Clinical trial · Interventional
Improving Erectile Function and Quality of Life After Prostate Cancer Treatment
NCT01996852CI-TRIAL-00038562terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Premature terminated at institution request
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
| Erectile Dysfunction Following Simple Prostatectomy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive-behavioral Meetings | Behavioral | — | UNRESOLVED |
| sildenafil citrate | Drug | — | UNRESOLVED |
| Vacuum Constriction Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Standard ED Care
- description
- Standard medical treatment of erectile dysfunction (ED) including administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)
- interventionNames
- Drug: sildenafil citrate
- Device: Vacuum Constriction Device
- type
- EXPERIMENTAL
- label
- Standard ED Care + Cognitive-Behavioral Intervention
- description
- standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings
- interventionNames
- Behavioral: Cognitive-behavioral Meetings
- Drug: sildenafil citrate
- Device: Vacuum Constriction Device
- type
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.References
Publications (0)
Data not yet available
No reference posted for this study.