Botulinum Neurotoxin Injections for Chronic Pelvic Pain

Recruiting in Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: HillMed Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate if it is possible to use intravaginal high-density surface electromyography to guide Botulinum neurotoxin (BoNT) injection to treat pelvic floor muscle overactivity that complicates Chronic Pelvic Pain (CPP).

Eligibility Criteria

Women aged 18-60 with chronic pelvic pain due to overactive pelvic floor muscles, diagnosed with interstitial cystitis or myofascial pain. They must have had symptoms like bladder discomfort and frequent urination for at least 6 months without other causes. Participants should not be pregnant, breastfeeding, planning pregnancy soon, have a history of certain diseases (like neurological disorders), previous pelvic surgeries, or substance abuse.

Inclusion Criteria

Ability to provide informed consent

I have had bladder or pelvic pain and frequent urination for over 6 months without any other known cause.

I have been diagnosed with muscle pain due to tight muscle fibers.

+4 more

Exclusion Criteria

I have a bleeding disorder.

Pregnancy, breast feeding or desiring for pregnancy in the coming year

I have a history of neurological disorders like MS or ALS.

+12 more

Participant Groups

The trial is testing if using high-density surface electromyography inside the vagina can help guide injections of Botulinum neurotoxin to treat overactivity in the pelvic floor muscles that contribute to chronic pelvic pain.

2Treatment groups

Experimental Treatment

Active Control

Group I: Guided InjectionExperimental Treatment2 Interventions

For the guided injection, pelvic floor injections (total of 4) will be made to the pubococcygeus and puborectalis muscles each, at NMJ locations (1.5 ml per site), at patient-specific locations and depths identified from vaginal HD-sEMG recordings. NMJ mappings will be generated for each participant. The channel locations will provide angle measurements for each NMJ. The device will calculate these parameters based on acquired HD-sEMG. The index finger will be used for palpation and guidance of injection needle through the vaginal mucosa to the defined injection sites. The BoNT dosage with respect to the total 200 units administered to each site will be patient specific, determined as the ratio of the resting average resting root-mean square (RMS) value of a specific region divided by the total average resting RMS.

Group II: Template InjectionActive Control1 Intervention

For the standard template injection, 200 units of BoNT diluted in 6mL of preservative saline will be prepared. 1/4 of the prepared BoNT solution will be administered to each of the pubococcygeus and puborectalis muscle at 5 and 7 o'clock position, respectively. The index finger will be used for palpation as the 20-gauge spinal needle with a trumpet guide (i.e. paracervical block kit) piercing through the vaginal mucosa to the intended muscle groups. The syringe will be withdrawn before each injection to avoid intravascular injection.