Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm
Condition: Vaginismus
MeSH terms: Vaginismus
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Botox
Intervention type(s): Drug
Intervention description(s): 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 intervention name(s): Clostridium Botulinum type A neurotoxin complex
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vaginismus; Botox; Sex; Clostridium; Botulinum; Neurotoxin; Perineal; Muscles