Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

All Conditions

Neoplasms

Behaviors and Mental Disorders

Urinary Incontinence

Prostatic Neoplasms

Enuresis

Urinary Incontinence, Stress

Urination Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Lower Urinary Tract Symptoms

Urological Manifestations

This group will receive immediate TMNS treatment beginning at baseline and ending at the 6 week point of the study.

This group will receive delayed TMNS treatment beginning at the 6 week point of the study and ending at 12 weeks.

A medical vibrator (FERTI CARE personal, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the frenulum of the glans penis. The stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz.

A daily stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used through 6 weeks.

Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)

Mikkel Fode, MD

During transcutaneous mechanical nerve stimulation in spinal cord injured men an increase in pressure was observed in the external urethral sphincter along with an increase in bladder capacity. In a subsequent study it was demonstrated that Transcutaneous Mechanical Nerve Stimulation (TMNS) in women could induce pressure increment of the external urethral sphincter. A pilot study have since shown that after 6 weeks of stimulation 24 out of 33 women suffering from urinary stress incontinence were able to contract their pelvic floor muscles and had become free of symptoms. Another pilot study has shown promising effect on the overactive bladder syndrome. Furthermore pilot studies in men who are incontinent after a radical prostatectomy have shown promising results. A randomized investigation of TMNS applied in the immediate period after a radical prostatectomy to investigate effects on both continence and erectile function is on going.

The present study aims to treat urinary incontinence in men who are still incontinent more than 1 year after a radical prostatectomy. A medical vibrator is used daily for a period of 6 weeks and the results of the treatment is then evaluated. The participants will be randomized to 2 groups. Group 1 starts vibration treatment at base line and group 2 starts after 6 weeks when group 1 is done. The groups are compared at baseline, at 6 weeks and at 12 weeks.

The stimulation will be performed at the frenulum of the glans penis every day for 6 weeks with an amplitude of 2 mm and a frequency of 100 Hz. Results will be evaluated on the basis of questionnaires, micturition diaries and diaper tests.

If the investigators are able to demonstrate a significant reduction in the incontinence symptoms in the subjects the investigators asses that vibration can be a way of reestablishing normal continence in men after a radical prostatectomy.

Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Participants will be provided diapers and they will wear them for 24 hours. The weight of all used diapers is then measured to assess how much urine is leaking.

The main outcome measure is the difference in leakage between groups 1 and 2 at 6 weeks (when group 1 has received treatment and group 2 has not).

Participants will be provided diapers and they will wear them for 24 hours. The weight of all used diapers is then measured to asses how much urine is leaking.

Here the leakage between groups 1 and 2 is measured at 12 weeks (when both groups have received treatment ).

The number of involuntary incontinence and normal micturition episodes are evaluated based on a patient diary. Here the difference in number of incontinence episodes between groups 1 and 2 are calculated at 6 weeks (when only group 1 has received treatment) and at 12 weeks (when both groups have received treatment).

The ICI-Q symptom score includes changes in incontinence and micturition patterns and patients' subjective assessment of their symptoms.

The scores are evaluated and differences between groups 1 and 2 are calculated at 6 weeks (when only group 1 has received treatment) and at 12 weeks (when both groups have received treatment).

The total score as well as storage and voiding domains are evaluated

Rigshospitalet, Denmark

Copenhagen University Hospital at Herlev

Rare Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Chronic Graft Versus Host Disease

Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy

Nerve Stimulation

Kenneth M Peters, MD

The goal of this study is to evaluate electrical stimulation of nerves responsible for erectile function after surgery to remove the prostate (prostatectomy). Electrical stimulation of the nerves responsible for erectile function is experimental. The investigators hypothesize that the subjects can tolerate nerve stimulation.

The objective of the study is to explore the feasibility of using an implantable neurostimulation device/leads post radical robotic prostatectomy as a method for enhancing neural recovery/penile rehabilitation and/or erectile dysfunction treatment. This will be a single center pilot study of up to 10 patients. The leads will be placed and stimulated intraoperatively to assess proper placement and stimulation parameters needed to achieve change in penile length and/or circumference. One week post operatively, the leads will be connected to an external stimulator device and activated. Subjects will be instructed to stimulate each lead by turning on the device each day for up to six weeks. The leads will be removed at six weeks post operative and subjects will be followed for up to two years.

