The effects of adding biofeedback to the pelvic floor muscles strengthening exercises on the treatment of women with urinary incontinence, a single-blinded randomized clinical trial
Studying the effects of pelvic floor muscles strengthening exercises with and without biofeedback on surface EMG variables including maximum and mean pelvic floor muscles strength and on the incontinence severity.
Design
A single-blind randomized clinical trial, with a parallel control group, consisting of 40 patients, done between July 2019 and March 2020, followed for 1 month.
Settings and conduct
The study population included all patients who referred to the gynecology and obstetrics clinic of Shohada Tajrish Hospital with a confirmed diagnosis of urinary incontinence. They were randomly divided into control and treatment groups. Physicians and therapists were blind to the patient groups. There was no ability to blind patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women aged 35 to 75 years with an approved diagnosis of urinary incontinence. Exclusion criteria: being single; history of diabetes mellitus, previous pelvic floor surgery, spinal cord injury, or pelvic trauma.
Intervention groups
Intervention group: Pelvic floor strengthening exercises plus biofeedback therapy. Control group: pelvic floor strengthening exercises only.
Main outcome variables
Mean & Maximum pelvic floor muscles strength, ICIQ-SF questionnaire findings
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201130049543N2
Registration date:2021-06-19, 1400/03/29
Registration timing:retrospective
Last update:2021-06-19, 1400/03/29
Update count:0
Registration date
2021-06-19, 1400/03/29
Registrant information
Name
Fateme Hojjati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
fatemehojjati@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2020-03-20, 1399/01/01
Actual recruitment start date
2019-08-06, 1398/05/15
Actual recruitment end date
2020-04-18, 1399/01/30
Trial completion date
2020-08-20, 1399/05/30
Scientific title
The effects of adding biofeedback to the pelvic floor muscles strengthening exercises on the treatment of women with urinary incontinence, a single-blinded randomized clinical trial
Public title
Biofeedback and urinary incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women
Aged 35-75 years
Confirmation of the diagnosis of urinary incontinence (stress, urgency, or mixed type) by a gynecologist
Exclusion criteria:
history of diabetes
previous pelvic floor surgery
history of spinal cord injury
history of pelvic trauma
being single
Age
From 35 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization by lottery or sortition method was used. According to the number of patients (40 patients), the numbers were considered from 1 to 40. The numbers were written on the cards. After placing the cards in closed envelopes, each patient randomly selected one of the envelopes. The number of each patient was delivered in a sealed envelope and only the doctor and therapist in charge of laser treatment were aware of its contents. Patients with envelopes containing numbers 1 to 20 were allocated in the control group, numbers 21 to 40 were in the biofeedback group.
Blinding (investigator's opinion)
Single blinded
Blinding description
This was a single-blinded study. A physical medicine and rehabilitation specialist (responsible for initial evaluation and re-evaluation after treatment and also teaching the patient how to do the exercises) was blind to each patient's treatment group. Another physical medicine and rehabilitation specialist was responsible for conducting biofeedback treatment sessions for patients in the second group (exercise + biofeedback). Due to the fact that providing biofeedback in the form of sham (placing the probe in the vagina but with the device turned off) can cause errors in the treatment process (feeling the probe in the vagina itself is a kind of feedback), sham-biofeedback was not done in the control group, so patients blinding could not be done.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran National Committee for Ethics in Biomedical Research
Street address
13th floor, Block A, Ministry of Health, Treatment and Medical Educatio, Iran TV Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۹۴۳۴۷۱
Approval date
2015-08-14, 1394/05/23
Ethics committee reference number
IR.SBMU.RAM.REC.1394.268
Health conditions studied
1
Description of health condition studied
Urinari Incontinence
ICD-10 code
R39.81
ICD-10 code description
Functional urinary incontinence
Primary outcomes
1
Description
Urinary incontinence severity
Timepoint
Before and 1 month after treatment
Method of measurement
ICIQ-SF questionnaire
Secondary outcomes
1
Description
Mean strength of pelvic floor muscles
Timepoint
Before and 1 month after treatment
Method of measurement
Surface electromyography
2
Description
Maximum strength of pelvic floor muscles
Timepoint
Before and 1 month after treatment
Method of measurement
Surface electromyography
Intervention groups
1
Description
Intervention group: Performing pelvic floor strengthening exercises along with treatment sessions using a biofeedback device. The duration of treatment was 4 weeks and 7 days a week, they performed pelvic floor strengthening exercises three times a day for 15 minutes. 2 sessions of 20 minutes per week, biofeedback treatment without electrical stimulation was also performed.
Category
Treatment - Devices
2
Description
Control group: Doing pelvic floor strengthening exercises. The duration of treatment was 4 weeks and 7 days a week, they performed pelvic floor strengthening exercises three times a day for 15 minutes.