Levator Ani Syndrome With Pain and/or Constipation Symptoms.NCT00564707
Comparison of Biofeedback vs. Botox Injection to Treat Levator Ani Syndrome
A study testing Biofeedback therapy and Botulinum Toxin Type A Injection in people with Levator Ani Syndrome With Pain and/or Constipation Symptoms., run by Walter Reed Army Medical Center at 1 site in United States.
Trial summary
Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A injection of the levator ani muscles has any effect on pain from the levator ani syndrome, and, in addition, to what extent either treatment is superior to the other in terms of anorectal physiologic measurements, and quality of… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Levator Ani Syndrome With Pain and/or Constipation Symptoms.
- What is being tested?
- Biofeedback therapy and Botulinum Toxin Type A Injection
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Aug 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients should be 18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial.
- History of chronic anorectal pain from levator ani spasm three or more months in duration.
- Pain involves only the anorectum, and is part of one of the established variants of levator ani syndrome including spasm, coccygodynia, proctalgia fugax.
- Written informed consent must be obtained from each patient prior to entering the study.
- Female patients will not be pregnant. Exclusion of the possibility of pregnancy by HCG testing (urine or serum) or by history (tubal ligation, hysterectomy, or menopause) is required prior to inclusion in the study.
- Patients should be willing to be followed within the military healthcare system during the course of study treatment and follow-up. Follow-up at other military facilities is acceptable.
- Ability to follow study instructions and likely to complete all required visits.
Who cannot join
- Patients with current participation in another clinical investigation of a medical device or a drug the requirements of which may preclude complete involvement in this study
- Active or previous (within 60 days prior to the study screening visit) chemotherapy
- Active or previous (within 60 days prior to the study screening visit) radiation
- Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits
- The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements
- Patients < 18 years of age
Show all 24Show fewer
- Incapable of providing informed consent
- Subject has chronic (>3 months) vaginal pain not related to levator spasm
- Patients who are pregnant.
- Patients unwilling, or unable, to be followed within the military healthcare system during the course of study treatment and follow-up.
- Documented urinary tract infection
- Genitourinary (GU) or anorectal malignancy
- Undergoing Botulinum toxin injection therapy or biofeedback therapy at the time of enrollment
- Known allergy or sensitivity to any study medication (Botulinum toxin, lidocaine)
- History of infection with Human Immunodeficiency Virus
- History of immunodeficiency disorders
- Patients taking antibiotics at the time of study enrollment
- Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, spinal cord injury or any other significant disease which might interfere with neuromuscular transmission.
- Concurrent use of agents that interfere with neuromuscular transmission
- Profound atrophy or excessive weakness on physical examination of the muscles to be injected with associated fecal incontinence
- Infection at the injection site
- Is overtly psychotic or suicidal.
- Anismus (inability to empty the rectum adequately during defecation) not associated with painful levator ani muscles
- History of anorectal or low pelvic surgery within the last year
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307
Jeffery M Nelson, MD
Todd S Albright, MD
About this study
Official title: Comparison of Biofeedback Therapy and Botulinum Toxin Type A Injections for Treatment of Painful Levator Ani Syndrome in Women: A Randomized, Prospective Trial
Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A injection of the levator ani muscles has any effect on pain from the levator ani syndrome, and, in addition, to what extent either treatment is superior to the other in terms of anorectal physiologic measurements, and quality of life.
Study Design: Randomized, prospective, unblinded double-armed study with crossover.
