Restricted Convalescence: Outcomes Following Urogynecologic Procedures

NCT02138487 | Completed DMC

• 1 other identifier: STU00084995
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 3

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.

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapse; reconstructive pelvic surgery; postoperative restrictions; patient satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Anatomic Outcomes

  12 weeks and 1 year following surgery

• Quality of Life

  12 weeks and 1 year following surgery

• Pain

  12 weeks and 1 year following surgery

• Activity level

  12 weeks and 1 year

Study Arms (2)

Restricted postoperative activity

ACTIVE COMPARATOR

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

Other: Restricted postoperative activity

Liberal postoperative activity

EXPERIMENTAL

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

Other: liberal postoperative activity

Interventions

liberal postoperative activity OTHER

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

Liberal postoperative activity

Restricted postoperative activity 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.

Restricted postoperative activity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (3)

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Virginia Tech Carilion School of Medicine

Roanoke, Virginia, 24016, United States

Location

Related Publications (3)

• 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.

  PMID: 32947549 DERIVED

• 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.

  PMID: 30570502 DERIVED

• 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.

  PMID: 28277355 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse; Patient Satisfaction

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kimberly Kenton, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynecology, Professor of Urology, Division Chief Female Pelvic Medicine and Reconstructive Surgery

Study Record Dates

• First Submitted: May 8, 2014
• First Posted: May 14, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

US (3)