Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Quality of Life

Anticoagulants

All Drugs and Chemicals

Vasodilator Agents

Urological Agents

Other Dietary Supplements

Citric Acid

Sodium Citrate

Sildenafil Citrate

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Citrate

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

standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings

Study participants will not receive any study intervention, but will continue with standard care.

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.

Cognitive-behavioral Meetings

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.

sildenafil citrate

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.

Vacuum Constriction Device

Amy Zhang, MD

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.

Erectile dysfunction (ED) is a common side effect of prostate cancer treatment. Existing medical treatment focuses on early penile rehabilitation, aiming to prevent penile shrinkage and preserve nerves and smooth muscles to facilitate erection return. It typically includes administration of phosphodiesterase type 5 inhibitor (PDE-5), application of vacuum constriction devices (VCD) or intracavernous injection immediately after prostate cancer treatment.

To evaluate the proposed intervention, a randomized, controlled longitudinal clinical trial will be conducted to examine the effect of this cognitive-behavioral intervention on early-stage prostate cancer patients with ED and their partners. The proposed study includes a pilot study, a randomized clinical trial (the main study) and data analysis. The study duration for main study participants is 10 months including one month of recruitment and baseline assessment, six months of intervention, and three months of follow-up. The study duration for pilot study participants is 7 months including one month of recruitment and baseline assessment plus six months of intervention.

The Pilot Study A pilot study will be conducted to develop and test the proposed study intervention over 12 months. The pilot study will recruit 36 early-stage prostate cancer patients and their partners. The 36 couples will be randomly assigned to three study arms: (1) standard medical treatment of ED (MED); (2) standard medical treatment of ED plus cognitive-behavioral intervention (MED+CBI); and (3) usual care (UC) in which the study participants will not receive any study intervention, but will continue with standard care that allows patient's request for ED treatment. The purpose to include the usual care group is to collect preliminary data to aid the estimation of intervention effect size, statistic power and sample size, and to compare the intervention outcome with the real world scenario in order to provide the justification for the inclusion or exclusion of the usual care arm in the main study. The pilot study participants will be assessed twice at baseline (T1) and 7 months (T2) only. Doppler Ultrasound of the penis will be performed at T1 and T2 to examine changes in the volume of penile blood flow in patients. Subjects are allowed to opt out of the Doppler Ultrasound test, because this pilot data is exploratory and five or more ultrasound tests per group are sufficient. Collecting and analyzing blood samples will be performed at T1 and T2 and subjects are allowed to opt out of this test as well. The blood sample will be collected in order to test transforming growth factor beta-1 (TGF-ß1) and to assess its relation to erectile function. The result will allow us to evaluate the intervention impact at molecular level and formulate a best possible intervention to ED.

The Main Study During a 4-year clinical trial study, 144 early-stage prostate cancer patients along with their partners will be randomly assigned to two study arms: (1) standard medical treatment of ED (MED) and (2) standard medical treatment of ED plus cognitive-behavioral intervention (MED+CBI). The MED includes administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump). The MED+CBI entails six in-person sessions and five telephone follow-ups over six months. The patients will be assessed on erectile function (EF), quality of life (QOL) and mood at baseline (T1), 7 months (T2) and 10 months (T3). The partners will be assessed on QOL and mood at T1, T2 and T3. Doppler Ultrasound of the penis will be performed at T1 and T2 to examine changes in the volume of penile blood flow among 50 patients who will be consecutively selected from the two study groups, with 25 per study arm.

The long-term primary goals of the study are to:

1. Assess the effect of the new treatment on erection function, quality of life, and mood.
2. Assess the treatment compliance and frequency of sexual activity of the new treatment.
3. Investigate the mechanism in which the new treatment works.

The long-term secondary goals of the study are to:

1. Assess the effect of the new treatment on the quality of life and mood of the patient's partner.
2. Assess the changes in the volume of penile blood flow due to study treatments.

Improving Erectile Function and Quality of Life After Prostate Cancer Treatment

Change from baseline in the mean score of Bandura's measure to assess self-efficacy. This scale is scored from 0-100, where 100 indicates complete confidence.

