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

Urinary Stress Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04817839
• Other study ID #: 2000029067
• Secondary ID: 000
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Oz Harmanli, MD
• Phone: 203-785-4002
• Email: oz.harmanli[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 205
• Est. completion date: January 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Urinary Incontinence, Stress
• Urinary Stress Incontinence

Intervention

Behavioral:
• 3-week post-operative activity restriction
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.
• 6-week post-operative activity restriction
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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 Months
Secondary	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)	6 months
Secondary	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 .	6 months
Secondary	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.	6 weeks, 6 months, and 1 year
Secondary	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).	3 weeks
Secondary	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)	6 months, 1 year