Obstructive Defecation SyndromePhase 4NCT06825260
PEG3350 vs Senna After Urogyn Surgery
A Phase 4 study testing Senna and Polyethylene glycol 3350 in people with Obstructive Defecation Syndrome and Postoperative Constipation, run by St. Joseph's Health, New York at 1 site in United States.
Trial summary
The goal of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is better at relieving postoperative constipation after urogynecologic surgery. The main questions it aims to answer are: What number of patients taking PEG3350 have obstructed defecation syndrome (ODS), a form of… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Defecation Syndrome, Postoperative Constipation
- What is being tested?
- Senna and Polyethylene glycol 3350
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2025to Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria includes women scheduled for urogynecologic surgery for pelvic organ prolapse and/or stress urinary incontinence and at least 18 years old.
Who cannot join
- Exclusion criteria include undergoing concomitant bowel surgery (colonic resection, anal sphincter repair, rectovaginal fistula repair, rectopexy) or placement of a sacral neuromodulation device alone.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Joseph's Health Hospital
Syracuse, New York, 13203
Keila S Muniz, MD, 631-896-7937, keila.muniz@sjhsyr.org
Keila S Muniz, MD
About this study
Official title: Polyethylene Glycol 3350 Compared With Senna After Urogynecologic Surgery A Randomized Controlled Trial
The goal of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is better at relieving postoperative constipation after urogynecologic surgery. The main questions it aims to answer are:
What number of patients taking PEG3350 have obstructed defecation syndrome (ODS), a form of constipation, vs those taking senna in the week after urogynecologic surgery? What patient-level and procedure-level characteristics are associated with postoperative ODS, in patients taking PEG3350 vs senna? participants will: Take their randomized medication daily for seven days after surgery Fill out an ODS questionnaire before and one week after surgery Complete a daily bowel diary for 7 days after surgery
Read the detailed description
The purpose of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is superior in the setting of postoperative constipation after urogynecologic surgery. This is a randomized controlled trial with the aim of comparing PEG3350 vs senna as postoperative recommended treatment for obstructive defecation constipation. Our hypothesis is that senna decreases the proportion of women with obstructive defecation constipation compared to use of PEG3350 after urogynecologic surgery. Women 18 years of age and older undergoing surgery for pelvic organ prolapse, stress urinary incontinence or both by the Department of Urogynecology at St. Joseph's Health Hospital, will be randomized to one of two study arms: senna or PEG3350. Arm 1: Polyethylene Glycol 3350, 17g, daily, oral. Arm 2: Senna (Sennosides) 8.6mg, 2 tablets daily, oral (up to 4 tablets twice a day). Interventions would be administered after surgery on postoperative day #0 and continue for 7 days total.
- Being tested
- Senna, Polyethylene glycol 3350
- Keywords
- obstructive defecation syndrome (ODS), Postoperative constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SennaDrug
Also called Senokot, Sennoside
Senna, oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days
Polyethylene glycol 3350Drug
Also called PEG 3350, Miralax
Polyethylene Glycol 3350, oral, 17g, daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Senna | Experimental | Senna (Sennosides), oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days Receives: Drug: Senna |
| Polyethylene Glycol 3350 | Active comparator | Polyethylene Glycol 3350, oral, 17g, daily for 7 days Receives: Drug: Polyethylene glycol 3350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative ODS in Patients Taking PEG3350 vs Senna
The primary outcome is to determine the proportion of patients with postoperative obstructed defecation syndrome (ODS), defined as a score of nine or greater on the ODS questionnaire, in patients taking PEG3350 vs senna in the week after urogynecologic surgery.
Measured: From enrollment to the end of treatment at 7 days after surgery.
Secondary outcomes (1)
Patient-level and Procedure-level Characteristics associated with Postoperative ODS in Patients Taking PEG3350 vs Senna
In order to identify postoperative bowel symptoms associated with ODS, enrolled participants will complete a bowel diary for 7 days after surgery. The bowel diary will include: type of bowel movement using the validated Bristol stool scale, degree of strain and pain measured on an 11-point numerical rating scale from 0-10 (zero denoting no presence of symptom and ten denoting the most severe symptom experienced), presence of splinting with bowel movements, sensation of incomplete evacuation (measured on an 11-point numerical rating scale from 0-10), additional medications taken to assist with bowel movements, fecal urgency, fecal incontinence, narcotic medication usage as well as time to first bowel movement. ODS score will be obtained preoperatively. Participants will be asked to estimate their preoperative frequency of bowel movements. Patients will self-identify their racial background. Medical records will be reviewed to obtain patient characteristics and perioperative data.
