Trial record 5 of 60 for:    Open Studies | "Vaginal Diseases"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Cairo University
Sponsor:
Information provided by (Responsible Party):
Abdel-Maguid Ramzy, Cairo University
ClinicalTrials.gov Identifier:
NCT01859507
First received: May 19, 2013
Last updated: December 31, 2013
Last verified: December 2013
  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: Injection of Botox in the perineal muscles in resistant cases of vaginismus

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 penetration of the penis through the vaginal introitus into the vagina [ Time Frame: Up to four weeks following the injection of Botox ] [ Designated as safety issue: No ]
    The primary outcome will be assessed by the couple


Secondary Outcome Measures:
  • Repeated vaginal penetration by the partner [ Time Frame: Within Two months after the Botox injection ] [ Designated as safety issue: No ]
    The degree of comfort and satisfaction by the couple


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Botox

Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.

Trade Name:

BOTOX 100 units vial

Drug: Injection of Botox in the perineal muscles in resistant cases of vaginismus
Other Names:
  • Botox
  • 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 be carried out which 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.

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 both before the injection and during the dilatation sessions. We did not use local anesthetic injections at the site of BOTOX injection. In addition we used ice packs pre-prepared in a surgical latex glove, on the perineum and introitus both before and during 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 puncture site, 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, in both sides of the muscle, right and left, as well as the origin of the muscle in the perineal body. 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, as well as combined per-rectum index and perineal thumb massage. 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. During the first week, the patient will be instructed to attend dilatation sessions twice weekly in the clinic, in the presence of the husband, for 4 weeks. We use silicone dilators covered by lubricated condoms. We prepared the vaginal skin by Xylocaine gel as surface anaesthetic followed 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, relax and feel comfortable. The husband may stand beside her and may hold her hand. After her approval, the husband will be allowed to follow the procedure visually to feel and understand what his wife will express of pain corresponding to each maneuver. This will be translated into understanding when they come to have real intercourse thereafter. In the initial phase of the dilatation procedure we start with the appropriate size of the dilator according to the capacity of the introitus 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. 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. At home, the couple will be instructed not to shift to the larger size of the vaginal dilators except if she is comfortable with the smaller. The couple will be instructed not to have trials of intercourse before the patient uses dilator number 3 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 vaginismus

Exclusion Criteria:

  • cases with congenital anomalies in the lower female genital tract
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859507

Contacts
Contact: AbdelMaguid I Ramzy, MD +201008606060 amramzy@gmail.com

Locations
Egypt
AbdelMaguid Ramzy Recruiting
Cairo, Egypt, 11341
Contact: AbdelMaguid I Ramzy, MD    +201008606060    amramzy@gmail.com   
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
Last Updated: December 31, 2013
Health Authority: Egypt: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 31, 2014