Treatment of Urinary Incontinence in Women With Spinal Cord Injury

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

Interventions

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.

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.

DRUG

vaginal electrical stimulator (CefarPeristim Pro)

electrical stimulation

Sponsors & Collaborators

• Herlev Hospital

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Glostrup University Hospital, Copenhagen

  lead OTHER

Principal Investigators

• Marlene Elmelund, MD · Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet and Department of Gynaecology and Obstetrics, Herlev University Hospital

• Fin Biering-Sørensen, MD DMSc Prof · Clinic for Spinal Cord Injuries, Glostrup University Hospital/Rigshospitalet

• Niels Klarskov, MD Lecturer · Department of Gynaecology and Obstetrics, Herlev University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-05-31

Primary Completion

2017-03-31

Completion

2017-03-31

Countries

• Denmark

Study Locations