A vaginal bowel-control system for the treatment of fecal incontinence

Holly E. Richter, Catherine A. Matthews, Tristi Muir, Michelle M. Takase-Sanchez, Douglass S. Hale, Douglas Van Drie, Madhulika G. Varma

    Research output: Contribution to journalArticle

    21 Citations (Scopus)

    Abstract

    OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<001); per protocol success, 85.7% (48/56, P<001) and 85.7% (48/56) considered bowel symptoms "very much better" or "much better." There was significant improvement in all Fecal Incontinence Quality of Life (P<001) and Modified Manchester (P≤007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73-95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period. CONCLUSION: In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures.

    Original languageEnglish (US)
    Pages (from-to)540-547
    Number of pages8
    JournalObstetrics and Gynecology
    Volume125
    Issue number3
    DOIs
    StatePublished - Mar 27 2015

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    Fecal Incontinence
    Equipment and Supplies
    Therapeutics
    Quality of Life
    Intention to Treat Analysis
    Confidence Intervals
    Safety
    Health

    ASJC Scopus subject areas

    • Obstetrics and Gynecology

    Cite this

    Richter, H. E., Matthews, C. A., Muir, T., Takase-Sanchez, M. M., Hale, D. S., Van Drie, D., & Varma, M. G. (2015). A vaginal bowel-control system for the treatment of fecal incontinence. Obstetrics and Gynecology, 125(3), 540-547. https://doi.org/10.1097/AOG.0000000000000639

    A vaginal bowel-control system for the treatment of fecal incontinence. / Richter, Holly E.; Matthews, Catherine A.; Muir, Tristi; Takase-Sanchez, Michelle M.; Hale, Douglass S.; Van Drie, Douglas; Varma, Madhulika G.

    In: Obstetrics and Gynecology, Vol. 125, No. 3, 27.03.2015, p. 540-547.

    Research output: Contribution to journalArticle

    Richter, HE, Matthews, CA, Muir, T, Takase-Sanchez, MM, Hale, DS, Van Drie, D & Varma, MG 2015, 'A vaginal bowel-control system for the treatment of fecal incontinence', Obstetrics and Gynecology, vol. 125, no. 3, pp. 540-547. https://doi.org/10.1097/AOG.0000000000000639
    Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D et al. A vaginal bowel-control system for the treatment of fecal incontinence. Obstetrics and Gynecology. 2015 Mar 27;125(3):540-547. https://doi.org/10.1097/AOG.0000000000000639
    Richter, Holly E. ; Matthews, Catherine A. ; Muir, Tristi ; Takase-Sanchez, Michelle M. ; Hale, Douglass S. ; Van Drie, Douglas ; Varma, Madhulika G. / A vaginal bowel-control system for the treatment of fecal incontinence. In: Obstetrics and Gynecology. 2015 ; Vol. 125, No. 3. pp. 540-547.
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    abstract = "OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50{\%} or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5{\%}) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7{\%} (48/61, P<001); per protocol success, 85.7{\%} (48/56, P<001) and 85.7{\%} (48/56) considered bowel symptoms {"}very much better{"} or {"}much better.{"} There was significant improvement in all Fecal Incontinence Quality of Life (P<001) and Modified Manchester (P≤007) subscales. Success rate at 3 months was 86.4{\%} (38/44; 95{\%} confidence interval 73-95{\%}). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7{\%}]), the majority of events (16/25 [64{\%}]) occurring during the fitting period. CONCLUSION: In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures.",
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    AU - Van Drie, Douglas

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    AB - OBJECTIVE: To evaluate the effectiveness and safety of a vaginal bowel-control device and pump system for fecal incontinence treatment. METHODS: Women with a minimum of four fecal incontinence episodes over 2 weeks were fit with the intravaginal device. Treatment success, defined as a 50% or greater reduction of incontinent episodes, was assessed at 1 month. Participants were invited into an optional extended-wear period of another 2 months. Secondary outcomes included symptom improvement measured by the Fecal Incontinence Quality of Life, Modified Manchester Health Questionnaire, and Patient Global Impression of Improvement. Adverse events were collected. Intention-to-treat analysis included participants who were successfully fit entering treatment. Per protocol, analysis included participants with a valid 1-month treatment diary. RESULTS: Sixty-one of 110 (55.5%) participants from six clinical sites were successfully fit and entered treatment. At 1 month, intention-to-treat success was 78.7% (48/61, P<001); per protocol success, 85.7% (48/56, P<001) and 85.7% (48/56) considered bowel symptoms "very much better" or "much better." There was significant improvement in all Fecal Incontinence Quality of Life (P<001) and Modified Manchester (P≤007) subscales. Success rate at 3 months was 86.4% (38/44; 95% confidence interval 73-95%). There were no serious adverse events; the most common study-wide device-related adverse event was pelvic cramping or discomfort (25/110 participants [22.7%]), the majority of events (16/25 [64%]) occurring during the fitting period. CONCLUSION: In women successfully fit with a vaginal bowel-control device for nonsurgical treatment for fecal incontinence, there was significant improvement in fecal incontinence by objective and subjective measures.

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