Botulinum Neurotoxin Injections for Chronic Pelvic Pain

This trial tests a new method of using Botulinum Neurotoxin (BoNT) injections to treat Chronic Pelvic Pain (CPP). Researchers aim to determine if a special device can better target overactive pelvic floor muscles during injections. Participants are divided into two groups: one receives standard injections, while the other receives injections guided by a high-density surface electromyographic, precision Botulinum Neurotoxin injection guidance medical device. Women who have experienced bladder or pelvic pain for at least six months, along with frequent urination, and have been diagnosed with interstitial cystitis/bladder pain syndrome may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking medical advancements.

The trial protocol does not specify if you need to stop taking your current medications, but it mentions that ongoing Botulinum neurotoxin therapies require a complete washout period (time without taking the medication) before participation.

Research has shown that botulinum toxin (BoNT) injections are generally safe for treating chronic pelvic pain. Studies have found these injections to be effective and usually well-tolerated by patients with similar conditions. For example, in other studies on chronic pelvic pain, BoNT injections reduced symptoms without causing major side effects.

Researchers are excited about these treatments for chronic pelvic pain because they offer a more tailored approach than traditional methods like pain medications, physical therapy, or surgery. The Botulinum Neurotoxin injections being studied have two distinctive methods: Template Injection and Guided Injection. The Template Injection delivers the neurotoxin to standard muscle sites, whereas the Guided Injection uses high-definition surface electromyography (HD-sEMG) to map and target specific neuromuscular junctions for each patient. This personalized targeting could enhance effectiveness by ensuring the neurotoxin reaches the most relevant areas for pain relief, potentially leading to more significant symptom improvement compared to the more general approaches used today.

Research has shown that botulinum neurotoxin (BoNT) can help reduce chronic pelvic pain. Studies have found that many women experienced at least a 33% decrease in pain after receiving these injections. In this trial, participants will receive either a standard template injection or a guided injection using high-density surface electromyography (HD-sEMG) to map muscle activity. The guided injection aims to increase precision and possibly enhance effectiveness. These findings suggest that BoNT injections, particularly when precisely guided, might offer relief for those with chronic pelvic pain.¹²³⁴⁶