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

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: Senna+ docusate; Drug: placebo

• Registration Number: NCT00571896
• Lead Sponsor: Hartford Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2007-12-10
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-12
• Study Start: 2008-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-03
• Last Update Posted: 2012-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SennaS	Senna+ docusate	This group of participants will receive SennaS to use after surgery.
Placebo	placebo	This group of participants will receive placebo pills to use after surgery.

Primary Outcome Measures

Name	Time	Method
1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period.	7 weeks post-operatively

Secondary Outcome Measures

Name	Time	Method
Straining and pain with bowel movements in the immediate post-operative period	First post-operative week

Trial Locations

Locations (1)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States