The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hartford Hospital
ClinicalTrials.gov Identifier:
NCT00571896
First received: December 10, 2007
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

We are doing this study to see if using an over the counter mild laxative, SennaS, there is a difference in time required to have a bowel movement in women who are having surgery for prolapse (when your uterus and/or vagina drop after childbirth or with age) and/or incontinence (when you leak urine or stool without your control) as compared to a sugar pill or placebo.


Condition Intervention Phase
Constipation
Drug: Senna+ docusate
Drug: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery: a Randomized Double Blinded Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hartford Hospital:

Primary Outcome Measures:
  • 1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period. [ Time Frame: 7 weeks post-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Straining and pain with bowel movements in the immediate post-operative period [ Time Frame: First post-operative week ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SennaS
This group of participants will receive SennaS to use after surgery.
Drug: Senna+ docusate
Senna+Docusate: dose will be 8.6 mg senna concentrate with 50 mg docusate. The participants will take the medication as follows: 1. Drink 4-6 glasses of fluid a day for the first two weeks after surgery 2. Take 2 SennaS tabs at bedtime the first night home from the hospital 3. If no bowel movement that next morning, take 2 tabs after breakfast. 4. If no bowel movement by evening, take 3 tabs at bedtime 5. If no bowel movement that next morning, take 3 tabs after breakfast 6. Once you do have a bowel movement, use the regimen described in the step two steps prior to the last one you used as your daily regimen. So, if you had a BM the morning after 3 tabs at bedtime, use steps 2 & 3 (2 tabs at night and in the morning) until the first-postoperative visit.
Other Name: SennaS or Senokot-S
Placebo Comparator: Placebo
This group of participants will receive placebo pills to use after surgery.
Drug: placebo
Placebo pill: The participants will use the placebo pills in the following manner: 1. Drink 4-6 glasses of fluid a day for the first two weeks after surgery 2. Take 2 SennaS tabs at bedtime the first night home from the hospital 3. If no bowel movement that next morning, take 2 tabs after breakfast. 4. If no bowel movement by evening, take 3 tabs at bedtime 5. If no bowel movement that next morning, take 3 tabs after breakfast 6. Once you do have a bowel movement, use the regimen described in the step two steps prior to the last one you used as your daily regimen. So, if you had a BM the morning after 3 tabs at bedtime, use steps 2 & 3 (2 tabs at night and in the morning) until the first-postoperative visit.
Other Names:
  • Placebo
  • Blank pill

Detailed Description:

Right now, doctors use mild laxatives and stool softeners to help you have a bowel movement earlier and with less pain after surgery. Sometimes if the stool softener or mild laxatives do not work, you may need to use stronger laxatives or enemas. We want to see if specifically using SennaS is better for having a bowel movement soon after surgery and with less pain. SennaS is FDA approved for constipation. It has a stool softener and a mild laxative and has been shown to be safe and effective for treating constipation.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Women undergoing pelvic reconstructive surgery, including any combination of:

  • Posterior/rectocele repair
  • Paravaginal repair
  • Anterior/cystocele repair
  • Suburethral sling
  • Abdominal sacrocolpopexy
  • Midurethral sling (obturator pass)
  • Burch urethropexy
  • Midurethral sling (retropubic pass)
  • Colpocleisis/colpectomy
  • Uterosacral ligament suspension
  • Sacrospinous ligament fixation
  • Enterocele repair
  • Anal sphincter repair
  • Perineorrhaphy
  • Use of graft material (synthetic or biologic) of any form/size does not affect inclusion, use of laparoscopy or robotic-assisted laparoscopy does not affect inclusion

Exclusion Criteria:

  • Male
  • Pregnancy (based on positive urine or serum ß-HCG measurement preoperatively in women who are not menopausal or have prior hysterectomy)
  • Concurrent bowel resection,
  • Hirschsprung's Disease or gastroparesis,
  • Irritable & inflammatory bowel disease (Crohn's Disease/ulcerative colitis) formally diagnosed,
  • Clostridium difficile colitis during present hospitalization
  • Inability to understand written study material,
  • Inability to give consent
  • Rectal bleeding or presently diagnosed colorectal cancer,
  • Documented preoperative daily use of SennaS for more than 3 weeks,
  • Known allergy to SennaS
  • Inability to use suppositories/enemas
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571896

Locations
United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Investigators
Principal Investigator: Christine A LaSala, MD Hartford Hospital, Division of Urogynecology
  More Information

Publications:

Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT00571896     History of Changes
Other Study ID Numbers: PATE002472HE
Study First Received: December 10, 2007
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hartford Hospital:
constipation
SennaS

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Senna Extract
Sennoside A&B
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014