Pelvic Organ ProlapseMICRONCT03841513
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
A study testing Laparoscopic Burch Colposuspension in people with Pelvic Organ Prolapse and Urinary Incontinence,Stress, run by Northwestern University at 2 sites in United States.
Trial summary
This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence. Half of the participants will undergo Burch colposuspension procedure at the time of sacrocolpopexy, and half of the participants will undergo… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Urinary Incontinence,Stress, Urinary Incontinence, Urge
- What is being tested?
- Laparoscopic Burch Colposuspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2019to 27 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- English or Spanish speaking and reading
- Symptomatic pelvic organ prolapse with any compartment at or beyond the hymen
- Stress-continent, as defined as response of "no" to question 17 of PFDI-20: "Do you usually experience urine leakage related to coughing, sneezing, or laughing?", as well as a negative empty supine stress test.
- Planning laparoscopic or robotic sacrocolpopexy, with or without hysterectomy
- Have completed childbearing
Who cannot join
- Adults unable to consent
- Pregnant women or patients desiring future pregnancy
- Patients undergoing uterine sparing surgery
- Individuals under age 18
- Prior procedure for stress urinary incontinence
- Prior retropubic surgery
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University Prentice Women's Hospital
Chicago, Illinois, 60611
Loyola University Hospital
Maywood, Illinois, 60153
About this study
This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence. Half of the participants will undergo Burch colposuspension procedure at the time of sacrocolpopexy, and half of the participants will undergo sacrocolpopexy alone.
Read the detailed description
In the United States it is estimated that 13% of women will undergo surgery for POP by age 80. In patients without symptoms of stress urinary incontinence (SUI), surgical correction of pelvic organ prolapse (POP) by itself can result in postoperative occult SUI. Two multicenter randomized trials of stress-continent women undergoing vaginal or open prolapse surgery showed lower rates of postoperative SUI if patients undergo concomitant anti-incontinence procedures. However, adverse outcomes vary based on the type of anti-incontinence procedure (open Burch colposuspension or retropubic midurethral sling) and route of surgery (open or vaginal), and therefore the preferred approach to address occult SUI is unknown.
Sacrocolpopexy is the gold standard surgical repair of pelvic organ prolapse of the apical compartment. The Burch colposuspension is a retropubic procedure in which the periurethral tissue of the anterior vagina is affixed to Cooper's ligament on either side using permanent suture bridges. In the Colpopexy and Urinary Reduction Efforts (CARE) trial patients without preoperative symptoms of SUI were randomized to receive or not to receive concomitant prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy. At three months, the subjects who underwent the Burch procedure were found to have lower rates of SUI after surgery (33.6%) compared to the control group (57.4%). Furthermore, of patients who tested negative for SUI on preoperative urodynamic testing, 22.9 % of those who underwent the Burch procedure had SUI compared to 47.9% in the control group. Burch colposuspension did not increase the rate of urinary retention, urge incontinence, urinary urgency, urinary tract infection, intra or post-operative complications. The data in this trial supported the placement of prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy.
Over the last decade, there has been a shift away from open routes of surgical access secondary to decreased morbidity and quicker recovery associated with minimally invasive procedures. As a result, open abdominal sacrocolpopexy with Burch colposuspension has fallen out of favor, and minimally invasive laparoscopic sacrocolpopexy is performed with greater frequency. Additionally, midurethral slings (MUS) have become the gold standard surgical procedure for the treatment of SUI and are performed more frequently than Burch colposuspension at the time of prolapse surgery. The Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (OPUS) study examined the placement of prophylactic MUS at the time of vaginal prolapse surgery. Patients with MUS had lower rates of SUI than control group at 3 months (23.6% vs 49.4%) and at 12 months (27.3% vs 43%). However, unlike the CARE trial, patients with concomitant anti-incontinence procedure had higher rates of adverse events including bladder perforation (6.7% vs 0%), UTI (31.0% vs 18.3%), major bleeding (3.1% vs 0%), and incomplete bladder emptying at 6 weeks (3.7% vs 0%). In addition, MUS carries the risk of mesh erosion into the vagina or urinary tract.
By studying the addition of laparoscopic (including robotic) Burch colposuspension to laparoscopic sacrocolpopexy, the investigators anticipate optimizing surgical outcomes and minimizing complications for patients.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence,Stress, Urinary Incontinence, Urge, Bowel Dysfunction, Sexual Dysfunction
- Being tested
- Laparoscopic Burch Colposuspension
- Keywords
- Burch Colposuspension, Sacrocolpopexy, Laparoscopy, Robotic Surgery
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress, Urinary Incontinence, Urge, Intestinal Diseases, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Burch ColposuspensionProcedure or surgery
The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension |
| Laparoscopic Burch Colposuspension | Active comparator | Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension Receives: Procedure: Laparoscopic Burch Colposuspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Stress Urinary Incontinence
Rate of Stress Urinary Incontinence, as defined as a participant satisfying one or more of the following:
- A positive retro-fill cough stress test at 300mL
- Answer of "yes" to question #17 of Pelvic Floor Distress Inventory 20 (PFDI-20)
- Any treatment for stress urinary incontinence after the study surgery
Measured: 3 months following study intervention
Secondary outcomes (8)
Number of Participants With Urinary Urgency Incontinence
Rate of Urgency Urinary Incontinence, as defined as a participant satisfying one or more of the following:
- Answer of "yes" to question #16 of Pelvic Floor Distress Inventory 20 (PFDI-20)
- Any treatment for urgency urinary incontinence after the study surgery
Measured: 3 months following study intervention
Number of Participate With Urinary Frequency
Values based on response of "moderately" or "quite a bit" to Question #15 of PFDI-20: "Do you usually experience frequent urination?"
