Vaginismus Clinical Trial
Official title:
Open Label, Single Center, Pilot Study of the Use of BOTOX Injections, Sensorcaine Injections and Progressive Dilation Under Anesthesia for the Treatment of Primary Vaginismus
The use of Botox injections intravaginally and progressive dilation under anesthesia has been
shown to cure vaginismus. This study expands the use of Botox injections to include
progressive dilation, post procedure supervised dilation and sex counseling to help women
transition from dilators to intercourse. Since 2005 patients continue to experience a cure
rate in excess of 90%. As of December 2012 more than 200 vaginismus patients have been
treated this way.
In this completed study of 30 patients with a minimum of one year follow-up 29 vaginismus
patients were able to advance to pain free intercourse (97%) and one patient failed to
achieve her goals presumably due to uncontrolled anxiety relating to vaginal penetration.
Vaginismus is the most common reason for unconsummated marriages. The more severe forms of
vaginismus are often refractory to a variety of treatments such as Kegel exercises, dilator
therapy, psychotherapy, sex counseling physical therapy, hypnotherapy, biofeedback,
anti-depressants, anti-anxiety drugs, hymenectomy and vestibulectomy. In the larger cohort of
200 patients, a detailed data analysis of 150 patients (paper submitted) the average length
of time of failed treatments was more than 7 years. 25% of vaginismus women suffered with
this condition for more than a decade.
Spasm of the vaginal muscles is well defined in the scientific literature, first described by
Sims in his 1861 report, as well as Lamont in 1978 and currently included in the DSM-IV
definition of vaginismus. Pacik has reported on the prevalence of spasm of the
bulbocavernosum, especially in the more severe forms of vaginismus, consistent with the
history that intercourse feels like it is "hitting a wall", also noted by Lamont. The use of
Botox injections as a treatment for vaginismus dates back to 1997. Since then several
reports, including papers and presentations from our practice, have shown the efficacy of
Botox injections for vaginismus. Botox is a very safe drug when used correctly. As of
December 2012 more than 200 patients have been treated in our practice, mostly the more
severe forms of vaginismus, who have been refractory to other forms of therapy. In this
population dating back to 2005, the cure rate is in excess of 90%. There have been three
minor complications of mild stress incontinence all of which resolved after about four months
when the Botox was no longer active. One patient in this large cohort developed excessive
vaginal dryness, likely due to block of the parasympathetic nerves which govern "letdown".
Several patients have become pregnant and delivered normal children by vaginal childbirth.
The program to cure vaginismus is more than just injecting Botox under anesthesia and
incorporates the following additional essential steps:
The areas of maximum spasm of the vaginal muscles are identified under sedation to determine
where the Botox should be injected. The injections done under anesthesia are followed by
additional injections of a long acting local anesthetic bupivacaine. After this the vagina is
progressively dilated while the patient is still under anesthesia, and the dilators are
further coated with a topical anesthetic. All these measures allow the patient to wake up in
the recovery room with the large dilator in place and no discomfort. Following this,
supervised dilation continues so that the patient becomes comfortable moving the dilator in
and out of the vagina. This supervised dilation continues for a total of two to three
mornings. During this time counseling is done with the couple to help instruct the correct
use of the dilators, transition from dilators to intercourse, positions of pelvic floor
relaxation and couple's counseling. Written instructions are given as well as a DVD
addressing these aspects and close follow up and support by phone and email to ensure success
of the program.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT00638066 -
Botulinum Toxin Injection for Treatment of Vaginismus
|
Phase 3 | |
Not yet recruiting |
NCT01530113 -
Childhood Sexual Abuse, Vaginismus and Labor Dystocia
|
N/A | |
Recruiting |
NCT05529407 -
Trial of SVTampons vs Glass Vaginal Dilators in Treatment of Vaginismus
|
N/A | |
Completed |
NCT01859507 -
Injection of Botox in the Perineal Muscles in Resistant Cases of Vaginal Spasm
|
N/A | |
Completed |
NCT04436172 -
Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus
|
N/A | |
Completed |
NCT00281372 -
Sexual Dysfunction and Dental Care
|
N/A | |
Completed |
NCT03176069 -
Evaluation and Comparison of Women Pelvic Floor With and Without Sexual Dysfunction (Vaginismus)
|
N/A | |
Recruiting |
NCT04635345 -
Feasibility of Use of Vibrators With Vaginal Dilators for Vaginismus. (Vibrator Therapy and Dilators in Vaginismus)
|
N/A | |
Recruiting |
NCT06397885 -
Prospective On Market Patient-reported Outcomes for Milli
|
||
Completed |
NCT02430038 -
Transperineal Ultrasound to Assess the Progress of Labour
|