At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Study of the Effectiveness and Safety of Clostridium Botulinum Type A Neurotoxin Complex Injection in the Perineal Muscles in Resistant Cases of Vaginismus
In Brief
A clinical study evaluating Botox for Vaginismus. Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.