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

STUDY2019000291

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).

2020-01-09

2023-02-21

2023-02-21

Withdrawn

Early phase I

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-04-19