CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
vaginal electrical stimulator (CefarPeristim Pro) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02427230
NCT02427230N/ACompleted

The Effect of Pelvic Floor Muscle Training and Neuromuscular Electrical Stimulation on Urinary Incontinence and Quality of Life in Women With Spinal Cord Injury

Glostrup University Hospital, Copenhagen·interventional·Posted Apr 27, 2015·Updated Aug 22, 2017

In Brief

A clinical study evaluating Pelvic floor muscle training and vaginal electrical stimulator (CefarPeristim Pro) for Spinal Cord Injury and Urinary Incontinence. Completed, enrolled 27 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 27, 2015
Enrollment StartMay 1, 2015
Primary CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.2 years ago

Interventions

Pelvic floor muscle trainingbehavioral

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 trainingbehavioral

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