Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Sexual Dysfunction, Physiological

Male Urogenital Diseases

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Radical prostatectomy without implantation of allograft

Radical prostatectomy with implantation of allograft

Interposition of resected neurovascular bundles with allograft Avance®

No interposition of resected neurvascular bundles

Hubert John, Chefarzt

Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.

The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.

In this prospective randomised and single-blind, clinical phase-IV study, 60 patients are randomized into the treatment group and the control group. The follow-up is at least 24 months.

The inclusion criteria were localized prostate cancers cT3 and/or Gleason score ≥ 7 (a or b) and/or prostate-specific antigen (PSA) ≥ 20 ng/ml and furthermore an erectile function with an IIEF ≥ 21 (IIEF-6).

The operation carried out is a standardised, robot assisted laparoscopic radical prostatectomy with total excision of both neurovascular bundles.

The Outcome measurement is done with the "quality of life questionnaire before and after prostate surgery" that includes the "International Index of Erectile Function" (IIEF) questionnaire.

The limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients.

Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial

How much operation-time takes the nerve implantation? The time is stopped which is required for the implantation of the nerve. Start is when the prostate was removed and was deposited in the extraction bag. Stop when the anastomosis of the nerves is stitched and the anastomosis of the urethra begins.

Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy. To show a complete impotence in the control group and an enhancement of the initial postoperative impotence in the treatment group

Monitoring of side effects and complications in connection with the nerve-implantation.

Kantonsspital Winterthur KSW

Genital Neoplasms, Male

Urogenital Neoplasms

Prostatic Diseases

All Drugs and Chemicals

Phosphodiesterase 5 Inhibitors

Patients will also be assessed for penile length and the presence of Peyronie's Disease at these specified times.

At the baseline visit, the patient's co-morbidities, height, weight with calculation of body mass index will be documented.

After surgery, the patient will be instructed to keep a diary to record erectile function including how often they use a PDE-5 inhibitor or injection therapy and each time they get an erection and the level of rigidity. The diary is required to document PDE-5 inhibitor and injection therapy use and response in each sexual encounter, unlike the IIEF questionnaire, which addresses erectile function over a 4-week period. Accurate documentation is essential for erectile function assessment, as patient choice of erectile function medication may differ in each sexual encounter, and accordingly, the achieved rigidity level.

Penile Exam, Peyronie's Plaque and Erectile function assessment

John Mulhall, MD

Some men complain of changes in the shape or dimensions of their penis after undergoing radical prostatectomy (removal of the prostate) for prostate cancer. Changes in penile dimensions include shortening or decreased girth. Changes in shape include a curvature or bending of the penis, and/or the appearance of indentation. These changes may be associated with formation of scar tissue involving the covering of the erection chambers, known as "plaque". The appearance of indurated plaque and a resultant curvature or indentation is a well described medical condition known as "Peyronie's Disease" and may occur in men who did or did not undergo radical prostatectomy. The purpose of this study is to evaluate these changes in penile shape and dimensions.

Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

Assessing the Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy

Memorial Sloan Kettering Cancer Center

Nervous System Diseases

Wounds and Injuries

Peripheral Nerve Injuries

Peripheral Nervous System Diseases

Neuromuscular Diseases

Trauma, Nervous System

Implantation of appropriate length of processed human nerve scaffold at the time of surgery.

Processed Human Nerve Tissue Scaffold

Joseph J Smith, MD

The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.

Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer

A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy

Axogen Corporation

Symptoms and General Pathology

Gland and Hormone Related Diseases

Anxiety Disorders

Depression

Depressive Disorder

Cognitive Dysfunction

Fatigue

Testicular Neoplasms

Cognition Disorders

Neurocognitive Disorders

Endocrine Gland Neoplasms

Endocrine System Diseases

Testicular Diseases

Gonadal Disorders

Quality of Life

This is a prospective observational study, that investigates men diagnosed with testicular cancer before and after treatment.

