Levator Ani SyndromePhase 4NCT04216797
Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome
A Phase 4 study testing Diazepam Tablets in people with Levator Ani Syndrome, run by Swedish Medical Center at 1 site in United States.
Trial summary
This research involves collecting data about levator ani syndrome (LAS) associated rectal pain and a comparison of diazepam treatment administration routes. The goal of this research is to see if an alternative route of diazepam administration provides sufficient control of LAS discomfort and low sleep quality while… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Levator Ani Syndrome
- What is being tested?
- Diazepam Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2020to 21 Feb 2023
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of LAS according to the Rome IV criteria with:
- Chronic or recurrent rectal pain or aching
- Episodes lasting 30 minutes or longer
- Tenderness during traction on the puborectalis
- Exclusion of other causes of rectal pain
- Patients who agree to undergo pelvic floor PT for six weeks prior to starting the medication treatment.
- Women ≥ 18 years of age. Women of childbearing potential must undergo urine pregnancy testing prior to using the treatment medication.
- Men ≥ 18 years of age.
Who cannot join
- Participants who have had pelvic floor surgery or with recent conditions in which rectal suppositories are contraindicated.
- Non-English speaking participants.
- Women who are pregnant or breastfeeding.
- Participants who are cognitively impaired, illiterate, or have a condition in which they are unable to consent for themselves.
- Prisoners.
- Participants allergic to benzodiazepines or have a sensitivity/intolerance to benzodiazepines.
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- Participants to which benzodiazepines are contraindicated or are on medications that interact with benzodiazepines.
- Participants with current or history of Diagnostic and Statistical Manual of Mental Disorders (DSM-V) substance use disorder or Participants with a history of evidence of severe illness or any other conditions that would affect absorption or make the patient unsuitable for the study in the opinion of the investigator.
- Participants already receiving medications in the benzodiazepine class within 2 weeks of screening visit for any reasons will be excluded based on increased risk for medication tolerance.
- Participants who have undergone pelvic floor PT within 2 weeks of screening visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Swedish Medical Center Colon Rectal Clinic
Seattle, Washington, 98104
About this study
Official title: Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome in Participants Who Have Not Responded to Physical Therapy Treatment: A Prospective Randomized Study
This research involves collecting data about levator ani syndrome (LAS) associated rectal pain and a comparison of diazepam treatment administration routes. The goal of this research is to see if an alternative route of diazepam administration provides sufficient control of LAS discomfort and low sleep quality while minimizing systemic effects of diazepam (drowsiness).
Read the detailed description
Levator ani syndrome (LAS) is described as a dull, aching pain of a patient's pelvic floor musculature. There is no known cause for the syndrome, yet pelvic floor muscle spasm and increased anal resting pressures have been hypothesized to result in the syndrome. LAS is commonly seen in patients with constipation, specifically outlet dysfunction constipation. Treatment for the syndrome involves a combination of bowel management, medications, and pelvic floor physical therapy (PT). Pelvic floor PT uses a variety of methods to help patients with LAS, including biofeedback and massage. The literature and the investigators experience shows that these pelvic floor PT approaches do not resolve all LAS symptoms.
Diazepam (Valium®) is used to treat levator ani syndrome in conjunction with other treatments to help relax the pelvic floor muscle group (levator ani). Diazepam has U.S. Food and Drug Administration (FDA) approval for use as a muscle relaxant. Investigators at Swedish Colon \& Rectal Clinic are using diazepam intervention as a means for patients to gain relief from pain.
The work proposed aims to provide the first prospective, randomized, comparative study of the efficacy between administering diazepam rectally and administering the medication orally after pelvic floor PT treatment. Currently, other ways of administering diazepam have not been studied in the setting of the LAS condition. The Investigators performed a retrospective chart review last year and found some promising results for the efficacy of rectal and oral routes of diazepam for LAS. The Investigators want to determine if the route of administering diazepam as an adjunct to pelvic floor PT influences rectal pain relief for LAS patients.
Primary Objective: Compare the pain scores of participants with LAS after administering diazepam rectally or orally following six weeks of physical therapy.
Secondary Objectives:
- Measure and compare the drowsiness levels of participants using rectal diazepam or oral diazepam. 2. Measure and compare the sleep quality of participants using rectal diazepam or oral diazepam.
