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SENNA for Constipation

N/A
Waitlist Available
Led By Candace Parker-Autry, MD
Research Sponsored by Wake Forest University Health Sciences
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 post operative day (pod)1, pod2, pod3, pod4, and pod5
Awards & highlights

Study Summary

This trial will randomly assign women getting surgery for pelvic organ prolapse to either take oral senna or use a rectal bisacodyl suppository after the surgery.

Who is the study for?
This trial is for women aged 18 or older who are scheduled for vaginal surgery to fix pelvic organ prolapse. It's not open to those under 18, unable to consent, using laxatives long-term, or with conditions like inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, fistulas or concurrent bowel surgeries.Check my eligibility
What is being tested?
The study compares two methods of managing constipation after vaginal surgery: one group will use oral senna tablets and the other will use rectal bisacodyl suppositories. Women participating will be randomly assigned in equal numbers to either regimen.See study design
What are the potential side effects?
Possible side effects from both senna tablets and bisacodyl suppositories include abdominal pain, diarrhea, nausea and potential irritation at the site of the suppository insertion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post operative day (pod)1, pod2, pod3, pod4, and pod5
This trial's timeline: 3 weeks for screening, Varies for treatment, and post operative day (pod)1, pod2, pod3, pod4, and pod5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time in hours to first bowel movement comparison between the two arms
Secondary outcome measures
Bristol Stool Form Scale (BSFS) Scores
Change in Overall Satisfaction (TSQM) Scores
Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: SENNAExperimental Treatment1 Intervention
Group A participants will be prescribed oral senna (Senokot; Atlantis Consumer Healthcare Inc., Bridgewater, NJ) 8.6mg tablets and be instructed to start with two tablets on the morning of Post Operative Day (POD)#1. Participant will continue taking two tablets on the daily. If no bowel movement on the morning of POD#3 participant may take 2 tablets in the morning and another 2 tablets that evening. The same can be replicated on POD#4. If no bowel movement on the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the urology clinic for further instruction.
Group II: DULCOLAXExperimental Treatment1 Intervention
Group B participants will be prescribed bisacodyl rectal (Dulcolax Suppository; Sanofi S.A., Paris, France) 1 suppository to be placed rectally on the morning of Post Operative Day (POD)#1. Participant will continue placing a nightly rectal suppository until their first bowel movement. If no bowel movement by the morning of POD#5 participant may take magnesium hydroxide (Phillips' Milk of Magnesia; Bayer AG, Leverkusen, Germany) 30 mL by mouth and need to call the clinic for further instruction.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,243 Previous Clinical Trials
1,004,641 Total Patients Enrolled
1 Trials studying Constipation
12 Patients Enrolled for Constipation
Candace Parker-Autry, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
144 Total Patients Enrolled

Frequently Asked Questions

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

Are there currently opportunities for individuals to enroll as participants in this ongoing medical research study?

"As outlined on clinicaltrials.gov, the current status of this trial indicates that recruitment is no longer active. This study was initially listed on May 1st, 2024, with the latest update occurring on March 22nd, 2024. Despite the closure of this particular trial for enrollment, there are currently 86 alternative studies open to accepting new participants at present."

Answered by AI
Recent research and studies
American Journal of Obstetrics and GynecologyJournal
The Use of Senna with Docusate for Postoperative Constipation After Pelvic Reconstructive Surgery: A Randomized, Double-blind, Placebo-controlled Trial
Patel, Minita, Megan O. Schimpf, David M. O'Sullivan, and Christine A. LaSala. 2010. “The Use of Senna with Docusate for Postoperative Constipation After Pelvic Reconstructive Surgery: A Randomized, Double-blind, Placebo-controlled Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2010.01.003.
clinicaltrials.govStudy
Optimization of Postoperative Bowel Habits
2024. "Optimization of Postoperative Bowel Habits". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06335797.
All > Constipation
~59 spots leftby Jun 2025
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