Clinical trial · Interventional
Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery
Analysis of Technique Comparison With a Vacuum Erection Device as Part of an Erectile Rehabilitation Program Following Robotic Radical Prostatectomy: A Randomized Comparison of Methodology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine which technique in using a vacuum erection device (VED) is best. Erectile dysfunction (ED) after robotic prostate cancer surgery is a concern for both the surgeon and the patient. Recent studies have shown that beginning to use the vacuum pump on a daily basis starting with in 2-8 weeks may help prevent the start of penile shrinkage. This is a potential issue that can occur because of decreased blood flow after prostate cancer surgery. This study will allow researchers to determine and compare vacuum therapy techniques and erectile function outcomes of patients who have prostate cancer surgery
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Male Erectile Disorder | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Sexual Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daily vacuum therapy | Procedure | — | UNRESOLVED |
| management of therapy complications | Procedure | — | UNRESOLVED |
| Sexual Health Inventory for Men (SHIM) questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (vacuum therapy, holding erection for 2 minutes)
- description
- Patients receive daily vacuum therapy over 10 minutes while holding erection for 2 minutes after undergoing RALP. Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
- interventionNames
- Other: Sexual Health Inventory for Men (SHIM) questionnaire administration
- Procedure: management of therapy complications
- Procedure: Daily vacuum therapy
- type
- EXPERIMENTAL
- label
- Group B (vacuum therapy, holding erection for 5 minutes)
- description
- Patients receive daily vacuum therapy over 10 minutes while holding erection for 5 minutes after undergoing RALP. Patients complete erection process 2 times.Patients complete erection process 5 times. SHIM questionnaire administration will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Sexually active men without the consistent use of erectile aids pre-operatively (i.e. oral pharmacotherapy, intraurethral prostoglandin E1 \[PGE1\], intracavernosal injection therapy and penile implants) * Undergoing a bilateral nerve sparing robotic prostatectomy * Pre-operative baseline SHIM total score of greater than or equal to 17 * Presence of a female sexual partner * Dexterity necessary to operate vacuum pump Exclusion Criteria: * Has a history of cardiac failure, angina, or life-threatening arrhythmia within the past 6 months * Has taken or has been prescribed nitrate medication in any form in the last 6 months * Has a known sensitivity to Phosphodiesterase type 5 inhibitors such as Sildenafil, Tadalafil or Vardenafil * Men with sickle cell anemia * Men with insufficient manual dexterity to operate vacuum device * Men with a history of known penile deformity or Peyronie's disease * Pre or postoperative androgen therapy * Pre or postoperative radiation therapy to pelvic area * Men actively smoking at time of enrollment, 1 pack per day or more
References
Publications (0)
Data not yet available