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Effectiveness of biofeedback for sexual function in women with vaginismus: A randomized controlled trial

Protocol summary

Study aim
Effectiveness of biofeedback for sexual function in women with vaginismus
Design
It is a clinical trial with a control group, with parallel groups, double-blind and randomized. Statistical software will be used for randomization. With significance level of 5% and a test power of 80%, a sample size of 28 cases (2 groups of 14) was obtained. With the 10% chance of dropping samples, the final sample size was determined to be 32 (2 groups of 16).
Settings and conduct
After obtaining ethics approval and registering the study protocol in the Iranian Clinical Trials Registration System, eligible people are invited to attend the physiotherapy clinic of Isfahan Faculty of Rehabilitation Sciences. If desired, the person enters the study. The persons performing the assessments and statistical analysis are unaware of the patient grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Married women (18-45 years) who have not yet succeeded in intercourse, Primary vaginismus grade 2 to 4. Exclusion criteria: Pregnancy, Secondary vaginismus, Hymen structural disorders, Vulvodynia, Infection, Menopause, Pelvic pathology, Psychological diseases, Spouse's sexual disorders, History of urogenital surgeries
Intervention groups
Patients receive general education about their sexual organs. The physiotherapist teaches the person how to use the dilator with the lubricating gel. In the control group, the patient inserts the dilator into the vagina and holds it for 10 minutes. Then, the physiotherapist inserts the dilator. The dilators used include six standard sizes that increase in size progressively. The intervention group will also receive biofeedback in addition to the dilator. All patients are treated for six weeks, twice a week, every other day.
Main outcome variables
Female Sexual Function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200710048069N2
Registration date: 2023-08-23, 1402/06/01
Registration timing: prospective

Last update: 2023-08-23, 1402/06/01
Update count: 0
Registration date
2023-08-23, 1402/06/01
Registrant information
Name
Maedeh Fani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3627 8341
Email address
maedeh.fani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-21, 1402/06/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of biofeedback for sexual function in women with vaginismus: A randomized controlled trial
Public title
Effectiveness of biofeedback for sexual function in women with vaginismus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Married women who have not yet succeeded in intercourse through penetration. Age range from 18 to 45 years. Primary vaginismus grade 2 to 4 (according to the Lamont classification). The patient's desire for treatment.
Exclusion criteria:
Pregnancy Secondary vaginismus The presence of hymen structural disorders Congenital vaginal disorders Vulvodynia Infection Menopause Pelvic pathology (such as malignant masses, fractures, etc.) Psychological diseases Spouse's sexual disorders (erectile dysfunction, premature ejaculation, etc.) History of urogenital surgeries (such as labiaplasty, hymenectomy, etc.)
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block randomization method is used (block size 2 or 4) with the help of statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blind. The evaluator is not aware of the grouping of the patients. Therefore, the evaluator does not know what treatment each person received. In this study, the person who performs the statistical analysis of the study is also unaware of the grouping of patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Nursing, Management, and Rehabilitation - Isfahan University
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-08-12, 1402/05/21
Ethics committee reference number
IR.MUI.NUREMA.REC.1402.069

Health conditions studied

1

Description of health condition studied
Vaginismus
ICD-10 code
N94.2
ICD-10 code description
Vaginismus

Primary outcomes

1

Description
Female Sexual Function (including desire, arousal, lubrication, orgasm, satisfaction, and pain)
Timepoint
The Female Sexual Function Index questionnaire is completed by the patient at the beginning, at the end of 6 weeks of treatment, and also one month after the end of treatment.
Method of measurement
Female Sexual Function Index questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Control group: In the first session, all patients receive general information about the anatomy of the pelvic floor and their genitals using moulages. Then the physiotherapist teaches the patient how to use the dilator with the lubricating gel. The patient inserts the dilator and uses it according to the instructions. For insertion of the dilator, the person is in a supine and lithotomy position. The dilator is smeared with lubricant gel and inserted into the vagina at a downward angle, and then she keeps it for 10 minutes without moving it. After that, the physiotherapist inserts the dilator herself to the patient vagina to take away the penetration control from the patient. The dilators used in this study include six sizes of standard dilators, which progressively increase in length and width. Their material is silicone, which is suitable for sterilization in an autoclave. A condom is used every time a dilator is used.
Category
Rehabilitation

2

Description
Intervention group: The protocol of dilator use for intervention group is the same as the control group. After the patient succeeds in using the third size dilator, the biofeedback device (Uranus model, manufactured by Danesh Bonyan Teb and Sanat Sharif Company) is used. For this purpose, the patient is placed in a supine position with the knees bent so that the soles of the feet are on the bed. Then, the vaginal probe, specific to each patient, is smeared with a little lubricant gel and slowly enters the vaginal area. It is explained to the patient that with the contraction of the pelvic floor muscles (PFM), the signals of the biofeedback device increase, and after the relaxation of these muscles, the electrical signals decrease. Then biofeedback relaxation mode is used with the aim of retraining the PFM. Each biofeedback session consists of following: 1. Ten maximum PFM contraction with 5 s contraction and 5 s rest interval for two sets with 60 s rest between the two sets. 2. Fifteen maximum PFM contraction with 10 s contraction and 10 s rest for one set. 3. One maximum PFM contraction for 60 seconds. The duration of biofeedback program in each session is about 15 minutes.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences
Full name of responsible person
Maedeh Fani
Street address
Isfahan University of Medical Sciences, hezar jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5000
Email
maedeh.fani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice President of Research and Technology of Isfahan University of Medical Sciences
Street address
Hezar Jarib St., Isfahan University of Medical Sciences and Health Care Services, Building No. 4, Research and Technology Vice-Chancellor
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maedeh Fani
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University of Medical Sciences and Health Services, hezar jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5000
Email
maedeh.fani@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maedeh Fani
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University of Medical Sciences and Health Services, hezar jarib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5000
Email
maedeh.fani@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maedeh Fani
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Isfahan University of Medical Sciences, hezar jarib St
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5000
Email
maedeh.fani@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome measure, can be shared.
When the data will become available and for how long
The access period starts one month after the publication of the results.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Any analysis of the delivered data is permitted.
From where data/document is obtainable
maedeh.fani@gmail.com Maedeh Fani
What processes are involved for a request to access data/document
After receiving the email from the applicant, the documents will be provided to the person within two months.
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