood flow due to study treatments.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard ED Care | Active comparator | Drug: sildenafil citrate, Device: Vacuum Constriction DeviceStandard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump) |
| Standard ED Care + Cognitive-Behavioral Intervention | Experimental | Behavioral: Cognitive-behavioral Meetings, Drug: sildenafil citrate, Device: Vacuum Constriction Devicestandard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings |
| Usual Care (UC) | No intervention | –Study participants will not receive any study intervention, but will continue with standard care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage I, II, and III prostate cancer
- Having completed definite treatment of localized prostate cancer (surgery or radiation);
- Presence of erectile dysfunction symptoms;
- Have a stable partner for six months who is willing to participate;
- Sexually active prior to cancer treatment (≥17 on the Sexual Health Inventory For Men- ("SHIM")).
Key exclusion criteria (18 listed)
- Receiving hormonal treatment;
- Cognitive impairment (≥5 on the Short Portable Mental Status Questionnaire (SPMSQ));
- Severe marital maladjustment that prevents a patient from benefiting from the proposed intervention (<85 on the Locke-Wallace Marital Adjustment Test);
- Taking nitrates of any kind;
- Congenital bleeding disorder or predisposition to priapism that is contraindicative to VCD use;
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 |
|---|---|---|
| Cognitive-behavioral MeetingsThe cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support. Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review. Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min. | Behavioural | Standard ED Care + Cognitive-Behavioral Intervention |
| sildenafil citrateAlso: Viagra100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed. To increase external validity, participants will be given the choice of using Sildenafil in the study. | Drug | Standard ED Care, Standard ED Care + Cognitive-Behavioral Intervention |
| Vacuum Constriction DeviceAlso: VCD, PumpThe medical treatment entails a 10-minute daily use of VCD (pump). The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call. | Device | Standard ED Care, Standard ED Care + Cognitive-Behavioral Intervention |
Primary outcome
Erectile Function Improvement
Time frame: 10 months after start of treatment
Change in Total score in the International Index of Erectile Function (IIEF) between baseline and 10 months. The IIEF assesses male sexual function in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Higher scores indicate improved functioning.
Change in Number of Erections
Time frame: 10 months after start of treatment
Change from baseline in the number of patients with a score of >=22 on the International Index of Erectile Function (IIEF). This score signifies the presence of erection.
Erectile Function Improvement
Time frame: 7 months after start of treatment
Change in Total score in the International Index of Erectile Function (IIEF) between baseline and 7 months. The IIEF assesses male sexual function in five domains: erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction. Higher scores indicate improved functioning.
Change in Number of Erections
Time frame: 7 months after start of treatment
Change from baseline in the number of patients with a score of >=22 on the International Index of Erectile Function (IIEF). This score signifies the presence of erection.
9 secondary outcomes
Sexual Quality of Life (QoL) Improvement
Time frame: 10 months after start of treatment
Change in Overall Quality of Life (QoL) Score
Time frame: 10 months after start of treatment
Improved Mood Score
Time frame: 10 months after start of treatment
Change in Treatment Compliance
Time frame: 10 months after start of treatment
Change in Frequency of Sexual Activity
Time frame: 7 months after start of treatment
Change in Frequency of Sexual Activity
Time frame: 10 months after start of treatment
Change in Treatment Compliance
Time frame: 7 months after start of treatment
Sexual Quality of Life (QoL) Improvement
Time frame: 7 months after start of treatment
Change in Overall Quality of Life (QoL) Score
Time frame: 7 months after start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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. This study is not recruiting at the moment.
Amy Zhang, MD principal investigator
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral Meetings, sildenafil citrate and Vacuum Constriction Device in people with Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, run by Case Comprehensive Cancer Center 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 6 inclusion and 18 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: stopped early, as of the sponsor's last update on 10 May 2019. 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?
Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Function Improvement (time frame: 10 months after start of treatment). The study lists 4 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 10 May 2019.