Trial Outcomes & Findings for Improving Erectile Function and Quality of Life After Prostate Cancer Treatment (NCT NCT01996852)
NCT ID: NCT01996852
Last Updated: 2019-05-10
Results Overview
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.
TERMINATED
NA
34 participants
10 months after start of treatment
2019-05-10
Participant Flow
Participant milestones
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Standard ED Care
Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)
sildenafil citrate: 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 Device: 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.
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Standard ED Care + Cognitive-Behavioral Intervention
standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings
Cognitive-behavioral Meetings: 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.
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Usual Care (UC)
Study participants will not receive any study intervention, but will continue with standard care.
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Erectile Function and Quality of Life After Prostate Cancer Treatment
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 10 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 10 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 7 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
Change from baseline in the total score of the Sexual Quality of Life (male/female) scales. Higher scores indicate better quality of life.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 10 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
Change from baseline in the total score of the Sexual Quality of Life (male/female) scales
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 months after start of treatmentPopulation: The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 months after start of treatmentChange from baseline in the mean score of Bandura's measure to assess self-efficacy. This scale is scored from 0-100, where 100 indicates complete confidence.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 months after start of treatmentChange from baseline in the mean score of Bandura's measure to assess self-efficacy. This scale is scored from 0-100, where 100 indicates complete confidence.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 months after start of treatmentChange from baseline in a sub-score of the Sexual Function Questionnaire where higher scores indicate greater pleasure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 months after start of treatmentChange from baseline in a sub-score of the Sexual Function Questionnaire where higher scores indicate greater pleasure.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 months after start of treatmentchange from baseline in a total score from a sub-scale of the Social Support for Exercise Behavior Questionnaire as modified by the study team to measure partner support for rehabilitation. Higher scores will indicate greater support.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 months after start of treatmentchange from baseline in a total score from a sub-scale of the Social Support for Exercise Behavior Questionnaire as modified by the study team to measure partner support for rehabilitation. Higher scores will indicate greater support.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 monthsChange from baseline in the total length of patients flaccid penis. Length will be measured using Mounding's method
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 monthsChange from baseline in the total length of patients flaccid penis. Length will be measured using Mounding's method
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 monthsChange from baseline in the total length of patients stretched penis. Length will be measured using Mounding's method
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 monthsChange from baseline in the total length of patients stretched penis. Length will be measured using Mounding's method
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 7 months after start of treatmentChange from baseline in the total penile blood flow will be assessed by a color and spectral Doppler ultra sound of the cavernosal arteries
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 months after start of treatmentChange from baseline in the total penile blood flow will be assessed by a color and spectral Doppler ultra sound of the cavernosal arteries
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline - 1 week after start of treatmentTotal level of Transforming Growth Factor Beta-1 levels will be assessed using a commercially available assay
Outcome measures
Outcome data not reported
Adverse Events
Standard ED Care
Standard ED Care + Cognitive-Behavioral Intervention
Usual Care (UC)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place