Transvaginal Electrical Stimulation for Pelvic Pain

Overseen By Nasaura Richard, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Prior pelvic procedures, UTI, Pregnancy, Drug addiction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must refrain from starting any new treatments that could affect your pain during the study.

What data supports the effectiveness of the treatment Transvaginal Electrical Stimulation for Pelvic Pain?

Research shows that intravaginal electrical stimulation can help reduce chronic pelvic pain, including pain from conditions like levator ani spasm and deep endometriosis. This suggests that similar treatments, like transvaginal electrical stimulation, may also be effective for pelvic pain. ^{1 2 3 4 5}

Is transvaginal electrical stimulation safe for humans?

Research on intravaginal electrical stimulation (IVES) for conditions like chronic pelvic pain and stress urinary incontinence suggests it is generally safe for humans, as it has been used in clinical trials without significant safety concerns reported. ^{1 2 3 5 6}

How does Transvaginal Electrical Stimulation differ from other treatments for pelvic pain?

Transvaginal Electrical Stimulation (TES) is unique because it directly targets the pelvic muscles through electrical impulses delivered via a vaginal probe, which can help relieve pain by relaxing muscle spasms. Unlike other treatments that might involve medication or surgery, TES is a non-invasive option that specifically addresses muscle-related pelvic pain. ^{1 2 3 4 5}

What is the purpose of this trial?

Myofascial Pelvic Pain (MPP) is a frequently overlooked musculoskeletal cause of chronic pelvic pain affecting 10-20% of all adult women. Despite high prevalence and societal costs, few effective treatments exist and are difficult to access due to shortages of skilled personnel. Treatments for MPP using electrical stimulation to induce muscle fatigue have proven efficacy at reducing pain, improving circulation, and promoting tissue healing, but have proven difficult to implement in gynecologic practice. The aim of this three-arm randomized study is to evaluate the utility of transvaginal electrical stimulation at a fixed frequency of 200 Hz in women with symptomatic MPP in comparison to the standard, first-line treatment with education, stretching, and low-impact exercise. Nursing staff without prior training will be taught to deliver this high-frequency transvaginal electrical stimulation (HF-TES) treatment using the device. Responses to treatment provided by a specialist physician and licensed vocational nurse will be compared. Patients with \>50% pain improvement will determine the effectiveness of HF-TES. Responses to treatment provided by a specialist physician and licensed vocational nurse will also be compared. Participants will be followed for 3 months following treatment completion.

Research Team

A. Lenore Ackerman, MD, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

This trial is for women aged 18-65 with chronic pelvic pain lasting over 6 months and a daily pain score of at least 4. Participants should have palpable trigger points in their pelvic floor muscles but no other major health issues or causes for their pain, such as interstitial cystitis or recent surgeries. They must not be pregnant, planning pregnancy, or have had childbirth within the last year.

Inclusion Criteria

I am a woman aged between 18 and 65.

I have noticeable pain points in my pelvic floor muscles.

I agree not to start any new pain treatments during the study.

Exclusion Criteria

I cannot attend weekly clinic visits.

I have been diagnosed with a specific cause of pelvic pain.

Inability to sign an informed consent, fill out questionnaires, or complete study interviews

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either high-frequency transvaginal electrical stimulation (HF-TES) or usual care for myofascial pelvic pain

8 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

2 visits (in-person)

Treatment Details

Interventions

• Transvaginal Electrical Stimulation

Trial Overview The study tests transvaginal electrical stimulation using a device called Urostym against standard care (education, stretching, low-impact exercise) to treat Myofascial Pelvic Pain. It's a three-arm randomized study where nursing staff will administer the treatment and compare it to specialist-provided care over a period of three months.

Participant Groups

Group I: Usual Care Active Control 1 Intervention

The current standard, first line treatment for MPP is a program of education, home exercises, and stretching. At enrollment, subjects will be counseled about the origins of myofascial pain in a one-on-one setting with the aid of informational handouts. They will be counseled about specific practices, such as Kegel exercises, volitional holding of urine or stool, and intensive exercise, that aggravate pelvic floor hypertonicity. They will be counseled about appropriate hydration and maintaining an adequate bowel regimen to avoid constipation. A stretching regimen aimed at abdominal and pelvic muscle release with elements of self-massage should be performed three times daily. Lastly, subjects will be prescribed 20 minutes of walking daily. Subjects will be recommended to continue this long-term, self-care program indefinitely.

Group II: HF-TES by LVN Active Control 1 Intervention

In-office pulsed HF-TES will be delivered by licensed vocational nurse using the Urostym® clinic-based Pelvic Floor Rehabilitation System. An LVN will undergo didactic and practical training, which will include a detailed orientation to the device. Sessions of electric muscle stimulation will be performed at a frequency of 200 Hz (to induce a passive pelvic floor muscle contraction) for 20 min weekly using a pulse duration of 1 ms of stimulation and an interpulse interval of 4.1 ms. Stimulation intensity (current) will be adjusted manually to palpable, but not painful, stimulation. Vaginal and surface abdominal electromyographic monitoring (EMG) will be conducted throughout the treatment session, recording the average pre- and post-treatment values for each session. In subjects whose pelvic floor EMG does not normalize to \<4 millielectronvolts (mV) in a 20-minute session, the subsequent session will be increased to 30 minutes.

Group III: HF-TES by Physician Active Control 1 Intervention

A urogynecologic specialist will deliver HF-TES in office using Urostym® pelvic floor rehabilitation system. A physician will undergo didactic and practical training, which will include a detailed orientation to the device. Sessions of electric muscle stimulation will be performed at a frequency of 200 Hz (to induce a passive pelvic floor muscle contraction) for 20 min weekly using a pulse duration of 1 ms of stimulation and an interpulse interval of 4.1 ms. Stimulation intensity (current) will be adjusted manually to palpable, but not painful, stimulation. Vaginal and surface abdominal electromyographic monitoring (EMG) will be conducted throughout the treatment session, recording the average pre- and post-treatment values for each session. In subjects whose pelvic floor EMG does not normalize to \<4 millielectronvolts (mV) in a 20-minute session, the subsequent session will be increased to 30 minutes.

Transvaginal Electrical Stimulation is already approved in European Union, United States for the following indications:

Approved in European Union as Transvaginal Electrical Stimulation for:

• Urinary incontinence
• Pelvic floor disorders
• Myofascial pelvic pain

Approved in United States as Transvaginal Electrical Stimulation for:

• Urinary incontinence
• Pelvic floor disorders
• Myofascial pelvic pain

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

Findings from Research

Intravaginal electrical stimulation (IVES) significantly reduced chronic pelvic pain (CPP) in women compared to a placebo, with 80% of those starting with active IVES reporting lower pain scores after treatment.

In a crossover study of 26 women, those who initially received placebo showed a notable improvement in pain levels when switched to active IVES, indicating its efficacy in managing CPP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial. de Bernardes, NO., Marques, A., Ganunny, C., et al.[2010]

In a study of 66 women with chronic pelvic pain due to levator ani spasm, 52% reported improvement in their pain after receiving intravaginal electrical stimulation, suggesting it can be an effective adjunctive therapy.

Follow-up data indicated that 51% of patients maintained their improvement for at least 30 weeks, highlighting the potential long-term benefits of this treatment without significant differences in demographics affecting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation in the treatment of pelvic pain due to levator ani spasm. Fitzwater, JB., Kuehl, TJ., Schrier, JJ.[2019]

A randomized controlled trial involving 22 women with deep endometriosis showed that both acupuncture-like TENS and self-applied TENS significantly reduced chronic pelvic pain and deep dyspareunia after 8 weeks of treatment.

Both TENS methods improved the quality of life for participants, indicating that TENS can be an effective complementary treatment for managing pain associated with deep endometriosis, even in women already undergoing hormone therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of complementary pain treatment for women with deep endometriosis through Transcutaneous Electrical Nerve Stimulation (TENS): randomized controlled trial. Mira, TA., Giraldo, PC., Yela, DA., et al.[2022]

A study involving 24 women with chronic pelvic pain showed that intravaginal electrical stimulation significantly reduced pain levels immediately after treatment and continued to provide relief at 2 weeks, 4 weeks, and 7 months post-treatment.

The treatment also led to a significant decrease in complaints of dyspareunia (pain during intercourse), indicating its potential effectiveness in improving overall pelvic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravaginal electrical stimulation for the treatment of chronic pelvic pain. de Oliveira Bernardes, N., Bahamondes, L.[2006]

Electrical stimulation (ES) significantly improved pelvic floor muscle function and reduced pain in 29 women with sexual pain disorders, as evidenced by a decrease in Visual Analog Scale (VAS) pain scores and improvements in the Female Sexual Function Index (FSFI).

The study showed that the intensity of electrical current tolerated by participants increased over the 10-week treatment period, indicating a positive adaptation to the therapy, and 4 out of 9 women with vaginism were able to resume coital activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical stimulation (ES) in the management of sexual pain disorders. Nappi, RE., Ferdeghini, F., Abbiati, I., et al.[2004]

Both surface electrical stimulation (SES) and intravaginal electrical stimulation (IVES) significantly improved urinary leakage and pelvic floor muscle (PFM) contraction pressure in women with stress urinary incontinence (SUI), based on a study of 48 women aged over 50.

While both treatments enhanced quality of life and reduced urinary incontinence, only IVES resulted in a significant increase in PFM strength, indicating that the method of stimulation may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of surface and intravaginal electrical stimulation in the treatment of women with stress urinary incontinence: randomized controlled trial. Correia, GN., Pereira, VS., Hirakawa, HS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Use of intravaginal electrical stimulation for the treatment of chronic pelvic pain: a randomized, double-blind, crossover clinical trial. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

Electrical stimulation in the treatment of pelvic pain due to levator ani spasm. [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of complementary pain treatment for women with deep endometriosis through Transcutaneous Electrical Nerve Stimulation (TENS): randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Intravaginal electrical stimulation for the treatment of chronic pelvic pain. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Electrical stimulation (ES) in the management of sexual pain disorders. [2004]

6. Ireland pubmed.ncbi.nlm.nih.gov

Effects of surface and intravaginal electrical stimulation in the treatment of women with stress urinary incontinence: randomized controlled trial. [2022]