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Completed

NCT Number: NCT00571896

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

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hartford Hospital

Hartford, Connecticut, 06106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Senna+ docusate

Drug

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.

Other names: SennaS or Senokot-S

Placebo

Drug

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.

Other names: Blank pill

Primary outcomes

  1. 1. Time to first bowel movement after surgery. 2. Need for magnesium citrate or enemas in the immediate post-operative period.

    Time frame: 7 weeks post-operatively

Secondary outcomes

  1. Straining and pain with bowel movements in the immediate post-operative period

    Time frame: First post-operative week

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Dec 12, 2007
Registry last updated
Jan 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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