Urinary Stress IncontinenceNCT04817839
Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures
A study testing 3-week post-operative activity restriction and 6-week post-operative activity restriction in people with Urinary Stress Incontinence, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- 3-week post-operative activity restriction and 6-week post-operative activity restriction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 16 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age,
- Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence
Who cannot join
- • 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Hospital
New Haven, Connecticut, 06512
About this study
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.
Read the 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.
- Conditions
- Urinary Stress Incontinence
- Being tested
- 3-week post-operative activity restriction, 6-week post-operative activity restriction
- Keywords
- post-operative physical restrictions
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-week post-operative activity restrictionBehavioural
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 restrictionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 3-week post-operative activity restriction | Experimental | 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. Receives: Behavioral: 3-week post-operative activity restriction |
| 6-week post-operative activity restriction | Experimental | 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. Receives: Behavioral: 6-week post-operative activity restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 Months
Secondary outcomes (5)
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)
Measured: 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 .
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jul 2021
- Primary completion5 Apr 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Oz Harmanli, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817839
- Sponsor's protocol ID
- 2000029067
- Other IDs
- 000
- Status last verified
- Feb 2026
- First submitted
- 23 Mar 2021
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Duration of Post-Operative Activity Restriction After Midurethral Sling Procedures
- ClinicalTrials.gov ID
- NCT04817839
- Acronym / sponsor ID
- 2000029067
- Conditions
- Urinary Stress Incontinence
- Keywords
- post-operative physical restrictions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-week post-operative activity restriction | Experimental | Behavioral: 3-week post-operative activity restrictionParticipants 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 | Experimental | Behavioral: 6-week post-operative activity restrictionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age,
- Patients who are ambulatory and scheduled for midurethral sling placement surgery only for treatment of stress urinary incontinence
Key exclusion criteria (3 listed)
- • Patients who are unable to read, understand, or complete study documents in English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-week post-operative activity restrictionParticipants 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. | Behavioural | 3-week post-operative activity restriction |
| 6-week post-operative activity restrictionParticipants 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. | Behavioural | 6-week post-operative activity restriction |
Primary outcome
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.
5 secondary outcomes
Patient Global Impression of Improvement (PGI-I)
Time frame: 6 months
Incontinence Impact Questionnaire Short Form (IIQ-7)
Time frame: 6 months
Change in Patient Satisfaction Post-Operative Questionnaire
Time frame: 6 weeks, 6 months, and 1 year
Activity Assessment Scale (AAS)
Time frame: 3 weeks
Change in cough stress test
Time frame: 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- BackgroundFitzGerald 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oz Harmanli, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-week post-operative activity restriction and 6-week post-operative activity restriction in people with Urinary Stress Incontinence, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urogenital distress inventory (UDI) stress score (time frame: Baseline, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04817839, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.