Treatment of Urinary Incontinence in Women With Spinal Cord Injury

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

Tracking Information

• First Submitted Date: April 22, 2015
• First Posted Date: April 27, 2015
• Last Update Posted Date: August 22, 2017
• Study Start Date: May 2015
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

• Spinal Cord Injury
• Urinary Incontinence

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.

  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

• 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 *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 21, 2017): 27
• Original Estimated Enrollment (submitted: April 24, 2015): 40
• Actual Study Completion Date: March 2017
• Actual Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02427230
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Marlene Elmelund, Glostrup University Hospital, Copenhagen
• Study Sponsor: Glostrup University Hospital, Copenhagen

Collaborators

• Herlev Hospital
• University of Copenhagen
• Rigshospitalet, Denmark

Investigators

• 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