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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of SennaS for Prevention of Post-operative Constipation After Urogynecologic Surgery: a Randomized Double Blinded Placebo Controlled Trial

Conditions
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Constipation

Intervention / Treatment
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* Drug: Senna+ docusate
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SennaS<br>This group of participants will receive SennaS to use after surgery. | Drug: Senna+ docusate<br>* 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.<br>* Other names: SennaS or Senokot-S;|
| Placebo Comparator: Placebo<br>This group of participants will receive placebo pills to use after surgery. | Drug: placebo<br>* 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.<br>* Other names: Blank pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Straining and pain with bowel movements in the immediate post-operative period |  | First post-operative week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, SennaS