Clinical Trial: Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Brief Summary: The investigators are conducting a study to better understand the relationship between activity restrictions and women's satisfaction following urogynecologic surgery for prolapse. We hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.

Detailed Summary: Pelvic floor disorders (PFD) dramatically affect millions of women's quality of life (QOL), and 30% of American women will undergo reconstructive surgery for urinary incontinence or pelvic organ prolapse to improve bothersome symptoms and quality of life. Surgical goals of women with PFD is often to resume their normal activities, which they have limited secondary to bothersome symptoms. Yet, traditionally surgeons placed strict postoperative restrictions on patient's activity levels for 3 months; sometimes even recommending life long lifting and activity restrictions. Activity restrictions are imposed on the premise that exercise can "weaken" surgical healing; however, emerging data from other fields suggests that increased activity may actually promote the healing process. We aim to determine whether satisfaction, recovery, and anatomic outcomes after surgery are related to type of postoperative activity recommendations (liberal versus restricted). Women having surgery for PFD will be randomized to receive either liberal or restricted postoperative activity recommendations and satisfaction, symptoms, QOL and anatomic outcomes will be measured after surgery. We hypothesize that women with liberal activity recommendations will recover more quickly and report higher satisfaction and QOL, have fewer symptoms, and have similar anatomic outcomes to women with restricted activity restrictions. These data will change paradigms of women's health and recovery after surgery.
Sponsor: Northwestern University

Current Primary Outcome: Satisfaction [ Time Frame: 12 weeks following surgery ]

Satisfaction will be assessed following reconstructive pelvic surgery for prolapse using a question which assesses a patient's global impression. Specifically, patients will be asked the question "how satisfied are you with your prolapse surgery?" at 12 wks to assess overall satisfaction. Possible responses include "completely satisfied," "mostly satisfied," "neutral," "mostly dissatisfied," and "completely dissatisfied."


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anatomic Outcomes [ Time Frame: 12 weeks and 1 year following surgery ]
    Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic surgery.
  • Quality of Life [ Time Frame: 12 weeks and 1 year following surgery ]
    Quality of life will be assessed using several validated questionnaires at 12 weeks and 1 year following reconstructive pelvic surgery for prolapse.
  • Pain [ Time Frame: 12 weeks and 1 year following surgery ]
    Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery.
  • Activity level [ Time Frame: 12 weeks and 1 year ]
    Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery.


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: May 8, 2014
Date Started: August 2014
Date Completion: December 2018
Last Updated: March 28, 2017
Last Verified: March 2017