WithdrawnPhase 4

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

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.

United States0Started 2020-01-09

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.
✕. 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.

What they're measuring

Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS)

Timeframe: 10 weeks

Trial details

NCT IDNCT04216797

SponsorSwedish Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-21

View on ClinicalTrials.gov More Levator Ani Syndrome trials