This study aimed to compare the effect of laser with common treatment of biofeedback therapy in patients with Overactive bladder syndrome (Urgency incontinence which is often associated with frequent urination in day and night). In this clinical trial, 60 patients with pelvic floor disorders referred to clinic of Imam Khomeini hospital in the year of 2016 were included. The inclusion criteria were Age more than 50 years, clinical diagnostic for overactive bladder, urgency and mixed urgency and Exclusion criteria were diabetes, the BMI more than 30 and not to use any previous treatments. The patients were randomly divided in to Laser and Biofeedback treatment groups. Thirty pockets for the laser and 30 pockets for the biofeedback group were assigned for randomization and patients drew out one card and were assigned to the groups according to the name written on the card. This process continued until the desired sample size was reached. The patients in the laser group (n=30) were treated with fractional laser CO2 during three sessions with one-month interval. The intervention for biofeedback group was pelvic exercise and assessment of the feedback in pelvis, twice a week lasting for 4 weeks. One month after treatment, the quality of life; the chart of three-day urinary symptoms and urinary symptoms were re-evaluated by the questionnaires in patients. The urinary urgency and frequency were the primary outcomes and the quality of life was the secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016052127998N1
Registration date:2017-04-04, 1396/01/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-04, 1396/01/15
Registrant information
Name
Maryam Hajihashemi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3776 6578
Email address
m_hajihashemy@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for researc of Tehran University of Medical Sciences.
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial to compare the effect of CO2 laser and biofeedback therapy on quality of life in patients with overactive bladder syndrome.
Public title
Comparison of the treatment effects with laser and biofeedback on overactive bladder syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age more than 50 years; presence of clinical diagnosis for overactive bladder; urgent or mixed incontinence; frequency of urination more than 8 times during the day; urination more than once at night.
Exclusion Criteria: absence of patient satisfaction; use of the other treatment during past 3 months; stage 3 or 4 of pelvic floor prolapse; vaginal lesions; use of previous Isoteritinoin; abnormal Pap smear; Diabetes; BMI more than 30.
Age
From 50 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical sciences, Ghods Street
City
Tehran
Postal code
14194
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1672
Health conditions studied
1
Description of health condition studied
Overactive Bladder Syndrome
ICD-10 code
N32.8
ICD-10 code description
Other specified disorders of bladder
Primary outcomes
1
Description
Urinary frequency
Timepoint
one month after treatment
Method of measurement
Questionnaire
2
Description
Urge incontinence
Timepoint
one month after treatment
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
one month after treatment
Method of measurement
The quality of Life Questionaire
Intervention groups
1
Description
Intervention group1: The patients in the laser group were treated with fractional CO2 laser during three sessions with one-month interval between each two sessions.
Category
Treatment - Drugs
2
Description
Intervention group2: Patients in the biofeedback group were treated twice a week, for 4 weeks. The intervention in this group was pelvic exercise and observing pelvic feedback.