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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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