Dyssynergic DefaecationNCT04879524
Infracoccygeal Botox for Dyssynergia
An observational study of Dyssynergic Defaecation and Evacuation Disorder, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Background: Constipation is a common problem, affecting up to 20% of the population during their lifetime. Some patients respond poorly to standard treatments such as laxatives. A subgroup of these have dyssynergic defaecation where the muscles that control bowel movements fail to relax during pushing, preventing… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dyssynergic Defaecation, Evacuation Disorder, Anismus
- What is being tested?
- Percutaneous infracoccygeal Botulinum toxin injection to puborectalis
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Aug 2021to 20 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients diagnosed with dyssynergic defaecation using Rome IV criteria
Who may be able to join
- Adult patients aged between 18 and 80 years
- Diagnosis of dyssynergic defaecation using Rome IV criteria
- Ability to understand written and spoken English
- Ability and willingness to give informed consent
Who cannot join
- Paediatric patients (age under 18 years)
- Diagnosis of defined structural or metabolic diseases that could cause constipation, such as Hirschsprung's disease, Parkinson's disease, multiple sclerosis, hypothyroidism (untreated), diabetic neuropathy, muscular dystrophy, motor neurone diseases, spinal injury leading to paraplegia, cauda equina syndrome
- Psychiatric or physical inability to comply with the study protocol (including e-diary assessments) at investigator discretion.
- Contra-indications to BTXA such as allergies, pregnancy (or intention to become pregnant during study period), breastfeeding, generalised disorders of muscle activity, myasthenia gravis
- Contra-indications to infracoccygeal injection at injection site such as infection or pressure sore, spina bifida, pilonidal disease, bleeding disorders (including therapeutic anticoagulation)
- Morbid obesity (BMI ≥ 40)
- Defunctioning loop or end stoma in situ
- External rectal prolapse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis for the Treatment of Dyssynergic Defaecation: a Prospective Observational Study
Background:
Constipation is a common problem, affecting up to 20% of the population during their lifetime. Some patients respond poorly to standard treatments such as laxatives. A subgroup of these have dyssynergic defaecation where the muscles that control bowel movements fail to relax during pushing, preventing evacuation of stools. Currently, the mainstay of treatment requires muscle retraining by a therapist using a technique called biofeedback. Patients in whom biofeedback has failed are left with few options, one of which includes Botox injection into the pelvic floor muscles involved in the defaecation process. However, current method of injection is inaccurate and often requires anaesthesia. The investigators propose a novel technique for Botox delivery which reduces the risks and associated costs.
Read more
Objectives:
- The primary objective is to demonstrate technical feasibility of percutaneous infracoccygeal Botox injection as an alternative to transanal puborectalis muscle injection for the treatment of dyssynergic defaecation.
- The secondary objectives are to assess the safety and acceptability of this technique, and to derive pilot clinical effectiveness data to inform future studies.
Methods:
The investigators will carry out Botox injection into the puborectalis muscle under ultrasound guidance in the outpatient department. This will be done by percutaneous injection below the coccyx where the puborectalis has been demonstrated to be easily accessible. An electromyography of the puborectalis is obtained before the injection to demonstrate proof of mechanism. The investigators will collect data using a combination of questionnaires, patient baseline data, and anorectal physiology test results before and after the treatment.
Outcomes:
- Feasibility: procedure duration, rate of identification of puborectalis by ultrasound scan and pre-injection EMG, procedure limitations, and successful injection rate
- Safety: rate of adverse events
- Acceptability: patient pain and comfort, willingness to undergo repeat procedure
- Preliminary data on effectiveness: Cleveland Clinic constipation score, anorectal physiology test results
Read the detailed description
Patients with dyssynergic defaecation represent a subgroup of a larger group of patients presenting with symptoms of chronic constipation. The disorder is characterised by impaired stool expulsion as a result of inappropriate contraction of the pelvic floor musculation despite normal propulsive force during attempted defaecation. Failure of the puborectalis and/or anal sphincter muscles to relax during evacuation leads to a closed anal canal which prevents the emptying of stools.
A Cochrane review in 2014 on the treatment of chronic constipation in adults demonstrated a high prevalence of dyssynergic defaecation and a variety of treatments. In this group, biofeedback was found to be superior to oral diazepam, sham treatment, and laxatives; while surgical procedures such as partial division of the puborectalis muscle were more efficacious, the risks of adverse reaction, namely incontinence, were high. Thus, biofeedback therapy is the current gold-standard for the treatment of dyssynergia. The success rate of biofeedback in correcting or improving the symptoms in patients with dyssynergia varies between 33% and 80%. Difficulty arises in those in whom biofeedback is unsuccessful, as there is little, and conflicting, low quality evidence on alternative therapies.
