Treatment of Urinary Incontinence in Women With Spinal Cord Injury

NCT02427230 | Completed

• 2 other identifiers: H-2-2014-11320.941
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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).

Conditions

Spinal Cord Injury; Urinary Incontinence

Keywords

Pelvic Floor Muscle Training; Neuromuscular Electrical Stimulation; Urinary Incontinence; Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)

  up to week 24

Secondary Outcomes (6)

• International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB)

  up to week 24

• Urethral Pressure Reflectometry (UPR) parameters

  up to week 24

• 3 days voiding diary

  3 days

• 24 hour pad test

  24 hour

• International Spinal Cord Injury Quality of Life Basic Data Set

  up to week 24

Study Arms (2)

Pelvic floor muscle training (PFMT)

ACTIVE COMPARATOR

Pelvic floor muscle training daily during 12 weeks.

Behavioral: Pelvic floor muscle training

PFMT and electrical stimulation

ACTIVE COMPARATOR

Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.

Behavioral: Pelvic floor muscle training; Drug: vaginal electrical stimulator (CefarPeristim Pro)

Interventions

Pelvic floor muscle training BEHAVIORAL

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.

Also known as: Group 1

Pelvic floor muscle training (PFMT)

vaginal electrical stimulator (CefarPeristim Pro) DRUG

electrical stimulation

PFMT and electrical stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• Herlev Hospital: collaborator
• University of Copenhagen: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Department of Gynaecology and Obstetrics, Herlev University Hospital

Herlev, 2730, Denmark

Location

Related Publications (6)

• 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.

  PMID: 19488052 BACKGROUND

• 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.

  PMID: 23246103 BACKGROUND

• 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.

  PMID: 16637070 BACKGROUND

• 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.

  PMID: 17705160 BACKGROUND

• 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.

  PMID: 10024253 BACKGROUND

• 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.

  PMID: 17016844 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Urinary Incontinence

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marlene Elmelund, MD

  Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet and Department of Gynaecology and Obstetrics, Herlev University Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: May 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 22, 2017

Record last verified: 2017-08

Locations

DK (1)