The purpose of this study is to evaluate the effect of Kegel exercise with and without Kegelmaster device on sexual function and satisfaction in the middle-aged woman.
Design
a clinical trial with using block randomization in two groups of 43 controls and intervention, with parallel groups.
Settings and conduct
In this clinical trial, 86 women referring to the menopause clinic of Imam Khomeini hospital in Ahvaz and the East's number one health center in Ahvaz, with poor pelvic floor muscle are randomly divided into 2 groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Middle-aged woman؛ Permanent marriage؛ A score of 28 or less with a Prinometer؛ negative urine culture
Exclusion criteria: urogenital infection؛ any systemic disorders؛ Addicted to drugs and alcohol؛ Experience of severe emotional stress within the previous three months؛ Physical or mental diseases affected on sexual function؛ Taking medicines affected on sexual function؛ Having urinary incontinence؛ mental or physical problems of the husband.
Intervention groups
control group: participant will do kegel exercises without the device (including vaginal muscles contractions for 5-10 seconds, with 5-10 seconds rest in between), three times a day for thirty times, for a total duration of 12 weeks.
Intervention group: participant will do exercise with kegel master device, three times a day for thirty times for a total duration of 12 weeks.
Main outcome variables
Pelvic floor muscles strength; Sexual function; sexual satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171021036916N2
Registration date:2018-04-17, 1397/01/28
Registration timing:retrospective
Last update:2018-04-17, 1397/01/28
Update count:0
Registration date
2018-04-17, 1397/01/28
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 1373 8331
Email address
tafakh.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-07, 1396/10/17
Expected recruitment end date
2018-04-07, 1397/01/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Kegel exercise with and without Kegel Master device on the sexual function and satisfaction in the middle-aged woman
Public title
The effect of Kegel exercise with and without Kegel Master device on the sexual function and satisfaction in the middle-aged woman
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Middle-aged woman
Permanent marriage
A score of 28 or less with a Prinometer
Normal urine culture
Exclusion criteria:
Urogenital infection
Any systemic disorders
Addicted to drugs and alcohol
Experience of severe emotional stress within the previous three months
Physical or mental diseases affected on sexual function
Taking medicines affected on sexual function
Underlying medical diseases
Having urinary incontinence
mental or physical problems of husband affecting on couple sexual function
Age
From 40 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Randomized
Randomization description
In this study the subjects will be divided into two groups of 43, using block randomization.
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
Ethical Committee of Ahvaz Jundishapur University of Medical Sciences.
Street address
Ground Floor, Department of Research and Information Technology Jundishapur University of Medical Sciences, City University, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-08-21, 1396/05/30
Ethics committee reference number
IR.AJUMS.REC.1396.395
Health conditions studied
1
Description of health condition studied
Female genital prolapsed
ICD-10 code
N81
ICD-10 code description
Female genital prolapse
2
Description of health condition studied
sexual function
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Sexual satisfaction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
sexual function
Timepoint
Before the intervention and after 3 months
Method of measurement
Standard questionnaire (FSFI)
2
Description
sexual satisfaction
Timepoint
Before and 3 months after interventions
Method of measurement
Larson s standard sexual satisfaction questionarie
Secondary outcomes
1
Description
pelvic floor muscles strength
Timepoint
Before and post treatment intervention
Method of measurement
perinometer
Intervention groups
1
Description
Control group: Each participant should lie down on the back while bending her knee.then they will be asked to perform Kegel exercises without the device (including vaginal muscles contractions for 5-10 seconds with 5-10 seconds rest in between), three times a day for thirty times, for a total duration of 12 weeks.
Category
Rehabilitation
2
Description
Intervention group: The keglemaster device will buy from the ronas medicine company.The participant will be trained to open the device first and place the spring on the nearest place of the hinge. Then, The participant lies on the back while bending her knee, and slowly put the device in her vagina and opens it till it is completely fit. While doing the Kegel exercises, if no pressure was felt inside the vagina muscle, The participant need to relocate the spring and move it one step forward. the vaginal contraction should take 2 seconds. Each participant will do the kegel exercises with a keglemaster device in three sets every day with thirty repetitions each for twelve weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
menopause clinic of Imam Khomeyni Hospitaا
Full name of responsible person
Samane Tafakh
Street address
Imam Khomeyni Hospital,Azadegan Sq., Ahvaz.
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahwaz JundiShapur University of Medical Sciences
Full name of responsible person
Dr. Behzad Sharif Makhmal Zadeh
Street address
Ahwaz Jundishapur University of Medical Sciences, opposite the central building, Vice Chancellor for Research, Ahvaz University of Medical Sciences,
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3336 2414
Email
saamanetafakh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahwaz JundiShapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Samane tafakh
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3373 8331
Email
tafakh@ac.ajums.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Purandokht Afshari
Position
Master of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61337338396
Email
pafshary@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Purandokht Afshari
Position
Master of midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Midwifery Department, Nursing & Midwifery School, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61337338396
Email
pafshary@ajums.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