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Comparison of chronic pelvic pain and sexual satisfaction in women with endometriosis in two groups with and without botulinum toxin injection

Protocol summary

Study aim
An interventional study that is designed to compare chronic pelvic pain and sexual satisfaction in women with endometriosis in two groups with and without botulinum toxin injection .
Design
Phase 3 clinical trial with a control group, parallel design, using the random allocation rule is performed on 32 patients.
Settings and conduct
This randomized study will be performed on 32 patients with pelvic endometriosis and chronic pelvic pain, who refer to Yas Hospital, using a convenient sampling method. This is a double-blind study, the patient and analyzer do not know the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18-50 years, chronic pelvic pain for at least 3 months, and do not start new analgesic strategies since one month before the intervention. Exclusion criteria: the existence of other causes of chronic pelvic pain, having severe untreated cervical dysplasia, History of hysterectomy and bilateral salpingo-oophorectomy, Allergy to botulinum toxin, Pregnancy or breastfeeding, History of urinary and fecal incontinence, Known pelvic prolapse, and Neuromuscular disorders.
Intervention groups
After a vaginal digital examination to identify pelvic muscles with spasms, and 20 to 30 minutes before the intervention, up to 10 mg of oral diazepam is administered and lidocaine cream 4% is applied to the determined location in the vaginal mucosa. Then, in the intervention group, a vial of 100 units of anabotulinum toxin A (Botox) is placed in 4 ccs of saline (final concentration 25 units/ml). In the control group, two to five ccs of normal saline are injected instead of Botox. The injection is performed by a gynecologist with experience in endometriosis using a sterile technique.
Main outcome variables
Chronic pelvic pain, Dysmenorrhea, Dyspareunia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20091012002576N20
Registration date: 2021-07-02, 1400/04/11
Registration timing: prospective

Last update: 2021-07-02, 1400/04/11
Update count: 0
Registration date
2021-07-02, 1400/04/11
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of chronic pelvic pain and sexual satisfaction in women with endometriosis in two groups with and without botulinum toxin injection
Public title
The effect of Botox on chronic pelvic pain and sexual satisfaction in women with endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-50 years Chronic pelvic pain for at least 3 months Do not start new analgesic strategies since one month before the intervention
Exclusion criteria:
The primary cause of chronic pelvic pain is the following: infection, gastrointestinal or psychological disorder, fibromyalgia, chronic fatigue syndrome Severe untreated cervical dysplasia History of hysterectomy and bilateral salpingo-oophorectomy Allergy to botulinum toxin Pregnancy or breastfeeding History of urinary and fecal incontinence Known pelvic prolapse Neuromuscular disorders such as myasthenia gravis or Lambert Aton syndrome
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 16 letters A and 16 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (botulinum toxin) or B (normal saline) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed double-blind, the participants and the analyzer do not know the type of treatment. Patients in the control group do not know their group therapy, with using the normal saline injection in Botox-like syringes. Also, the data analyzer does not know the codes defined for the treatment groups in the SPSS file.
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
Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2021-06-14, 1400/03/24
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.258

Health conditions studied

1

Description of health condition studied
Endometriosis
ICD-10 code
N80.9
ICD-10 code description
Endometriosis, unspecified

Primary outcomes

1

Description
Chronic pelvic pain
Timepoint
Twice, before the intervention and one month after the intervention
Method of measurement
Visual Analog Scale (VAS Ruler)

Secondary outcomes

1

Description
Sexual satisfaction rate
Timepoint
Once, at the end of the study
Method of measurement
Female Sexual Function Index Scoring

2

Description
Dysmenorrhea
Timepoint
Twice, before the intervention and one month after the intervention
Method of measurement
Visual Analog Scale (VAS Ruler)

3

Description
Dyspareunia
Timepoint
Twice, before the intervention and one month after the intervention
Method of measurement
Visual Analog Scale (VAS Ruler)

Intervention groups

1

Description
Intervention group: After a vaginal digital examination to identify pelvic muscles with spasms, and 20 to 30 minutes before the start of the intervention, up to 10 mg of oral diazepam is administered and lidocaine cream 4% is applied to the determined location in the vaginal mucosa. Then, a vial of 100 units of anabotulinum toxin A (Botox) is placed in 4 ccs of saline (final concentration 25 units/ml). The injection is performed by a gynecologist with experience in endometriosis using a sterile technique. When Botox is injected into one muscle, the removed needle is then inserted into the next muscle. In fact, the total dose of 100 units is divided between three to four identified areas of muscles with spasms.
Category
Treatment - Drugs

2

Description
Control group: After a vaginal digital examination to identify pelvic muscles with spasms, and 20 to 30 minutes before the start of the intervention, up to 10 mg of oral diazepam is administered and lidocaine cream 4% is applied to the determined location in the vaginal mucosa. Then, two to five ccs of normal saline are prepared. The injection is performed by a gynecologist with experience in endometriosis using a sterile technique. When normal saline is injected into one muscle, the removed needle is then inserted into the next muscle.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Davari Tanha
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
fdavaritanha@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Sahraiyan
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3689
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Fatemeh Davari Tanha
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8831 3955
Fax
+98 21 8831 3955
Email
fdavaritanha@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Profosor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8831 3955
Fax
+98 21 8831 3955
Email
fdavaritanha@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fatemeh Davari Tanha
Position
Profosor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8831 3955
Fax
+98 21 8831 3955
Email
fdavaritanha@sina.tums.ac.ir

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
Undecided - It is not yet known if there will be 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
No - There is not 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
All data is potentially shareable after unidentified participants
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Davari-Tanha, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Davari-Tanha fdavaritanha@sina.tums.ac.ir
What processes are involved for a request to access data/document
Any request for data must be sent to Dr. Davari-Tanha by email and accompanied by a written proposal confirmed by a local ethics committee.
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