Measured: From enrollment to the end of treatment at 7 days after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start23 Apr 2025
- Primary completionMar 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Defecation SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Health, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keila S. Muniz, MD, St. Joseph's Health, New York
- Investigators
- Keila S Muniz, MD, Principal investigator, St. Joseph's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825260
- Sponsor's protocol ID
- StJosephNewYork
- Status last verified
- Apr 2025
- First submitted
- 8 Feb 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyethylene Glycol 3350 Compared With Senna After Urogynecologic Surgery A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06825260
- Acronym / sponsor ID
- StJosephNewYork
- Keywords
- obstructive defecation syndrome (ODS), Postoperative constipation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- St. Joseph's Health, New YorkUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is better at relieving postoperative constipation after urogynecologic surgery. The main questions it aims to answer are:
What number of patients taking PEG3350 have obstructed defecation syndrome (ODS), a form of constipation, vs those taking senna in the week after urogynecologic surgery? What patient-level and procedure-level characteristics are associated with postoperative ODS, in patients taking PEG3350 vs senna? participants will: Take their randomized medication daily for seven days after surgery Fill out an ODS questionnaire before and one week after surgery Complete a daily bowel diary for 7 days after surgery
Detailed description
The purpose of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is superior in the setting of postoperative constipation after urogynecologic surgery. This is a randomized controlled trial with the aim of comparing PEG3350 vs senna as postoperative recommended treatment for obstructive defecation constipation. Our hypothesis is that senna decreases the proportion of women with obstructive defecation constipation compared to use of PEG3350 after urogynecologic surgery. Women 18 years of age and older undergoing surgery for pelvic organ prolapse, stress urinary incontinence or both by the Department of Urogynecology at St. Joseph's Health Hospital, will be randomized to one of two study arms: senna or PEG3350. Arm 1: Polyethylene Glycol 3350, 17g, daily, oral. Arm 2: Senna (Sennosides) 8.6mg, 2 tablets daily, oral (up to 4 tablets twice a day). Interventions would be administered after surgery on postoperative day #0 and continue for 7 days total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senna | Experimental | Drug: SennaSenna (Sennosides), oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days |
| Polyethylene Glycol 3350 | Active comparator | Drug: Polyethylene glycol 3350Polyethylene Glycol 3350, oral, 17g, daily for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria includes women scheduled for urogynecologic surgery for pelvic organ prolapse and/or stress urinary incontinence and at least 18 years old.
Key exclusion criteria (1 listed)
- Exclusion criteria include undergoing concomitant bowel surgery (colonic resection, anal sphincter repair, rectovaginal fistula repair, rectopexy) or placement of a sacral neuromodulation device alone.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SennaAlso: Senokot, SennosideSenna, oral, 8.6mg, 2 tablets daily (up to 4 tablets twice a day) for 7 days | Drug | Senna |
| Polyethylene glycol 3350Also: PEG 3350, MiralaxPolyethylene Glycol 3350, oral, 17g, daily for 7 days | Drug | Polyethylene Glycol 3350 |
Primary outcome
Postoperative ODS in Patients Taking PEG3350 vs Senna
Time frame: From enrollment to the end of treatment at 7 days after surgery.
The primary outcome is to determine the proportion of patients with postoperative obstructed defecation syndrome (ODS), defined as a score of nine or greater on the ODS questionnaire, in patients taking PEG3350 vs senna in the week after urogynecologic surgery.
1 secondary outcome
Patient-level and Procedure-level Characteristics associated with Postoperative ODS in Patients Taking PEG3350 vs Senna
Time frame: From enrollment to the end of treatment at 7 days after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keila S Muniz, MD principal investigator
St. Joseph's Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Senna and Polyethylene glycol 3350 in people with Obstructive Defecation Syndrome and Postoperative Constipation, run by St. Joseph's Health, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keila S Muniz, MD (631-896-7937, keila.muniz@sjhsyr.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative ODS in Patients Taking PEG3350 vs Senna (time frame: From enrollment to the end of treatment at 7 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025.