Stress Urinary IncontinencePARSNCT04552457
Postoperative Activity Restrictions After Slings
A study testing No activity restrictions and Activity restrictions in people with Stress Urinary Incontinence and Patient Satisfaction, run by Northwell Health at 1 site in United States.
Trial summary
Postoperative restrictions are often based on expert opinion and "common sense". There is a wide variety in the recommended activity limitation amongst pelvic floor surgeons. Many patients undergo urogynecologic procedures to improve their quality of life, and these additional restrictions decrease their quality of… Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Urinary Incontinence, Patient Satisfaction, Surgery
- What is being tested?
- No activity restrictions and Activity restrictions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2020to 20 Jan 2023
- 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 to 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-85 years
- Urodynamic-proven stress incontinence or stress leakage on physical exam
- Desires surgical management for stress incontinence with a midurethral sling
Who cannot join
- Prior midurethral sling or urethropexy
- Prior pelvic reconstruction
- Prior pelvic radiation
- Connective tissue disorder
- Severe physical limitation at baseline
- Currently pregnant or desires future childbearing potential
- Concomitant surgeries (except for anterior colporrhaphy for anterior wall prolapse less than 0 on POPQ or other minor procedures).
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore University Hospital
Great Neck, New York, 11030
About this study
Official title: Do Liberal Versus Strict Postoperative Restrictions After Mid-urethral Slings Affect Outcomes?
Postoperative restrictions are often based on expert opinion and "common sense". There is a wide variety in the recommended activity limitation amongst pelvic floor surgeons. Many patients undergo urogynecologic procedures to improve their quality of life, and these additional restrictions decrease their quality of life in the short term. Our hypothesis is that unrestricted activity after a mid-urethral sling will not negatively impact a patient's recovery or likelihood of surgical success.
Eligible participants will be randomized to no postoperative instructions or traditional postoperative instructions. Patients will be followed up at 2 weeks, 6 weeks, and 6 months postoperatively. Data will be collected throughout the follow up period, but the primary endpoint is at 6 months. At the 6 month visit, subjects' activity level, leakage symptoms, and postoperative satisfaction will be assessed.
Read the detailed description
There is a limited body of literature regarding restrictions for gynecologic surgery. Most of these studies have looked at patients with prolapse and incontinence, and many of the postoperative recommendations are intended for both classes of procedures. Most surgeons restrict their patients' activities postoperatively but to varying degrees and for variable amounts of time. One study in 2017 showed no adverse effect on short term outcomes after prolapse repair with liberal postoperative restrictions compared to stricter, traditional restrictions. No studies have been performed to look at postoperative restrictions after mid-urethral slings.
A common reason for limiting activity is due to the unproven concern about increased intra-abdominal pressure on healing and surgical success. At this time, no studies have shown causality. The range of intra-abdominal pressures generated during "unavoidable" activities, such as coughing, standing, and bending, overlaps with the range of pressures generated during activities that are typically restricted. Another study showed the intra-abdominal pressures generated during activities of daily living overlapped with pressures generated by women performing CrossFit exercises.
A 2017 study showed no effect on outcomes with unrestricted activity after pelvic reconstructive surgery. Orthopedic literature suggests better outcomes with early postoperative activity over immobilization. There is a significant body of literature showing potential detrimental effects of sedentary behavior and bed rest.
In 2010, an estimated 28.1 million women had urinary incontinence; however only 260,000 sling surgeries were performed that year. As stress urinary incontinence is primarily thought to result from a loss of support for the urethra, anatomic repair key to its treatment. Many women delay any type of treatment for stress urinary incontinence due to lack of awareness or belief in the myth that stress incontinence is a "normal part of aging". The arbitrary activity restrictions serve as yet another obstacle to treatment, especially for women who work as physical laborers. Since these activity restrictions are rooted in medical dogma and there is no evidence supporting the necessity of postoperative activity restrictions, this is a significant, iatrogenic barrier to care for all women with stress urinary incontinence. Our study could provide objective evidence of the effects of activity on satisfaction and surgical success after mid-urethral slings.
- Conditions
- Stress Urinary Incontinence, Patient Satisfaction, Surgery
- Being tested
- No activity restrictions, Activity restrictions
- Keywords
- Mid-urethral sling, Postoperative activity, Activity restriction
- Medical subject headings
- Urinary Incontinence, Stress, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No activity restrictionsBehavioural
Patients in the "No activity restrictions" group will be allowed to return to their normal activity immediately.
