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Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04216797
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : January 14, 2020
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center

Brief 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 minimizing systemic effects of diazepam (drowsiness).

Condition or disease Intervention/treatment Phase
Levator Ani Syndrome Drug: Diazepam Tablets Phase 4

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:

1. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Actual Study Start Date : January 9, 2020
Estimated Primary Completion Date : January 13, 2025
Estimated Study Completion Date : January 13, 2026


Arm Intervention/treatment
Active Comparator: Oral Administration
10 mg diazepam tablets to be taken orally once daily for 4 weeks.
Drug: Diazepam Tablets
Participants will be randomly assigned to either an oral or rectal administration of once daily 10 mg diazepam tablets for four weeks.

Active Comparator: Rectal Administration
10 mg diazepam tablets to be taken rectally once daily for 4 weeks.
Drug: Diazepam Tablets
Participants will be randomly assigned to either an oral or rectal administration of once daily 10 mg diazepam tablets for four weeks.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Participant drowsiness while taking diazepam rectally versus orally [ Time Frame: 10 weeks ]
    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.

  2. Participant sleep quality while taking diazepam rectally versus orally: Pittsburg Sleep Quality Index [ Time Frame: 10 weeks ]

    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.


  3. Study Medication Adherence [ Time Frame: 4 weeks ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of LAS according to the Rome IV criteria with:

    1. Chronic or recurrent rectal pain or aching
    2. Episodes lasting 30 minutes or longer
    3. Tenderness during traction on the puborectalis
    4. Exclusion of other causes of rectal pain
  2. Patients who agree to undergo pelvic floor PT for six weeks prior to starting the medication treatment.
  3. Women ≥ 18 years of age. Women of childbearing potential must undergo urine pregnancy testing prior to using the treatment medication.
  4. Men ≥ 18 years of age.

Exclusion Criteria:

  1. Participants who have had pelvic floor surgery or with recent conditions in which rectal suppositories are contraindicated.
  2. Non-English speaking participants.
  3. Women who are pregnant or breastfeeding.
  4. Participants who are cognitively impaired, illiterate, or have a condition in which they are unable to consent for themselves.
  5. Prisoners.
  6. Participants allergic to benzodiazepines or have a sensitivity/intolerance to benzodiazepines.
  7. Participants to which benzodiazepines are contraindicated or are on medications that interact with benzodiazepines.
  8. 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.
  9. 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.
  10. Participants who have undergone pelvic floor PT within 2 weeks of screening visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216797


Contacts
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Contact: Justin P Rueda 206-215-4330 justin.rueda@swedish.org

Locations
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United States, Washington
Swedish Medical Center Colon Rectal Clinic Recruiting
Seattle, Washington, United States, 98104
Contact: Cecilia A Lynn    206-386-6600    Cecilia.Lynn@swedish.org   
Contact: John Griffin    (206) 386-6600    John.Griffin@swedish.org   
Principal Investigator: Cecila Lynn, ARNP         
Principal Investigator: John Griffin, MD         
Principal Investigator: Melinda Hawkins, MD         
Sponsors and Collaborators
Swedish Medical Center
Investigators
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Principal Investigator: Cecilia A Lynn Swedish Medical Center
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Responsible Party: Swedish Medical Center
ClinicalTrials.gov Identifier: NCT04216797    
Other Study ID Numbers: STUDY2019000291
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anus Diseases
Crigler-Najjar Syndrome
Syndrome
Pain
Disease
Pathologic Processes
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
Hyperbilirubinemia, Hereditary
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Diazepam
Adjuvants, Anesthesia
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents