Outcomes of Limited Postoperative Restrictions Following Sling Placement: A Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorUniversity of Iowa
About this trial
The purpose of this research study is to better understand optimal restrictions for patients postoperatively following a mesh urethral sling placement for patients with stress urinary incontinence.
Patients undergoing a midurethral sling procedure will be assigned to one of two groups. One group with be given standard postprocedural restrictions including instructions to avoid moderate activity and no lifting over 15lbs for six weeks after surgery. The other group will have fewer restrictions, with no restrictions on activity or lifting.
Participants will complete surveys at 2 weeks, 3 months and 1 year following their procedure to help providers better understand how patients are following postoperative restrictions and if there were any differences in the outcome of the procedure between the two groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Limited Restrictions
BehavioralPatients will receive a handout with the following instructions: After discharge from the hospital, resume your normal activities as soon as you feel comfortable. There is no weight limit on lifting. There are no specific activities you should avoid (other than pelvic rest as described below). We recommend pelvic rest, nothing in the vagina (no intercourse, hot tubs, tub bathing or swimming) for 2 weeks.
Standard Restrictions
BehavioralPatient will receive a handout with the following instructions: After discharge from the hospital, avoid doing any strenuous activity (any activity that requires so much exertion that you cannot have a conversation comfortably while doing it). Do not lift anything over 15 pounds for 6 weeks after surgery. For 6 weeks, we recommend complete pelvic rest, nothing in the vagina (no intercourse, hot tubs, tub bathing or swimming).
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Limited RestrictionsExperimental treatment 1 intervention
Group B: Standard RestrictionsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Urogenital Distress Inventory
Questionnaire to assess the severity of lower urinary trat symptoms. Baseline compared to 3 months postoperatively with the hypothesis limited postoperative restrictions will result in non-inferior urinary symptoms compared to standard restrictions
Time frame
3 months and 1 year postoperativelySecondary outcomes
1
Incidence of adverse events
All adverse events will be recorded for both groups
Time frame
Primarily 3 months, will offer 1 year survey follow up2
Self-reported activity
Using the Rapid Assessment of Physical Activity questionnaire, we will compare groups to assess if activity levels were different between the groups
Time frame
2 weeks and 3 months postoperatively3
Post-operative pain scores
Comparing post-operative pain scores at 2-weeks and 3-months post-operatively using the Numerical Pain Rating Scale from 0-10
Time frame
2 weeks and 3 months postoperatively4
Changes to Sexual Function
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-IR) will be administered at baseline, 3 months postoperatively and 1 year postoperatively to compare
Time frame
3 months and 1 year postoperativelySponsors and contacts
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Source ClinicalTrials.gov