Spinal Cord InjuryNCT02427230
Treatment of Urinary Incontinence in Women With Spinal Cord Injury
A study testing Pelvic floor muscle training and vaginal electrical stimulator (CefarPeristim Pro) in people with Spinal Cord Injury and Urinary Incontinence, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Spinal Cord Injury, Urinary Incontinence
- What is being tested?
- Pelvic floor muscle training and vaginal electrical stimulator (CefarPeristim Pro)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- May 2015to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gynaecology and Obstetrics, Herlev University Hospital
Herlev, 2730
About this study
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
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).
Read the 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.
- Conditions
- Spinal Cord Injury, Urinary Incontinence
- Being tested
- Pelvic floor muscle training, vaginal electrical stimulator (CefarPeristim Pro)
- Keywords
- Pelvic Floor Muscle Training, Neuromuscular Electrical Stimulation, Urinary Incontinence, Spinal Cord Injury
- Medical subject headings
- Spinal Cord Injuries, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor muscle trainingBehavioural
Also called Group 1
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 trainingBehavioural
Also called Group 2
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)Drug
electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| Pelvic floor muscle training (PFMT) | Active comparator | Pelvic floor muscle training daily during 12 weeks. Receives: Behavioral: Pelvic floor muscle training |
| PFMT and electrical stimulation | Active comparator | Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks. Receives: Behavioral: Pelvic floor muscle training; Drug: vaginal electrical stimulator (CefarPeristim Pro) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)
Measured: up to week 24
Secondary outcomes (6)
International Consultation on Incontinence Questionnaire, Overactive Bladder (ICIQ-AOB)
Measured: up to week 24
Urethral Pressure Reflectometry (UPR) parameters
UPR is a novel method of measuring the pressure and cross-sectional area in the female urethra
Measured: up to week 24
3 days voiding diary
Measured: 3 days
24 hour pad test
Measured: 24 hour
International Spinal Cord Injury Quality of Life Basic Data Set
Measured: up to week 24
Patient Global Index of Improvement scale (PGI-I)
Measured: up to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, University of Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Marlene Elmelund, Glostrup University Hospital, Copenhagen
- Investigators
- Marlene Elmelund, MD, Principal investigator, Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet and Department of Gynaecology and Obstetrics, Herlev University HospitalFin Biering-Sørensen, MD DMSc Prof, Study director, Clinic for Spinal Cord Injuries, Glostrup University Hospital/RigshospitaletNiels Klarskov, MD Lecturer, Study director, Department of Gynaecology and Obstetrics, Herlev University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427230
- Sponsor's protocol ID
- H-2-2014-113
- Other IDs
- 20.941
- Status last verified
- Aug 2017
- First submitted
- 22 Apr 2015
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19488052Jerez-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.
PubMed 23246103McClurg 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.
PubMed 16637070McClurg 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.
PubMed 17705160Bo 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.
PubMed 10024253Klarskov 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.
PubMed 17016844
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02427230
- Acronym / sponsor ID
- H-2-2014-113
- Conditions
- Spinal Cord Injury, Urinary Incontinence
- Keywords
- Pelvic Floor Muscle Training, Neuromuscular Electrical Stimulation, Urinary Incontinence, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- Herlev Hospital, University of Copenhagen, Copenhagen University Hospital, Rigshospitalet
- Study start
- May 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic floor muscle training (PFMT) | Active comparator | Behavioral: Pelvic floor muscle trainingPelvic floor muscle training daily during 12 weeks. |
| PFMT and electrical stimulation | Active comparator | Behavioral: Pelvic floor muscle training, Drug: vaginal electrical stimulator (CefarPeristim Pro)Pelvic floor muscle training and intravaginal neuromuscular electrical stimulation daily during 12 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor muscle trainingAlso: Group 1The 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. | Behavioural | Pelvic floor muscle training (PFMT) |
| Pelvic floor muscle trainingAlso: Group 2The 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. | Behavioural | PFMT and electrical stimulation |
| vaginal electrical stimulator (CefarPeristim Pro)electrical stimulation | Drug | PFMT and electrical stimulation |
Primary outcome
International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF)
Time frame: up to week 24
6 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Background: PubMed 19488052Hansen 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.
- Background: PubMed 23246103Jerez-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.
- Background: PubMed 16637070McClurg 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.
- Background: PubMed 17705160McClurg 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.
- Background: PubMed 10024253Bo 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.
- Background: PubMed 17016844Klarskov 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Elmelund, MD 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 study director
Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet
Niels Klarskov, MD Lecturer study director
Department of Gynaecology and Obstetrics, Herlev University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor muscle training and vaginal electrical stimulator (CefarPeristim Pro) in people with Spinal Cord Injury and Urinary Incontinence, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Consultation on Incontinence Questionnaire, Urinary Incontinence, Short Form (ICIQ-UI-SF) (time frame: up to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02427230, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.