Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2020-01-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Restricted postoperative activity

Women in the "restricted postoperative activity" group must abstain from exercise and heavy lifting for 3 months postoperatively

Group Type ACTIVE_COMPARATOR

Restricted postoperative activity

Intervention Type 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.

Liberal postoperative activity

Women in the "liberal postoperative activity" group will be allowed to resume their normal activities without restriction.

Group Type EXPERIMENTAL

liberal postoperative activity

Intervention Type OTHER

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

Interventions

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liberal postoperative activity

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

Intervention Type OTHER

Restricted postoperative activity

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

Intervention Type OTHER

Eligibility Criteria

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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