Thermiva ® FAQ's

Pre-Treatment

1. Is this procedure permitted if a patient is breastfeeding?

You can treat all breastfeeding patients.

3. What is the post vaginal delivery recommendation for treatment?

6 weeks for an uneventful normal vaginal delivery. By then, any vaginal repair has healed and tissue response to ThermiVa is outstanding.

4. Can we treat women who complain of painful intercourse?

Those with painful intercourse may benefit dramatically from ThermiVa. It all depends on what the pain is stemming from. The patient will need a workup for painful intercourse before treatment. If the cause of painful intercourse is from atrophic vaginitis, then ThermiVa will be an excellent therapy. If painful intercourse is from a pelvic surgery, such as a mesh repair, then that should have a surgical work up. Patients with mesh are considered safe, unless they have had complications. Again, we are early in this knowledge; those with mesh, should be evaluated by an experienced pelvic surgeon. Providers, who do not preform pelvic surgery, should not do ThermiVa on mesh repair patients without medical clearance.

5. How should we treat undiagnosed pelvic pain?

ThermiVa has been an incredible treatment for the following complications; atrophic vaginitis, levator spasms, and even those with introital pain from lichen schlerosis and hyperplastic dystrophy. I would not treat a patient with a vulvar lesion that has not been diagnosed or biopsied. You never want to treat a patient with VAIN/VIN/Precancer of the vulvar or vagina. To be perfectly safe, treat only those with a completely normal visual vulva/vagina.

6. What is the recommended age range that can be treated?

The average age treated is 18 + to infinity, depending on complaint and issue. This is a procedure for both the pre and postmenopausal  women.

7. Can patients with a verified proper IUD placement have ThermiVa ® treatments?

That is perfectly fine. Patients with IUDs are safe to treat because IUDs are in the uterine cavity away from the vaginal cavity with the thick and firm cervix acting as a bank vault door. The only time it may even be an issue is if the uterus with an IUD is prolapsing into the vagina. In that case, it is advised not treating uterine prolapse patients earlier in this FAQ. Even if you did treat a patient with an IUD inside a prolapsing uterus, the uterine wall is of sufficient thickness to be a barrier to RF energy, therefore not affecting the IUD. Mirena IUD has no metal parts and is completely safe to treat. Progestasert and other metal containing IUDs are protected by the cervix and uterine wall that RF energy will not affect.

8. How should the diagnosis of prolapsed uterus be ascertained?

The patient should be cleared from prolapse and have a pelvic exam before treatment. Pelvic exams can come from anyone who does paps/pelvics and are proficient at it. If a doctor does not feel confident in their pelvic exam then the patient can see her primary care and get examined. The treating doctor should then request a report stating the pelvic exam is normal and that there are no vulvovaginal lesions and no uterine prolapse. If there is a bladder or rectal prolapse then that can be treated.

9. Should patients have a recent pap smear?

It is suggested to have a recent physical and or pap smear (when applicable) within the last 2 years (since women without a cervix do not have a pap smear). I believe that ThermiVa treatments are best for those with normal paps. However, I believe it is also acceptable to treat women with low risk HPV subtypes. Those with high risk HPV should be managed and treated before proceeding with ThermiVa treatments. Once you have a normal pap, Thermiva treatments are acceptable.

10. Can you treat a patient that has Lichen Sclerosus?

Yes. Many patients have been treated that state their post treatment skin is less sensitive and irritated. It is thought that treating this skin may thicken it, making it less sympotomatic. It’s likely that ThermiVa will become a good option as a future treatment on those with a biopsy proving LS and/or any vulvar dystrophy short of pre cancer. ThermiVa has also been used on those with very thickened vulvar skin that patients complain to be itchy (hyperplastic dystrophy). Previously this condition was treated with topical steroids such as Lidex and Clobetasol Propionate. ThermiVa has helped these patients with symptoms. These symp-toms are not a contraindiction at   all.

11. Who suffers from vaginal laxity?

Vaginal Laxity is very common after vaginal delivery. This condition can also be the result of aging, obesity, hormones, chronic constipation, straining, lifting, or any activity that would cause  the vagina to stretch beyond its normal  capacity.

12. Who are candidates for ThermiVa ®?

• Women who are experiencing vaginal laxity and a loose or rubbing feeling

• Women who are displeased with the appearance of their labia majora, especially while wearing bathing suits, athletic attire, leggings, jeans, etc.

• Women who are experiencing any sexual dysfunction or orgasmic issues

• Women who are having difficulty retaining tampons or may have pelvic prolapse, such as fallen bladder or fallen rectum

• Women who may suffer from urinary leakage or stress incontinence.

• Women who may suffer from dryness of their vagina or labia (atrophic vaginitis) due to the effects of menopause

13. Do women on hormone replacement therapy need to stop at any time?

No need to stop, change, or alter the way you are taking your hormone replacement therapy. If using vaginal estrogens apply AFTER treatment.

