Botox for Pelvic Floor Disorders

Overseen By Yingchun Zhang, PhD

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of Miami

Disqualifiers: Males, Pelvic malignancy, Neurological disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 15 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether targeted Botox injections can better relieve pain and tightness in the pelvic floor compared to usual methods. Researchers aim to understand both the benefits and drawbacks of these precise injections for women with pelvic floor disorders. Participants will begin with either a standard injection or a specialized guided injection, then switch to the other method, remaining in the trial for up to 15 months. Women who have experienced pelvic pain or discomfort for over six months, without a clear cause like a urinary infection, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that botulinum neurotoxin, or Botox, has been studied for its safety and effectiveness in treating pelvic floor disorders. In one study, patients experienced less pain six weeks after receiving Botox injections, suggesting it can help reduce pain for some people. However, another study did not find Botox helpful for managing chronic pelvic pain in women. This mixed evidence indicates that while Botox may work for some, it might not be effective for everyone.

In terms of safety, Botox is usually well-tolerated, but like any treatment, it can have side effects. Some studies have reported issues like fecal incontinence (difficulty controlling bowel movements) after Botox treatments. These side effects may not occur in everyone, but they are important to consider.

As this is a Phase 1 trial, the main focus is on assessing the safety of the treatment. Researchers are closely monitoring for any side effects to ensure it is safe for people to use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about this trial because it aims to refine how botulinum neurotoxin, commonly known as Botox, is used for pelvic floor disorders. Unlike traditional treatment methods that typically involve standard injection protocols, this trial is exploring the potential benefits of using high-density surface electromyography (HD-sEMG) to guide injections. This approach could make Botox injections for pelvic floor disorders more precise by targeting the injections more accurately, potentially improving outcomes and reducing side effects. By comparing standard injection techniques with this advanced, guided method, researchers hope to discover a more effective way to alleviate symptoms for patients.

What evidence suggests that botulinum neurotoxin might be an effective treatment for pelvic floor disorders?

Research has shown that Botox, a well-known treatment, might help reduce pelvic floor pain. In one study, patients reported significantly less pain six weeks after receiving Botox injections. Another study found that over 33% of patients experienced a clear reduction in their average pain levels. However, some studies did not find improvement in women with chronic pelvic pain who had previous muscle therapy. Despite these mixed results, this trial will explore two different injection methods for administering Botox to see if it can improve life for those with chronic pelvic pain. Participants will be assigned to either Group A, which uses a standard injection template followed by HD-sEMG guided injection, or Group B, which uses HD-sEMG guided injection followed by a standard injection template. ^{1 2 6 7 8}

Who Is on the Research Team?

Yingchun Zhang, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for women experiencing chronic pelvic pain due to pelvic floor disorders. Participants should be seeking treatment and have a diagnosis of hypertonicity (tightness) in the pelvic muscles.

Inclusion Criteria

Able to provide informed consent

I am a woman aged between 18 and 60.

I have been diagnosed with interstitial cystitis or bladder pain.

Exclusion Criteria

Hypersensitivity to botulinum neurotoxin

I am a woman under 18 or over 60 years old.

I have a bleeding disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard injection template followed by HD-sEMG guided injection or HD-sEMG guided injection followed by standard injection template

15 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Botulinum neurotoxin

Trial Overview The study tests if targeted Botox injections using a high-density surface electromyographic device can provide better pain relief than standard injection methods for women with tight pelvic muscles.

How Is the Trial Designed?

Group I: Group B: HD-sEMG guided injection followed by standard injection template Experimental Treatment 2 Interventions

Participants will be in this group for up to 15 months

Group II: Group A: Standard injection template followed by HD-sEMG guided injection Experimental Treatment 2 Interventions

Participants will be in this group for up to 15 months

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

Botulinum toxin injections into the pelvic floor muscles significantly reduce pain in female patients with pelvic floor myofascial pain, with a mean pain score reduction of 20.3 at 6 weeks and 19.4 at 12 weeks post-injection.