Activity restrictionsBehavioural
Patients in the "Activity restrictions" group will not be allowed to perform strenuous exercise or lift anything greater than 10lbs. "Strenuous exercise" will be defined as is any activity that requires so much exertion that one cannot have a conversation comfortably while doing it.
| Study group | Role | What they receive |
|---|---|---|
| No activity restrictions | Experimental | Not described Receives: Behavioral: No activity restrictions |
| Activity restrictions | Active comparator | Not described Receives: Behavioral: Activity restrictions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with postoperative course
5-point scale with minimum of 1 and maximum of 5 points, higher scores corresponding to more satisfaction
Measured: 6 months
Secondary outcomes (1)
Surgical success
Presence of persistent or recurrent stress urinary incontinence as defined as positive cough stress test and positive response on Urogenital Distress Inventory short form.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start7 Aug 2020
- Primary completion30 Nov 2022
- Study completion20 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04552457
- Sponsor's protocol ID
- 20-0141
- Acronym
- PARS
- Status last verified
- Feb 2023
- First submitted
- 10 Sep 2020
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gephart LF, Doersch KM, Reyes M, Kuehl TJ, Danford JM. Intraabdominal pressure in women during CrossFit exercises and the effect of age and parity. Proc (Bayl Univ Med Cent). 2018 Apr 9;31(3):289-293. doi: 10.1080/08998280.2018.1446888. eCollection 2018 Jul.
PubMed 29904290Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.
PubMed 28277355Weir LF, Nygaard IE, Wilken J, Brandt D, Janz KF. Postoperative activity restrictions: any evidence? Obstet Gynecol. 2006 Feb;107(2 Pt 1):305-9. doi: 10.1097/01.AOG.0000197069.57873.d6.
PubMed 16449116McCormack R, Bovard J. Early functional rehabilitation or cast immobilisation for the postoperative management of acute Achilles tendon rupture? A systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2015 Oct;49(20):1329-35. doi: 10.1136/bjsports-2015-094935. Epub 2015 Aug 17.
PubMed 26281836Nygaard IE, Hamad NM, Shaw JM. Activity restrictions after gynecologic surgery: is there evidence? Int Urogynecol J. 2013 May;24(5):719-24. doi: 10.1007/s00192-012-2026-2. Epub 2013 Jan 23.
PubMed 23340879FitzGerald MP, S. S., Shott S, Brubaker L (2001).
Magon N, Kalra B, Malik S, Chauhan M. Stress urinary incontinence: What, when, why, and then what? J Midlife Health. 2011 Jul;2(2):57-64. doi: 10.4103/0976-7800.92525.
PubMed 22408333Murphy M. Restrictions and limitations after pelvic floor surgery: what's the evidence? Curr Opin Obstet Gynecol. 2017 Oct;29(5):349-353. doi: 10.1097/GCO.0000000000000393.
PubMed 28719393Lai E, McDonald K, Chopra V, Robinson L, Alvarez A, O'Shaughnessy D, Pillalamarri N, Polland A, Shalom D, Winkler H. Postoperative Activity Restrictions After Slings: A Randomized Controlled Trial. Urogynecology (Phila). 2025 Jun 1;31(6):619-626. doi: 10.1097/SPV.0000000000001515. Epub 2024 May 6.
PubMed 38710013
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Liberal Versus Strict Postoperative Restrictions After Mid-urethral Slings Affect Outcomes?
- ClinicalTrials.gov ID
- NCT04552457
- Acronym / sponsor ID
- PARS / 20-0141
- Conditions
- Stress Urinary Incontinence, Patient Satisfaction, Surgery
- Keywords
- Mid-urethral sling, Postoperative activity, Activity restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 7 Aug 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 20 Jan 2023 (actual)
- First posted
- 17 Sep 2020 (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.
Postoperative restrictions are often based on expert opinion and "common sense". There is a wide variety in the recommended activity limitation amongst pelvic floor surgeons. Many patients undergo urogynecologic procedures to improve their quality of life, and these additional restrictions decrease their quality of life in the short term. Our hypothesis is that unrestricted activity after a mid-urethral sling will not negatively impact a patient's recovery or likelihood of surgical success.
Eligible participants will be randomized to no postoperative instructions or traditional postoperative instructions. Patients will be followed up at 2 weeks, 6 weeks, and 6 months postoperatively. Data will be collected throughout the follow up period, but the primary endpoint is at 6 months. At the 6 month visit, subjects' activity level, leakage symptoms, and postoperative satisfaction will be assessed.
Detailed description
There is a limited body of literature regarding restrictions for gynecologic surgery. Most of these studies have looked at patients with prolapse and incontinence, and many of the postoperative recommendations are intended for both classes of procedures. Most surgeons restrict their patients' activities postoperatively but to varying degrees and for variable amounts of time. One study in 2017 showed no adverse effect on short term outcomes after prolapse repair with liberal postoperative restrictions compared to stricter, traditional restrictions. No studies have been performed to look at postoperative restrictions after mid-urethral slings.
A common reason for limiting activity is due to the unproven concern about increased intra-abdominal pressure on healing and surgical success. At this time, no studies have shown causality. The range of intra-abdominal pressures generated during "unavoidable" activities, such as coughing, standing, and bending, overlaps with the range of pressures generated during activities that are typically restricted. Another study showed the intra-abdominal pressures generated during activities of daily living overlapped with pressures generated by women performing CrossFit exercises.
A 2017 study showed no effect on outcomes with unrestricted activity after pelvic reconstructive surgery. Orthopedic literature suggests better outcomes with early postoperative activity over immobilization. There is a significant body of literature showing potential detrimental effects of sedentary behavior and bed rest.
