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Completed

NCT Number: NCT02138487

Restricted Convalescence: Outcomes Following Urogynecologic Procedures

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University, Feinberg School of Medicine, Chicago, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Ambulatory women undergoing surgical management of pelvic organ prolapse
  • Prolapse > to Stage II on POP-Q
  • Age >18 yrs
  • Completed childbearing
  • All subjects must have given signed, informed consent prior to registration on study
  • All subjects must be able to read and complete study documents

Exclusion criteria

  • Wheelchair-bound women
  • Women with neurologic disease (Multiple Sclerosis, Parkinson's Disease)
  • Abdominal approach with laparotomy

Treatment and study plan

liberal postoperative activity

Other

Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.

Restricted postoperative activity

Other

Women in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months.

Primary outcomes

  1. 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."

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: ReCOUP

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 14, 2014
Registry last updated
Jun 4, 2020

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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