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Completed

NCT Number: NCT04817839

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

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.

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Key information

Conditions

Urinary Stress Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

3-week post-operative activity restriction

Behavioral

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

Behavioral

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 outcomes

  1. Change in urogenital distress inventory (UDI) stress score

    Time frame: Baseline, 6 Months

    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 outcomes

  1. Patient Global Impression of Improvement (PGI-I)

    Time frame: 6 months

    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)

  2. Incontinence Impact Questionnaire Short Form (IIQ-7)

    Time frame: 6 months

    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 .

  3. Change in Patient Satisfaction Post-Operative Questionnaire

    Time frame: 6 weeks, 6 months, and 1 year

    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.

  4. Activity Assessment Scale (AAS)

    Time frame: 3 weeks

    This questionnaire is a 13-item postoperative functional activity scale. The AAS is scored from zero to 100 (higher scores=better activity function).

  5. Change in cough stress test

    Time frame: 6 months, 1 year

    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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 26, 2021
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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