All participants with the LAS diagnosis will initially receive 6 weeks of pelvic floor PT. After these six weeks, participants without effective pain relief will be randomized to one of two arms: rectal or oral diazepam administration. Participants will be dispensed 30 10 mg diazepam tablets to take daily (oral or rectal) for 4 weeks. Participants will be asked to complete 3 electronic questionnaires (VAS pain scale, Likert drowsiness scale, and Pittsburg Sleep Quality Index) each week while on the 10 week trial. Investigators plan to enroll 100 participants over approximately 5 years.
- Conditions
- Levator Ani Syndrome
- Being tested
- Diazepam Tablets
- Medical subject headings
- Levator syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diazepam TabletsDrug
Participants will be randomly assigned to either an oral or rectal administration of once daily 10 mg diazepam tablets for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Oral Administration | Active comparator | 10 mg diazepam tablets to be taken orally once daily for 4 weeks. Receives: Drug: Diazepam Tablets |
| Rectal Administration | Active comparator | 10 mg diazepam tablets to be taken rectally once daily for 4 weeks. Receives: Drug: Diazepam Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS)
Participants will complete weekly electronic Visual Analog Scale (VAS) for pain for 6 weeks while on Physical Therapy only, followed by 4 weeks while taking diazepam (orally or rectally). Participants will be asked to select a number on a scale of 1 to 10, where 1 equals no pain and 10 equals worst pain.
Measured: 10 weeks
Secondary outcomes (3)
Participant drowsiness while taking diazepam rectally versus orally
Participants will complete weekly electronic Likert drowsiness scale for 6 weeks while on Physical Therapy only, followed by 4 weeks while taking diazepam (orally or rectally). Participants will be asked to select a number on a scale of 1 to 5, where 1 equals much less drowsiness than usual and 10 equals much more drowsiness than usual.
Measured: 10 weeks
Participant sleep quality while taking diazepam rectally versus orally: Pittsburg Sleep Quality Index
Participants will complete weekly electronic Pittsburg Sleep Quality Index for 6 weeks while on Physical Therapy only, followed by 4 weeks while taking diazepam (orally or rectally).
The Pittsburg Sleep Quality Index measures overall sleep quality, evaluating seven categories of sleep: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The seven individual categories are weighted on a 0-3 interval scale. The global Pittsburg Sleep Quality Index score is then calculated by adding the seven individual category scores, which then provides a total score ranging from 0 to 21, where lower scores represent a healthier sleep quality.
Measured: 10 weeks
Study Medication Adherence
Participants will be instructed to take diazepam (orally or rectally) daily for 4 weeks. Participants will bring in their pill bottles so that the study staff can manually count their pills to check for adherence.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start9 Jan 2020
- Primary completion21 Feb 2023
- Study completion21 Feb 2023
Why it stopped: Enrollment was initially suspended due to COVID pandemic. As the number of cases subsided, enrollment was reopened but never regained momentum. PI has left the site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Levator Ani SyndromeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will initially receive 6 weeks of pelvic floor PT. After these six weeks, qualifying participants will be randomized to one of two arms: rectal or oral diazepam administration. Participants will be dispensed 30, 10 mg diazepam tablets to take daily (oral or rectal) for 4 weeks.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia A Lynn, Principal investigator, Swedish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04216797
- Sponsor's protocol ID
- STUDY2019000291
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2019
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome in Participants Who Have Not Responded to Physical Therapy Treatment: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04216797
- Acronym / sponsor ID
- STUDY2019000291
- Conditions
- Levator Ani Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment was initially suspended due to COVID pandemic. As the number of cases subsided, enrollment was reopened but never regained momentum. PI has left the site.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Swedish Medical CenterUniversity, hospital or other
- Study start
- 9 Jan 2020 (actual)
- Primary completion
- 21 Feb 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 3 Jan 2020 (actual)
- 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.
This research involves collecting data about levator ani syndrome (LAS) associated rectal pain and a comparison of diazepam treatment administration routes. The goal of this research is to see if an alternative route of diazepam administration provides sufficient control of LAS discomfort and low sleep quality while minimizing systemic effects of diazepam (drowsiness).
Detailed description
Levator ani syndrome (LAS) is described as a dull, aching pain of a patient's pelvic floor musculature. There is no known cause for the syndrome, yet pelvic floor muscle spasm and increased anal resting pressures have been hypothesized to result in the syndrome. LAS is commonly seen in patients with constipation, specifically outlet dysfunction constipation. Treatment for the syndrome involves a combination of bowel management, medications, and pelvic floor physical therapy (PT). Pelvic floor PT uses a variety of methods to help patients with LAS, including biofeedback and massage. The literature and the investigators experience shows that these pelvic floor PT approaches do not resolve all LAS symptoms.
