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

NCT01859507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2015-04-14

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Abdel-Maguid Ramzy

    lead OTHER

Principal Investigators

  • AbdelMaguid I Ramzy, MD · Cairo University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01859507 on ClinicalTrials.gov