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

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT00571896

Run by

Hartford Hospital

People needed

72

Starts

2008-01-01

Expected to finish

2009-06-01

Last updated by the study team

2012-01-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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