Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Udenafil

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Individuals who take placebo after total mesorectal excision

Individuals who take udenafil after total mesorectal excision

After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.

Placebo drug

After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.

Sexual dysfunctions are well-recognized complications after rectal cancer surgery. Damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. The purpose of this study is to evaluate the efficacy of Udenafil(Zydena®, Dong-A Pharmaceutical co., Ltd, Seoul, Korea) in penile rehabilitation for patients who undertake total mesorectal excision.

The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer

* IIEF-5 questionnaire is used to assess male erectile function
* IIEF-5 (5-item Version of the International Index of Erectile Function)is obtained by combining the scores of the responses to 5 questions. Each question is scored from 0-5 (1 questions is scored from 1-5) for IIEF-5 range of 1-25 points; lower numerical scores from the IIEF-5 questionnaire represnt greater severitt of erectile dysfunction.

* SEP Q2 (Sexual encounter profile Q2) and SEP Q3 (Sexual encounter profile Q3) are used to assess erectile function
* The efficaty of medication is followed by GEQ (Global efficacy question).

Kyungpook National University Hospital

Colorectal Cancer Center

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Shock

Urinary Bladder Neoplasms

Erectile Dysfunction

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Vasodilator Agents

Urological Agents

Anticoagulants

Other Dietary Supplements

Sildenafil Citrate

Citric Acid

Sodium Citrate

Citrate

Intervention include that patients will undergo penile low-intensity extracorporeal shock wave therapy, 6-12 sessions, 1500 shocks per session, two sesssions per week for 3 weeks then 3 weeks break and then 2 sessions per week for 3 weeks.

Intervention include that patients will intke oral tablets of PDE-5 inhibitors :

- Oral intake of 50 mg once daily for 6 months.

Patients will be only followed up without any therapy for assisting erection.

The patients in this arm will be subjected to Penile LI-SWT in the following parameters: 6 to 12 sessions with 1500 shocks per session. Each session will comprise the application of 300 shock waves (energy intensity of 0.09 mJ/mm2) to each of five different sites on the penis: three along the penile shaft and two at the crura with Frequency: 4 HZ. Energy level: 8 mJ/mm2. Rate: 120 shocks per minute.

-Intervals: 2 treatment sessions per week for 3 weeks, then 3-weeks no-treatment interval, then 3-weeks treatment period of 2 treatment sessions per week.

LI-ESWT group

The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.

PDE-5 inhibitors group

Tamer S. Zewin, MS

Ahmed M. Hazrra, MD

Tamer E. Zewin, Fellow

Ahmed M. Harraz, MD

Ahmed M. Asmy, MD

The aim of this clinical trial is to evaluate the role of extracorporeal low-intensity shock wave therapy in penile rehabilitation post nerve sparing radical cysto-prostatectomy.

60 patients for whom nerve sparing radical cystoprostatectomy will be carrried out, penile rehabilitation by using low intensity extracorporeal shock wave therapy will be applied in 20 patients, another 20 patients will receive oral phosphodiestrase type 5 inhibitorrs and 20 patients will not receive any interventions in the control group.

Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy

Mansoura University

Clinical Fellow in Urology and Nephrology center, Faculty of Medicine, Mansoura University

Prostatic Neoplasms

Genital Diseases

Genital Diseases, Male

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Platelet Aggregation Inhibitors

Pentoxifylline

Protective Agents

Radiation-Protective Agents

Antioxidants

Sildenafil 25 MG Oral Tablet

Placebo

Janet Schadee, RN

Pansy Uberoi, MD

Ileana King-Letzkus

Kuwong B Mwamukonda, MD

The study is a prospective, randomized, double-blind, placebo-controlled drug study to evaluate the pattern of erectile function recovery after robotic assisted laparoscopic prostatectomy (RALP). We hope to illustrate that early and continuous therapy with either Sildenafil citrate or pentoxyfylline after nerve sparing RALP will promote improved erectile function.

Evaluation of erectile function with the International Index of Erectile Function Questionnaire (IIEF) and measurement of penile length any time between the prostate biopsy and 3 days prior to RALP will be performed.

Patients will undergo a unilateral or bilateral nerve sparing-RALP.

Patients will be randomized to receive either 25mg Viagra twice daily, 400mg pentoxifylline twice daily or placebo twice daily, starting on the first postoperative day after surgery and continuing for one year. The biostatistician generates a table of random numbers. 120 subjects anticipated to enroll at Brooke Army Medical Center will be divided into 3 groups, sildenafil, pentoxifylline or placebo. The randomization table will be given to the research pharmacist.

Patients will have their erectile function evaluated at 3 months, 6 months, 9 months, and 12 months with IIEF and sexual intercourse diary. These visits are routine for post-operative care following a RALP, however, completion of the IIEF and sexual intercourse diary are being performed for study purposes.

Patients will stop therapy at 12 months and penile length will be re-measured. Measurement of penile length will be done for study purposes at the standard 1 year post-operative follow up visit.

Patient will undergo a 6 week washout period during which neither drug will be used, then repeat analysis of erectile function with IIEF will be performed, after which they may restart standard erectile dysfunction therapy as desired. This washout period and follow up will be for study purposes.

Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy

Patterns of Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy With and Without Penile Rehabilitation

Stretched length in cm from pubis to coronal ridge

Walter Reed National Military Medical Center

Brooke Army Medical Center

Staff Urologist

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer	NCT01421940	Rectal Cancer	Placebo drug Udenafil	20 Years - 65 Years	Kyungpook National University Hospital
The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer	NCT01421940	Rectal Cancer	Placebo drug Udenafil	20 Years - 65 Years	Kyungpook National University Hospital
Role of Low-intensity Shock Wave Therapy in Penile Rehabilitation Post Nerve Sparing Radical Cysto-prostatectomy	NCT02422277	Bladder Cancer	LI-ESWT group PDE-5 inhibitor...	30 Years - 75 Years	Mansoura University
The Efficacy of Penile Rehabilitation Using Udenafil After Total Mesorectal Excision of Rectal Cancer	NCT01421940	Rectal Cancer	Placebo drug Udenafil	20 Years - 65 Years	Kyungpook National University Hospital
Erectile Recovery After Robotic-Assisted Laparoscopic Prostatectomy	NCT03406169	Erectile Dysfun... Prostate Cancer	Sildenafil 25 M... Pentoxifylline Placebo	30 Years - 89 Years	Brooke Army Medical Center

Spots Global Cancer Trial Database for penile rehabilitation