search
Back to results

Treatment of Urinary Incontinence in Women With Spinal Cord Injury

Primary Purpose

Spinal Cord Injury, Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Pelvic floor muscle training
Pelvic floor muscle training
vaginal electrical stimulator (CefarPeristim Pro)
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Pelvic Floor Muscle Training, Neuromuscular Electrical Stimulation, Urinary Incontinence, Spinal Cord Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Gynaecology and Obstetrics, Herlev University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pelvic floor muscle training (PFMT)

PFMT and electrical stimulation

Arm Description

Pelvic floor muscle training daily during 12 weeks.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB)
Urethral Pressure Reflectometry (UPR) parameters
UPR is a novel method of measuring the pressure and cross-sectional area in the female urethra
3 days voiding diary
24 hour pad test
International Spinal Cord Injury Quality of Life Basic Data Set
Patient Global Index of Improvement scale (PGI-I)

Full Information

First Posted
April 22, 2015
Last Updated
August 21, 2017
Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Herlev Hospital, University of Copenhagen, Rigshospitalet, Denmark
search

1. Study Identification

Unique Protocol Identification Number
NCT02427230
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen
Collaborators
Herlev Hospital, University of Copenhagen, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Urinary Incontinence
Keywords
Pelvic Floor Muscle Training, Neuromuscular Electrical Stimulation, Urinary Incontinence, Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pelvic floor muscle training (PFMT)
Arm Type
Active Comparator
Arm Description
Pelvic floor muscle training daily during 12 weeks.
Arm Title
PFMT and electrical stimulation
Arm Type
Active Comparator
Arm Description
Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training
Other Intervention Name(s)
Group 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pelvic floor muscle training
Other Intervention Name(s)
Group 2
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
vaginal electrical stimulator (CefarPeristim Pro)
Intervention Description
electrical stimulation
Primary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)
Time Frame
up to week 24
Secondary Outcome Measure Information:
Title
International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB)
Time Frame
up to week 24
Title
Urethral Pressure Reflectometry (UPR) parameters
Description
UPR is a novel method of measuring the pressure and cross-sectional area in the female urethra
Time Frame
up to week 24
Title
3 days voiding diary
Time Frame
3 days
Title
24 hour pad test
Time Frame
24 hour
Title
International Spinal Cord Injury Quality of Life Basic Data Set
Time Frame
up to week 24
Title
Patient Global Index of Improvement scale (PGI-I)
Time Frame
up to week 24

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marlene Elmelund, MD
Organizational Affiliation
Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet and Department of Gynaecology and Obstetrics, Herlev University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fin Biering-Sørensen, MD DMSc Prof
Organizational Affiliation
Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Niels Klarskov, MD Lecturer
Organizational Affiliation
Department of Gynaecology and Obstetrics, Herlev University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Gynaecology and Obstetrics, Herlev University Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19488052
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.
Results Reference
background
PubMed Identifier
23246103
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.
Results Reference
background
PubMed Identifier
16637070
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.
Results Reference
background
PubMed Identifier
17705160
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.
Results Reference
background
PubMed Identifier
10024253
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.
Results Reference
background
PubMed Identifier
17016844
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.
Results Reference
background

Learn more about this trial

Treatment of Urinary Incontinence in Women With Spinal Cord Injury

We'll reach out to this number within 24 hrs