Diazepam (Valium®) is used to treat levator ani syndrome in conjunction with other treatments to help relax the pelvic floor muscle group (levator ani). Diazepam has U.S. Food and Drug Administration (FDA) approval for use as a muscle relaxant. Investigators at Swedish Colon \& Rectal Clinic are using diazepam intervention as a means for patients to gain relief from pain.
The work proposed aims to provide the first prospective, randomized, comparative study of the efficacy between administering diazepam rectally and administering the medication orally after pelvic floor PT treatment. Currently, other ways of administering diazepam have not been studied in the setting of the LAS condition. The Investigators performed a retrospective chart review last year and found some promising results for the efficacy of rectal and oral routes of diazepam for LAS. The Investigators want to determine if the route of administering diazepam as an adjunct to pelvic floor PT influences rectal pain relief for LAS patients.
Primary Objective: Compare the pain scores of participants with LAS after administering diazepam rectally or orally following six weeks of physical therapy.
Secondary Objectives:
- Measure and compare the drowsiness levels of participants using rectal diazepam or oral diazepam. 2. Measure and compare the sleep quality of participants using rectal diazepam or oral diazepam.
All participants with the LAS diagnosis will initially receive 6 weeks of pelvic floor PT. After these six weeks, participants without effective pain relief will be randomized to one of two arms: rectal or oral diazepam administration. Participants will be dispensed 30 10 mg diazepam tablets to take daily (oral or rectal) for 4 weeks. Participants will be asked to complete 3 electronic questionnaires (VAS pain scale, Likert drowsiness scale, and Pittsburg Sleep Quality Index) each week while on the 10 week trial. Investigators plan to enroll 100 participants over approximately 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will initially receive 6 weeks of pelvic floor PT. After these six weeks, qualifying participants will be randomized to one of two arms: rectal or oral diazepam administration. Participants will be dispensed 30, 10 mg diazepam tablets to take daily (oral or rectal) for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| Oral Administration | Active comparator | Drug: Diazepam Tablets10 mg diazepam tablets to be taken orally once daily for 4 weeks. |
| Rectal Administration | Active comparator | Drug: Diazepam Tablets10 mg diazepam tablets to be taken rectally once daily for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with a diagnosis of LAS according to the Rome IV criteria with:
- Patients who agree to undergo pelvic floor PT for six weeks prior to starting the medication treatment.
- Women ≥ 18 years of age. Women of childbearing potential must undergo urine pregnancy testing prior to using the treatment medication.
- Men ≥ 18 years of age.
Key exclusion criteria (10 listed)
- Participants who have had pelvic floor surgery or with recent conditions in which rectal suppositories are contraindicated.
- Non-English speaking participants.
- Women who are pregnant or breastfeeding.
- Participants who are cognitively impaired, illiterate, or have a condition in which they are unable to consent for themselves.
- Prisoners.
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 |
|---|---|---|
| Diazepam TabletsParticipants will be randomly assigned to either an oral or rectal administration of once daily 10 mg diazepam tablets for four weeks. | Drug | Oral Administration, Rectal Administration |
Primary outcome
Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS)
Time frame: 10 weeks
Participants will complete weekly electronic Visual Analog Scale (VAS) for pain for 6 weeks while on Physical Therapy only, followed by 4 weeks while taking diazepam (orally or rectally). Participants will be asked to select a number on a scale of 1 to 10, where 1 equals no pain and 10 equals worst pain.
3 secondary outcomes
Participant drowsiness while taking diazepam rectally versus orally
Time frame: 10 weeks
Participant sleep quality while taking diazepam rectally versus orally: Pittsburg Sleep Quality Index
Time frame: 10 weeks
Study Medication Adherence
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Levator Ani Syndrome
RecruitingObservational study
Targeting the Conus Medullaris With ECAP-Controlled Closed-Loop SCS for Treatment of Chronic Pelvic Pain: HOPE Trial
Chronic Pelvic Pain, Pudendal Neuralgia
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.
Cecilia A Lynn principal investigator
Swedish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diazepam Tablets in people with Levator Ani Syndrome, run by Swedish 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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 19 Apr 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS) (time frame: 10 weeks). 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 19 Apr 2023.