14. Research has shown there is a correlation between vaginal dryness and orgasmic dysfunction in women who have been on birth control for extended periods of time, due to a medical issue such as PCOS. Can ThermiVa ® help with this issue without having the patient stop the birth control?

Yes, definitely, if the patient had orgasmic dysfunction. ThermiVa can improve sensitivity in all patients, whether they are on hormones or birth control pills. In patients who suffer from orgasmic dysfunction (anorgasmia or taking too long to achieve orgasms), it can reduce the time to reach orgasm by one third to one half. However, if you have no such problem, it will not make you hyper-orgasmic. It only helps those who have orgasmic issues. Those who have normal orgasms when treated with ThermiVa continue to have normal orgasms, but can experience stronger and more coordinated muscular  contractions.

15. If a patient has had a previous hysterectomy or has an enterocele, are there any concerns for treating the vaginal apex for bowel injury concerns?

No concern. Hundreds of women have been treated post-hysterectomy. The tip is rounded and blunted, so the risk of perforating the vagina into the bowel/rectum/bladder is none, unless you force the device in with tremendous pressure. We recommend light pressure.

Treatment

1. How do we explain M.O.A. and results seen in regards to urinary stress incontinence?

This is a very remarkable story. Stress incontinence is from poor support of the mid urethra, resulting typically from stretched out pubocervical fascia that then fails to act like a backboard for the urethra to become compressed from pressure events of stress such as coughing/sneezing/ jumping. It can also occur because of damaged/stretched out or poorly contracting urethral muscles. This complex dual mechanism of the urethral muscles and the backboard theory are what provide continence. Anything that effects both, results in leakage or urine with stress. ThermiVa ® does two things to address these two issues. First, it contracts the pubocervical fascia, tightening it, and provides a firmer floor for the urethra to compress against when the patient coughs or sneezes. Instead of flopping, the firmer pubocervical fascia is now not getting stretched and pushed down now and provides floor pressure upwards to compress the urethra that is getting pushed downward. Next, ThermiVa ® has healing effects on the muscle and nerves, as well as, the fascia tissue. The healing effect on muscle is well known and is why it is used on damaged or sore muscles by physical therapists in pro sports. So, now radio frequency heals the torn or damaged muscles, plus the tightening effects, bring these torn and stretched out muscles closer in proximity together and now the individual muscle fibers act like a unit of muscle to increase pressure when contracted. Instead of individual muscle fibers working separately, the more closely tied in units of muscle; work together to improve the continence mechanism of the urethra. Lastly, it’s thought that the ThermiVa ® does have nerve healing effects that may increase the sensitivity of nerves of the urethral muscles and bladder. Nerves are more sensitive in detecting pressure changes and defensively contracting to provide continence. These same nerves that may be too sensitive or easily triggered from traumatic deliveries, menopausal changes, interstitial cystitis are now not “overactive” or spastic. Those with overactive bladder symptoms, typically feel a reduction in need to urinate frequently or sudden uncontrolled urge to urinate by  a third to a one half. They feel like they can go longer between voids, they have larger voids, and have a stronger stream, one that they can control better by the ability to stop midstream if they wanted to, when they could not prior to  treatment.

2. Why are some patients experiencing spotting or shedding?

Spotting can occur when ThermiVa electrode touches the cervix. We can see the same results with a pap swear. It can also occur if the patient has an untreated vaginitis (bacterial vaginitis, candida vaginitis, trichonomas vaginitis). More serious, is if they have an active/untreated gonorrhea or chlamydia infection. If patients have had a hysterectomy, then treat to the vaginal cuff. If bleeding is repetitive, encourage a pelvic exam be performed for visually inspection, vaginal cultures, GC and Chlamydia testing.

3. Do you see an increase in menstrual cycle after treatment?

No, increased menses has not been reported nor documented. Patients have reported no change in their cycle schedule, length or flow.

4. How are nerves affected by RF?

The RF affects nerves by increasing its release of vasoactive peptides that are then available at the nerve terminals. The increase in neurotransmitter activity at the nerve synapse is not clear. These vasoactive peptides result in vasodilation of the arterioles on the vulva/vagina/clitoral and G-Spot areas. The increased blood flow is similar in effect to Viagra in males. Increased blood flow results in increased plasma transudate from the arteriole through the vessel epithelium and out to the vaginal canal.

5. Can it treat episiotomy, hemorrhoids and scar tissue?

ThermiVa may soften scar tissue. It has been shown to soften skin. It’s likely to shrink hemor- rhoids. However, for hemorrhoids, the preference is to ablate and destroy them with higher tem- perature RF, such as the technology of the ThermiRase protocol at 80C.

6. When treating internally you can sometimes see a white discharge. Is this sloughing or something else? Please explain.

The white discharge when treating internally is transudate from stimulation or arousal. Not really vaginal sloughing per se. Very normal. This is actually a good sign that their response to treatment will be outstanding in terms of atrophic  vulvovaginitis.

