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Treatment of Urinary Incontinence in Women With Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02427230
Recruitment Status : Completed
First Posted : April 27, 2015
Last Update Posted : August 22, 2017
Sponsor:
Collaborators:
Herlev Hospital
University of Copenhagen
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Marlene Elmelund, Glostrup University Hospital, Copenhagen

Tracking Information
First Submitted Date  ICMJE April 22, 2015
First Posted Date  ICMJE April 27, 2015
Last Update Posted Date August 22, 2017
Study Start Date  ICMJE May 2015
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF) [ Time Frame: up to week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2015)
  • International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB) [ Time Frame: up to week 24 ]
  • Urethral Pressure Reflectometry (UPR) parameters [ Time Frame: up to week 24 ]
    UPR is a novel method of measuring the pressure and cross-sectional area in the female urethra
  • 3 days voiding diary [ Time Frame: 3 days ]
  • 24 hour pad test [ Time Frame: 24 hour ]
  • International Spinal Cord Injury Quality of Life Basic Data Set [ Time Frame: up to week 24 ]
  • Patient Global Index of Improvement scale (PGI-I) [ Time Frame: up to week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Urinary Incontinence in Women With Spinal Cord Injury
Official Title  ICMJE The Effect of Pelvic Floor Muscle Training and Neuromuscular Electrical Stimulation on Urinary Incontinence and Quality of Life in Women With Spinal Cord Injury
Brief Summary The purpose of this study is to determine whether pelvic floor muscle training (PFMT) and intravaginal neuromuscular electrical stimulation (NMES) are effective in reducing urinary incontinence and improving quality of life in women with spinal cord injury (SCI).
Detailed Description

SCI patients often experience neurogenic bladder dysfunction with neurogenic detrusor overactivity or areflexic bladder. Due to this, 40-50 % of the SCI population suffers from urinary incontinence, which often reduces the patient's quality of life.

In order to manage the neurogenic bladder dysfunction, SCI patients use specialized bladder emptying methods, most frequently clean intermittent catheterization. To reduce the symptoms of neurogenic detrusor overactivity and urinary incontinence in patients with a SCI, medical anticholinergic therapy can be assessed, but the effect is sparse and many adverse effects have been reported. Injection of Botulinum-A toxin in the bladder has shown great potential in minimizing the symptoms of neurogenic detrusor overactivity and urinary incontinence, though it is an expensive and invasive method that needs to be repeated due to its temporary effect.

PFMT and NMES of the pelvic muscles are non-invasive and cheap treatments without side effects and several studies have demonstrated the positive effect of intravaginal NMES and/or PFMT on urinary incontinence in able-bodied women as well as women with neurological disorders like multiple sclerosis.

Despite the fact that NMES of weak or paralyzed striated muscles has been used for decades in patients suffering from SCI, to our knowledge, no study has previously investigated the effect of PFMT and intravaginal NMES in women with SCI.

The aim of this study is to evaluate the effect of PFMT and intravaginal NMES on Urinary Incontinence and Quality of Life in women with SCI. In particular, we will investigate the potential additional effect of intravaginal NMES, when NMES is conducted in combination with PFMT.

This study is designed as a randomized clinical trial, investigating the effect of PFMT alone and in combination with intravaginal NMES. We will include 40 female patients with an incomplete SCI and urinary incontinence. After physiotherapeutic guidance, the patients perform PFMT or PFMT + NMES daily at home for 12 weeks with follow-up evaluations every fourth week.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injury
  • Urinary Incontinence
Intervention  ICMJE
  • Behavioral: Pelvic floor muscle training

    The intervention in group 1 consists of three private lessons in PFMT conducted by a physiotherapist every 4th week.

    At each consultation the physiotherapist will use manual palpation of the pelvic floor muscles and Electromyography Biofeedback (EMG). Patients will be instructed to carry out three series of approximately 10 near-maximal pelvic floor muscle contractions held for approximately 6-8 seconds daily during 12 weeks.

    Other Name: Group 1
  • Behavioral: Pelvic floor muscle training

    The intervention in group 2 consist of three private lessons in PFMT and intravaginal NMES conducted by a physiotherapist every 4th week.

    At each consultation the physiotherapist will use manual palpation of the pelvic floor muscles and Electromyography Biofeedback (EMG). Patients will be instructed to carry out three series of approximately 10 near-maximal pelvic floor muscle contractions held for approximately 6-8 seconds daily during 12 weeks.

    Additionally, patients will be instructed on how to use intravaginal NMES and each patient receives a vaginal electrical stimulator (CefarPeristim Pro). The NMES settings consist of two different frequencies, 40 Hz and 10 Hz, and patients are instructed to use both settings daily for maximum 30 minutes during 12 weeks.

    Other Name: Group 2
  • Drug: vaginal electrical stimulator (CefarPeristim Pro)
    electrical stimulation
Study Arms  ICMJE
  • Active Comparator: Pelvic floor muscle training (PFMT)
    Pelvic floor muscle training daily during 12 weeks.
    Intervention: Behavioral: Pelvic floor muscle training
  • Active Comparator: PFMT and electrical stimulation
    Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.
    Interventions:
    • Behavioral: Pelvic floor muscle training
    • Drug: vaginal electrical stimulator (CefarPeristim Pro)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2017)
27
Original Estimated Enrollment  ICMJE
 (submitted: April 24, 2015)
40
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Incomplete SCI graded C, D og E on ASIA Impairment Scale, sustained minimum 3 months ago
  • urinary incontinence, corresponding to a total ICIQ-UI-SF score ≥ 8

Exclusion Criteria:

  • Regular treatment with botox bladder injections or < 1 year since last botox injection
  • Lack of urodynamic investigation after the SCI
  • Pregnancy
  • Pacemaker
  • Lack of ability to contract the pelvic floor muscles during objective clinical examination
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427230
Other Study ID Numbers  ICMJE H-2-2014-113
20.941 ( Other Grant/Funding Number: Gross. L.F. Foghts Fond )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Marlene Elmelund, Glostrup University Hospital, Copenhagen
Study Sponsor  ICMJE Glostrup University Hospital, Copenhagen
Collaborators  ICMJE
  • Herlev Hospital
  • University of Copenhagen
  • Rigshospitalet, Denmark
Investigators  ICMJE
Principal Investigator: Marlene Elmelund, MD Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet and Department of Gynaecology and Obstetrics, Herlev University Hospital
Study Director: Fin Biering-Sørensen, MD DMSc Prof Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet
Study Director: Niels Klarskov, MD Lecturer Department of Gynaecology and Obstetrics, Herlev University Hospital
PRS Account Glostrup University Hospital, Copenhagen
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP