NCT00955929 · STUDY IN CONTEXT

Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Difference in the Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) Between the 3 Groups at 24 Months.

Data were not collected

→

secondary · POSTED

The Time to Return of Spontaneous Functional Erections.

Data were not collected

→

secondary · POSTED

The Time for Patients to Respond to Oral Erectogenic Therapy.

Data were not collected

→

secondary · POSTED

The Proportion of Patients Who Have Normalization of Their Erectile Function (Normalization of the EF Domain of the IIEF).

Data were not collected

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-penile-cancer
nct id: NCT00955929
trial label: Pharmacological Penile Rehabilitation in the Preservation of Erectile Function Following Bilateral Nerve-Sparing Radical Prostatectomy
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 3
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0000
source section id
NCT00955929-om-0000
source outcome index
0
endpoint
Difference in the Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) Between the 3 Groups at 24 Months.
endpoint definition
Difference in the Erectile Function (EF) Domain Score of the International Index of Erectile Function (IIEF) Between the 3 Groups at 24 Months.
time origin
2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Data were not collected
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0001
source section id
NCT00955929-om-0001
source outcome index
1
endpoint
The Time to Return of Spontaneous Functional Erections.
endpoint definition
The Time to Return of Spontaneous Functional Erections.
time origin
2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data were not collected
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0002
source section id
NCT00955929-om-0002
source outcome index
2
endpoint
The Time for Patients to Respond to Oral Erectogenic Therapy.
endpoint definition
The Time for Patients to Respond to Oral Erectogenic Therapy.
time origin
2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data were not collected
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0003
source section id
NCT00955929-om-0003
source outcome index
3
endpoint
The Proportion of Patients Who Have Normalization of Their Erectile Function (Normalization of the EF Domain of the IIEF).
endpoint definition
The Proportion of Patients Who Have Normalization of Their Erectile Function (Normalization of the EF Domain of the IIEF).
time origin
2 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Data were not collected
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0000
arm key
OG000
arm label
PRN Sildenafil
regimen
Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery. Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0000
arm key
OG001
arm label
Nightly Sildenafil Arm
regimen
Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0000
arm key
OG002
arm label
Combination Therapy Arm
regimen
Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training). Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0001
arm key
OG000
arm label
PRN Sildenafil
regimen
Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery. Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0001
arm key
OG001
arm label
Nightly Sildenafil Arm
regimen
Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0001
arm key
OG002
arm label
Combination Therapy Arm
regimen
Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training). Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0002
arm key
OG000
arm label
PRN Sildenafil
regimen
Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery. Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0002
arm key
OG001
arm label
Nightly Sildenafil Arm
regimen
Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0002
arm key
OG002
arm label
Combination Therapy Arm
regimen
Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training). Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0003
arm key
OG000
arm label
PRN Sildenafil
regimen
Placebo QHS (blinded) and sildenafil 100mgs (open-label) as required for sexual relations. The placebo will be omitted on nights that 100mgs is used. Placebo will start within 24-48 hours post-surgery. Placebo QHS and sildenafil and questionnaires: Pts will be offered sildenafil 100 mg to be used before intercourse on an as-required basis. They will be given six 100 mg doses, per month, for a 12-month duration. Each patient in this group will use a placebo pill (blinded) each night, except on a nights that 100mg is taken for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0003
arm key
OG001
arm label
Nightly Sildenafil Arm
regimen
Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Sildenafil and questionnaire: Patients will be instructed to take sildenafil 50 mg QHS (blinded) except on nights that they are interested in sexual relations, they will then be instructed to use sildenafil 100mgs (open-label) and skip the 50mg dose. Sildenafil treatment will start within 24-48 hours post-surgery. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
outcome key
om-0003
arm key
OG002
arm label
Combination Therapy Arm
regimen
Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL), at initial dose of 5 units (0.05ml) will be given; the first 2 injections will be done in the MSKCC urology outpatient clinic (if needed, the investigator can determine appropriate amount of injections for patient training). Trimix combination (Papavarine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mmL) and questionnaires: Intracavernous injections of a trimix combination (Papaverine 30mg/mL Phentholamine 1mg/mL Prostaglandin E1 10 mcg/mL) will be injected three times a week, and sildenafil 50mg taken on the other four (non-injection) nights. Injection therapy can be used for the purpose of sexual relations. Patients will be evaluated in the clinic and will complete the questionnaires at baseline (pre-treatment evaluation), 3, 6, 9, 12, 18 and 24 months after the operation. At 12 months postoperatively, all patients will stop treatment. Visits 3, 6, 9, 12, 18, and 24 months will have ±2 week window.
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00955929-om-0003#groups/OG002

harms

release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
harm key
EG000
source section id
NCT00955929-ae
event group key
EG000
event group label
PRN Sildenafil
serious affected
0
serious at risk
13
other affected
0
other at risk
13
frequency threshold
5
collection period
1 year
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
harm key
EG001
source section id
NCT00955929-ae
event group key
EG001
event group label
Nightly Sildenafil Arm
serious affected
1
serious at risk
30
other affected
0
other at risk
30
frequency threshold
5
collection period
1 year
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-penile-cancer
nct id
NCT00955929
harm key
EG002
source section id
NCT00955929-ae
event group key
EG002
event group label
Combination Therapy Arm
serious affected
2
serious at risk
33
other affected
0
other at risk
33
frequency threshold
5
collection period
1 year
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice