Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm (VginsmsBOTOX)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abdel-Maguid Ramzy, Cairo University
ClinicalTrials.gov Identifier:
NCT01859507
First received: May 19, 2013
Last updated: April 9, 2015
Last verified: April 2015
  Purpose

During the first visit, the couple will be acquainted with their condition. This will include the epidemiology of their condition, some sex education tips, as well as the therapeutic modalities available. This is followed by short description of the protocol. In the procedure room, each patient will be examined to determine the degree of vaginismus and classify her condition according to Lemont's classification as modified by Pacik, from 1 to 5. In the same or subsequent sessions, surface anesthesia of the area of injection followed by ice packs is used before the BOTOX is injected into the muscle.


Condition Intervention
Vaginismus
Drug: Botox

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Effectiveness and Safety of Clostridium Botulinum Type A Neurotoxin Complex Injection in the Perineal Muscles in Resistant Cases of Vaginismus

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain [ Time Frame: Up to four weeks following the last session of the vaginal dilatation. ] [ Designated as safety issue: No ]
    The primary outcome will be assessed by the couple. The couple is allowed to visit for follow up in a 4 weeks' time. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completed without premature interruption from either partners.


Secondary Outcome Measures:
  • Successful Sexual Relationship [ Time Frame: Within twelve months after the Botox injection ] [ Designated as safety issue: No ]
    The level of comfort by the couple. The secondary outcome will be assessed by the couple. The couple is allowed to visit for follow up every three months for twelve months. Our inquiry is on the success of full and repeated penetration of the penis through the vaginal introitus into the vagina without or with acceptable pain. An acceptable outcome will be at least twice weekly successful sexual relationship that was completedwithout premature interruption from either partners.


Enrollment: 32
Study Start Date: January 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BOTOX group
Injection of BOTOX in the perineal muscles in resistant cases of vaginismus. Proper informed consent forms will be signed. The injection procedure is done under local anesthesia for most of our patients. We followed up the patient by phone calls for possible adverse effects following the procedure for 4 days.The patient is then instructed to attend dilatation sessions twice weekly in the clinic, in the presence of the husband, for 3-4 weeks. We use silicone dilators, of ascending sizes, covered by lubricated condoms. In the initial phase of the dilatation procedure we start each session with the appropriate size of the dilator according to the capacity of the introitus and the degree of vaginismus, and thereafter increase the size gradually.
Drug: Botox
In the first session, proper history taking and proper counseling of the couple including the description of the new modality (BOTOX injection) of treatment and subsequent dilatation sessions. During examination, all our maneuvers are gentle to gain trust of the patient. Following sterilization, we used surface (Xylocaine gel 2% ASTRA ZENECA) anesthesia before the injection. In addition we used finger like ice packs pre-prepared in a surgical latex glove, on the perineum. We made sure to check that the tip of the needle is not in a vessel by aspirating before proceeding with the injection of each bolus of BOTOX.
Other Name: Clostridium Botulinum type A neurotoxin complex

Detailed Description:

In the first session, proper history taking includes the difficulties they are facing, and the measures taken to solve it whether medical or folk treatment. Proper counseling of the couple to describe the new modality including the BOTOX injection and subsequent dilatation sessions. Proper informed consent forms will be signed. Therapy sessions will starts with the gentle informed approach to the genital area to gain trust of the patient. This is followed by the digital vaginal examination of the patient to determine the degree of spasm and the muscle(s) involved.

The patient will be asked to lie down comfortably on the examination table in the lithotomy position. Her husband is allowed to stand on her left shoulder side and may be allowed to hold her hand. We started by sterilizing the perineal area and injection site in the vaginal introitus using povidone iodine solution. The patient is warned effectively before each step of the procedure and what to expect as regards pain. We used surface (Xylocaine gel) anesthesia half an hour before the injection.We did not use local anesthetic infiltration injections at the site of BOTOX injection. In addition we used ice packs, pre-prepared in a surgical latex glove finger, on the perineum and introitus before the injection of BOTOX to act as a counter irritant. However in advanced cases of Vaginismus (V4-5), we used general intravenous anesthesia

We made sure to check that the tip of the needle is not in a vessel by aspirating before proceeding with the injection of each bolus of BOTOX. We only did one skin puncture, and used that to radially injecting the intended area by changing the direction of the tip of the needle. We found this much less painful to the patient. The injection site will be monitored by the other free hand index and thumb. Following the withdrawal of the needle from the muscle, we distributed the bolus of BOTOX uniformly within the muscle digitally using an arc fashion massage of the introitus. We applied pressure, whenever needed to stop the bleeding from the injection site.

Following the procedure, we instruct the patient to do Kegel exercises as much as 100 contractions or more over 48 hours. This will help in distributing the BOTOX within the muscles as well as recognition of the patient of the whereabouts of the muscles involved in vaginismus. We followed up on our patients daily by phone calls for 4 days following the procedure for possible adverse effects.

Thereafter, the patient will be instructed to attend dilatation sessions twice weekly in the clinic, in the presence of the husband, for 3-4 weeks. We use silicone dilators covered by lubricated condoms. We prepared the vaginal introitus by the use K-Y jelly for lubrication of the dilators. The patient is introduced to the dilator and allowed to hold it in her hand, for size and feel, prior to its introduction into her vagina. During each session the patient will be asked to lie down on the examination table in the lithotomy position, relax and feel comfortable. The husband may stand beside her and may hold her hand. In the initial phase of the dilatation procedure we start with the appropriate size of the dilator according to the capacity of the introitus and the degree of vaginismus, in each session, and increase the size gradually. We always start by the smaller size and move up size wise. At later sessions we allow the patient herself with its introduction into the vagina using only her tactile sense, with no visual aid or doctor instructions, covering her thighs with sheets to feel more private. She is asked to report the termination of the introduction or difficulties she is facing. Verbal support is always and repeatedly used. In case of difficulty, the doctor does not offer to help and ask the patient to try on her own once more. This helps her to be proactive and gain control of the procedure. They usually succeed to carry on the procedure on their own. The couple will be instructed not to have trials of intercourse before the patient uses dilator number 4 comfortably.

  Eligibility

Ages Eligible for Study:   16 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • cases with resistant vaginismus

Exclusion Criteria:

  • cases with congenital anomalies in the lower female genital tract
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01859507

Locations
Egypt
AbdelMaguid Ramzy
Cairo, Egypt, 11341
Sponsors and Collaborators
Abdel-Maguid Ramzy
Investigators
Principal Investigator: AbdelMaguid I Ramzy, MD Cairo University
  More Information

Additional Information:
Publications:
Responsible Party: Abdel-Maguid Ramzy, Prof. Of OB. GYN.,, Cairo University
ClinicalTrials.gov Identifier: NCT01859507     History of Changes
Other Study ID Numbers: ramzy9501
Study First Received: May 19, 2013
Results First Received: March 20, 2015
Last Updated: April 9, 2015
Health Authority: Egypt: Institutional Review Board

Keywords provided by Cairo University:
Vaginismus
Botox
Sex
Clostridium
Botulinum
Neurotoxin
Perineal
Muscles

Additional relevant MeSH terms:
Vaginismus
Genital Diseases, Female
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Vaginal Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2015