Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01540656
Study type	Interventional
Source	Copenhagen University Hospital at Herlev
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	June 2012
Completion date	January 2014

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05534412` - A Practice-Based Intervention To Improve Care for a Diverse Population Of Women With Urinary Incontinence	N/A
Recruiting	`NCT05515198` - Improving Care for Women With Urinary Incontinence (EMPOWER)	N/A
Completed	`NCT04071301` - Collection of Real-life Measurement Data for TENA SmartCare Change Indicator in Subjects With Urinary Incontinence	N/A
Completed	`NCT03623880` - Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders	N/A
Recruiting	`NCT05880862` - Comparative Effectiveness of Initial OAB Treatment Options Among Older Women at High Risk of Falls	Early Phase 1
Recruiting	`NCT04159467` - Effect of Pelvic Floor Muscle Training on Urinary Incontinence Reports in Obese Women Undergoing a Low Calorie Diet	N/A
Completed	`NCT05485922` - Performance of a Single-use Intermittent Micro-hole Zone Catheter	N/A
Completed	`NCT06268782` - The Effectiveness of an Online Exercise Program on Well-being of Postpartum Women	N/A
Not yet recruiting	`NCT03027986` - Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy	N/A
Recruiting	`NCT02490917` - ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence	N/A
Enrolling by invitation	`NCT02529371` - Pre-Marketing Feasibility Evaluation of the UriCap-RM - Urine Collection in Hospitalized Male Patients	N/A
Enrolling by invitation	`NCT02530372` - Feasibility of the UriCap-F for Urine Collection in Hospitalized Women	N/A
Completed	`NCT02338726` - Pelvic Floor Symptoms and Quality of Life in Elderly Women - a Population-based Pilot Study	N/A
Completed	`NCT02600676` - Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis	N/A
Completed	`NCT02549729` - Effect of the Pelvic Floor Training in Postmenopausal Women With or Without Hormonal Therapy	N/A
Completed	`NCT02368262` - Prevalence of Incontinence and Risk Factors in Children With Cerebral Palsy	N/A
Completed	`NCT02239796` - Feasibility Controlled Trial of Tibial Nerve Stimulation for Stroke Related Urinary Incontinence	N/A
Completed	`NCT01942681` - Female Patients With Signs of uRgE and Stress Urinary Incontinence Study of Propiverine Hydrochloride	N/A
Recruiting	`NCT01804153` - Stem Cells Tratment for the Local Feminine Stress Urinary Incontinence Treatment (HULPURO)	Phase 1/Phase 2
Completed	`NCT01520948` - Behavioral Therapy to Treat Urinary Symptoms in Parkinson Disease	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Mechanical Nerve Stimulation in the Treatment of Post Prostatectomy Incontinence

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms