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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

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Interstitial Cystitis Overview

In this post, we want to give a high-level overview of interstitial cystitis and an introduction to other resources if you’d like to dive deeper into treatment the condition.  There’s a printable, patient-friendly version of this overview if you’d like to use it in describing the condition with patients.  In addition, you may want to review the 8 Myths of Interstitial Cystitis series and the AUA Guidelines for Interstitial Cystitis.

Definition

Interstitial cystitis is defined as pain or pressure perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes.

Unfortunately, for physicians, pelvic floor dysfunction falls under category of ‘unidentifiable cause.’  Interstitial cystitis is really more of a description of symptoms, rather than a discrete diagnosis, and the condition presents in many different ways.

Interstitial Cystitis Overview

Symptoms

The hallmarks of interstitial cystitis are pelvic pain, often in the suprapubic area or inner thighs, and urinary urgency and frequency. Other common symptoms include pain with intercourse, nocturia, low back pain, constipation, and urinary retention.

Many patients are surprised to realize that symptoms like painful intercourse, low back pain, and constipation are related to their IC diagnosis. This challenges the misconception that issues are arising solely from the bladder, and is a good way to help patients (and their physicians) understand that IC is about more than just the bladder.

Diagnosis

Interstitial cystitis is fundamentally a diagnosis of exclusion.  Most patients suspect a urinary tract infection (UTI) when their symptoms first present.  It’s actually common for symptoms to start as the result of a UTI, and simply not resolve once the infection has cleared.  Patients are often treated with multiple rounds of antibiotics for these ‘phantom’ UTIs, where cultures have come back negative, before an IC diagnosis is considered.

It’s important for us as physical therapists to be able to share with patients that no testing is required to confirm an IC diagnosis, it can be diagnosed clinically. In practice, a urologist will likely want to conduct a cystoscopy, which can rule out more serious issues like bladder cancer as well as check for Hunner’s lesions (wounds in the bladder that are present in about 10% of IC patients).  However, after that, no additional testing is needed. The potassium sensitivity test (PST) was formerly used by some urologists, but it has been shown to be useless diagnostically and extremely painful for patients and is not recommended by the American Urological Association. Urodynamic testing is also often conducted, but again is not necessary to establish an IC diagnosis.

Physical Therapy for IC

According to the American Urological Association, physical therapy is the most proven treatment for interstitial cystitis. It’s given an evidence grade of ‘A’ (the only treatment with that grade) and recommended in the first line of medical treatment.

In controlled clinical trials, manual physical therapy has been shown to benefit up to 85% of both men and women.  These trials reported benefits after ten visits of one-hour treatment sessions.

In a study conducted at our clinic , PelvicSanity, we found that physical therapy was able to reduce pain for IC patients from an average of 7.6 (out of 10) before treatment to 2.6 following physical therapy. Similarly, how much their symptoms bothered patients fell from 8.3 to 2.8. More than half of patients reported improvements within the first three visits.

Unfortunately, many patients still aren’t referred to pelvic physical therapy by their physician. More than half of the patients in the study had seen more than 5 physicians before finding pelvic PT, and only 7% of patients felt they had been referred to physical therapy at the appropriate time by their doctor.

Multi-Disciplinary Approach

Patients with interstitial cystitis or pelvic pain always benefit from a multidisciplinary approach to treatment.This can include:

  • Stress relief to downregulate the nervous system can decrease symptoms and reduce flares. Gentle exercise, meditation, yoga, deep breathing, or working with a psychologist can all provide benefits for patients.
  • Diet and nutrition are important when working with IC patients. There is no formal ‘IC Diet’, but most patients are sensitive to at least a few trigger foods. The gold standard of treatment is an elimination diet, where the common culprits are completely removed from the diet and then added back in one at a time. This identifies which foods are triggers for patients. With nutrition for IC, patients should avoid their personal trigger foods and eat healthy – it doesn’t have to be any more restrictive or complicated.
  • Alternative treatments like acupuncture have been shown to reduce pelvic pain in patients, and several supplements have shown benefits in trials or anecdotally among patients.
  • Bladder treatments include instillations and nerve stimulation. Some patients may benefit from bladder instillations, but many others find that the process of the instillation actually causes additional symptoms.  If instillations are beneficial, patients should be encouraged to address the underlying issues during the reprieve that instillations bring. Percutaneous tibial nerve stimulation or an implanted nerve stimulation device can both be possible treatment options.
  • Oral medications can also reduce symptoms, but do not address the underlying cause of symptoms in patients. Medication that dampens the nervous system, often an anti-depressant or similar medication, can reduce pain and hypersensitivity. Anti-inflammatories may be beneficial in lowering inflammation and helping break the cycle of dysfunction-inflammation-pain. Most patients are started on Elmiron®, the only FDA-approved medication for IC; unfortunately, in the most recent clinical trial research Elmiron has been shown to be no more effective than a placebo. If it is effective, it only is beneficial for about one-third of patients, and many won’t be compliant with the drug due to cost and side effects.

Nicole CozeanNicole Cozean, PT, DPT, WCS (www.pelvicsanity.com/about-nicole) is the founder of PelvicSanity physical therapy in Southern California.  Name the 2017 PT of the Year by the ICN, she’s the first physical therapist to serve on the Interstitial Cystitis Association’s Board of Directors and the author of the award-winning book The IC Solution (www.pelvicsanity.com/the-ic-solution).  She teaches at her alma mater, Chapman University, as well as continuing education through Herman & Wallace.  Nicole also founded the Pelvic PT Huddle (www.facebook.com/groups/pelvicpthuddle), an online Facebook group for pelvic PTs to collaborate.

Interstitial Cystitis Course

In our upcoming course for physical therapists in treating interstitial cystitis (April 6-7, 2019 in Princeton, New Jersey), we’ll focus on the most important physical therapy techniques for IC, home stretching and self-care programs, and information to guide patients in creating a holistic treatment plan.  The course will delve into how to handle complex IC presentations.  It’s a deep dive into the condition, focusing not just on manual treatment techniques but also how to successfully manage an IC patient from beginning to resolution of symptoms.

Additional Resources

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Specific Myofascial Release as a Treatment for Clitoral Phimosis

Myofascial release (MFR) can be one of your greatest treatment tools as a pelvic rehabilitation practitioner. Just in case you don’t think about fascia often here are a couple helpful things to remember. Fascia is the irregular connective tissue that covers the entire body, and it is the largest sensory system in the body, making it highly innervated. The mobilizing effect of MFR techniques occurs by stimulating various mechanoreceptors within the fascia (not by the actual force applied). MFR techniques can help to reduce tissue tension, relax hypertonic muscles, decrease pain, reduce localized edema, and improve circulation just to name a few physiological effects.

An interesting case report published in 2015 by the Journal of Women’s Health Physical Therapy1 offers a wonderful example of how a physical therapist used specific MFR techniques for a patient with clitoral phimosis and dyspareunia. The specific MFR techniques used helped to provide relief and restore mobility to the pelvic tissues for this patient.

Clitoral phimosis is adherence between the clitoral prepuce (also known as the clitoral hood) and the glans. This condition can be the result of blunt trauma, chronic infection, inflammatory dermatoses, and poor hygiene. In this case report, the 41-year-old female patient had sustained a blunt trauma injury to the vulva (when her toddler son charged, contacting his head forcibly into her pubic region). She presented to physical therapy with complaints of dyspareunia, low back pain, a bruised sensation of her pubic region, vulvar pain provoked by sexual arousal, decreased clitoral sensitivity, and anorgasmia. The physical therapist completed an orthopedic assessment for the lower quarter (including spine and extremities), as well as a thorough pelvic floor muscle assessment.

Treatment for this patient addressed not only the pelvic complaints, but the lower quarter complaints as well. A detailed treatment summary for each visit is outlined in the case report. The clitoral MFR and stretching was performed by applying a small amount of topical lubricant to the clitoral prepuce. Then, a gloved finger or a cotton swab was used to stabilize the clitoris, a prolonged MFR or sustained stretch was applied in the direction away from the fixated clitoris by the therapist’s other finger. The therapist applied this technique along the entire length of the prepuce. The other physical therapy interventions this patient was treated with were stretching, joint mobilization, muscle energy techniques, transvaginal pelvic floor muscle massage, clitoral prepuce MFR techniques, biofeedback, Integrative Manual Therapy (IMT) techniques, nerve mobilization, and therapeutic and motor control exercises. Additionally, between the physical therapy evaluation and the second visit the patient did use topical Clobetasol 0.05% cream (commonly prescribed for vulvar dermatitis issues such as Lichen Sclerosis) for 30 days with no change to her clitoral phimosis.

After 11 sessions, the patient had resolution of dyspareunia, vulvar pain, pubic pain, and reduced low back pain. Also, the patient had 100% restored mobility of the clitoral prepuce, as well as normalized clitoral sensitivity and clitoral orgasm. The patient felt these improvements were still present at her 6-month follow-up interview over the phone. Current medical management for clitoral phimosis is surgical release or topical/injectable corticosteroids. Having a conservative treatment option, such as MFR, for this condition can be helpful for patients. As with most evolving treatment techniques, more research and studies are appropriate.