The patients are included at their visit at the Fertility clinic in Horsens, where they deposit semen for cryopreservation prior to surgery and potential systemic treatment. Here the patients, who want to participate will perform a cognitive test and afterwards complete a questioner (T1). After 9 month the patients will be invited to perform the cognitive test and complete the questionnaire again (T2).

Mental Health of Men Before and After Testicular Cancer Treatment

Mental Health of Men Before and After Testicular Cancer Treatment. Danish: "Mænds Mentale Sundhed før og Efter Behandling af testikulær kræft"

The cognitive test is performed on an iPad using the validated Cambridge Neuropsychological Test Automated Battery (CANTAB) Connect Research software. The cognitive domains assessed are sensorimotor function and comprehension, processing and psychomotor speed, sustained attention, visual episodic memory, working memory and strategy, visual working memory and planning, each at T1 and T2. Comparison of test results from T1 and T2 will assess if there is a change in the cognitive performance.

Assessed by The Patients Assessment of Own Functioning Inventory (PAOFI)

Assessed by the EORTC Sexual Health Questionnaire (EORTC SHQ-C22)

Assessed by The International Index of Erectile Function (IIEF-5)

Assessed by the Hospital Anxiety and Depression Scale (HADS). The HADS is a 14-item scale with 2 subscales measuring severity of anxiety (HADS-A) and depression (HADS-D) symptoms. Each subscale has 7 items and each item is scored from 0-3. Thus, the total score for each subscale range from 0-21, with 0 indicating no symptoms and 21 severe symptoms.

Assessed by the FACIT_Fatigue Questionnaire. The questionnaire consists of 13-items each scored from 0-4. The scores are summarized, and the total score range from 0-52 with higher score denoting less fatigue.

Assessed by the Pittsburgh Sleep Quality Index (PSQI)

The quality of life is assessed by a subscale from the WHO Quality of Life (WHOQOL)-BREF questionnaire. The subscale has 2 questions each scored from 1-5. Thus, the total score for this subscale range from 2-10 with higher scores denoting higher quality of life.

The wellbeing is assessed by the WHO (Five) Well-being scale (WHO-5), that has 5 questions each scored from 0-5. The raw score ranges from 0-25 and is multiplied by 4 to give the final score that ranges from 0-100, with higher scores denoting higher wellbeing.

The patient answers 5 questions regarding fertility related concerns, investigating if he has concerns about being able to become a father with or without fertility assistance. Also, the patient answers 4 questions regarding the information given by healthcare professionals, to assess if he finds, that he has been given enough information regarding semen deposit and possible later fertility assistance.

None of these 9 questions are validated.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial	NCT01770340	Erectile Dysfun...	Radical prostat... Radical prostat...	18 Years -	Kantonsspital Winterthur KSW
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial	NCT01770340	Erectile Dysfun...	Radical prostat... Radical prostat...	18 Years -	Kantonsspital Winterthur KSW
Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy	NCT00800813	Prostate Cancer	Penile Exam, Pe...	21 Years -	Memorial Sloan Kettering Cancer Center
Change in Penile Length Following Bilateral Nerve-Sparing Radical Prostatectomy	NCT00800813	Prostate Cancer	Penile Exam, Pe...	21 Years -	Memorial Sloan Kettering Cancer Center
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial	NCT01770340	Erectile Dysfun...	Radical prostat... Radical prostat...	18 Years -	Kantonsspital Winterthur KSW
Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer	NCT00953277	Peripheral Nerv... Prostate Cancer Radical Prostat... Nerve Reconstru... Cavernous Nerve...	Processed Human...	18 Years - 70 Years	Axogen Corporation
Mental Health of Men Before and After Testicular Cancer Treatment	NCT03880994	Testis Cancer Cognitive Impai... Sexual Dysfunct...		18 Years - 45 Years	University of Aarhus

Spots Global Cancer Trial Database for erectile function