Treatment of Urinary Incontinence in Women With Spinal Cord Injury

Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427230
• Other study ID #: H-2-2014-113
• Secondary ID: 20.941
• Status: Completed
• Phase: N/A
• First received: April 22, 2015
• Last updated: August 21, 2017
• Start date: May 2015
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Enuresis
• Spinal Cord Injuries
• Spinal Cord Injury
• Urinary Incontinence
• Wounds and Injuries

Intervention

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.
• 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.

Drug:
• vaginal electrical stimulator (CefarPeristim Pro)
electrical stimulation

Locations

Country	Name	City	State
Denmark	Department of Gynaecology and Obstetrics, Herlev University Hospital	Herlev

Sponsors (4)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Herlev Hospital, Rigshospitalet, Denmark, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

Bø 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. — View Citation

Hansen RB, Biering-Sørensen 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. — View Citation

Jerez-Roig J, Souza DL, Espelt A, Costa-Marín 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. Review. English, Spanish. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)		up to week 24
Secondary	International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB)		up to week 24
Secondary	Urethral Pressure Reflectometry (UPR) parameters	UPR is a novel method of measuring the pressure and cross-sectional area in the female urethra	up to week 24
Secondary	3 days voiding diary		3 days
Secondary	24 hour pad test		24 hour
Secondary	International Spinal Cord Injury Quality of Life Basic Data Set		up to week 24
Secondary	Patient Global Index of Improvement scale (PGI-I)		up to week 24