One further therapeutic option uses injection of Botulinum toxin type A (BTXA) into the puborectalis and/or external anal sphincter muscles. This is currently the second-line treatment for dyssynergic defaecation in whom biofeedback has failed. A systematic review in 2016 on the use of BTXA in patients with 'anismus', a term previously used to describe dyssynergic defaecation, demonstrated initial clinical improvement in symptoms in 77.4% of patients. Two of the seven studies were conducted on participants in whom biofeedback therapy had failed. Complications were reported in 7.4% of patients (0 to 22.6%) and included faecal incontinence, which was minor and transient, posterior anal fissure, and rectal prolapse. The effect of BTXA was not permanent, with clinical improvement declining to 46% at four months after the injection. For this reason, several studies offered repeated treatments.
The delivery of BTXA injection varied between studies and institutions in terms of dosage and position of injection, but all were performed via perianal or transanal approaches, often requiring sedation or anaesthesia. There are several disadvantages of this approach including cost (operating theatre utilisation) and risks associated with anaesthesia and infection from passing the needle through a contaminated operative field. In addition, the injection site is defined blind by the surgeon's finger (an issue of accuracy of injection and hazard of needle stick injury).
The proposed study aims to demonstrate the technical feasibility of an alternative approach to delivering BTXA injection in adult patients with dyssynergic defaecation. This novel technique injects BTXA into the puborectalis muscle percutaneously using an infracoccygeal approach under ultrasound guidance. This allows the procedure to be performed in an outpatient radiology setting without the need for any form of anaesthesia or analgesia. The injection is performed in a clean operative field away from the anus, minimising risk of infection and the muscle can be clearly visualised (see below). These advantages will be particularly valuable in patients who require repeated procedures or those with multiple co-morbidities at high anaesthetic risk.
The utilisation of BTXA in human is well established. This medication is licensed for use in focal spasticity with well-established side-effects and interactions. Current evidence for the use of BTXA in dyssynergic defaecation is based on the conventional transanal approach, with report on efficacy and complications as previously stated.
The puborectalis is easily accessible below the coccyx, and is the site for ultrasonic assessment in the paediatric population. The identification of puborectalis muscle in the infracoccygeal position has not been described in the literature in the adult population. However, pilot imaging studies on a small number of non-obese subjects have been successful in easily identifying the puborectalis using ultrasound scan. This approach has the potential to allow accurate administration of BTXA injection under ultrasonic guidance in the outpatient setting without the need for anaesthesia or operating theatre utilisation. The general aim of this study is to demonstrate that percutaneous infracoccygeal BTXA injection is a valid alternative approach to transanal injection for the treatment of dyssynergic defaecation. Specifically, the investigators will determine technical feasibility (including pilot proof of mechanism), patient acceptability, safety, and pilot efficacy outcomes for a future definitive trial.
- Being tested
- Percutaneous infracoccygeal Botulinum toxin injection to puborectalis
- Keywords
- Botulinum toxin type A, Botox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous infracoccygeal Botulinum toxin injection to puborectalisProcedure or surgery
The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance.
In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete.
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous infracoccygeal Botulinum toxin injection to puborectalis | 100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units Receives: Procedure: Percutaneous infracoccygeal Botulinum toxin injection to puborectalis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rate of Identification of Puborectalis During Ultrasound Scan
The investigator will record the number of times the puborectalis muscle is successfully identified using ultrasound scan (muscle seen to contract on volition) and pre-injection EMG (change in EMG waveform on volitional contraction) by the radiologist and neurologist, respectively, at the beginning of the injection procedure.
Measured: Visit 3: week 18
Procedure Duration
The investigator will record the time (in minutes) taken to for the radiologist to complete the injection procedure
Measured: Visit 3: week 18
Procedure Limitations
The investigator will record any procedure or patient related factors which prevented a successful injection, e.g. body habitus or equipment failure.
Measured: Visit 3: week 18
Secondary outcomes (3)
Rate of Adverse Events
Any adverse events reported by the patients or their clinician following the injection
Measured: From visit 3 to visit 6: week 18 to 42
Patient's Level Pain and Comfort Assessed at Post-procedure
Following the procedure, the patient will complete a post-procedure questionnaire.
- The patient is asked to give their response to the statement "the procedure was painful" on a 5-point rating scale (strongly agree/ agree/ neutral/ disagree/ strongly disagree).
- The patient is asked to give their response to the statement "the procedure was comfortable" on a 5-point rating scale (strongly agree/ agree/ neutral/ disagree/ strongly disagree).