Change from baseline in a sub-score of the Sexual Function Questionnaire where higher scores indicate greater pleasure.

change from baseline in a total score from a sub-scale of the Social Support for Exercise Behavior Questionnaire as modified by the study team to measure partner support for rehabilitation. Higher scores will indicate greater support.

Change from baseline in the total length of patients flaccid penis. Length will be measured using Mounding's method

Change from baseline in the total length of patients stretched penis. Length will be measured using Mounding's method

Change from baseline in the total penile blood flow will be assessed by a color and spectral Doppler ultra sound of the cavernosal arteries

Total level of Transforming Growth Factor Beta-1 levels will be assessed using a commercially available assay

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.

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.

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.

Change from baseline in the total score of the Sexual Quality of Life (male/female) scales. Higher scores indicate better quality of life.

Change in the total score from baseline on the Short-Form-36 Health Survey (SF36) will be used to show changes in QoL. Higher scores indicate increased QoL. QOL in eight dimensions, including physical, role and social functioning, role limitations, and general physical and mental health.

Change from baseline in the sub-score from the 21-item Profile of Mood States (POMS) will be used to measure psychological adjustment to cancer. It will be used to measure depression, anxiety and anger. Higher scores indicate more mood disorder.

Change from baseline in the number of patients compliant with treatment. Patients will be described as regular user, intermittent user, or drop out based on the information recorded in the patients Sex Diary over the previous seven days.

Change from baseline in the mean value of sexual activities ((1) Sexual encounters; (2) Sexual simulation; (3) intercourse; and (ejaculation)) experienced by each participant over the previous seven days

Change from baseline in the total score of the Sexual Quality of Life (male/female) scales

The Cleveland Clinic

University Hospitals Cleveland Medical Center

Case Comprehensive Cancer Center

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

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

sildenafil citrate: 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.

Vacuum Constriction 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.

Standard ED Care

standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings

Cognitive-behavioral Meetings: 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

Usual Care (UC)

standard medical treatment of ED (administration of sildenafil citrate (Viagra) and/or vacuum constriction devices (pump)) in addition to cognitive-behavioral meetings

Cognitive-behavioral Meetings: 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

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Amy Zhang

Erectile Function Improvement

Change in Number of Erections

Sexual Quality of Life (QoL) Improvement

Change in Overall Quality of Life (QoL) Score

Improved Mood Score

Change in Treatment Compliance

Change in Frequency of Sexual Activity

Self-Efficacy Improvement

Change in Level of Sensual Pleasure of Sex

Change in Perceived Partner Support

Change in Flaccid Penile Length

Change in Stretched Penile Length

Change in Volume of Flaccid Penile Blood Flow

TGF-B1 Levels

Overall Study

Sildenafil with dose escalation as needed from 50 mg to 100 mg/day prn for 12 weeks.

Placebo with similar "dose escalation" opportunity for 12 weeks.

Placebo

Deborah Watkins Bruner, RN, PhD

RATIONALE: Sildenafil may be effective in helping patients who have undergone treatment for prostate cancer to have an erection for sexual activity and may improve sexual satisfaction and quality of life.

PURPOSE: Randomized clinical trial to study the effectiveness of sildenafil in treating erectile dysfunction in patients who have undergone radiation therapy and hormone therapy for prostate cancer in clinical trial RTOG-9910.

OBJECTIVES:

* Compare the effect of sildenafil vs placebo on erectile dysfunction in patients with prostate cancer treated with radiotherapy and antiandrogens on RTOG-9910.
* Compare the overall sexual function and satisfaction of patients treated with these regimens.
* Compare sexual satisfaction of partners of patients treated with these regimens.
* Compare patient and partner marital adjustment after treatment with these regimens.
* Determine factors that may predict response to sildenafil, including age, pretreatment sexual function, tobacco use, and comorbidities in these patients.

