Proposed Randomized Trial of Acupuncture Point S3 Sacral Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder

by | Jun 20, 2019 | Uncategorized | 0 comments

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ClinicalTrials.gov Identifier: NCT02452593
Recruitment Status  : Unknown

First Posted  :  June 21, 2019
Last Update Posted  : June 21, 2019
Sponsor:
CollaboratorD:
TBD
Information provided by (Responsible Party):

 

    • Study Details
Study Description
Brief Summary:
Urinary incontinence is defined according to the International Continence Society as any involuntary loss of urine, which may bring several negative consequences on women’s lives, and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20% emergency.
The overactive bladder present in urge incontinence and mixed cause significant impacts on people’s lives and has a prevalence of 16.5% in the US population.
Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment. Drug therapy using drugs which are not specific for the bladder and are associated with many unwanted systemic side effects.
The results obtained by researchers in several countries using conservative techniques in the treatment of patients with urinary incontinence are encouraging and this study aims to evaluate carefully and systematically the effectiveness of sacral nerve electro acupuncture point S3 stimulation technique with controlled protein expressions.
Importantly, also, that conservative techniques have lower cost than the surgical treatment and have virtually no side effects as most of the drugs used in the pharmacological treatment of female urinary incontinence.
Condition or disease  Intervention/treatment  Phase 
Urge Incontinence Other: “Sacral nerve S3 electro acupuncture point stimulation” and “pelvic floor exercises” Not Applicable

Detailed Description:
Goal
Development of instrumentation for home treatment of overactive bladder and urgency / mixed incontinence using S3 acupuncture point electroacupuncture sacral nerve stimulation with controlled protein expressions for SDF1, PDGF, VEGF, IGF1, Klotho, Follistatin, Sonic Hedgehog, Tropoelastin and pelvic floor exercises.
Secondary objectives
  • Development of an innovative portable equipment, with in clinic stimulation of the posterior sacral nerve stimulation technique using electro acupuncture needles at S3.
  • Comparison of the effectiveness of sacral nerve stimulation techniques and pelvic floor exercises in the treatment of overactive bladder and urgency / mixed incontinence.
Design Randomized Clinical Trial
Sample Women over the age of 18, complaining of urinary incontinence Urgency or Mixed (with main urgency component), catered in Urogynecology Ambulatory of Hospital de Clinicas de Porto Alegre.
Study Design
Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Sacral Nerve Electroacupuncture Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder, Urge and Mixed Urinary Incontinence
Study Start Date  : Summer 2019
Estimated Primary Completion Date  : Winter 2020
Estimated Study Completion Date  : March 2020
Resource links provided by the National Library of Medicine

Arms and Interventions
Go to  
Arm  Intervention/treatment 
Active Comparator: “Sacral Nerve Stimulation”

This group will do transcutaneous electrical stimulation of the sacral nerve stimulation in clinic
Development of an innovative portable equipment, with in clinic application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes.  Frequencies include: 10 Hz, 20 Hz, 50 Hz Pulse width: 200 us; duration > plus bioelectric signaling sequences for controlling expressions of SDF1, PDGF, VEGF, IGF1, Klotho, Follistatin, Tropoelastin, Sonic Hedgehog : 30 minutes 2X a week for 8 weeks.
 Other: “Sacral nerve stimulation” and “pelvic floor exercises”

A group will make sacral nerve stimulation and the other will make pelvic floor training. After 8 weeks the patients exchanges their therapeutic approaches for over 8 weeks
Active Comparator: “Pelvic Floor Exercises”

This group will make pelvic muscle training 3 times a day . In decubit dorsal posture, legs flexed and abductee. Perform pelvic floor contractions keeping 2 seconds and relaxing 4 seconds for 10 times, and contractions keeping 4 seconds and relaxing 8 seconds for 10 times.
 Other: “Sacral nerve stimulation” and “pelvic floor exercises”

A group will make sacral nerve stimulation and the other will make pelvic floor training. After 8 weeks the patients exchanges their therapeutic approaches for over 8 weeks
Outcome Measures
Primary Outcome Measures  :

  1. Number of participants with Urinary incontinence [ Time Frame: 3 months ]
Eligibility Criteria
Information from the National Library of Medicine

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Ages Eligible for Study: 18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:
– Women with Urinary Incontinence of Urgency or Mixed older than 18 years
Exclusion Criteria:
  • Presence Of vaginal or urinary infection
  • Not understand or sign the informed consent
  • Not understand or are unable to perform the proposed treatment
  • Pregnancy or the postpartum period covering the period up to 6 months after delivery
  • Women in previous use of chronically used drugs (antidepressants, diuretics, and others) that can evidently alter the urinary function.
  • Stress Urinary Incontinence of pure or mixed incontinence with a predominance of Stress component neurogenic bladder
  • Use of Botox® in the bladder or pelvic muscles in the last year
  • Use Interstim® or Bion®
  • Use pacemaker or implantable defibrillator
  • Current use of TENS in the pelvic region, lower back or legs
  • Previous use of percutaneous tibial stimulation
  • Drug / experimental devices in the past 4 weeks,
  • Participation in any clinical research involving or affecting the urinary or renal function in the last 4 weeks.
  • Pelvic radiotherapy;
  • Changes in sensibility Lower Limb;

Contacts and Locations
  – TBD
References:

Percutaneous electrical stimulation for overactive bladder in children …


https://www.ncbi.nlm.nih.gov/pubmed/30414712
by U Barroso Jr – ‎2019 – ‎Related articles

Oct 11, 2018 – Percutaneous electrical stimulation for overactive bladder in children: a pilot study. … of Urology, Federal University of Bahia, Salvador, Bahia, Brazil. … of once-a-week parasacralpercutaneous electrical nerve stimulation ..

 

Percutaneous tibial nerve stimulation vs sacral nerve stimulation for …


https://www.ncbi.nlm.nih.gov/pubmed/24911219

by S Al Asari – ‎2014 – ‎Cited by 18 – ‎Related articles

AIM: The study assessed the initial experience with posterior tibial nerve stimulation (PTNS) for faecal incontinence and compared it with sacral nerve …

Sacral nerve stimulation versus percutaneous tibial nerve stimulation …


https://www.ncbi.nlm.nih.gov/pubmed/29470730
by C Simillis – ‎2018 – ‎Cited by 5 – ‎Related articles

Feb 22, 2018 – Sacral nerve stimulation versus percutaneous tibial nerve stimulation for … stimulation (SNS) are both second-line treatments for faecal incontinence (FI). … in order to identify studies comparing SNS and PTNS for treating FI.