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Botulinum Toxin

Botulinum Neurotoxin Injections for Chronic Pelvic Pain

Phase < 1
Waitlist Available
Research Sponsored by HillMed Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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., urinary tract infection)
Myofascial pain diagnosed with palpable contracted muscle fibers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-months post injection
Awards & highlights

Study Summary

This trial will test if using electromyography to guide botulinum toxin injection can help treat pelvic floor muscle overactivity that causes chronic pelvic pain.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include localized pain where the injection was given, muscle weakness around the treated area, allergic reactions to Botulinum neurotoxin, and less commonly systemic effects such as general muscle weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had bladder or pelvic pain and frequent urination for over 6 months without any other known cause.
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I have been diagnosed with muscle pain due to tight muscle fibers.
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I am a woman aged between 18 and 60.
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I have been diagnosed with interstitial cystitis/bladder pain syndrome.
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I have been diagnosed with pelvic muscle tenderness.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-months post injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-months post injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hypertonic metrics of the pelvic muscles defined by intra-vaginal surface EMG
Secondary outcome measures
Global response assessment

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Botulinum Neurotoxin
2020
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

HillMed Inc.Lead Sponsor
Baylor College of MedicineOTHER
997 Previous Clinical Trials
6,001,973 Total Patients Enrolled
3 Trials studying Chronic Pain
265 Patients Enrolled for Chronic Pain
University of HoustonOTHER
146 Previous Clinical Trials
47,491 Total Patients Enrolled
1 Trials studying Chronic Pain
117 Patients Enrolled for Chronic Pain

Media Library

Botulinum Neurotoxin (Botulinum Toxin) Clinical Trial Eligibility Overview. Trial Name: NCT05062902 — Phase < 1
Chronic Pain Research Study Groups: Template Injection, Guided Injection
Chronic Pain Clinical Trial 2023: Botulinum Neurotoxin Highlights & Side Effects. Trial Name: NCT05062902 — Phase < 1
Botulinum Neurotoxin (Botulinum Toxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05062902 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research program have any open spots for participants?

"Clinicaltrials.gov has this study listed as not actively recruiting, with the initial post date being January 1st 2023 and an update on June 7th 2022. While it is not taking in patients at the moment, there remain 492 other trials that are still onboarding participants."

Answered by AI

Are there any openings for me to partake in this clinical experiment?

"This research project seeks 46 eligible participants aged 18 to 60, with clinically diagnosed interstitial cystitis/bladder pain syndrome (IC/BPS). Eligibility criteria include: myofascial discomfort and pelvic muscle tenderness on digital examination, hypertonicity of pelvic floor muscles as measured by vaginal manometry (>35 cm∙H2O), chronic bladder and/or pelvic area pain for six months or more unassociated other causes, and the ability to provide informed consent."

Answered by AI

Does this clinical examination accept individuals aged 55 and over?

"Patients between 18 and 60 years old are eligible for this medical trial. Young participants can look into the 41 different clinical trials available to them, while seniors have access to 432 studies catered specifically to their age group."

Answered by AI
~31 spots leftby Dec 2027