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Benzodiazepine

Oral Administration for Pelvic Floor Dysfunction

Phase 4
Waitlist Available
Led By Cecilia A Lynn
Research Sponsored by Swedish Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Study Summary

This trial is testing if an alternative way to take the drug diazepam can help control discomfort and poor sleep quality caused by levator ani syndrome, while minimizing drowsiness.

Eligible Conditions
  • Pelvic Floor Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of rectal administration versus oral administration in LAS pain management: Visual Analog Scale (VAS)
Secondary outcome measures
Participant drowsiness while taking diazepam rectally versus orally
Diazepam
Study Medication Adherence

Trial Design

2Treatment groups
Active Control
Group I: Oral AdministrationActive Control1 Intervention
10 mg diazepam tablets to be taken orally once daily for 4 weeks.
Group II: Rectal AdministrationActive Control1 Intervention
10 mg diazepam tablets to be taken rectally once daily for 4 weeks.

Who is running the clinical trial?

Swedish Medical CenterLead Sponsor
53 Previous Clinical Trials
8,294 Total Patients Enrolled
Cecilia A LynnPrincipal InvestigatorSwedish Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has this clinical trial recruited so far?

"Affirmative. According to clinicaltrials.gov, this research endeavour is in the process of recruiting individuals for participation. This investigation was initially listed on September 1st 2020 and has been refreshed as recently as August 8th 2022; it aims to enrol 100 people across a single center."

Answered by AI

In what instances is Oral Administration the preferred treatment?

"Oral Administration is a method of administering medication to patients, which can be employed for sedation or used as part of treatment plans for athetosis, refractory epilepsy and syndrome."

Answered by AI

Is there still room available to join this research project?

"Affirmative. According to information hosted on clinicaltrials.gov, the trial began accepting applications in early January 2020 and is still recruiting as of August 2022. The study requires 100 participants from single site for enrollment."

Answered by AI

Have there been prior experiments with Oral Administration?

"Currently, 5 clinical trials are conducting research on Oral Administration. None of these studies have progressed to Phase 3 yet. Although the majority of these live trials are located in Ratchathewi, Bangkok, there is a total 19 different medical sites that partaking in this experiment."

Answered by AI

Is it safe to administer treatments orally for patients?

"Oral Administration has already been approved for public use, so it received a safety rating of 3."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Swedish Medical Center Colon Rectal Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Currently undergoing PF therapy and looking for any other helpful resources, recommendations and treatment.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome
2020. "Rectal Versus Oral Diazepam Administration in the Treatment of Levator Ani Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04216797.
~0 spots leftby Apr 2025
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