Measured: 3 months following study intervention
Number of Participants With Urinary Retention
Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization
Measured: 3 months following study intervention
Number of Participants With Urinary Tract Infection
Rate of Urinary Tract Infection, defined as a positive urine culture obtained from a straight catheterized urine specimen, from participants with symptoms of urinary tract infection (fever, dysuria, urinary urgency, urinary frequency).
Measured: 3 months following study intervention
Pelvic Organ Prolapse Symptoms
Compare Pelvic Organ Prolapse Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #1-6. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 24.
Measured: 3 months following study intervention
Bowel Symptoms
Compare Bowel Symptoms utilizing the Pelvic Floor Distress Inventory 20 (PFDI-20), questions #7-14. Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 32.
Measured: 3 months following study intervention
Sexual Function
Compare Sexual Function utilizing the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ-12). Participants respond to each question on a scale of 0 to 4, with higher scores indicating greater dysfunction. The sum of scores is reported for this subscale, with a minimum score of 0 and maximum score of 48.
Measured: 3 months following study intervention
Number of Participants With Surgical Complication
Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system.
Measured: 3 months following study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start29 Jan 2019
- Primary completion27 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled subjects will be assigned to one of two treatment groups with equal probability. A randomly permuted blocked randomization schema will be generated and maintained by a statistician not otherwise involved in the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Friends of Prentice
- Responsible party
- Principal investigator, Sarah Collins, Northwestern University
- Investigators
- Sarah A Collins, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841513
- Sponsor's protocol ID
- STU00208016
- Acronym
- MICRO
- Status last verified
- Aug 2025
- First submitted
- 23 Jan 2019
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
PubMed 24807341Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208.
PubMed 16611949Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
PubMed 22716974Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.
PubMed 19037026Hsiao KC, Latchamsetty K, Govier FE, Kozlowski P, Kobashi KC. Comparison of laparoscopic and abdominal sacrocolpopexy for the treatment of vaginal vault prolapse. J Endourol. 2007 Aug;21(8):926-30. doi: 10.1089/end.2006.0381.
PubMed 17867956Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8. doi: 10.1016/j.ajog.2004.11.051.
PubMed 15902189
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
- ClinicalTrials.gov ID
- NCT03841513
- Acronym / sponsor ID
- MICRO / STU00208016
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence,Stress, Urinary Incontinence, Urge, Bowel Dysfunction, Sexual Dysfunction
- Keywords
- Burch Colposuspension, Sacrocolpopexy, Laparoscopy, Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Friends of Prentice
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 27 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence. Half of the participants will undergo Burch colposuspension procedure at the time of sacrocolpopexy, and half of the participants will undergo sacrocolpopexy alone.
Detailed description
In the United States it is estimated that 13% of women will undergo surgery for POP by age 80. In patients without symptoms of stress urinary incontinence (SUI), surgical correction of pelvic organ prolapse (POP) by itself can result in postoperative occult SUI. Two multicenter randomized trials of stress-continent women undergoing vaginal or open prolapse surgery showed lower rates of postoperative SUI if patients undergo concomitant anti-incontinence procedures. However, adverse outcomes vary based on the type of anti-incontinence procedure (open Burch colposuspension or retropubic midurethral sling) and route of surgery (open or vaginal), and therefore the preferred approach to address occult SUI is unknown.
Sacrocolpopexy is the gold standard surgical repair of pelvic organ prolapse of the apical compartment. The Burch colposuspension is a retropubic procedure in which the periurethral tissue of the anterior vagina is affixed to Cooper's ligament on either side using permanent suture bridges. In the Colpopexy and Urinary Reduction Efforts (CARE) trial patients without preoperative symptoms of SUI were randomized to receive or not to receive concomitant prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy. At three months, the subjects who underwent the Burch procedure were found to have lower rates of SUI after surgery (33.6%) compared to the control group (57.4%). Furthermore, of patients who tested negative for SUI on preoperative urodynamic testing, 22.9 % of those who underwent the Burch procedure had SUI compared to 47.9% in the control group. Burch colposuspension did not increase the rate of urinary retention, urge incontinence, urinary urgency, urinary tract infection, intra or post-operative complications. The data in this trial supported the placement of prophylactic Burch colposuspension at the time of abdominal sacrocolpopexy.