In 2010, an estimated 28.1 million women had urinary incontinence; however only 260,000 sling surgeries were performed that year. As stress urinary incontinence is primarily thought to result from a loss of support for the urethra, anatomic repair key to its treatment. Many women delay any type of treatment for stress urinary incontinence due to lack of awareness or belief in the myth that stress incontinence is a "normal part of aging". The arbitrary activity restrictions serve as yet another obstacle to treatment, especially for women who work as physical laborers. Since these activity restrictions are rooted in medical dogma and there is no evidence supporting the necessity of postoperative activity restrictions, this is a significant, iatrogenic barrier to care for all women with stress urinary incontinence. Our study could provide objective evidence of the effects of activity on satisfaction and surgical success after mid-urethral slings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No activity restrictions | Experimental | Behavioral: No activity restrictions |
| Activity restrictions | Active comparator | Behavioral: Activity restrictions |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-85 years
- Urodynamic-proven stress incontinence or stress leakage on physical exam
- Desires surgical management for stress incontinence with a midurethral sling
Key exclusion criteria (7 listed)
- Prior midurethral sling or urethropexy
- Prior pelvic reconstruction
- Prior pelvic radiation
- Connective tissue disorder
- Severe physical limitation at baseline
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 |
|---|---|---|
| No activity restrictionsPatients in the "No activity restrictions" group will be allowed to return to their normal activity immediately. | Behavioural | No activity restrictions |
| Activity restrictionsPatients in the "Activity restrictions" group will not be allowed to perform strenuous exercise or lift anything greater than 10lbs. "Strenuous exercise" will be defined as is any activity that requires so much exertion that one cannot have a conversation comfortably while doing it. | Behavioural | Activity restrictions |
Primary outcome
Patient satisfaction with postoperative course
Time frame: 6 months
5-point scale with minimum of 1 and maximum of 5 points, higher scores corresponding to more satisfaction
1 secondary outcome
Surgical success
Time frame: 6 months
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 3 Feb 2023.
- Background: PubMed 29904290Gephart LF, Doersch KM, Reyes M, Kuehl TJ, Danford JM. Intraabdominal pressure in women during CrossFit exercises and the effect of age and parity. Proc (Bayl Univ Med Cent). 2018 Apr 9;31(3):289-293. doi: 10.1080/08998280.2018.1446888. eCollection 2018 Jul.
- Background: PubMed 28277355Mueller MG, Lewicky-Gaupp C, Collins SA, Abernethy MG, Alverdy A, Kenton K. Activity Restriction Recommendations and Outcomes After Reconstructive Pelvic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2017 Apr;129(4):608-614. doi: 10.1097/AOG.0000000000001924.
- Background: PubMed 16449116Weir LF, Nygaard IE, Wilken J, Brandt D, Janz KF. Postoperative activity restrictions: any evidence? Obstet Gynecol. 2006 Feb;107(2 Pt 1):305-9. doi: 10.1097/01.AOG.0000197069.57873.d6.
- Background: PubMed 26281836McCormack R, Bovard J. Early functional rehabilitation or cast immobilisation for the postoperative management of acute Achilles tendon rupture? A systematic review and meta-analysis of randomised controlled trials. Br J Sports Med. 2015 Oct;49(20):1329-35. doi: 10.1136/bjsports-2015-094935. Epub 2015 Aug 17.
- Background: PubMed 23340879Nygaard IE, Hamad NM, Shaw JM. Activity restrictions after gynecologic surgery: is there evidence? Int Urogynecol J. 2013 May;24(5):719-24. doi: 10.1007/s00192-012-2026-2. Epub 2013 Jan 23.
- BackgroundFitzGerald MP, S. S., Shott S, Brubaker L (2001).
- Background: PubMed 22408333Magon N, Kalra B, Malik S, Chauhan M. Stress urinary incontinence: What, when, why, and then what? J Midlife Health. 2011 Jul;2(2):57-64. doi: 10.4103/0976-7800.92525.
- Background: PubMed 28719393Murphy M. Restrictions and limitations after pelvic floor surgery: what's the evidence? Curr Opin Obstet Gynecol. 2017 Oct;29(5):349-353. doi: 10.1097/GCO.0000000000000393.
- Derived from this study: PubMed 38710013Lai E, McDonald K, Chopra V, Robinson L, Alvarez A, O'Shaughnessy D, Pillalamarri N, Polland A, Shalom D, Winkler H. Postoperative Activity Restrictions After Slings: A Randomized Controlled Trial. Urogynecology (Phila). 2025 Jun 1;31(6):619-626. doi: 10.1097/SPV.0000000000001515. Epub 2024 May 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No activity restrictions and Activity restrictions in people with Stress Urinary Incontinence and Patient Satisfaction, run by Northwell Health 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 3 inclusion and 7 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 3 Feb 2023. 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?
Patient satisfaction with postoperative course (time frame: 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 NCT04552457, which also lists 9 linked publications.
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 3 Feb 2023.