Measured: Visit 3: week 18
The Number of Patient Indicating *Yes*, They Would be Willing to Undergo a Repeat Procedure
The number of patients who answered Yes when asked if they will be willing to undergo a repeat procedure (yes/no) in a post-procedure questionnaire.
Measured: Visit 3: week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start6 Aug 2021
- Primary completion1 Aug 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dyssynergic DefaecationStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charles H Knowles, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879524
- Sponsor's protocol ID
- 291709
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2021
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Infracoccygeal Botulinum Toxin Injection to Puborectalis for the Treatment of Dyssynergic Defaecation: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04879524
- Acronym / sponsor ID
- 291709
- Keywords
- Botulinum toxin type A, Botox
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Constipation is a common problem, affecting up to 20% of the population during their lifetime. Some patients respond poorly to standard treatments such as laxatives. A subgroup of these have dyssynergic defaecation where the muscles that control bowel movements fail to relax during pushing, preventing evacuation of stools. Currently, the mainstay of treatment requires muscle retraining by a therapist using a technique called biofeedback. Patients in whom biofeedback has failed are left with few options, one of which includes Botox injection into the pelvic floor muscles involved in the defaecation process. However, current method of injection is inaccurate and often requires anaesthesia. The investigators propose a novel technique for Botox delivery which reduces the risks and associated costs.
Objectives:
- The primary objective is to demonstrate technical feasibility of percutaneous infracoccygeal Botox injection as an alternative to transanal puborectalis muscle injection for the treatment of dyssynergic defaecation.
- The secondary objectives are to assess the safety and acceptability of this technique, and to derive pilot clinical effectiveness data to inform future studies.
Methods:
The investigators will carry out Botox injection into the puborectalis muscle under ultrasound guidance in the outpatient department. This will be done by percutaneous injection below the coccyx where the puborectalis has been demonstrated to be easily accessible. An electromyography of the puborectalis is obtained before the injection to demonstrate proof of mechanism. The investigators will collect data using a combination of questionnaires, patient baseline data, and anorectal physiology test results before and after the treatment.
Outcomes:
- Feasibility: procedure duration, rate of identification of puborectalis by ultrasound scan and pre-injection EMG, procedure limitations, and successful injection rate
- Safety: rate of adverse events
- Acceptability: patient pain and comfort, willingness to undergo repeat procedure
- Preliminary data on effectiveness: Cleveland Clinic constipation score, anorectal physiology test results
Detailed description
Patients with dyssynergic defaecation represent a subgroup of a larger group of patients presenting with symptoms of chronic constipation. The disorder is characterised by impaired stool expulsion as a result of inappropriate contraction of the pelvic floor musculation despite normal propulsive force during attempted defaecation. Failure of the puborectalis and/or anal sphincter muscles to relax during evacuation leads to a closed anal canal which prevents the emptying of stools.
A Cochrane review in 2014 on the treatment of chronic constipation in adults demonstrated a high prevalence of dyssynergic defaecation and a variety of treatments. In this group, biofeedback was found to be superior to oral diazepam, sham treatment, and laxatives; while surgical procedures such as partial division of the puborectalis muscle were more efficacious, the risks of adverse reaction, namely incontinence, were high. Thus, biofeedback therapy is the current gold-standard for the treatment of dyssynergia. The success rate of biofeedback in correcting or improving the symptoms in patients with dyssynergia varies between 33% and 80%. Difficulty arises in those in whom biofeedback is unsuccessful, as there is little, and conflicting, low quality evidence on alternative therapies.
One further therapeutic option uses injection of Botulinum toxin type A (BTXA) into the puborectalis and/or external anal sphincter muscles. This is currently the second-line treatment for dyssynergic defaecation in whom biofeedback has failed. A systematic review in 2016 on the use of BTXA in patients with 'anismus', a term previously used to describe dyssynergic defaecation, demonstrated initial clinical improvement in symptoms in 77.4% of patients. Two of the seven studies were conducted on participants in whom biofeedback therapy had failed. Complications were reported in 7.4% of patients (0 to 22.6%) and included faecal incontinence, which was minor and transient, posterior anal fissure, and rectal prolapse. The effect of BTXA was not permanent, with clinical improvement declining to 46% at four months after the injection. For this reason, several studies offered repeated treatments.
The delivery of BTXA injection varied between studies and institutions in terms of dosage and position of injection, but all were performed via perianal or transanal approaches, often requiring sedation or anaesthesia. There are several disadvantages of this approach including cost (operating theatre utilisation) and risks associated with anaesthesia and infection from passing the needle through a contaminated operative field. In addition, the injection site is defined blind by the surgeon's finger (an issue of accuracy of injection and hazard of needle stick injury).
