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Can botulinum toxin calm stubborn pelvic muscle pain?

NCT ID NCT01967524

Symptom relief Sponsor: Nantes University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether injecting botulinum toxin A along with the local anesthetic ropivacaine into painful pelvic floor muscle trigger points eases chronic myofascial pelviperineal pain better than ropivacaine alone. The trial enrolls adults who have had pelvic or perineal pain for at least six months that persists despite painkillers and physical therapy. Participants receive one set of injections and researchers track their pain and quality of life for up to six months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
botulinum toxin A combined with ropivacaine, a local anesthetic
What this could lead to
If it works, this could offer a longer-lasting injection option for chronic pelvic and perineal muscle pain that has not responded to physical therapy or standard painkillers.
What could go wrong
Botulinum toxin can cause temporary muscle weakness or spread beyond the injection site, and the trial may show no added benefit over the local anesthetic alone. Results from 80 people may not apply to everyone with this pain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

80 people

The number who actually took part.

Start date

Sep 2013

Finished

Aug 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age \> 18 years * Patient presenting a "dysfunctional" pain of the pelvis or the perineum (without lesional pathology justifying a specific treatment) by an endopelvic touch * Pain evolving since at least 6 months and persisting in spite of the analgesic treatments and the physiotherapy * Patient presenting to the clinical examination one or several active triggerpoints found on the internal obturating muscles and/or elevators of the anus, with a maximum of 10 triggerpoints on the whole body. * Patient presenting an average of the maximal pains of the week before the inclusion superior or equal to 4 and inferior or equal to 9/10 (evaluation of the daily maximal pain on a digital scale from 0 to 10) * Signed informed consent * Subjects affiliated with an appropriate social security system Exclusion Criteria: * Patients with bleeding risk and anticoagulant therapy * Intolerance of botulinum toxin A, ropivacaïne and nitrous oxide * Injection of botulinum toxin in any place whatsoever in the previous 3 months * Pregnancy and breast feeding * Antibiotic treatment by aminoglycosides * Recent anti-inflammatory treatment * Severe myasthenia * Lambert-Eaton syndrome * Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia * Beck score \> 16 * Patients having an average of the maximal pains of the previous week lower than 4

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myofascial pelviperineal pain

Contacts and locations

Locations

  • Besançon University Hospital

    Besançon, 25030, France

  • Clermont-Ferrand University Hospital

    Clermont-Ferrand, 63003, France

  • Clinique Axium

    Aix-en-Provence, 13097, France

  • La Réunion University Hospital

    Saint Denis de La Réunion, 97405, France

  • Nantes University Hospital

    Nantes, 44093, France

  • Rennes University Hospital

    Rennes, 35033, France