Treatment of Urinary Incontinence in Women With Spinal Cord Injury
NCT ID: NCT02427230
Last Updated: 2017-08-22
Study Results
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Basic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2015-05-31
2017-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pelvic floor muscle training (PFMT)
Pelvic floor muscle training daily during 12 weeks.
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.
PFMT and electrical stimulation
Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.
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.
vaginal electrical stimulator (CefarPeristim Pro)
electrical stimulation
Interventions
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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.
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.
vaginal electrical stimulator (CefarPeristim Pro)
electrical stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* urinary incontinence, corresponding to a total ICIQ-UI-SF score ≥ 8
Exclusion Criteria
* Lack of urodynamic investigation after the SCI
* Pregnancy
* Pacemaker
* Lack of ability to contract the pelvic floor muscles during objective clinical examination
18 Years
75 Years
FEMALE
No
Sponsors
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Herlev Hospital
OTHER
University of Copenhagen
OTHER
Rigshospitalet, Denmark
OTHER
Glostrup University Hospital, Copenhagen
OTHER
Responsible Party
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Marlene Elmelund
MD
Principal Investigators
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Marlene Elmelund, MD
Role: PRINCIPAL_INVESTIGATOR
Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet and Department of Gynaecology and Obstetrics, Herlev University Hospital
Fin Biering-Sørensen, MD DMSc Prof
Role: STUDY_DIRECTOR
Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet
Niels Klarskov, MD Lecturer
Role: STUDY_DIRECTOR
Department of Gynaecology and Obstetrics, Herlev University Hospital
Locations
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Department of Gynaecology and Obstetrics, Herlev University Hospital
Herlev, , Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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20.941
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-2-2014-113
Identifier Type: -
Identifier Source: org_study_id
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