Constipation
Conditions
Keywords
constipation, SennaS
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.
Interventions
DRUGSenna+ 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.
DRUGplacebo
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.
Sponsors
Hartford Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Straining and pain with bowel movements in the immediate post-operative period | First post-operative week |
Countries
United States
Outcome results
None listed