liberal postoperative activity
OtherWomen will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.
NCT Number: NCT02138487
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Not applicable
Northwestern University, Feinberg School of Medicine, Chicago, Illinois, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding 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.
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."
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.
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.
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.
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.
Northwestern University
Other
Acronym: ReCOUP
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.
Published trials that share one or more normalized conditions with this study.
NCT06934304
Behavior, Health Behavior
Dallas, Texas, United States
View Trial DetailsNCT02111642
Behavior, Female Urogenital Diseases
Washington D.C., District of Columbia, United States
View Trial DetailsNCT01864408
Behavior, Health Behavior
Chapel Hill, North Carolina, United States
View Trial DetailsNCT07008898
Behavior, Female Urogenital Diseases
Birmingham, Alabama, United States
View Trial Details