The Pacik Vaginismus Treatment Trial

I recently assisted at a Pelvic Floor Level 2B course which has been updated with recent research, new sections, and less repetition from Pelvic Floor Level 1. In the course they mentioned this article which sparked a lively discussion and I had to learn more. It is rare to see a study with a large number of participants in pelvic health and especially with a vaginismus diagnosis.

Vaginismus is defined as a genito-pelvic pain/penetration disorder along with dyspareunia under the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders; Fifth Edition) in which penetration is often impossible due to pain and fear. Vaginismus is both a physical and psychological disorder as it exhibits both muscle spasms and fear/anxiety of penetration. Symptoms vary by severity. Common presentation is an inability or discomfort to insert/remove a tampon, pain with penetration, and complaints of “hitting a wall” in attempted penetration; and inability to participate in gynecological exams.

The authors of this study evaluated the severity of vaginismus. The penetrative history was used in addition to presentation at pelvic exam, and then given a level. There are 2 grading systems, Lamont and Pacik, that indicate the level of fear and anxiety about being touched. They found that those with severe vaginismus were Lamont levels 3 and 4, and Pacik level 5. For example, a Pacik Level 5 includes Lamont grade 4 “generalized retreat: buttocks lift up; thighs close, patient retreats” plus a visceral reaction such as “palpitations, hyperventilation, sweating, severe trembling, uncontrollable shaking, screaming, hysteria, wanting to jump off the table, a feeling of going unconscious, nausea, vomiting and even a desire to attack the doctor”.

241 patients participated in this study, with a mean duration of 7.8 years. 70% of participants were a Lamont level 4 or Pacik level 5 at baseline. The authors looked at previous treatments tried and coping strategies; 74% had tried lube, 73% had tried dilators, 50% had tried Kegels, 28% had tried physical therapy, 3% had tried a surgical vestibulectomy. The full table 2 is in the article. Most participants had a mean of at least 4 failed treatments.

The aim was to help these women to achieve pain free intercourse after treatment. In order to tolerate the treatment, many were sedated with midazolam before the Q-tip test, and more sedation given as needed. The treatment lasted for about 30 minutes and consisted of:

• Q-tip test with as minimal sedation as possible to rule out vulvodynia and provoked vestibulodynia
• Digital exam of tolerance in order to assess the level of spasm in introitus. Graded 0 (no spasm) to 4 (severe spasm where digital insertion was difficult)
• Botox 50 U injections to right and left submucosal space near the bulbospongiosus muscle administered with a pediatric speculum placed. Additional Botox was injected submucosally into levator ani muscles if also in spasm/tight
• Injections 0.25% bupivacaine (a numbing agent) 1 mL increments along right and left lateral vaginal walls (9 mL per side) from cervix to introitus
• Progressive dilation; circumference 3 inches (#4), 4 inches (#5), 5 inches (#6)
• Reassessed with digital examination
• Re-insert #5 or #6 dilator and patient was awakened and taken to recovery

If the patient consented, her partner could be present during the procedure and was allowed to palpate the level of spasm with gloved digit and was educated on dilator insertion. The authors noted that many partners had a ‘profound’ experience.

A nurse worked with the couple for about two hours in the recovery room to help them be more comfortable moving the dilator in and out with minimal-to-no pain as the numbing agent lasts 6-8 hours. Three participants were treated each time and consented to meet each other. Patients were discharged with #4 dilator in place and asked to keep in until the next day. They were given Ibuprofen and sleeping aids as needed.

Day 1
Participants return with partners and progress up to larger sizes (#5 and #6). They participate in group counseling with the primary researcher Dr. Pacik. This lasted about 5 hours; and consisted of education of dilator progression, returning to intercourse and lubricants. If participants wished to have private counseling instead that was granted. Many exchanged contact information. They were encouraged to continue seeing their healthcare clinicians as indicated; sex therapists, physical therapists, psychologists.

Dilator Progression

Month 1
- 2 hours of dilator per day. Either in 1 sitting or 1 hour of dilator work x2 per day
- Progress to bigger sizes until #5 or #6 is comfortable

Month 2
- 1 hour of dilator use per day and continue toward larger sizes

Month 3
- 15-30 minutes of dilator use per day

Months 4-12
- 10-15 minutes of dilator use per day or every other day

During the counseling session post-procedure, the recommendations for returning to intercourse included:

• Delaying intercourse until #5 dilator was able to be easily inserted
• It is helpful to do 1 hour of dilator work before attempting intercourse for the first time
• If partner’s penis is larger progress to larger dilators (#7 - 6 inch circumference or #8 7 inch circumference)
• Goal of the first few attempts is to insert tip of dilator only
• Once tip can be inserted easily then progress to full penetration; restrain from thrusting
• Try “spooning position” if ‘leg lock’ occurs
• Try different positions with dilator work and intercourse to see what works best

71% of participants achieved pain-free coitus 5 weeks after the procedure. 2.5% could not achieve coitus within one-year period although they could use #5 or #6 dilators. The participants were given a validated outcome tool, the Female Sexual Function Index (FSFI), before and after the procedure and at 1-month, 3-months, 6-months, and 1-year; with significant improvement at each interval. The patients were followed for one year, and often remained in contact with the authors for much longer ranging from 16-months to 9-years.

The authors propose that use of dilators at the time of botox and post procedure counseling and support help participants ‘break through’, whereas previous treatment may not be as multidimensional and limit efficacy. Botox lasts 2-4 months and allowed for dilation progression.

Initially after reading this article the treatment seemed a little drastic to me, but then I considered the women with this level of vaginismus are often not coming into my clinic. They may need this level of structure, consistently, and multidimensional treatment as half measures have failed them. I am so glad they were persistent and found the help they needed.

Pacik, P., Geletta, S. Vaginismus Treatment: Clinical Trials Follow Up 241 Patients. Sex Med 2017;5:e114-e123