Aims:Evaluation of therapeutic efficacy of physiotherapy and botulinum toxin injection in treatment of vaginismus and comparison of sexual function of them in vaginismus patients referred to women sexual health and women clinics of Imam Khomeini hospital
Backgrounds : The Diagnostic and Statistical Manual of Mental
Disorders (DSM IV) defines vaginismus as occurring when there is recurrent or persistent involuntary spasm of the musculature of the outer third of the vagina that interferes with coitus and causes marked distress or interpersonal difficulty. clinical prevalence vary from5% to 17%. It could lead to marital disharmony, guilt feeling, anxiety and low self confidence. The aim of this study was to assess the therapeutic efficacy of physiotherapy and botulinum toxin injection in treatment of vaginismus and comparison of sexual function of them in vaginismus patients.
Methods: this study is a clinical trial .74 patients from sexual health and women clinics of Imam Khomeini hospital were enrolled in the study.Inclusion criteria is 20-40 years old nonpregnant women of sexual health and women clinics of Emam Khomeini hospital which have grade 3 or 4 vaginismus on lamont grading; they dont have any botulinum toxin containdication( albumin and botulinum or injectable component alergy; infection of injection site; pregnancy; nerve and muscle desease such as Myasthenia Gravis and Lambert Eaton syndrome; coagulation disorders; anticoagulant drugs.Exclusion criteria is pregnant women; pregnancy planing; botulinum contraindication; poor cooperation; secondary vaginismus; Vvlvdynya; skin .patient were divided randomly into two groups(35 cases & 35 control) : physiotherapy and dysport. on the method of dysport 150-400 U disport was equally injected in the puborectalis muscles ,3 points on each side .on the method of physiotherapy patients undergoing pelvic floor anatomy training ,massage the muscle of the pelvic floor ,biofeedback and sensation focus during weekly session till 10session.a week of completed treatment ,we check libido,arousal,lubrication,orgasm,sexual satisfaction,pain. questionaries were completed by patients and results in SPSS software and with statistical using tests were analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016061828486N1
Registration date:2017-03-12, 1395/12/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-12, 1395/12/22
Registrant information
Name
Mansooreh Yaraghi
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 0618
Email address
dr_m_yaraghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-02-08, 1395/11/20
Expected recruitment end date
2017-04-08, 1396/01/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic efficacy of physiotherapy and botulinum toxin injection in treatment of vaginismus and comparison of sexual function of them
Public title
Effect of physiotherapy and botulinum toxin injection in treatment of vaginismus
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:20-40 years old nonpregnant women of sexual health and women clinics of emem khomeini hospital which have grade 3 or 4 vaginismus on lamont grading; they dont have any botulinum toxin containdication( albumin and botulinum or injectable component alergy; infection of injection site; pregnancy; nerve and muscle desease such as Myasthenia Gravis and Lambert Eaton syndrome; coagulation disorders; anticoagulant drugs
exclusion criteria:pregnant women; pregnancy planing; botulinum contraindication; poor cooperation; secondary vaginismus; Vvlvdynya; skin disorders of vulve or Perineum; anal fissure; urinary or deficatory disorders; infection of injection site; previous botulinum treatment; previous physiotherapy
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Table of random numbers
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran medical University
City
Tehran
Postal code
Approval date
2017-02-07, 1395/11/19
Ethics committee reference number
IR.TUMS.IKHC.REC.1395.1665
Health conditions studied
1
Description of health condition studied
Psychogenic vaginismus
ICD-10 code
F52.5
ICD-10 code description
Spasm of the pelvic floor muscles that surround the vagina, causing occlusion of the vaginal opening. Penile entry is either impossible or painful
Primary outcomes
1
Description
Libido
Timepoint
before and 1week after Treatment
Method of measurement
Demographic questionaries and women sexual function questionaries(FSFI)
2
Description
arousal
Timepoint
before and 1 week after Treatment
Method of measurement
Demographic questionaries and women sexual function questionaries(FSFI)
3
Description
lubrication
Timepoint
before and 1 week after Treatment
Method of measurement
Demographic questionaries and women sexual function questionaries(FSFI)
4
Description
orgasm
Timepoint
before and 1 week after Treatment
Method of measurement
Demographic questionaries and women sexual function questionaries(FSFI)
5
Description
Sexual Satisfaction
Timepoint
before and 1 week after Treatment
Method of measurement
Demographic questionaries and women sexual function questionaries(FSFI)
6
Description
pain
Timepoint
before and 1 week after Treatment
Method of measurement
Demographic questionaries and women sexual function questionaries(FSFI)
Secondary outcomes
empty
Intervention groups
1
Description
intervention group 1:injection of botulinum toxin (dysport ):500 unit is diluted in 1.5 cc N/S.150-400 U disport was equally injected in the puborectalis muscles ,3 points on each side with 23 needle.in severe desease before injection 1_5 mg midazolam and 50-150 mg phentanyle are used for sedation.during treatment oxygen and pulse oximetry is done.the initial dose is 150-200 u and may gradually increase till 400 unit to prevent side effect.after injection the paitent is discharged.
Category
Treatment - Drugs
2
Description
Control group:Physiotherapy: relaxation exercises, biofeedback, desensitization and focus sensory (sensation focus) is used during weekly meetings.Patients initially trained in pelvic floor anatomy . At each visit, pelvic floor muscle massage is done in lithotomy position under infrared light to increase blood flow by therapist and exercises to relax the pelvic floor muscles and breathing exercises will be taught to do at home.Then, when the patient is admitted vaginal examination,The therapist began to gradually vaginal penetration with a finger and When patients tolerate a fingerو vaginal tampon used for 5 hours to cause further relaxation.This practice will be repeated up to three times per dey at home.At this time, in addition to tampons , vaginal electrodes tense and frequency waves used for analgesic.Sensation focus technique done by the partner at home,Where massage the entire body except breast and genital areas without penetration causes the patient feel peace. Therapy sessions along with home exercise therapy in patients continue to recover. Average of meeting are 10 sessions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini Hospital,Sexual Health Clinic and Gynecologic Clinic
Full name of responsible person
Mansooreh Yaraghi dr
Street address
Emam Khomeini Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
-
Street address
Keshavarz street,Ghods street,central Organization of Tehran University of Medical Sciences,6 floor
City
Tehran
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 of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University Of Medical sciences
Full name of responsible person
Tahereh Eftekhar dr
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini hospital,Valiasr hospital
City
Tehran
Postal code
Phone
+98 21 6643 8633
Fax
+98 21 6643 8633
Email
eftekhart@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical sciences
Full name of responsible person
Tahereh Eftekhar dr
Position
Assistant Professor
Other areas of specialty/work
Street address
Emam Khomeini Hospital, Valiasr Hospital
City
Tehran
Postal code
Phone
+98 21 6643 8633
Fax
+98 21 6643 8633
Email
eftekhart@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Mansooreh Yaraghi dr
Position
Fellowship
Other areas of specialty/work
Street address
EmamKhomeini Hospital, Valiasr Hospital
City
Tehran
Postal code
Phone
+98 21 8828 0618
Fax
+98 21 6643 8633
Email
m-yaraghi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)