Clinical trial NCT02427230: Treatment of Urinary Incontinence in Women With Spinal Cord Injury
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Urinary Incontinence
Keywords: Pelvic Floor Muscle Training
Neuromuscular Electrical Stimulation
Urinary Incontinence
Spinal Cord Injury
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: University of Copenhagen
name: Rigshospitalet, Denmark
First posted: 2015-04-27
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)
timeFrame: up to week 24
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB)
timeFrame: up to week 24
measure: Urethral Pressure Reflectometry (UPR) parameters
timeFrame: up to week 24
measure: 3 days voiding diary
timeFrame: 3 days
measure: 24 hour pad test
timeFrame: 24 hour
measure: International Spinal Cord Injury Quality of Life Basic Data Set
timeFrame: up to week 24
measure: Patient Global Index of Improvement scale (PGI-I)
timeFrame: up to week 24
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Gynaecology and Obstetrics, Herlev University Hospital
Study officials:
affiliation: Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet and Department of Gynaecology and Obstetrics, Herlev University Hospital
name: Marlene Elmelund, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet
name: Fin Biering-Sørensen, MD DMSc Prof
role: STUDY_DIRECTOR
affiliation: Department of Gynaecology and Obstetrics, Herlev University Hospital
name: Niels Klarskov, MD Lecturer
role: STUDY_DIRECTOR
References:
citation: Hansen RB, Biering-Sorensen F, Kristensen JK. Urinary incontinence in spinal cord injured individuals 10-45 years after injury. Spinal Cord. 2010 Jan;48(1):27-33. doi: 10.1038/sc.2009.46. Epub 2009 Jun 2.
citation: Jerez-Roig J, Souza DL, Espelt A, Costa-Marin M, Belda-Molina AM. Pelvic floor electrostimulation in women with urinary incontinence and/or overactive bladder syndrome: a systematic review. Actas Urol Esp. 2013 Jul-Aug;37(7):429-44. doi: 10.1016/j.acuro.2012.08.003. Epub 2012 Dec 13. English, Spanish.
citation: McClurg D, Ashe RG, Marshall K, Lowe-Strong AS. Comparison of pelvic floor muscle training, electromyography biofeedback, and neuromuscular electrical stimulation for bladder dysfunction in people with multiple sclerosis: a randomized pilot study. Neurourol Urodyn. 2006;25(4):337-48. doi: 10.1002/nau.20209.
citation: McClurg D, Ashe RG, Lowe-Strong AS. Neuromuscular electrical stimulation and the treatment of lower urinary tract dysfunction in multiple sclerosis--a double blind, placebo controlled, randomised clinical trial. Neurourol Urodyn. 2008;27(3):231-7. doi: 10.1002/nau.20486.
citation: Bo K, Talseth T, Holme I. Single blind, randomised controlled trial of pelvic floor exercises, electrical stimulation, vaginal cones, and no treatment in management of genuine stress incontinence in women. BMJ. 1999 Feb 20;318(7182):487-93. doi: 10.1136/bmj.318.7182.487.
citation: Klarskov N, Lose G. Urethral pressure reflectometry; a novel technique for simultaneous recording of pressure and cross-sectional area in the female urethra. Neurourol Urodyn. 2007;26(2):254-61. doi: 10.1002/nau.20283.