OUTLINE: This is a randomized, placebo-controlled, multicenter study. Patients are stratified according to prior use of sildenafil after treatment on RTOG-9910 and level of response (No vs yes \[unsatisfactory\] vs yes \[satisfactory\]), International Index of Erectile Function (IIEF) Question #1 score (0-1 vs 2-3), and RTOG-9910 treatment arm (I vs II). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral sildenafil 1 hour prior to desired sexual intercourse.
* Arm II: Patients receive oral placebo 1 hour prior to desired sexual intercourse.

Treatment on both arms continues for 12 weeks. Patients then cross over to treatment on the other arm for 12 weeks.

Quality of life, including sexual function, marital adjustment, and partner's satisfaction, is assessed at baseline, at 12 and 25 weeks, and at 1 year.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 332 patients (166 per treatment arm) will be accrued for this study.

Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer

Treatment Of Erectile Dysfunction In Patients Treated On RTOG-9910 For Prostate Cancer: Impact On Patient And Partner Quality Of Life

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Platelet Aggregation Inhibitors

Alprostadil

Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

alprostadil

robotic-assisted laparoscopic surgery

quality-of-life assessment

questionnaire administration

Laura Crocitto

RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction.

PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical prostatectomy for nonmetastatic prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the rate of erectile function (defined as the ability to achieve and maintain an erection sufficient for intercourse without the use of pharmacological assistance) at 1 year post-operatively in men undergoing BNS-RAP without the use of post-operative maintenance pharmacotherapy.

II. To describe whether early post-operative maintenance pharmacotherapy Viagra can improve return of erectile function at 1 year post-operatively in patients undergoing BNS-RAP.

III. To describe if early post-operative maintenance pharmacotherapy Viagra can decrease the time-to-return of erectile function in patients undergoing BNS-RAP.

SECONDARY OBJECTIVES:

I. To describe whether early post-operative maintenance pharmacotherapy MUSE can improve return of erectile function at 1 year post-operatively in patients undergoing BNS-RAP.

II. To describe if early post-operative maintenance pharmacotherapy MUSE can decrease the time-to-return of erectile function in patients undergoing BNS-RAP.

III. To compare sexual function quality of life in men undergoing early post-operative maintenance pharmacotherapy to those without early post-operative maintenance pharmacotherapy.

IV. To compare the rate of potency at 1, 3, 6, 9, 12, and 18 months in men using Viagra versus MUSE for early post-operative maintenance pharmacotherapy.

V. To describe the dropout rate for MUSE maintenance pharmacotherapy secondary to urethral pain in men using 2% Lidocaine lubricant.

VI. To describe if penile length is decreased following BNS-RAP. VII. To describe if penile length at one year is different in men who have return of potency versus those with no return of potency.

OUTLINE: Patients receive 2 doses of intraurethral alprostadil prior to undergoing bilateral nerve-sparing robotic-assisted prostatectomy. Within 4 weeks after surgery, patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.

ARM II: Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months.

ARM III: Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.

After completion of study treatment, patients are followed periodically for up to 18 months.

ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer

Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer

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

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

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.

measurement of penile length in centimeters

City of Hope Medical Center

The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.

Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate: Given orally

alprostadil: Given intraurethrally

robotic-assisted laparoscopic surgery: Undergo prostatectomy

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

Sildenafil Citrate/Mo+Aprostadil/Day

Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate: Given orally

robotic-assisted laparoscopic surgery: Undergo prostatectomy

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

Sildenafil Citrate Monthly

Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate: Given orally

robotic-assisted laparoscopic surgery: Undergo prostatectomy

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

Daily Sildenafil Citrate

Sildenafil Citrate Monthly Daily Sildenafil Citrate

Age, Continuous

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.

Laura Crocitto, M.D.

These are the patients who remained on treatment for the duration of the 12 months and were evaluable at that time point.

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

compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)

6 month potency

18 month potency

P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate: Given orally

robotic-assisted laparoscopic surgery: Undergo prostatectomy

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

patients who were evaluated at 6 months, 18 months

Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra

SHIM score 1 month

SHIM score 3 months

SHIM score 6 months

SHIM score 9 months

SHIM score 12 months

SHIM score 18 months

SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups

ANOVA test to compare difference of penile length (from baseline to month 18) across arms.

calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken.

Baseline Penile Measurement

Month 18 Penile Measurement

patients who were willing to have penile measurements taken at baseline

Penile Length

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Patients receive sildenafil citrate PO before the initiation of standard robotic partial nephrectomy.

Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.

placebo

Undergo standard robotic partial nephrectomy

therapeutic conventional surgery

Ashok Hemal

This randomized pilot clinical trial studies sildenafil citrate before surgery in improving kidney function in patients with kidney cancer. Sildenafil citrate may help protect the kidney from the side effects of surgery and improve kidney function after surgery.

PRIMARY OBJECTIVES:

I. To assess accrual, retention, and participation rates for patients receiving sildenafil (sildenafil citrate) compared to placebo in patients undergoing robotic partial nephrectomy (RPN) for a suspected renal malignancy.

SECONDARY OBJECTIVES:

I. To evaluate individual alterations in glomerular filtration rate (GFR) at 24 hours, 48 hours and one month following RPN and compare these to the placebo group.

II. To evaluate individual alterations in proteinuria at 24 hours, 48 hours, one month and three months following RPN and compare these to the placebo group.

III. To measure between-group differences in estimated blood loss and hemoglobin concentration at 24 hours following RPN.

IV. To describe individual changes in blood pressure measurements as noted in the preoperative holding area, throughout the procedure and in the post-anesthesia care unit.

V. To describe between-group variations in vasopressor support or intravenous fluid requirements during the operative procedure.

VI. To compare overall complication rates (within 90 days postoperatively) between groups.

VII. To obtain a preliminary effect size of sildenafil on change in GFR at three months following RPN.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sildenafil citrate orally (PO) before the initiation of standard robotic partial nephrectomy.

ARM II: Patients receive placebo PO before the initiation of standard robotic partial nephrectomy.

After completion of study treatment, patients are followed up at 1 and 3 months.

Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer

Sildenafil Prior to Robotic Partial Nephrectomy to Improve Postoperative Renal Function: A Randomized, Placebo-Controlled Pilot Study

Reasons for declining enrollment to the study will be documented on the Declined Participation Form at the time patients are presented with the study.

Retention will be assessed by whether or not the patient attends his or her 1 and 3 month postoperative visits.

Regression analysis will be used; the change will be modeled, with adjustment for baseline GFR, to assess difference in the two study groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Erectile Function and Quality of Life After Prostate Cancer Treatment	NCT01996852	Prostate Cancer Erectile Dysfun... Erectile Dysfun... Erectile Dysfun...	Cognitive-behav... sildenafil citr... Vacuum Constric...	21 Years -	Case Comprehensive Cancer Center
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer	NCT00057759	Prostate Cancer Psychosocial Ef... Radiation Toxic... Sexual Dysfunct... Sexuality and R...	sildenafil citr... Placebo	18 Years -	Radiation Therapy Oncology Group
Sildenafil in Treating Erectile Dysfunction in Patients With Prostate Cancer	NCT00057759	Prostate Cancer Psychosocial Ef... Radiation Toxic... Sexual Dysfunct... Sexuality and R...	sildenafil citr... Placebo	18 Years -	Radiation Therapy Oncology Group
ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer	NCT00544076	Prostate Cancer Male Erectile D... Stage I Prostat... Stage II Prosta...	sildenafil citr... alprostadil robotic-assiste... quality-of-life... questionnaire a...	18 Years - 65 Years	City of Hope Medical Center
Sildenafil Citrate Before Surgery in Improving Kidney Function in Patients With Kidney Cancer	NCT01950923	Kidney Tumor	sildenafil citr... placebo therapeutic con...	18 Years -	Wake Forest University Health Sciences
Sorafenib, Valproic Acid, and Sildenafil in Treating Patients With Recurrent High-Grade Glioma	NCT01817751	Glioblastoma Recurrent Adult... Malignant Gliom... WHO Grade III G...	sorafenib tosyl... valproic acid sildenafil citr...	18 Years -	Virginia Commonwealth University

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