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临床试验/NCT01859507
NCT01859507已完成不适用

Study of the Effectiveness and Safety of Clostridium Botulinum Type A Neurotoxin Complex Injection in the Perineal Muscles in Resistant Cases of Vaginismus

Abdel-Maguid Ramzy1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 44 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • cases with resistant vaginismus

排除标准

  • cases with congenital anomalies in the lower female genital tract

研究组 & 干预措施

BOTOX group

Experimental

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.

干预措施: Botox (Drug)

结局指标

主要结局

Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain

时间窗: Up to four weeks following the last session of the vaginal dilatation.

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.

次要结局

  • Successful Sexual Relationship(Within twelve months after the Botox injection)

研究者

发起方
Abdel-Maguid Ramzy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Abdel-Maguid Ramzy

Prof. Of OB. GYN.,

Cairo University

研究点 (1)

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