Not one health care professional had ever assessed the fascial mobility of the clitoris until this physical therapist did. This case report is an example of how MFR techniques can be effective treatment tools for your patients with pelvic disorders and a good reminder to check the fascial mobility of the pelvic tissues.

Morrison, P., Spadt, S. K., & Goldstein, A. (2015). The Use of Specific Myofascial Release Techniques by a Physical Therapist to Treat Clitoral Phimosis and Dyspareunia. Journal of Women’s Health Physical Therapy, 39(1), 17-28.

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Differential Diagnosis: A Case Study

My job as a pelvic floor therapist is rewarding and challenging in so many ways. I have to say that one of my favorite "job duties" is differential diagnosis. Some days I feel like a detective, hunting down and piecing together important clues that join like the pieces of a puzzle and reveal the mystery of the root of a particular patient's problem. When I can accurately pinpoint the cause of someone's pain, then I can both offer hope and plan a road to healing.

Recently a lovely young woman came into my office with the diagnosis of dyspareunia. As you may know dyspareunia means painful penetration and is somewhat akin to getting a script that says "lower back pain." As a therapist you still have to use your skills to determine the cause of the pain and develop an appropriate treatment plan.

My patient relayed that she was 6 months post partum with her first child. She was nursing. Her labor and delivery were unremarkable but she tore a bit during the delivery. She had tried to have intercourse with her husband a few times. It was painful and she thought she needed more time to heal but the pain was not changing. She was a 0 on the Marinoff scare. She was convinced that her scar was restricted. "Oh Goodie," I thought. "I love working with scars!" But I said to her, "Well, we will certainly check your scar mobility but we will also look at the nerves and muscles and skin in that area and test each as a potential pain source, while also completing a musculoskeletal assessment of the rest of you."

Her "external" exam was unremarkable except for adductor and abdominal muscle overactivity. Her internal exam actually revealed excellent scar healing and mobility. There was significant erythemia around the vestibule and a cotton swab test was positive for pain in several areas. There was also significant muscle overactivity in the bulbospongiosis, urethrovaginal sphincter and pubococcygeus muscles. Also her vaginal pH was a 7 (it should normally be a 4, this could indicate low vaginal estrogen). I gave her the diagnosis of provoked vestibulodynia with vaginismus. Her scar was not the problem after all.

Initially for homework she removed all vulvar irritants, talked to her doctor about trying a small amount of vaginal estrogen cream, and worked on awareness of her tendency to clench her abdominal, adductor, and pelvic floor muscles followed by focused relaxation and deep breathing. In the clinic I performed biofeedback for down training, manual therapy to the involved muscles, and instructed her in a dilator program for home. This particular patient did beautifully and her symptoms resolved quite quickly. She sent me a very satisfied email from a weekend holiday with her husband and daughter.

Although this case was fairly straightforward, it is a great example of how differential diagnosis is imperative to deciding and implementing an effective treatment plan for our patients. In Herman & Wallace courses you will gain confidence in your evaluation skills and learn evidence based treatment processes that will enable you to be more confident in your care of both straightforward and complex pelvic pain cases. Hope to see you in class!

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Sex and Pelvic Health at Menopause

After menopause, more than half of women may have vulvovaginal symptoms that can impact their lifestyle, emotional well-being and sexual health. What's more, the symptoms tend to co-exist with issues such as prolapse, urinary and/or bowel problems. But unfortunately many women aren't getting the help they need, despite a growing body of evidence that skilled pelvic rehab interventions are effective in the management of bladder/bowel dysfunctions, POP, sexual health issues and pelvic pain.

Vaginal dryness, hot flashes, night sweats, disrupted sleep, and weight gain have been listed as the top five symptoms experienced by postmenopausal women in North America and Europe, according to a study by Minkin et al 2015, and they also concluded ‘The impact of postmenopausal symptoms on relationships is greater in women from countries where symptoms are more prevalent.’

Between 17% and 45% of postmenopausal women say they find sex painful, a condition referred to medically as dyspareunia. Vaginal thinning and dryness are the most common cause of dyspareunia in women over age 50. However pain during sex can also result from vulvodynia (chronic pain in the vulva, or external genitals) and a number of other causes not specifically associated with menopause or aging, particularly orthopaedic dysfunction, which the pelvic physical therapist is in an ideal position to screen for.

