ConstipationNCT06335797
Optimization of Postoperative Bowel Habits
A study testing Senna Tab and Dulcolax Suppositories in people with Constipation, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Senna Tab and Dulcolax Suppositories
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2024to May 2027
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages 18 and older scheduled to undergo vaginal pelvic organ prolapse repair
Who cannot join
- Women younger than 18 years old
- Those unable to provide consent
- Preexisting chronic laxative use
- Conditions that could affect bowel function including, inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, rectovaginal fistula; concurrent bowel surgery; intraoperative bowel injury
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
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Christina M Mezes, MD, 336-713-4098, cmezes@wakehealth.edu
Sachin N Vyas, MS, PhD, 336.713.4098, svyas@wakehealth.edu
About this study
Official title: Optimization of Postoperative Bowel Habits Following Pelvic Reconstructive Surgery: a Randomized Controlled Trial
Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository.
Read the detailed description
Delayed return to bowel function following vaginal surgery for pelvic organ prolapse has been deemed to be highly distressing for patients, and is ranked as one of the most common reasons for emergency department visits and telephone calls in the immediate post-operative period.
Despite the prevalence of constipation and significant effect on quality of life, few studies have examined an evidence-based bowel regimen for postoperative constipation prevention in the Urogynecology population.
As per available medical literature, the onset of action for oral senna occurs within 6-12 hours, while bisacodyl suppository can take effect between 15 and 60 minutes following rectal administration. Proposed trial comparing oral senna to rectal bisacodyl suppositories for the prevention of postoperative constipation in women undergoing vaginal reconstructive surgery for symptomatic prolapse.
- Conditions
- Constipation
- Being tested
- Senna Tab, Dulcolax Suppositories
- Keywords
- Bowel Habits, Pelvic Surgery, Laxatives
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senna TabDietary supplement
Also called Senokot
Senna 8.6mg two tablets per day post operative day 1 and and if needed, then continue on the same dose regiment until post operative day 5.
Dulcolax SuppositoriesDietary supplement
Also called Bisacodyl Suppositories
Dulcolax 1 suppository to be placed rectally on the evening of post operative day 1 and if needed, then continue using the same dose regiment until the post operative day 5.
| Study group | Role | What they receive |
|---|---|---|
| SENNA | Experimental | 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. Receives: Dietary Supplement: Senna Tab |
| DULCOLAX | Experimental | 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. Receives: Dietary Supplement: Dulcolax Suppositories |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in hours to first bowel movement comparison between the two arms
To compare the time to first bowel movement after use of bisacodyl suppositories or oral senna in women undergoing vaginal reconstructive surgery for pelvic organ prolapse. Time in hours will be recorded from the end of the surgical procedure. That is Post Operative Day (POD) 0. First bowel movement will be recorded up to POD5.
Measured: up to Post Operative Day (POD) 5
Secondary outcomes (4)
Change in Overall Satisfaction (TSQM) Scores
Patients will complete the Treatment Satisfaction Questionnaire for Medicine (TSQM) at 1 week postop. The TSQM is a validated survey assessing patient satisfaction to treatment - It consists of 14 questions, with 7 possible answers for each question, ranging from "extremely agree" to extremely disagree. Higher Scores meaning more satisfaction.
Measured: Day 7
Visual Analog Scale (VAS) Pain Scores
Patients will be asked to rate their pain with first bowel movement using an 11-point visual analog scale (VAS), in which a score of 0 equates to "no pain" and a score of 10 equates to the "worst pain possible." - VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.
Measured: Post Operative Day (POD)1, POD2, POD3, POD4, and POD5
Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores
The Patient Assessment of Constipation Symptom Questionnaire is a validated 12-item questionnaire based on the Rome criteria for constipation and is tailored to assess a change in short-term constipation symptoms after an intervention. A score of 0.35 or greater on the Patient Assessment of Constipation Symptom Questionnaire is consistent with constipation, and the changes in scores correlate with clinical changes in constipation symptoms. Items are scored on 5-point Likert scales, with scores ranging from 0 to 4 (0 = 'symptom absent', 1 = 'mild', 2 = 'moderate', 3 = 'severe' and 4 = 'very severe').
Measured: Baseline and Day 7
Bristol Stool Form Scale (BSFS) Scores
The Bristol Stool Form Scale (BSFS) is a visual bowel movement rating scale from 1 to 7 that provided a validated measure of gut transit time based on the shape, consistency, and appearance of the bowel movement. The BSFS is an ordinal scale of stool types ranging from the hardest (type 1) to the softest (type 7) that is widely used in practice and clinical research to measure stool form. Types 1 and 2 are considered abnormally hard stools (and in conjunction with other symptoms indicative of constipation).
Measured: Post Operative Day (POD)1, POD2, POD3, POD4, and POD5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start16 Oct 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candace Parker-Autry, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335797
- Sponsor's protocol ID
- IRB00110733
- Status last verified
- Feb 2026
- First submitted
- 22 Mar 2024
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Caljouw MA, Hogendorf-Burgers ME. GYNOTEL: telephone advice to gynaecological surgical patients after discharge. J Clin Nurs. 2010 Dec;19(23-24):3301-6. doi: 10.1111/j.1365-2702.2010.03395.x. Epub 2010 Oct 14.
PubMed 20946445Ramaseshan AS, LaSala C, O'Sullivan DM, Steinberg AC. Patient-Initiated Telephone Calls in the Postoperative Period After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Oct;26(10):626-629. doi: 10.1097/SPV.0000000000000636.
