EFFECTIVENESS OF THE NEUROADAPTATIVE FOR URGE INCONTINENCE (SCENAR-EC)

Fundacion para la Investigacion Biomedica del Hospital Universitario Principe de Asturias

Status: Unknown

Conditions: Urge Incontinence

Treatments: Device: SCENAR 1NT-02.2

Study type: Interventional

Funder types: Other

Identifiers

NCT04164589

SCENAR-EC

Details and patient eligibility

About

In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence

Full description

In this clinical trials the sponsor want to assess a self-controlled-energo-neuroadaptative-regulation in patient with urge incontinence and mixted incontinence

Enrollment: 62 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urge incontinence or mixed incontinence without urethral hypermobility
• Over 3 months of disease evolves.

Exclusion criteria

• Severe physical limitations that might interfere with applying the treatment.
• Severe mental disorders that need pharmacology treatments that may influence in neuronal activity
• Oncological processes in the lower abdomen that had required radical surgery.
• Neurogenic bladder.
• Blockage of the bladder
• Vaginal infection
• Bladder infection or disorder of kidney function
• Have received, in the last year, botulinum toxin in bladder or pelvic organs.
• Have received pharmacological treatment for urge incontinence in the last month (before entry date in the trial)
• Be receiving pharmacological treatment for urge incontinence.
• Stress incontinence due to urethral hypermobility which was treatable with surgery.
• Pregnant women
• Patients with pacemarker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

The Neuro-Adaptative Regulation will be carried out in the regime of switched off power supply in vulvo-perineal and sacral area.

Treatment:

Device: SCENAR 1NT-02.2

Experimental

Experimental group

Description:

The neuro-adaptative regulation will be carried out in vulvo-perineal and sacarl area.

Treatment:

Device: SCENAR 1NT-02.2