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NCT06796985 · ClinicalTrials.gov registry record · Phase 1

Botox for Chronic Pelvic Pain

A Phase 1 study of Pelvic Floor Disorders, sponsored by University of Miami.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
1
Study location

NCT06796985: Recruiting Phase 1 study of Pelvic Floor Disorders, sponsored by University of Miami.

NCT06796985 is a Phase 1 study of Pelvic Floor Disorders that is actively recruiting participants, run by University of Miami. The registered enrollment target is 30 participants, below the 113-participant average among 11 other Pelvic Floor Disorders trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06796985, a Phase 1 study of Pelvic Floor Disorders, is actively recruiting participants, sponsored by University of Miami.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

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.

Conditions Studied

Interventions

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

Study Locations (1)

Florida

  • University of Miami - Miami

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2025-02-24
Est. Completion 2027-03-22
Phase Phase 1
University of Miami

721 total trials

What NCT06796985 shows while recruiting

NCT06796985 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 113-participant average among 11 other Pelvic Floor Disorders trials with a reported enrollment target (73% lower).

The record links to 1 condition, with Pelvic Floor Disorders appearing as the primary indexed condition, and to 2 interventions - of which Botulinum neurotoxin is the first listed.

NCT06796985 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT06796985 about?

NCT06796985 is a clinical study titled "Botox for Chronic Pelvic Pain". 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) o...

What is the current status of trial NCT06796985?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-02-24. Estimated completion is 2027-03-22.

What conditions does trial NCT06796985 study?

This clinical trial studies the following conditions: Pelvic Floor Disorders.

What interventions are being tested in trial NCT06796985?

The interventions under investigation include: Botulinum neurotoxin (DRUG), High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device (DEVICE).

Who is sponsoring clinical trial NCT06796985?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06796985 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pelvic Floor Disorders

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06796985's enrollment target sits among peer trials

30 11th of 11 higher than 1 of 11 other Pelvic Floor Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pelvic Floor Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06796985, the US trial registry maintained by the National Library of Medicine. NCT06796985 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.