Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm

NCT01859507 | Completed Results DMC

• 1 other identifier: ramzy9501
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vaginismus

Keywords

Vaginismus; Botox; Sex; Clostridium; Botulinum; Neurotoxin; Perineal; Muscles

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

• Successful Sexual Relationship

  Within twelve months after the Botox injection

Study Arms (1)

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.

Drug: Botox

Interventions

Botox DRUG

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.

Also known as: Clostridium Botulinum type A neurotoxin complex

BOTOX group

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• cases with resistant vaginismus

You may not qualify if:

• cases with congenital anomalies in the lower female genital tract

Sponsors & Collaborators

• Abdel-Maguid Ramzy: lead

Study Sites (1)

AbdelMaguid Ramzy

Cairo, 11341, Egypt

Location

Related Publications (1)

• Pacik PT. Vaginismus: review of current concepts and treatment using botox injections, bupivacaine injections, and progressive dilation with the patient under anesthesia. Aesthetic Plast Surg. 2011 Dec;35(6):1160-4. doi: 10.1007/s00266-011-9737-5. Epub 2011 May 10.

  PMID: 21556985 BACKGROUND

Related Links

• Botox Injection for Treatment of Vaginismus. Peter T. Pacik

MeSH Terms

Conditions

Vaginismus; Coitus

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Abdelmaguid Ramzy
• Organization: Cairo University. Department of Obstetrics and Gynecology

amramzy@gmail.com

+201008606060

Study Officials

• AbdelMaguid I Ramzy, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Of OB. GYN.,

Study Record Dates

• First Submitted: May 19, 2013
• First Posted: May 22, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 14, 2015
• Results First Posted: April 14, 2015

Record last verified: 2015-04

Locations

EG (1)