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Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures

Primary Purpose

Urinary Stress Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3-week post-operative activity restriction
6-week post-operative activity restriction
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Urinary Stress Incontinence focused on measuring post-operative physical restrictions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years of age,
  • Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence

Exclusion Criteria:

  • • Patients who are unable to read, understand, or complete study documents in English or Spanish

    • Patient undergoing concomitant surgery for pelvic organ prolapse other than midurethral sling
    • Patients who are unable to commit to 6 weeks of no heavy lifting (20 lbs)

Sites / Locations

  • Yale New Haven HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3-week post-operative activity restriction

6-week post-operative activity restriction

Arm Description

Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.

Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.

Outcomes

Primary Outcome Measures

Change in urogenital distress inventory (UDI) stress score
UDI form calculator assesses life quality and symptom distress in women suffering from urinary incontinence. The range is 0 to 70, higher means worse, lowers means better (higher is more symptoms.

Secondary Outcome Measures

Patient Global Impression of Improvement (PGI-I)
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse)
Incontinence Impact Questionnaire Short Form (IIQ-7)
Incontinence Impact Questionnaire (IIQ) short form at 6 months. The IIQ-7 has 7 questions that evaluate quality of life related to urinary symptoms. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. Higher scores indicate worse quality of life .
Change in Patient Satisfaction Post-Operative Questionnaire
This is a questionnaire that will evaluate patient's satisfaction. Assessed on a 5-point Likert scale with question "How satisfied are you with the result of your incontinence surgery." Range is 0-5. Higher number means more satisfied.
Activity Assessment Scale (AAS)
This questionnaire is a 13-item postoperative functional activity scale. The AAS is scored from zero to 100 (higher scores=better activity function).
Change in cough stress test
Cough stress test is a clinic evaluation to assess stress urinary incontinence. Positive (leaking of urine w cough) or Negative (no leaking urine w cough)

Full Information

First Posted
March 23, 2021
Last Updated
December 19, 2022
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT04817839
Brief Title
Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures
Official Title
Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare postoperative outcomes and patient satisfaction between 3 and 6-week postoperative restrictions after a midurethral sling procedure.
Detailed Description
This is a blinded, randomized controlled trial. Patients undergoing midurethral sling placement for stress urinary incontinence will be asked to participate in the study. If eligible and willing to participate, patients will be randomized to a "3 weeks post-operative restriction" or "6-week post-operative restriction" of activities group. Currently, pelvic surgeons' recommendations for activity and lifting restrictions during post-operative period vary widely from 1 to 50 pounds (10). Given variation in literature and reasonable expectations for lifting restrictions, 20-pound lifting restriction was considered to be a reasonable and attainable expectation from patients. Both groups will be given an identical set of postoperative instructions which include refrainment from lifting anything over 20 pounds, avoid strenuous exercise, running, or perform high-impact aerobic activities during the restricted activity period. Depending on their random allocation, patients will follow these instructions either for 3 or 6 postoperative weeks. The activities which all patients will be allowed to do during their postoperative recovery include walking, using stairs and showering in both groups. All patient will be asked to refrain from sexual intercourse for 6 weeks consistent with current routine post op recommendations (6). Other than the time of activity restriction post op (heavy lifting, strenuous exercise, running, high impact exercise), patients will receive identical postoperative instructions otherwise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence
Keywords
post-operative physical restrictions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
205 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3-week post-operative activity restriction
Arm Type
Experimental
Arm Description
Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.
Arm Title
6-week post-operative activity restriction
Arm Type
Experimental
Arm Description
Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.
Intervention Type
Behavioral
Intervention Name(s)
3-week post-operative activity restriction
Intervention Description
Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.
Intervention Type
Behavioral
Intervention Name(s)
6-week post-operative activity restriction
Intervention Description
Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.
Primary Outcome Measure Information:
Title
Change in urogenital distress inventory (UDI) stress score
Description
UDI form calculator assesses life quality and symptom distress in women suffering from urinary incontinence. The range is 0 to 70, higher means worse, lowers means better (higher is more symptoms.
Time Frame
Baseline, 6 Months
Secondary Outcome Measure Information:
Title
Patient Global Impression of Improvement (PGI-I)
Description
The Patient Global Impression of Improvement (PGI-I) is a global index that may be used to rate the response of a condition to a therapy (transition scale). The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1 (Very much better) to 7 (Very much worse)
Time Frame
6 months
Title
Incontinence Impact Questionnaire Short Form (IIQ-7)
Description
Incontinence Impact Questionnaire (IIQ) short form at 6 months. The IIQ-7 has 7 questions that evaluate quality of life related to urinary symptoms. Item responses are assigned values of 0 for "not at all," 1 for "slightly," 2 for "moderately," and 3 for "greatly." The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100. Higher scores indicate worse quality of life .
Time Frame
6 months
Title
Change in Patient Satisfaction Post-Operative Questionnaire
Description
This is a questionnaire that will evaluate patient's satisfaction. Assessed on a 5-point Likert scale with question "How satisfied are you with the result of your incontinence surgery." Range is 0-5. Higher number means more satisfied.
Time Frame
6 weeks, 6 months, and 1 year
Title
Activity Assessment Scale (AAS)
Description
This questionnaire is a 13-item postoperative functional activity scale. The AAS is scored from zero to 100 (higher scores=better activity function).
Time Frame
3 weeks
Title
Change in cough stress test
Description
Cough stress test is a clinic evaluation to assess stress urinary incontinence. Positive (leaking of urine w cough) or Negative (no leaking urine w cough)
Time Frame
6 months, 1 year

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females only
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age, Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence Exclusion Criteria: • Patients who are unable to read, understand, or complete study documents in English or Spanish Patient undergoing concomitant surgery for pelvic organ prolapse other than midurethral sling Patients who are unable to commit to 6 weeks of no heavy lifting (20 lbs)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oz Harmanli, MD
Phone
203-785-4002
Email
oz.harmanli@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro Alvarez, MD
Phone
203-785-4002
Email
pedro.alvarez@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oz Harmanli, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oz Harmanli, MD
Phone
203-785-4002
Email
oz.harmanli@yale.edu
First Name & Middle Initial & Last Name & Degree
Oz Harmanli, MD

12. IPD Sharing Statement

Citations:
Citation
FitzGerald MP, Shisler S, Shott S, Brubaker L. Physical Limitations After Gynecologic Surgery, Journal of Pelvic Surgery: May-June 2001 - Volume 7 - Issue 3 - p 136-139
Results Reference
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Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures

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