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

NCT00571896 | Completed Phase 2

• 1 other identifier: PATE002472HE
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Keywords

constipation; SennaS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  First post-operative week

Study Arms (2)

SennaS

EXPERIMENTAL

This group of participants will receive SennaS to use after surgery.

Drug: Senna+ docusate

Placebo

PLACEBO COMPARATOR

This group of participants will receive placebo pills to use after surgery.

Drug: placebo

Interventions

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.

Also known as: SennaS or Senokot-S

SennaS

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.

Also known as: Blank pill

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Hartford Hospital: lead

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (14)

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  PMID: 11405974 BACKGROUND

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  PMID: 2989052 BACKGROUND

• Schmelzer M. Effectiveness of wheat bran in preventing constipation of hospitalized orthopaedic surgery patients. Orthop Nurs. 1990 Nov-Dec;9(6):55-9. doi: 10.1097/00006416-199011000-00010.

  PMID: 2177180 BACKGROUND

• Kacmaz Z, Kasici M. Effectiveness of bran supplement in older orthopaedic patients with constipation. J Clin Nurs. 2007 May;16(5):928-36. doi: 10.1111/j.1365-2702.2006.01766.x.

  PMID: 17462043 BACKGROUND

• Franneby U, Gunnarsson U, Wollert S, Sandblom G. Discordance between the patient's and surgeon's perception of complications following hernia surgery. Hernia. 2005 May;9(2):145-9. doi: 10.1007/s10029-004-0310-x. Epub 2005 Feb 10.

  PMID: 15703861 BACKGROUND

• Corman ML. Management of postoperative constipation in anorectal surgery. Dis Colon Rectum. 1979 Apr;22(3):149-51. doi: 10.1007/BF02586804.

  PMID: 87299 BACKGROUND

• Jelovsek JE, Barber MD, Paraiso MF, Walters MD. Functional bowel and anorectal disorders in patients with pelvic organ prolapse and incontinence. Am J Obstet Gynecol. 2005 Dec;193(6):2105-11. doi: 10.1016/j.ajog.2005.07.016.

  PMID: 16325624 BACKGROUND

• Arya LA, Novi JM, Shaunik A, Morgan MA, Bradley CS. Pelvic organ prolapse, constipation, and dietary fiber intake in women: a case-control study. Am J Obstet Gynecol. 2005 May;192(5):1687-91. doi: 10.1016/j.ajog.2004.11.032.

  PMID: 15902178 BACKGROUND

• Bradley CS, Brown MB, Cundiff GW, Goode PS, Kenton KS, Nygaard IE, Whitehead WE, Wren PA, Weber AM; Pelvic Floor Disorders Network. Bowel symptoms in women planning surgery for pelvic organ prolapse. Am J Obstet Gynecol. 2006 Dec;195(6):1814-9. doi: 10.1016/j.ajog.2006.07.008. Epub 2006 Sep 25.

  PMID: 16996465 BACKGROUND

• da Silva GM, Gurland B, Sleemi A, Levy G. Posterior vaginal wall prolapse does not correlate with fecal symptoms or objective measures of anorectal function. Am J Obstet Gynecol. 2006 Dec;195(6):1742-7. doi: 10.1016/j.ajog.2006.07.034.

  PMID: 17132476 BACKGROUND

• Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.

  PMID: 9299672 BACKGROUND

• Mahony R, Behan M, O'Herlihy C, O'Connell PR. Randomized, clinical trial of bowel confinement vs. laxative use after primary repair of a third-degree obstetric anal sphincter tear. Dis Colon Rectum. 2004 Jan;47(1):12-7. doi: 10.1007/s10350-003-0009-6. Epub 2004 Jan 14.

  PMID: 14719145 BACKGROUND

• Griffenberg L, Morris M, Atkinson N, Levenback C. The effect of dietary fiber on bowel function following radical hysterectomy: a randomized trial. Gynecol Oncol. 1997 Sep;66(3):417-24. doi: 10.1006/gyno.1997.4797.

  PMID: 9299255 BACKGROUND

• Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327.

  PMID: 10522604 BACKGROUND

MeSH Terms

Conditions

Constipation

Interventions

doxidan

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christine A LaSala, MD

  Hartford Hospital, Division of Urogynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: January 5, 2012

Record last verified: 2012-01

Locations

US (1)