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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
206
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.
Yale New Haven Hospital
New Haven, Connecticut, United States
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.
Time frame: Baseline, 6 Months
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)
Time frame: 6 months
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 .
Time frame: 6 months
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.
Time frame: 6 weeks, 6 months, and 1 year
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).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 weeks
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)
Time frame: 6 months, 1 year