Trial · NCT00544076
ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
NCT00544076, Phase 3, Terminated, City of Hope Medical Center; results first posted 2019-01-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer. Trials, record NCT00544076. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00544076
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
- NCT number
- NCT00544076
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 110 participants, actual
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Prostate Cancer, Male Erectile Disorder, Stage I Prostate Cancer, Stage II Prostate Cancer
- Interventions
- sildenafil citrate, alprostadil, robotic-assisted laparoscopic surgery, quality-of-life assessment, questionnaire administration
- First posted
- 2007-10-16
- Last updated
- 2019-01-02
- Results first posted
- 2019-01-02
- Limitations and caveats
In addition to the fact that the trial was closed mid-way through accrual, nearly half of those that accrued dropped out prior to completing treatment. There is not enough power to make any conclusions regarding any of the aims set forth.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months | 12 months following BNS-RAP | Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test |
| Secondary | Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | At 6 and 18 months | Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra were compared at each of 6 and 18 months |
| Secondary | SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups | At 1, 3, 6, 9, 12, and 18 months | Median and range of SHIM scores evaluated at 1, 3, 6, 9, 12, and 18 months. SHIMS-5 is the Sexual Health Inventory for Men, which includes 5 questions that are scored from 1 to 5 each. The total score is obtained by adding all five response scores, and can range from 5 to 25 when all 5 questions are answered. Questions that are left unanswered are scored as a 0, and can result in an overall score lower than 5 (as low as 0). Higher scores are more desirable. A Score of 22-25 = no ED, 17-21=Mild ED, 12-16=Mild to moderate ED, 8-11=Moderate ED, and 5-7 =Severe ED (ED=Erectile Dysfunction). There are no sub-scale scores within this questionnaire. |
| Secondary | Penile Length | At pre-treatment and 18 months | measurement of penile length in centimeters |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months | 12 months following BNS-RAP | These are the patients who remained on treatment for the duration of the 12 months and were evaluable at that time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | At 6 and 18 months | patients who were evaluated at 6 months, 18 months | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups | At 1, 3, 6, 9, 12, and 18 months | patients with shim scores at 1 month | units on a scale | MEDIAN |
| SECONDARY | Penile Length | At pre-treatment and 18 months | patients who were willing to have penile measurements taken at baseline | centimeters | MEDIAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months | Sildenafil Citrate/Mo+Aprostadil/Day | 13 | Participants | ||
| Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months | Sildenafil Citrate Monthly | 16 | Participants | ||
| Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months | Daily Sildenafil Citrate | 16 | Participants | ||
| Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | Sildenafil Citrate/Mo+Aprostadil/Day | 6 month potency | 10 | Participants | |
| Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | Sildenafil Citrate Monthly | 6 month potency | 11 | Participants | |
| Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | Daily Sildenafil Citrate | 6 month potency | 17 | Participants | |
| Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | Sildenafil Citrate/Mo+Aprostadil/Day | 18 month potency | 14 | Participants | |
| Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | Sildenafil Citrate Monthly | 18 month potency | 16 | Participants | |
| Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra | Daily Sildenafil Citrate | 18 month potency | 15 | Participants | |
| SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups | Sildenafil Citrate/Mo+Aprostadil/Day | SHIM score 1 month | 9.5 | Full Range 1 to 24 | units on a scale |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sildenafil Citrate/Mo+Aprostadil/Day | 34 | |
| Overall Study | STARTED | Sildenafil Citrate Monthly | 35 | |
| Overall Study | STARTED | Daily Sildenafil Citrate | 31 | |
| Overall Study | COMPLETED | Sildenafil Citrate/Mo+Aprostadil/Day | 17 | |
| Overall Study | COMPLETED | Sildenafil Citrate Monthly | 19 | |
| Overall Study | COMPLETED | Daily Sildenafil Citrate | 20 | |
| Overall Study | NOT COMPLETED | Sildenafil Citrate/Mo+Aprostadil/Day | 17 | |
| Overall Study | NOT COMPLETED | Sildenafil Citrate Monthly | 16 | |
| Overall Study | NOT COMPLETED | Daily Sildenafil Citrate | 11 |
Source ClinicalTrials.gov
Adverse events231
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Sildenafil Citrate/Mo+Aprostadil/Day | 5 | 34 | 5 |
| other | Anemia | Blood and lymphatic system disorders | Sildenafil Citrate Monthly | 7 | 35 | 7 |
| other | Anemia | Blood and lymphatic system disorders | Daily Sildenafil Citrate | 3 | 31 | 3 |
| other | External ear inflammation | Ear and labyrinth disorders | Sildenafil Citrate/Mo+Aprostadil/Day | 0 | 34 | 0 |
| other | External ear inflammation | Ear and labyrinth disorders | Sildenafil Citrate Monthly | 1 | 35 | 1 |
| other | External ear inflammation | Ear and labyrinth disorders | Daily Sildenafil Citrate | 0 | 31 | 0 |
| other | External ear pain | Ear and labyrinth disorders | Sildenafil Citrate/Mo+Aprostadil/Day | 0 | 34 | 0 |
| other | External ear pain | Ear and labyrinth disorders | Sildenafil Citrate Monthly | 1 | 35 | 1 |
| other | External ear pain | Ear and labyrinth disorders | Daily Sildenafil Citrate | 0 | 31 | 0 |
| other | Cataract | Eye disorders | Sildenafil Citrate/Mo+Aprostadil/Day | 1 | 34 | 2 |
1 to 10 of 231Source ClinicalTrials.gov
See all 231 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sildenafil Citrate/Mo+Aprostadil/Day | 0 | 34 |
| Total, all-cause mortality | Sildenafil Citrate Monthly | 0 | 35 |
| Total, all-cause mortality | Daily Sildenafil Citrate | 0 | 31 |
| Total, other adverse events | Sildenafil Citrate/Mo+Aprostadil/Day | 24 | 34 |
| Total, other adverse events | Sildenafil Citrate Monthly | 19 | 35 |
| Total, other adverse events | Daily Sildenafil Citrate | 24 | 31 |
| Total, serious adverse events | Sildenafil Citrate/Mo+Aprostadil/Day | 0 | 34 |
| Total, serious adverse events | Sildenafil Citrate Monthly | 0 | 35 |
| Total, serious adverse events | Daily Sildenafil Citrate | 0 | 31 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00544076
GET https://conductscience.org/api/trials/v1/NCT00544076/results?page=2