Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Pelvic Organ Prolapse Clinical Trial

— ReCOUP  

Official title:

Restricted Convalescence: Outcomes Following Urogynecologic Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138487
• Other study ID #: STU00084995
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: January 2020

Study information

• Verified date: June 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Convalescence
• Pelvic Organ Prolapse
• Prolapse

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University, Feinberg School of Medicine	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Virginia Tech Carilion School of Medicine	Roanoke	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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