According to the North America Menopause Society, ‘…beyond the immediate effects of the pain itself, pain during sex (or simply fear or anticipation of pain during sex) can trigger performance anxiety or future arousal problems in some women. Worry over whether pain will come back can diminish lubrication or cause involuntary—and painful—tightening of the vaginal muscles, called vaginismus. The result can be a vicious circle, again highlighting how intertwined sexual problems can become.’

‘The impact of postmenopausal symptoms on relationships is greater in women from countries where symptoms are more prevalent.’

The research has demonstrated that the optimal strategy for post-menopausal stress incontinence is a combination of local hormonal treatment and pelvic floor muscle training – the strategy of combining the two approaches has been shown to be superior to either approach used individually (Castellani et al 2015, Capobianco et al 2012) and similar conclusions can be drawn for promoting sexual health peri- and post-menopausally.

The pelvic rehab specialist may be called upon to screen for orthopaedic dysfunction in the spine, hips or pelvis, to discuss sexual ergonomics such as positioning or the use of lubricant as well as providing information and education about sexual health before, during and after menopause.

To learn more about sexual health and pelvic floor function/dysfunction at menopause, join me in Atlanta in March for Menopause: A Rehab Approach!


Prevalence of postmenopausal symptoms in North America and Europe, Minkin, Mary Jane MD, NCMP1; Reiter, Suzanne RNC, NP, MM, MSN2; Maamari, Ricardo MD, NCMP3, Menopause:November 2015 - Volume 22 - Issue 11 - p 1231–1238
Low-Dose Intravaginal Estriol and Pelvic Floor Rehabilitation in Post-Menopausal Stress Urinary Incontinence, Castellani D. · Saldutto P. · Galica V. · Pace G. · Biferi D. · Paradiso Galatioto G. · Vicentini C., Urol Int 2015;95:417-421

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Pelvic Health at Menopause

After menopause, more than half of women may have vulvovaginal symptoms that can impact their lifestyle, emotional well being and sexual health. What's more, the symptoms tend to co-exist with issues such as prolapse, urinary and/or bowel problems. But unfortunately many women aren't getting the help they need, despite a growing body of evidence that skilled pelvic rehab interventions are effective in the management of bladder/bowel dysfunctions, POP, sexual health issues and pelvic pain.

Vaginal dryness, hot flashes, night sweats, disrupted sleep, and weight gain have been listed as the top five symptoms experienced by postmenopausal women in North America and Europe, according to a study by Minkin et al 2015, and they also concluded ‘The impact of postmenopausal symptoms on relationships is greater in women from countries where symptoms are more prevalent.’ Between 17% and 45% of postmenopausal women say they find sex painful, a condition referred to medically as dyspareunia. Vaginal thinning and dryness are the most common cause of dyspareunia in women over age 50. However pain during sex can also result from vulvodynia (chronic pain in the vulva, or external genitals) and a number of other causes not specifically associated with menopause or aging, particularly orthopaedic dysfunction, which the pelvic physical therapist is in an ideal position to screen for.

According to the North America Menopause Society, ‘…beyond the immediate effects of the pain itself, pain during sex (or simply fear or anticipation of pain during sex) can trigger performance anxiety or future arousal problems in some women. Worry over whether pain will come back can diminish lubrication or cause involuntary—and painful—tightening of the vaginal muscles, called vaginismus. The result can be a vicious circle, again highlighting how intertwined sexual problems can become.’

The research has demonstrated that the optimal strategy for post-menopausal stress incontinence is a combination of local hormonal treatment and pelvic floor muscle training – the strategy of combining the two approaches has been shown to be superior to either approach used individually (Castellani et al 2015, Capobianco et al 2012) and similar conclusions can be drawn for promoting sexual health peri- and post-menopausally.

The pelvic rehab specialist may be called upon to screen for orthopaedic dysfunction in the spine, hips or pelvis, to discuss sexual ergonomics such as positioning or the use of lubricant as well as providing information and education about sexual health before, during and after menopause.

To learn more about sexual health and pelvic floor function/dysfunction at menopause, join me in Atlanta in March for Menopause: A Rehab Approach.


Prevalence of postmenopausal symptoms in North America and Europe, Minkin, Mary Jane MD, NCMP1; Reiter, Suzanne RNC, NP, MM, MSN2; Maamari, Ricardo MD, NCMP3, Menopause:November 2015 - Volume 22 - Issue 11 - p 1231–1238
Low-Dose Intravaginal Estriol and Pelvic Floor Rehabilitation in Post-Menopausal Stress Urinary Incontinence, Castellani D. · Saldutto P. · Galica V. · Pace G. · Biferi D. · Paradiso Galatioto G. · Vicentini C., Urol Int 2015;95:417-421

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Upcoming Continuing Education Courses

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