Health TrialsbyHealthPanel

Botox for Chronic Pelvic Pain

ConditionPelvic Floor Disorders
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorUniversity of Miami

About this trial

The purpose of this research study is to find out if precise, targeted injection of botulinum neurotoxin (commonly known as Botox) provides better relief of pelvic floor hypertonicity and pain than the standard method being used. The researchers want to better understand the effects (good and bad) of targeted botulinum neurotoxin injections in women with pelvic floor disorders.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females between 18 and 75 years of age

Clinical diagnosis of chronic pelvic pain

Complaints of pain, pressure, or discomfort in the bladder and/or pelvic area for the past 6 months or more, associated with lower urinary tract symptoms (such as frequency of urination), in the absence of other explanation of the symptoms (e.g., UTI) *

Myofascial pain diagnosed with palpable bands or nodules of contracted muscle fibers

Disqualifiers

Males

Women < 18 and > 76 years of age

History of pelvic malignancy and sexual transmitted diseases that is currently not in remission

Bleeding disorder such as coagulopathy

Trial design

Design model

Crossover

Treatments tested in this trial

  • Botulinum neurotoxin

    Drug

    Botulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm). Participants will receive this drug twice throughout the duration of the study. Approximately 200 units of botulinum neurotoxin will be administered per injection.

  • High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device

    Device

    A personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management. The device will be used five times during the study. Each use will last approximately ten minutes.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Group A: Standard injection template followed by HD-sEMG guided injectionExperimental treatment 2 interventions
Group B: Group B: HD-sEMG guided injection followed by standard injection templateExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Hypertonic index of the pelvic muscles as measured by high-density surface-EMG (HD-sEMG)

The muscle hypertonicity Index measured by using HD-sEMG which is a ratio between the root mean square (RMS) of pelvic floor muscle EMG at rest and contraction.

Time frame
1 month post-injection

Secondary outcomes

1

Change in Self-Report Pelvic Pain as measured by Global Response Assessment (GRA)

Assessment is scored 0-6. Lower score indicates less pain while higher score indicates more pain.

Time frame
Baseline, 1 month post-injection
2

Change in Self-Report Pelvic Symptoms as measured by Global Response Assessment (GRA)

Assessment is scored 1-7. Lower score indicates worse symptoms while higher score indicates less symptoms.

Time frame
Baseline, 1 month post-injection
3

Change in Self-Report Pelvic Pain as measured by the Female Genitourinary Index

Sum score will be collected and scores range from 0-45. Lower score indicates less pain while higher score indicates more pain.

Time frame
Baseline, 1 month post-injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov
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