Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Study Overview
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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.

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.

Official Title
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Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Other: liberal postoperative activity
* Other: Restricted postoperative activity


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Restricted postoperative activity<br>Women in the restricted postoperative activity group must abstain from exercise and heavy lifting for 3 months postoperatively | Other: Restricted postoperative activity<br>* Women in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months.<br>|
| Experimental: Liberal postoperative activity<br>Women in the liberal postoperative activity group will be allowed to resume their normal activities without restriction. | Other: liberal postoperative activity<br>* Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction | 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. | 12 weeks following surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse, reconstructive pelvic surgery, postoperative restrictions, patient satisfaction