The treatment also improves secondary symptoms such as dyspareunia (pain during intercourse), dyschezia (pain during bowel movements), and overall quality of life, indicating its potential as an effective intervention for pelvic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Botulinum Toxin for Treatment of Symptomatic Pelvic Floor Myofascial Pain in Women: A Systematic Review and Meta-analysis. Meister, MR., Brubaker, A., Sutcliffe, S., et al.[2022]

In a study of four patients with puborectalis syndrome who did not respond to previous treatments, botulinum toxin injections significantly improved bowel movement frequency from zero to six per week, with only one patient needing laxatives after treatment.

The treatment also reduced anal resting tone and improved the anorectal angle, indicating better bowel function, although one patient experienced a recurrence of symptoms after 16 weeks, highlighting the need for potential repeat injections to maintain benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin in the treatment of outlet obstruction constipation caused by puborectalis syndrome. Maria, G., Brisinda, G., Bentivoglio, AR., et al.[2019]

Botulinum neurotoxin injections into the prostate have shown promising results in reducing prostate size, lowering prostate-specific antigen levels, and improving urinary flow rates, with effects lasting over 6 months, based on a review of 8 peer-reviewed studies.

While botulinum toxin may serve as a potential treatment for benign prostatic hyperplasia and chronic prostatitis, its use in the prostate is currently off-label, and further large-scale studies are needed to confirm its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of botulinum toxin in the prostate. Chuang, YC., Chancellor, MB.[2010]

Botulinum neurotoxin is effective in treating lower urinary tract dysfunction and prostatic disorders, providing a therapeutic option for these conditions.

Recent studies also indicate that botulinum toxin can effectively manage vaginismus in women with pelvic floor muscle tension, highlighting its expanding role in pelvic health treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum toxin for urogenital conditions. Eccleston, KJ., Woolley, PD.[2013]

In a pilot study of 28 women with high-tone pelvic floor dysfunction (HTPFD), electromyography-guided Botox injections significantly improved pelvic pain and quality of life, with 80.9% of participants reporting improvement at 8, 12, and 24 weeks post-injection.

The treatment also led to a notable reduction in dyspareunia (pain during intercourse), with 83.3% of sexually active participants reporting less pain by 24 weeks, indicating that Botox may effectively alleviate symptoms in women who have not responded to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulinum Toxin A Injections Into Pelvic Floor Muscles Under Electromyographic Guidance for Women With Refractory High-Tone Pelvic Floor Dysfunction: A 6-Month Prospective Pilot Study. Morrissey, D., El-Khawand, D., Ginzburg, N., et al.[2022]

In a study of 15 patients with nonrelaxing puborectalis syndrome, botulinum A toxin injections led to significant improvement in symptoms for 13 patients, with issues like straining during defecation disappearing and stool frequency normalizing.

The treatment was safe, with no adverse side effects reported, and the benefits lasted for an average of 4.8 months before requiring reinjection, making it a viable option after biofeedback therapy fails.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Botulin toxin in the treatment of nonrelaxing puborectalis syndrome. Shafik, A., El-Sibai, O.[2018]

Botulinum toxin, while used to treat pelvic floor tension myalgia, has a poorly understood safety profile, as highlighted by a reported case of ischiorectal fossa abscess following injections.

This case emphasizes the need for physicians to be cautious about potential complications and to consider alternative injection techniques and proper antiseptic preparation before administering botulinum toxin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischiorectal fossa abscess after pelvic floor injection of botulinum toxin. Brueseke, TJ., Lane, FL.[2016]

Botulinum toxin (BoNT) has been effectively used since the 1970s for treating muscle disorders, and its applications have expanded to include various urological and pelvic floor dysfunctions, such as overactive bladder and chronic anal fissures.

BoNT works by blocking cholinergic nerve endings, which helps reduce excessive muscle contractions, but it does not affect responses mediated by nitric oxide, indicating a specific mechanism of action that could be beneficial for targeted treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of bladder, prostatic and pelvic floor disorders. Brisinda, G., Maria, G., Bentivoglio, AR., et al.[2019]

A novel technique using four-dimensional ultrasound (4D-US) for injecting botulinum toxin-A (BoNT-A) into pelvic floor muscles was successfully performed on 31 women, demonstrating accurate placement and confirmation of fluid expansion within the muscle.

This ultrasound-guided method may be safer than traditional finger-guided techniques, reducing the risk of needle-stick injuries for the operator while effectively treating pelvic floor muscle overactivity associated with chronic pelvic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Four-dimensional ultrasound guidance for pelvic floor Botulinum toxin-A injection in chronic pelvic pain: a novel technique. Nesbitt-Hawes, EM., Dietz, HP., Abbott, JA.[2018]

Botulinum toxin is a safe and effective treatment for conditions like overactive bladder and neurogenic detrusor overactivity, especially when other drug therapies are ineffective or poorly tolerated, as demonstrated in large multicenter randomized controlled trials.

In addition to its approved uses, botulinum toxin is also being used off-label for urological issues such as detrusor external sphincter dyssynergia and pelvic pain syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Urologic applications of botulinum toxin. King, A., Quirouet, A., Moore, CK.[2016]

A study analyzing 162 individual case safety reports of botulinum neurotoxin type A (BoNT-A) in children with cerebral palsy found a significant association between BoNT-A and adverse drug reactions (ADRs), particularly a higher risk of serious outcomes like death (ROR=11.1).

The most common ADRs reported were dysphagia, asthenia, and muscular weakness, indicating that the systemic spread of BoNT-A may contribute to these adverse effects, suggesting that children may experience a higher risk of ADRs compared to adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug reactions of botulinum neurotoxin type A in children with cerebral palsy: a pharmaco-epidemiological study in VigiBase. Montastruc, J., Marque, P., Moulis, F., et al.[2017]

Botulinum neurotoxin shows promise for treating urological conditions such as overactive bladder and chronic pelvic pain, although it is not yet approved for these uses.

The treatment is generally well tolerated with predictable side effects primarily affecting the urogenital tract, but there have been rare reports of severe complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Botulinum toxin useful in urological problems]. Vaarala, M., Perttilä, I., Hellström, P.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7793632/

Effectiveness of botulinum toxin for treatment ... A statistically significant reduction in patient-reported pain scores was noted at 6 weeks after botulinum toxin injection.

2. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/1471-0528.17991

The Efficacy of Botulinum Toxin A Injection in Pelvic Floor ... Mixed models for repeated measurements were used for analysis. Results. A 33% reduction or more in average pain score was reported by 15 ...

3. obgproject.com obgproject.com/2024/12/06/rct-results-do-botox-injections-improve-symptoms-for-women-with-chronic-pelvic-pain-unresponsive-to-pelvic-floor-muscle-therapy/

RCT Results: Do Botox Injections Improve Symptoms for ... BTA injections do not seem to improve chronic pelvic pain among women who underwent previous pelvic floor muscle therapy; The authors state.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0041010125001102

Chronic pelvic pain and botulinum toxin Botulinum toxin is being explored as a treatment for chronic pelvic pain, a major cause of suffering and disability in both women and men worldwide.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9569307/

The efficacy of botulinum toxin a injections in pelvic floor ... The available studies show that BTA injections significantly reduce pain levels and improve quality of life at 6 months follow-up.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06796985

Study Details | NCT06796985 | Botox for Chronic Pelvic Pain The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders. Official ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0041010123002970

Effectiveness and safety of botulinum neurotoxin for ... The outcomes comprise short-term and long-term symptom improvement, various anorectal function measurements, complications of fecal incontinence, and symptom ...

8. ics.org ics.org/2023/abstract/97

Patient Reported Outcomes of Electrical-Stimulation ... Electrical stimulation-guided Botulinum toxin A to the pelvic floor muscles provided significant relief of pelvic pain in a majority of patients ...