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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Urinary Incontinence Behavioral: Pelvic floor muscle training Drug: vaginal electrical stimulator (CefarPeristim Pro) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Pelvic Floor Muscle Training and Neuromuscular Electrical Stimulation on Urinary Incontinence and Quality of Life in Women With Spinal Cord Injury
Study Start Date : May 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Pelvic floor muscle training (PFMT)
Pelvic floor muscle training daily during 12 weeks.
 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
Active Comparator: PFMT and electrical stimulation
Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.
 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


Outcome Measures
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Primary Outcome Measures :
  1. International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF) [ Time Frame: up to week 24 ]

Secondary Outcome Measures :
  1. International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB) [ Time Frame: up to week 24 ]
  2. 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. 3 days voiding diary [ Time Frame: 3 days ]
  4. 24 hour pad test [ Time Frame: 24 hour ]
  5. International Spinal Cord Injury Quality of Life Basic Data Set [ Time Frame: up to week 24 ]
  6. Patient Global Index of Improvement scale (PGI-I) [ Time Frame: up to week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427230


Locations
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Denmark
Department of Gynaecology and Obstetrics, Herlev University Hospital
Herlev, Denmark, 2730
Sponsors and Collaborators
Glostrup University Hospital, Copenhagen
Herlev Hospital
University of Copenhagen
Rigshospitalet, Denmark
Investigators
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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
More Information
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Publications:

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Responsible Party: Marlene Elmelund, MD, Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier: NCT02427230    
Other Study ID Numbers: H-2-2014-113
20.941 ( Other Grant/Funding Number: Gross. L.F. Foghts Fond )
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Keywords provided by Marlene Elmelund, Glostrup University Hospital, Copenhagen:
Pelvic Floor Muscle Training
Neuromuscular Electrical Stimulation
Urinary Incontinence
Spinal Cord Injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Incontinence
Enuresis
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
 Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders