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| Name | Class |
|---|---|
| Friends of Prentice | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic Burch Colposuspension | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Stress Urinary Incontinence | Rate of Stress Urinary Incontinence, as defined as a participant satisfying one or more of the following:
| 3 months following study intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Urinary Urgency Incontinence | Rate of Urgency Urinary Incontinence, as defined as a participant satisfying one or more of the following:
| 3 months following study intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah A Collins, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Prentice Women's Hospital | Chicago | Illinois | 60611 | United States | ||
| Loyola University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24807341 | Background | 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. | |
| 16611949 | Background | Brubaker 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension |
| FG001 | Laparoscopic Burch Colposuspension | Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension Laparoscopic Burch Colposuspension: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension |
| BG001 | Laparoscopic Burch Colposuspension |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Stress Urinary Incontinence | Rate of Stress Urinary Incontinence, as defined as a participant satisfying one or more of the following:
| Posted | Count of Participants | Participants | 3 months following study intervention |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tsung Mou | TMC | 6176365890 | tmou@tuftsmedicalcenter.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2020 | Dec 19, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| D007410 | Intestinal Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
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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.
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The study surgeons will provide clinical care to study participants, and therefore blinding the surgeon to treatment allocation is not feasible. However, we intend that all outcomes assessors and participants will be blinded to treatment allocation until 3-months outcomes are collected.
|
| 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?" | 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 | 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). | 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. | 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. | 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. | 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. | 3 months following study intervention |
| Maywood |
| Illinois |
| 60153 |
| United States |
| 22716974 | Background | Wei 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. |
| 19037026 | Background | Geller 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. |
| 17867956 | Background | Hsiao 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. |
| 15902189 | Background | Paraiso 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. |
Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension
Laparoscopic Burch Colposuspension: 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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Mean | Inter-Quartile Range | kg/m^2 |
|
| Baseline POP-Q Stage | The plane of the hymen being defined as zero, all measures are in centimeters above / proximal to the hymen. Once all measurements have been made the stage of the prolapse can be identified; Stage 0: No prolapse is observed. Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen. Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen. Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm. Stage 4: vaginal eversion has taken place. | Median | Inter-Quartile Range | stage |
|
| POPDI | Pelvic Organ Prolapse Distress Inventory. To provide a symptom inventory and to measure the degree of bother and distress caused by the broad array of pelvic floor symptoms, in particular related to pelvic organ prolapse. The responses are scored to generate a total POPDI-6 score, which can range from 0 to 100, with higher scores indicating greater distress. | Mean | Standard Deviation | scores on a scale |
|
| CRADI | he Colorectal Anal Distress Inventory (CRADI) is a questionnaire used to assess the level of distress experienced by individuals with bowel symptoms. The CRADI score is calculated by taking the mean value of all answered questions and then multiplying by 25 (range 0 to 100). Higher score means worse symptom and distress. | Median | Full Range | score on a scale |
|
| UDI | The Urinary Distress Inventory (UDI) is a questionnaire used to assess the impact of urinary symptoms on a person's life. It helps measure the severity of symptoms like frequent urination, urine leakage, and voiding difficulties, as well as how much these symptoms bother the individual. It's scored by summing the responses to 6 questions, each with a rating scale of 0-3 (not at all to greatly). A higher total score indicates greater distress and impact on quality of life. The final score is then adjusted to a 0-100 scale. | Median | Full Range | score on a scale |
|
| PISQ-12 | PISQ-12 (Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire, 12-item form), each of the 12 questions is scored on a Likert scale from 0 (always) to 4 (never). Items 1-4 are reverse-scored, meaning "always" is scored as 4 and "never" as 0, and the reverse for items 5-12. The total score is the sum of all 12 item scores, ranging from 0 to 48. A higher score indicates better sexual function. | Mean | Standard Deviation | score on a scale |
|
|
|
| Secondary | Number of Participants With Urinary Urgency Incontinence | Rate of Urgency Urinary Incontinence, as defined as a participant satisfying one or more of the following:
| Posted | Count of Participants | Participants | 3 months following study intervention |
|
|
|
| Secondary | 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?" | Posted | Count of Participants | Participants | 3 months following study intervention |
|
|
|
| Secondary | Number of Participants With Urinary Retention | Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization | Posted | Count of Participants | Participants | 3 months following study intervention |
|
|
|
| Secondary | 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). | Posted | Count of Participants | Participants | 3 months following study intervention |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | score on a scale | 3 months following study intervention |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | score on a scale | 3 months following study intervention |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | score on a scale | 3 months following study intervention |
|
|
|
| Secondary | Number of Participants With Surgical Complication | Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system. | Posted | Count of Participants | Participants | 3 months following study intervention |
|
|
|
| 3 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Laparoscopic Burch Colposuspension | Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, with the addition of a laparoscopic/robotic Burch colposuspension Laparoscopic Burch Colposuspension: 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. | 5 | 26 | 0 | 26 | 0 | 26 |
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| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D000091662 | Genital Diseases |