The proposed study aims to demonstrate the technical feasibility of an alternative approach to delivering BTXA injection in adult patients with dyssynergic defaecation. This novel technique injects BTXA into the puborectalis muscle percutaneously using an infracoccygeal approach under ultrasound guidance. This allows the procedure to be performed in an outpatient radiology setting without the need for any form of anaesthesia or analgesia. The injection is performed in a clean operative field away from the anus, minimising risk of infection and the muscle can be clearly visualised (see below). These advantages will be particularly valuable in patients who require repeated procedures or those with multiple co-morbidities at high anaesthetic risk.
The utilisation of BTXA in human is well established. This medication is licensed for use in focal spasticity with well-established side-effects and interactions. Current evidence for the use of BTXA in dyssynergic defaecation is based on the conventional transanal approach, with report on efficacy and complications as previously stated.
The puborectalis is easily accessible below the coccyx, and is the site for ultrasonic assessment in the paediatric population. The identification of puborectalis muscle in the infracoccygeal position has not been described in the literature in the adult population. However, pilot imaging studies on a small number of non-obese subjects have been successful in easily identifying the puborectalis using ultrasound scan. This approach has the potential to allow accurate administration of BTXA injection under ultrasonic guidance in the outpatient setting without the need for anaesthesia or operating theatre utilisation. The general aim of this study is to demonstrate that percutaneous infracoccygeal BTXA injection is a valid alternative approach to transanal injection for the treatment of dyssynergic defaecation. Specifically, the investigators will determine technical feasibility (including pilot proof of mechanism), patient acceptability, safety, and pilot efficacy outcomes for a future definitive trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Percutaneous infracoccygeal Botulinum toxin injection to puborectalis | – | Procedure: Percutaneous infracoccygeal Botulinum toxin injection to puborectalis100 units of Botulinum toxin type A (Botox, Allergan, Ireland) injection into the puborectalis muscle to each side of the midline, achieving a total of 200 units |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with dyssynergic defaecation using Rome IV criteria
Key inclusion criteria (4 listed)
- Adult patients aged between 18 and 80 years
- Diagnosis of dyssynergic defaecation using Rome IV criteria
- Ability to understand written and spoken English
- Ability and willingness to give informed consent
Key exclusion criteria (8 listed)
- Paediatric patients (age under 18 years)
- Diagnosis of defined structural or metabolic diseases that could cause constipation, such as Hirschsprung's disease, Parkinson's disease, multiple sclerosis, hypothyroidism (untreated), diabetic neuropathy, muscular dystrophy, motor neurone diseases, spinal injury leading to paraplegia, cauda equina syndrome
- Psychiatric or physical inability to comply with the study protocol (including e-diary assessments) at investigator discretion.
- Contra-indications to BTXA such as allergies, pregnancy (or intention to become pregnant during study period), breastfeeding, generalised disorders of muscle activity, myasthenia gravis
- Contra-indications to infracoccygeal injection at injection site such as infection or pressure sore, spina bifida, pilonidal disease, bleeding disorders (including therapeutic anticoagulation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous infracoccygeal Botulinum toxin injection to puborectalisThe intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance. In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete. | Procedure or surgery | Percutaneous infracoccygeal Botulinum toxin injection to puborectalis |
Primary outcome
The Rate of Identification of Puborectalis During Ultrasound Scan
Time frame: Visit 3: week 18
The investigator will record the number of times the puborectalis muscle is successfully identified using ultrasound scan (muscle seen to contract on volition) and pre-injection EMG (change in EMG waveform on volitional contraction) by the radiologist and neurologist, respectively, at the beginning of the injection procedure.
Procedure Duration
Time frame: Visit 3: week 18
The investigator will record the time (in minutes) taken to for the radiologist to complete the injection procedure
Procedure Limitations
Time frame: Visit 3: week 18
The investigator will record any procedure or patient related factors which prevented a successful injection, e.g. body habitus or equipment failure.
3 secondary outcomes
Rate of Adverse Events
Time frame: From visit 3 to visit 6: week 18 to 42
Patient's Level Pain and Comfort Assessed at Post-procedure
Time frame: Visit 3: week 18
The Number of Patient Indicating *Yes*, They Would be Willing to Undergo a Repeat Procedure
Time frame: Visit 3: week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dyssynergic Defaecation
Recruiting
Efficacy of Cognitive Behavioral Therapy Administered in Patients With Dyssynergic Defecation
Dyssynergic Defaecation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles H Knowles, PhD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyssynergic Defaecation and Evacuation Disorder, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Rate of Identification of Puborectalis During Ultrasound Scan (time frame: Visit 3: week 18). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.