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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hartford Hospital
• Treatments: Bismuth subsalicylate; Senna Extract; Sennoside A&B

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