Comparison the effect of radiofrequency and laser treatment on symptoms of Iranian menopausal women with mixed urinary incontinence and vulvovaginal atrophy
Comparison the effect of radiofrequency and laser treatment on mixed urinary incontinence (UI) and vulvovaginal atrophy (VVA) in Iranian menopausal women
Design
A randomized controlled clinical trial with two intervention and one control group, consisted of 240 patients, 80 patients in each group.
Settings and conduct
After definite diagnosis of UI and VVA and randomized allocation of patients to each group, the RF and laser treatments will be performed in the treatment groups while patients in the control group only received placebo treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: history of UI symptoms; having sexual intercourse; having sexual problems due to VVA; at least one year after the termination of menstruation; presence of VVA symptoms; sexual dysfunction.
Non-inclusion criteria: patients with urinary infection; hematuria; pelvic organ prolapse ICS>2; abnormal vaginal bleeding; radical hysterectomy with noropathy; leakage of urine more than 50 g per hour
Intervention groups
Intervention group 1: laser treatment.
Intervention group 2: RF treatment.
Control groups: placebo treatment.
Main outcome variables
Urinary incontinence; Vulvovaginal atrophy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044143N1
Registration date:2019-09-01, 1398/06/10
Registration timing:retrospective
Last update:2019-09-01, 1398/06/10
Update count:0
Registration date
2019-09-01, 1398/06/10
Registrant information
Name
Farima Mohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 0980
Email address
fa.mohamadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-06-21, 1398/03/31
Trial completion date
2019-06-21, 1398/03/31
Scientific title
Comparison the effect of radiofrequency and laser treatment on symptoms of Iranian menopausal women with mixed urinary incontinence and vulvovaginal atrophy
Public title
Comparison the effect of radiofrequency and laser treatment on mixed urinary incontinence and vulvovaginal atrophy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
history of UI symptoms
having sexual intercourse
having sexual problems due to vulvovaginal atrophy (VVA)
at least one year past from the termination of menstruation
presence of VVA symptoms
sexual dysfunction
Exclusion criteria:
urinary infection
hematuria
pelvic organ prolapse
ICS>2
pregnancy
childbirth in less than a year
abnormal vaginal bleeding
damaged vaginal tissue
history of damage to spinal nerves
radical hysterectomy with noropathy
epilepsy
autoimmune diseases
leakage of urine more than 50 g per hour
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Actual sample size reached:
246
Randomization (investigator's opinion)
Randomized
Randomization description
According to random numbers table
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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
No.78, Moosivand avenue, Shariati street
City
Tehran
Province
Tehran
Postal code
1933983911
Approval date
2019-05-01, 1398/02/11
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.035
Health conditions studied
1
Description of health condition studied
Mixed Urinary Incontinence
ICD-10 code
N39.4
ICD-10 code description
Other specified urinary incontinence
Primary outcomes
1
Description
Urinary incontinence includes the frequency of urinary leakage, urine leakage, the effect of urine leakage on quality of life and urinary leakage time.
Timepoint
pre and post of intervention
Method of measurement
ICIQ-SF questionnaire
2
Description
Vaginal atrophy including burning, itching, dryness, dispersion and dysuria
Timepoint
pre and post of intervention
Method of measurement
Visual analog score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1: Laser treatment will consist of a series of 2 treatments, 4 weeks apart, taking about 1-2 min per session, as an in-office procedure using Monalisa Touch device aimed at treatment of VVA, UI, and sexual problems.
Category
Treatment - Other
2
Description
Intervention group 2: In RF therapy group, all patients have 3 sessions of treatment, with 4-6 weeks frequency. Each session will be held in groups for 30 minutes with a working temperature range of 40–45°C.
Category
Treatment - Other
3
Description
Control group: no treatment
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of pelvic floor of Valiasr Hospital in Tehran
Full name of responsible person
Fatemeh Dolatshad
Street address
After Mirdamad, Valiasr street
City
Tehran
Province
Tehran
Postal code
1996714184
Phone
+98 21 2269 1330
Email
dolatshadf@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Dolatshad
Street address
No.78, Moosivand Ave., Shariati Blvd.
City
Tehran
Province
Tehran
Postal code
1933983911
Phone
+98 21 2269 1330
Email
dolatshadf@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vic-Chancellor in Research of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Laila Ghorbani
Position
gynecologist
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Valiasr Hospital, After Mirdamad, Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1996714184
Phone
+98 21 8123 5043
Email
l.ghorbani@icloud.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Laila Ghorbani
Position
gynecologist
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Valiasr Hospital, After Mirdamad, Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1996714184
Phone
+98 21 8123 5043
Email
l.ghorbani@icloud.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farima Mohamadi
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 78, Moosivand Ave., Shariati Blvd.
City
Tehran
Province
Tehran
Postal code
1933983911
Phone
+98 21 2269 1330
Email
fa.mohamadi@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available