Read more
Methodology: Female subjects, aged 18 and over, with painful levator ani muscle spasm for at least one month duration will be randomized to receive either biofeedback therapy or Botulinum toxin type A injection. After randomization they will all undergo visual analog pain scoring, anorectal manometry, colonoscopy (if clinically indicated), and self-reported SF-36 quality of life measurement. Each patient will also complete numerical pain scale scoring, an SF-36, and a satisfaction questionnaire at each treatment visit and follow-up visit. Patients will submit these by mail. Identification numbers will be assigned to each subject for use on the SF-36 and Satisfaction Questionnaires throughout the study. Subjects will again undergo anorectal manometry at the end of their treatment arms. In the biofeedback arm patients will be treated biweekly for up to eight treatments and be provided exercises to practice at home based on their muscle function noted during the biofeedback training session. Subjects will keep a treatment diary of the exercises they do at home to help ensure compliance with the protocol. In the Botulinum toxin injection arm patients will be treated with scheduled injections of the levator ani muscles every six weeks for up to three total injections of 100U each. These injections will be directed to the painful areas of the levator muscles as guided by physical exam and EMG measurements. Should any patient fail their initial randomized treatment assignment (failure defined as "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire), they will then be allowed to cross over to the other study arm. In addition to numerical pain scale scoring, an SF-36 questionnaire and anorectal manometry will also be repeated at the time of crossover. We intend to include all randomized patients in the final data analysis (according to their originally assigned treatment arm), regardless of outcome or reason for dropout, thus making this an "intent-to-treat" analysis.
Pivotal Study Definitions: The definition of adequate pain reduction, for the purposes of data analysis, will be a reduction in a subject's mean pain score of two on a numerical pain scale (0-10). Failure of either therapy will be defined as a response of "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire at the end of either biofeedback (eight treatment visits) or Botulinum toxin (three injections) both before and after crossover.
Outcomes: We will determine the following for biofeedback therapy and Botulinum toxin type A injection: mean pain reduction, any differences in anorectal physiologic measurements (such as mean resting anal sphincter pressure), any changes in self-reported quality of life, and overall patient satisfaction.
- Being tested
- Biofeedback therapy, Botulinum Toxin Type A Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback therapyBehavioural
EMG guided biofeedback therapy using standard biofeedback computer software
Botulinum Toxin Type A InjectionProcedure or surgery
Under EMG guidance Botox is injected directly into the painful levator ani muscle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Standard biofeedback therapy will be given for painful levator ani syndrome over a course of eight weeks. Receives: Behavioral: Biofeedback therapy |
| 2 | Active comparator | Botulinum toxin type A will be injected under EMG guidance into spastic and painful levator ani muscles. This may be repeated only twice on separate visits. Receives: Procedure: Botulinum Toxin Type A Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction from treatment with either Biofeedback, Botox injection, or both
Measured: Two years
Secondary outcomes (3)
Anorectal physiologic changes - increase or decrease in anal sphincter pressures
Measured: Two years
Overall patient satisfaction
Measured: Two years
Patient quality of life
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2007 (estimated)
- Study startAug 2007
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Levator Ani Syndrome With Pain and/or Constipation Symptoms.Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Walter Reed Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Jeffery M Nelson, MD, Principal investigator, Walter Reed Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564707
- Sponsor's protocol ID
- 07-20034
- Status last verified
- Nov 2007
- First submitted
- 26 Nov 2007
- Last updated
- 28 Nov 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Biofeedback Therapy and Botulinum Toxin Type A Injections for Treatment of Painful Levator Ani Syndrome in Women: A Randomized, Prospective Trial
- ClinicalTrials.gov ID
- NCT00564707
- Acronym / sponsor ID
- 07-20034
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Walter Reed Army Medical CenterUS federal agency
- Study start
- Aug 2007
- Study completion
- Aug 2009 (estimated)
- First posted
- 28 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: To assess whether EMG directed biofeedback therapy or Botulinum toxin type A injection of the levator ani muscles has any effect on pain from the levator ani syndrome, and, in addition, to what extent either treatment is superior to the other in terms of anorectal physiologic measurements, and quality of life.
Study Design: Randomized, prospective, unblinded double-armed study with crossover.
Methodology: Female subjects, aged 18 and over, with painful levator ani muscle spasm for at least one month duration will be randomized to receive either biofeedback therapy or Botulinum toxin type A injection. After randomization they will all undergo visual analog pain scoring, anorectal manometry, colonoscopy (if clinically indicated), and self-reported SF-36 quality of life measurement. Each patient will also complete numerical pain scale scoring, an SF-36, and a satisfaction questionnaire at each treatment visit and follow-up visit. Patients will submit these by mail. Identification numbers will be assigned to each subject for use on the SF-36 and Satisfaction Questionnaires throughout the study. Subjects will again undergo anorectal manometry at the end of their treatment arms. In the biofeedback arm patients will be treated biweekly for up to eight treatments and be provided exercises to practice at home based on their muscle function noted during the biofeedback training session. Subjects will keep a treatment diary of the exercises they do at home to help ensure compliance with the protocol. In the Botulinum toxin injection arm patients will be treated with scheduled injections of the levator ani muscles every six weeks for up to three total injections of 100U each. These injections will be directed to the painful areas of the levator muscles as guided by physical exam and EMG measurements. Should any patient fail their initial randomized treatment assignment (failure defined as "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire), they will then be allowed to cross over to the other study arm. In addition to numerical pain scale scoring, an SF-36 questionnaire and anorectal manometry will also be repeated at the time of crossover. We intend to include all randomized patients in the final data analysis (according to their originally assigned treatment arm), regardless of outcome or reason for dropout, thus making this an "intent-to-treat" analysis.
Pivotal Study Definitions: The definition of adequate pain reduction, for the purposes of data analysis, will be a reduction in a subject's mean pain score of two on a numerical pain scale (0-10). Failure of either therapy will be defined as a response of "very dissatisfied" or "dissatisfied" on the satisfaction questionnaire at the end of either biofeedback (eight treatment visits) or Botulinum toxin (three injections) both before and after crossover.
Outcomes: We will determine the following for biofeedback therapy and Botulinum toxin type A injection: mean pain reduction, any differences in anorectal physiologic measurements (such as mean resting anal sphincter pressure), any changes in self-reported quality of life, and overall patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Biofeedback therapyStandard biofeedback therapy will be given for painful levator ani syndrome over a course of eight weeks. |
| 2 | Active comparator | Procedure: Botulinum Toxin Type A InjectionBotulinum toxin type A will be injected under EMG guidance into spastic and painful levator ani muscles. This may be repeated only twice on separate visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients should be 18 years of age or older and capable of providing informed consent indicating awareness of the investigational nature of this trial.
- History of chronic anorectal pain from levator ani spasm three or more months in duration.
- Pain involves only the anorectum, and is part of one of the established variants of levator ani syndrome including spasm, coccygodynia, proctalgia fugax.
- Written informed consent must be obtained from each patient prior to entering the study.
- Female patients will not be pregnant. Exclusion of the possibility of pregnancy by HCG testing (urine or serum) or by history (tubal ligation, hysterectomy, or menopause) is required prior to inclusion in the study.
Key exclusion criteria (24 listed)
- Patients with current participation in another clinical investigation of a medical device or a drug the requirements of which may preclude complete involvement in this study
- Active or previous (within 60 days prior to the study screening visit) chemotherapy
- Active or previous (within 60 days prior to the study screening visit) radiation
- Physical or mental disability or geographical concerns (residence not within reasonable travel distance) that would hamper compliance with required study visits
- The Investigator believes that the subject will be unwilling or unable to comply with study protocol requirements
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 |
|---|---|---|
| Biofeedback therapyEMG guided biofeedback therapy using standard biofeedback computer software | Behavioural | 1 |
| Botulinum Toxin Type A InjectionUnder EMG guidance Botox is injected directly into the painful levator ani muscle. | Procedure or surgery | 2 |
Primary outcome
Pain reduction from treatment with either Biofeedback, Botox injection, or both
Time frame: Two years
3 secondary outcomes
Anorectal physiologic changes - increase or decrease in anal sphincter pressures
Time frame: Two years
Overall patient satisfaction
Time frame: Two years
Patient quality of life
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2007.
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.
Jeffery M Nelson, MD principal investigator
Walter Reed Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback therapy and Botulinum Toxin Type A Injection in people with Levator Ani Syndrome With Pain and/or Constipation Symptoms., run by Walter Reed Army Medical Center at 1 site in United States.
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 7 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 28 Nov 2007. 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 States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeffery M Nelson, MD (202-782-9691, Jeffery.Nelson@us.army.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction from treatment with either Biofeedback, Botox injection, or both (time frame: Two years). 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 28 Nov 2007.