PubMed 30247168Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032.
PubMed 15902178Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6.
PubMed 20207340Tarumi Y, Wilson MP, Szafran O, Spooner GR. Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. J Pain Symptom Manage. 2013 Jan;45(1):2-13. doi: 10.1016/j.jpainsymman.2012.02.008. Epub 2012 Aug 11.
PubMed 22889861
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Postoperative Bowel Habits Following Pelvic Reconstructive Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06335797
- Acronym / sponsor ID
- IRB00110733
- Conditions
- Constipation
- Keywords
- Bowel Habits, Pelvic Surgery, Laxatives
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Mar 2024 (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.
Project is a trial, in which women undergoing vaginal surgery for pelvic organ prolapse will be randomized 1:1 to a postoperative bowel regimen of either oral senna or rectal bisacodyl suppository.
Detailed description
Delayed return to bowel function following vaginal surgery for pelvic organ prolapse has been deemed to be highly distressing for patients, and is ranked as one of the most common reasons for emergency department visits and telephone calls in the immediate post-operative period.
Despite the prevalence of constipation and significant effect on quality of life, few studies have examined an evidence-based bowel regimen for postoperative constipation prevention in the Urogynecology population.
As per available medical literature, the onset of action for oral senna occurs within 6-12 hours, while bisacodyl suppository can take effect between 15 and 60 minutes following rectal administration. Proposed trial comparing oral senna to rectal bisacodyl suppositories for the prevention of postoperative constipation in women undergoing vaginal reconstructive surgery for symptomatic prolapse.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SENNA | Experimental | Dietary Supplement: Senna TabGroup 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. |
| DULCOLAX | Experimental | Dietary Supplement: Dulcolax SuppositoriesGroup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women ages 18 and older scheduled to undergo vaginal pelvic organ prolapse repair
Key exclusion criteria (4 listed)
- Women younger than 18 years old
- Those unable to provide consent
- Preexisting chronic laxative use
- Conditions that could affect bowel function including, inflammatory bowel disease, irritable bowel syndrome, colorectal cancer, rectovaginal fistula; concurrent bowel surgery; intraoperative bowel injury
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 |
|---|---|---|
| Senna TabAlso: SenokotSenna 8.6mg two tablets per day post operative day 1 and and if needed, then continue on the same dose regiment until post operative day 5. | Dietary supplement | SENNA |
| Dulcolax SuppositoriesAlso: Bisacodyl SuppositoriesDulcolax 1 suppository to be placed rectally on the evening of post operative day 1 and if needed, then continue using the same dose regiment until the post operative day 5. | Dietary supplement | DULCOLAX |
Primary outcome
Time in hours to first bowel movement comparison between the two arms
Time frame: up to Post Operative Day (POD) 5
To compare the time to first bowel movement after use of bisacodyl suppositories or oral senna in women undergoing vaginal reconstructive surgery for pelvic organ prolapse. Time in hours will be recorded from the end of the surgical procedure. That is Post Operative Day (POD) 0. First bowel movement will be recorded up to POD5.
4 secondary outcomes
Change in Overall Satisfaction (TSQM) Scores
Time frame: Day 7
Visual Analog Scale (VAS) Pain Scores
Time frame: Post Operative Day (POD)1, POD2, POD3, POD4, and POD5
Patient Assessment of Constipation Symptom Questionnaire (PAC-SYM) Scores
Time frame: Baseline and Day 7
Bristol Stool Form Scale (BSFS) Scores
Time frame: Post Operative Day (POD)1, POD2, POD3, POD4, and POD5
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 27 Feb 2026.
- Background: PubMed 20946445Caljouw MA, Hogendorf-Burgers ME. GYNOTEL: telephone advice to gynaecological surgical patients after discharge. J Clin Nurs. 2010 Dec;19(23-24):3301-6. doi: 10.1111/j.1365-2702.2010.03395.x. Epub 2010 Oct 14.
- Background: PubMed 30247168Ramaseshan AS, LaSala C, O'Sullivan DM, Steinberg AC. Patient-Initiated Telephone Calls in the Postoperative Period After Female Pelvic Reconstructive Surgery. Female Pelvic Med Reconstr Surg. 2020 Oct;26(10):626-629. doi: 10.1097/SPV.0000000000000636.
- Background: PubMed 15902178Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032.
- Background: PubMed 20207340Patel M, Schimpf MO, O'Sullivan DM, LaSala CA. The use of senna with docusate for postoperative constipation after pelvic reconstructive surgery: a randomized, double-blind, placebo-controlled trial. Am J Obstet Gynecol. 2010 May;202(5):479.e1-5. doi: 10.1016/j.ajog.2010.01.003. Epub 2010 Mar 6.
- Background: PubMed 22889861Tarumi Y, Wilson MP, Szafran O, Spooner GR. Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients. J Pain Symptom Manage. 2013 Jan;45(1):2-13. doi: 10.1016/j.jpainsymman.2012.02.008. Epub 2012 Aug 11.
- 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.
Candace Parker-Autry, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senna Tab and Dulcolax Suppositories in people with Constipation, run by Wake Forest University Health Sciences 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 4 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 27 Feb 2026. 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.
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 Christina M Mezes, MD (336-713-4098, cmezes@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in hours to first bowel movement comparison between the two arms (time frame: up to Post Operative Day (POD) 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06335797, which also lists 5 linked publications.
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 27 Feb 2026; AzTrials last refreshed its copy on 31 Oct 2026.