Improving Erectile Function and Quality of Life After Prostate Cancer Treatment

NCT01996852 | Terminated Results FDA Device

• 2 other identifiers: CASE1481205-12-05C
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy; Erectile Dysfunction Following Simple Prostatectomy; Erectile Dysfunction

Keywords

Erectile dysfunction; ED; Prostate; Prostatectomy

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  7 months after start of treatment

Secondary Outcomes (9)

• Sexual Quality of Life (QoL) Improvement

  10 months after start of treatment

• Change in Overall Quality of Life (QoL) Score

  10 months after start of treatment

• Improved Mood Score

  10 months after start of treatment

• Change in Treatment Compliance

  10 months after start of treatment

• Change in Frequency of Sexual Activity

  7 months after start of treatment

Other Outcomes (13)

• Self-Efficacy Improvement

  7 months after start of treatment

• Self-Efficacy Improvement

  10 months after start of treatment

• Change in Level of Sensual Pleasure of Sex

  7 months after start of treatment

Study Arms (3)

Standard ED Care

ACTIVE COMPARATOR

Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)

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

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.

Interventions

Cognitive-behavioral Meetings BEHAVIORAL

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.

Standard ED Care + Cognitive-Behavioral Intervention

sildenafil citrate DRUG

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.

Also known as: Viagra

Standard ED Care; Standard ED Care + Cognitive-Behavioral Intervention

Vacuum Constriction Device 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.

Also known as: VCD, Pump

Standard ED Care; Standard ED Care + Cognitive-Behavioral Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)).
• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• The Cleveland Clinic: collaborator
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

The study was terminated prematurely by the IRB. As per the IRB determination, data are not accessible to the study team for reporting.

Results Point of Contact

• Title: Dr. Amy Zhang
• Organization: Case Comprehensive Cancer Center

amy.zhang@case.edu

+1 216-368-0968

Study Officials

• Amy Zhang, MD

  University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: November 22, 2013
• First Posted: November 27, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 10, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-04

Locations

US (1)