NCT04164589

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

2.7 years

First QC Date

November 13, 2019

Last Update Submit

February 1, 2021

Conditions

Urge Incontinence

Outcome Measures

Primary Outcomes (2)

  • Resultant value achieved in the assessment scale of urge incontinence.

    Resultant value achieved in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). The ICIQ-UI Short Form is a questionnaire for evaluating the frequency, severity and impact on quality of life (QoL) of urinary incontinence. Question items: Frequency or urinary incontinence; Amount of leakage; Overall impact of urinary incontinence; Self-diagnostic ítem. Scoring scale: 0-21. Higher score mean a worse outcome.

    2 years

  • Sandvik Test for Urinary Incontinence

    It is a severity indez score of symptoms to calculate severity of urinary incontinence in women. Scores are from 0 to 12. The higher score: the more severe the urinary incontinence.

    2 years

Secondary Outcomes (5)

  • Intervals between voiding

    2 years

  • Frequency of nocturia

    2 years

  • Quality of life index (Potenziani-14-CI-IO-QOL-2000 index)

    2 years

  • Satisfaction with the treatment (Visual analogue scale.)

    2 years

  • Duration of the response to treatment

    2 years

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Device: SCENAR 1NT-02.2

Experimental

EXPERIMENTAL

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

Device: SCENAR 1NT-02.2

Interventions

SCENAR 1NT-02.2DEVICE

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

Also known as: Neuro-adaptative regulation
ControlExperimental

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Álvaro Zapico-Goñi

Madrid, 28805, Spain

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Alvaro Zapico-Goñi, MD

CONTACT

918878100azapicog1@gmail.com

Diana Barreira, Ph

CONTACT

918878100dbarreirahdez@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized, single blind placebo controlled clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

February 20, 2019

Primary Completion

October 20, 2021

Study Completion

December 20, 2021

Last Updated

February 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)