The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
72 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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