Over the last decade, there has been a shift away from open routes of surgical access secondary to decreased morbidity and quicker recovery associated with minimally invasive procedures. As a result, open abdominal sacrocolpopexy with Burch colposuspension has fallen out of favor, and minimally invasive laparoscopic sacrocolpopexy is performed with greater frequency. Additionally, midurethral slings (MUS) have become the gold standard surgical procedure for the treatment of SUI and are performed more frequently than Burch colposuspension at the time of prolapse surgery. The Outcomes Following Vaginal Prolapse Repair and Midurethral Sling (OPUS) study examined the placement of prophylactic MUS at the time of vaginal prolapse surgery. Patients with MUS had lower rates of SUI than control group at 3 months (23.6% vs 49.4%) and at 12 months (27.3% vs 43%). However, unlike the CARE trial, patients with concomitant anti-incontinence procedure had higher rates of adverse events including bladder perforation (6.7% vs 0%), UTI (31.0% vs 18.3%), major bleeding (3.1% vs 0%), and incomplete bladder emptying at 6 weeks (3.7% vs 0%). In addition, MUS carries the risk of mesh erosion into the vagina or urinary tract.
By studying the addition of laparoscopic (including robotic) Burch colposuspension to laparoscopic sacrocolpopexy, the investigators anticipate optimizing surgical outcomes and minimizing complications for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Enrolled subjects will be assigned to one of two treatment groups with equal probability. A randomly permuted blocked randomization schema will be generated and maintained by a statistician not otherwise involved in the study.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension |
| Laparoscopic Burch Colposuspension | Active comparator | Procedure: Laparoscopic Burch ColposuspensionPatients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- English or Spanish speaking and reading
- Symptomatic pelvic organ prolapse with any compartment at or beyond the hymen
- Stress-continent, as defined as response of "no" to question 17 of PFDI-20: "Do you usually experience urine leakage related to coughing, sneezing, or laughing?", as well as a negative empty supine stress test.
- Planning laparoscopic or robotic sacrocolpopexy, with or without hysterectomy
- Have completed childbearing
Key exclusion criteria (6 listed)
- Adults unable to consent
- Pregnant women or patients desiring future pregnancy
- Patients undergoing uterine sparing surgery
- Individuals under age 18
- Prior procedure for stress urinary incontinence
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 |
|---|---|---|
| Laparoscopic Burch ColposuspensionThe Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support. | Procedure or surgery | Laparoscopic Burch Colposuspension |
Primary outcome
Number of Participants With Stress Urinary Incontinence
Time frame: 3 months following study intervention
Rate of Stress Urinary Incontinence, as defined as a participant satisfying one or more of the following: * A positive retro-fill cough stress test at 300mL * Answer of "yes" to question #17 of Pelvic Floor Distress Inventory 20 (PFDI-20) * Any treatment for stress urinary incontinence after the study surgery
8 secondary outcomes
Number of Participants With Urinary Urgency Incontinence
Time frame: 3 months following study intervention
Number of Participate With Urinary Frequency
Time frame: 3 months following study intervention
Number of Participants With Urinary Retention
Time frame: 3 months following study intervention
Number of Participants With Urinary Tract Infection
Time frame: 3 months following study intervention
Pelvic Organ Prolapse Symptoms
Time frame: 3 months following study intervention
Bowel Symptoms
Time frame: 3 months following study intervention
Sexual Function
Time frame: 3 months following study intervention
Number of Participants With Surgical Complication
Time frame: 3 months following study intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24807341Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
- Background: PubMed 16611949Brubaker L, Cundiff GW, Fine P, Nygaard I, Richter HE, Visco AG, Zyczynski H, Brown MB, Weber AM; Pelvic Floor Disorders Network. Abdominal sacrocolpopexy with Burch colposuspension to reduce urinary stress incontinence. N Engl J Med. 2006 Apr 13;354(15):1557-66. doi: 10.1056/NEJMoa054208.
- Background: PubMed 22716974Wei JT, Nygaard I, Richter HE, Nager CW, Barber MD, Kenton K, Amundsen CL, Schaffer J, Meikle SF, Spino C; Pelvic Floor Disorders Network. A midurethral sling to reduce incontinence after vaginal prolapse repair. N Engl J Med. 2012 Jun 21;366(25):2358-67. doi: 10.1056/NEJMoa1111967.
- Background: PubMed 19037026Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with abdominal sacrocolpopexy. Obstet Gynecol. 2008 Dec;112(6):1201-1206. doi: 10.1097/AOG.0b013e31818ce394.
- Background: PubMed 17867956Hsiao KC, Latchamsetty K, Govier FE, Kozlowski P, Kobashi KC. Comparison of laparoscopic and abdominal sacrocolpopexy for the treatment of vaginal vault prolapse. J Endourol. 2007 Aug;21(8):926-30. doi: 10.1089/end.2006.0381.
- Background: PubMed 15902189Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8. doi: 10.1016/j.ajog.2004.11.051.
- Individual participant dataSharing planned: No
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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.
Sarah A Collins, MD principal investigator
Northwestern University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Burch Colposuspension in people with Pelvic Organ Prolapse and Urinary Incontinence,Stress, run by Northwestern University at 2 sites 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 5 inclusion and 6 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 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Stress Urinary Incontinence (time frame: 3 months following study intervention). 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 NCT03841513, which also lists 6 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 26 Aug 2025.