N/A
N=32
Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm
Vaginismus
Bottom Line
View on ClinicalTrials.gov: NCT01859507 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain — 28 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Botox (Drug)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Abdel-Maguid Ramzy
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Success of Repeated Penetration of the Penis Through the Vaginal Introitus Into the Vagina Without or With Acceptable Pain |
28 | — |
| SECONDARY Successful Sexual Relationship |
28 | — |
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.
Eligibility Criteria
Inclusion Criteria
- cases with resistant vaginismus
Exclusion Criteria
- cases with congenital anomalies in the lower female genital tract
Data sourced from ClinicalTrials.gov (NCT01859507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.