7. Can ThermiVa ® be combined with other procedures?

ThermiVa ® can be used with many other vulvovaginal treatments. For example, when treating a labia minoraplasty, ThermiVa ® treatments on the entire vulvar structures can provide an improved cosmetic appearance and post procedure improved skin softness/fullness/smoothness. For most patients, this is an added and unexpected benefit from ThermiVa ®. All of your vaginal surgical patients can be presented with ThermiVa ® as an add-on option that can be done at the same time as their insurance or cash based surgeries.

8. Are anesthetics needed for this procedure?

No. The treatment feels like a comfortable, warm heat and patient feedback is necessary.

9. How long does the procedure take?

Approximately 10-15 minutes for labia majora reduction and 15-20 minutes for vaginal tightening. The protocol consists of 3 treatments recommended one month  apart.

10. Is there any contraindiction to longer treatment?

No. But whether anything longer than 5 minutes is better than 3-5 minutes is not  known.

11. What would you say at this point would be your maximum treatment times for internal and external areas?

About 5 minutes is my maximum treatment per zone with excellent  results.

Post-Treatment/Results

1. Results: When should a patient expect to begin their “maintenance” program? Does this differ for internal and external treatments?

External Treatments:

If the patient has external issues and concerns, after the third treatment they may require additional treatments between 4-6 months. You can give the example of: this treatment is typically going to last as long as a Botox treatment.

Internal Treatments:

The maintenance treatments can be between 6 to 12 months after the 3rd treatment. The internal effects of comfort, moisture, fullness, incontinence and overactive bladder can have longer lasting effects than the external treatments. The results for orgasmic dysfunction can be longer lasting than other complaints and may last over 18 months. It’s an observation that when the nerves have been sensitized the effects are very enduring in terms of maintained sensitivity.

Always consider the number of treatments the patient has had when educating them on a maintenance program. If the patient has had less than the 3 treatments as recommended; than they may desire additional treatments sooner.

2. What results can you see with prolapse? Does the technique change for blad- der prolapse?

If the patient has pelvic prolapse, I would concentrate my treatment time on that particular compartment. Spend at least 5 minutes in the anterior compartment if the prolapse is of the bladder, then at least 5 minutes on the posterior compartment if the prolaspe is the rectum. Ten minutes total if the prolapse is located in both. ThermiVa has worked to reduce symptoms for patients with mild to moderate pelvic prolapse (up to stage 2 where the leading edge can go up to a cm past the hymen), but does not work well in severe prolapse when the tissue is visible and palpable. It will not be beneficial for those patients with uterine prolapse. What I have seen is that with ThermiVa treatments, you can reduce cystocele and rectocele stages by ½ to 1 Stage. This may be enough to avoid surgery in selected patients who have mild to moderate symptoms. It   is not recommend-ed for those with severe cystocele, rectocele, uterine prolapse or vaginal pro- lapse. Please note: ThermiVa reduces vaginal tissue stretched out and has no “tacking” abilities.

 

3. What is the furthest data recorded for ThermiVa ® patients?

For external vulvar treatments / introital treatments, patients are out almost two years. Different RF technologies have been used since 2009-2010, so we have RF patients out over 5 years. ThermiVa ® internal treatments, the patients are now out one year plus. We can report that with RF and ThermiVa ® we have had no reported serious complications.

4. What are the post op instructions regarding hot tubs and swimming?

Hot tubs and swimming are permitted after treatment. If the patient has had a rare spotting episode with treatment, they should wait a day or  two.

5. How soon can Thermiva ® treatments be repeated?

It is recommended that ThermiVa ® treatments should be done every 30 days for three treatments. Then start a maintenance program as needed based on results. Treatments have been done at 3-6 weeks. Treating every 2 weeks may be too soon because at 2 weeks is typically when my patients see and feel more dramatic changes occurring.

6. What could patients experience post procedure?

Patients may say that they will feel tighter immediately after treatments, but that it improves even more with time. Another example is with incontinence, where it is not unusual to have patients become dry immediately after their treatment. We often see that a morning ThermiVa treatment, results in no stress incontinence that evening. In regards to vaginal dryness, the moisture starts more dramatically at 2 weeks and it may only be slightly improved after the first treatment and start presenting itself more significantly after the 2nd or 3rd treatment. The doctor and patient should not be concerned that they are not as wet as they want to be after only 1 treatment. After 3 treatments there are no known failures for atrophic vaginitis treatments.

7. What are post-procedure expectations?

Post procedure patient may resume normal daily activities. There are no restrictions for physical or sexual activity. Patients may feel the tightening effects the same day, others will take more time and notice changes at 2 weeks. Immediately there may be mild cramping, but this should resolve within 24 hours. If cramping persists contact your physician. To avoid possible cramping stop when you encounter moderate resistance. Patients should not see an increase or change  in discharge. The interpreted increase in discharge is probably the gel used during treatment seeping out. The improvement in vaginal moisture post treatment does not typically show itself in the first week and is seen starting 2 weeks post treatment. In short, the answer is that there is no increase in vaginal discharge with ThermiVa.

8. When can women resume sexual activity?

Women can resume their normal activities of daily living. This includes resuming sexual activity the same day as long as no abnormal bleeding is reported.