Clinical trial NCT02138487: Restricted Convalescence: Outcomes Following Urogynecologic Procedures
Official title: Restricted Convalescence: Outcomes Following Urogynecologic Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Keywords: pelvic organ prolapse
reconstructive pelvic surgery
postoperative restrictions
patient satisfaction
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2014-05-14
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Satisfaction
timeFrame: 12 weeks following surgery
Secondary outcomes:
measure: Anatomic Outcomes
timeFrame: 12 weeks and 1 year following surgery
measure: Quality of Life
timeFrame: 12 weeks and 1 year following surgery
measure: Pain
timeFrame: 12 weeks and 1 year following surgery
measure: Activity level
timeFrame: 12 weeks and 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University, Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Roanoke
country: United States
facility: Virginia Tech Carilion School of Medicine
state: Virginia
Study officials:
affiliation: Northwestern University
name: Kimberly Kenton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller MG, Collins SA, Lewicky-Gaupp C, Tavathia M, Kenton K. Restricted Convalescence Following Urogynecologic Procedures: 1-Year Outcomes From a Randomized Controlled Study. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e336-e341. doi: 10.1097/SPV.0000000000000922.
citation: Bochenska K, Hall E, Griffith JW, Kenton K, Alverdy A, Lewicky-Gaupp C, Mueller M. The Promise of PROMIS in Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2019 Nov-Dec;25(6):426-429. doi: 10.1097/SPV.0000000000000685.
citation: Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.