A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Regeneration and Erectile Function

A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Neural Regeneration and Erectile Function

Evaluate the safety and tolerability of chronic cavernous nerve stimulation post radical prostatectomy by measuring the incidence of major complications that may include lead removal, infection at the site or painful stimulation requiring lead removal.

Explore the potential efficacy of chronic cavernous nerve stimulation on the return of erectile function post radical prostatectomy. Measures to assess efficacy include direct response to stimulation, changes in penile tumescence (girth) and sensory perception.

William Beaumont Hospitals

Chief of Urology

Adverse events (AEs) assessment will be performed at each study visit following implantation through 24 months. All AEs will be initially reviewed by the Principal Investigator (PI), The PI will determine severity and causality. AEs will be reported per institutional and FDA requirements.

Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy

Nerve Stimulation: Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Baseline data was collected on all 3 participants before they withdrew from study

Study was terminated early after technical problems with device caused device removal in all 3 enrolled subjects and withdrawal of all 3 enrolled subjects prior to data collection or analysis.

Deborah Hasenau, RN

All participants withdrawn from study prior to any data collection or analysis. No data analyzed to report.

Tolerability of Nerve Stimulation

Efficacy of Nerve Stimulation

Overall Study

Erectile Dysfunction

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Acute placement of electrodes and electrostimulation of the pelvic plexus nerves during open radical prostatectomy.

Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.

Spyridon Skoufias, MD

Ioannis Adamakis, MD

Constantinos A. Constantinides, MD

The purpose of this study is to evaluate the feasibility of electrical stimulation of nerves responsible for erectile function to evoke penile erection after surgery to remove the prostate (prostatectomy).

Prostate cancer is the main cancer in men. However, the survival rate for clinically localized prostate cancer is prominent mainly due to radical prostatectomy (RP), the gold standard treatment for non-metastatic cancers. Unfortunately, despite providing optimal cancer control, RP often lead to neuropraxia and persistent erectile dysfunction in approximately 80% of men 1 year after prostatectomy. Various erectile rehabilitation strategies have not been able to prove a beneficial action yet. However, electrical stimulation has been demonstrated to favour neuroregeneration and the functional recovery of neuromuscular systems and has been shown to induce and maintain penile erection in animals and humans. Therefore, electrical stimulation of the pelvic plexus nerves during radical prostatectomy is being investigated for its potential development into a treatment aimed at improving recovery of erectile function after prostatectomy.

The primary objective of this study is to explore the feasibility of using a neurostimulation device post radical prostatectomy as a method for neurogenic erectile dysfunction treatment. During standard open radical prostatectomy, the pelvic plexus nerves will be electrically stimulated intraoperatively and the modification of penile circumference will be recorded.

The secondary objective is to assess proper placement of the stimulation electrodes and stimulation parameters needed to achieve maximal change in penile circumference.

Intra-operative Neuromodulation of the Pelvic Plexus

Change in penile circumference \[mm\] in response to electrical stimulation of the pelvic plexus nerves measured by a penile plethysmograph.

The anatomic location of the stimulation site on the pelvic floor (determined by the surgeon).

Amplitude in volts of the electrical stimulation pulses to induce penile response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence	NCT01540656	Urinary Inconti... Radical Prostat...	Transcutaneous ...	18 Years -	Copenhagen University Hospital at Herlev
A Pilot Study of the Feasibility of Chronic Cavernous Nerve Stimulation to Promote Regeneration and Erectile Function	NCT02006927	Prostate Cancer	Nerve Stimulati...	40 Years - 80 Years	William Beaumont Hospitals
Intra-operative Neuromodulation of the Pelvic Plexus	NCT03425240	Erectile Dysfun... Prostate Cancer	Nerve Stimulati...	40 Years - 75 Years	Laikο General Hospital, Athens
Intra-operative Neuromodulation of the Pelvic Plexus	NCT03425240	Erectile Dysfun... Prostate Cancer	Nerve Stimulati...	40 Years - 75 Years	Laikο General Hospital, Athens

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