Clinical trial NCT04216797: Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Levator Ani Syndrome
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2020-01-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS)
timeFrame: 10 weeks
Secondary outcomes:
measure: Participant drowsiness while taking diazepam rectally versus orally
timeFrame: 10 weeks
measure: Participant sleep quality while taking diazepam rectally versus orally: Pittsburg Sleep Quality Index
timeFrame: 10 weeks
measure: Study Medication Adherence
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center Colon Rectal Clinic
state: Washington
Study officials:
affiliation: Swedish Medical Center
name: Cecilia A Lynn
role: PRINCIPAL_INVESTIGATOR
References: