Bowel Dysfunction, Pelvic Organ Prolapse, Sexual Dysfunction, Urinary Incontinence,Stress, Urinary Incontinence, Urge
Conditions
Keywords
Burch Colposuspension, Sacrocolpopexy, Laparoscopy, Robotic Surgery
Brief 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 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.
Interventions
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.
Sponsors
Study design
Masking description
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.
Intervention 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.
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Stress Urinary Incontinence | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participate With Urinary Frequency | 3 months following study intervention | Values based on response of moderately or quite a bit to Question #15 of PFDI-20: Do you usually experience frequent urination? |
| Number of Participants With Urinary Retention | 3 months following study intervention | Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization |
| Number of Participants With Urinary Tract Infection | 3 months following study intervention | 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). |
| Number of Participants With Urinary Urgency Incontinence | 3 months following study intervention | 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 |
| Bowel Symptoms | 3 months following study intervention | 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. |
| Sexual Function | 3 months following study intervention | 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. |
| Number of Participants With Surgical Complication | 3 months following study intervention | Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system. |
| Pelvic Organ Prolapse Symptoms | 3 months following study intervention | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension | 24 |
| 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. | 26 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Laparoscopic Burch Colposuspension | Control |
|---|---|---|---|
| Age, Continuous | 64 years | 66 years | 61 years |
| Baseline POP-Q Stage | 3 stage | 3 stage | 3 stage |
| BMI | 25.4 kg/m^2 | 25.6 kg/m^2 | 25.1 kg/m^2 |
| CRADI | 18.8 score on a scale | 14.1 score on a scale | 23.4 score on a scale |
| PISQ-12 | 14.5 score on a scale STANDARD_DEVIATION 6 | 15.1 score on a scale STANDARD_DEVIATION 6.2 | 13.8 score on a scale STANDARD_DEVIATION 5.8 |
| POPDI | 41.7 scores on a scale STANDARD_DEVIATION 23.6 | 35.7 scores on a scale STANDARD_DEVIATION 24.3 | 47.7 scores on a scale STANDARD_DEVIATION 23 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 46 Participants | 24 Participants | 22 Participants |
| Sex: Female, Male Female | 50 Participants | 26 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| UDI | 24.0 score on a scale | 25.0 score on a scale | 22.9 score on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 24 | 5 / 26 |
| other Total, other adverse events | 0 / 24 | 0 / 26 |
| serious Total, serious adverse events | 0 / 24 | 0 / 26 |
Outcome results
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
Time frame: 3 months following study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Stress Urinary Incontinence | 10 Participants |
| Laparoscopic Burch Colposuspension | Number of Participants With Stress Urinary Incontinence | 13 Participants |
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.
Time frame: 3 months following study intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Bowel Symptoms | 6.3 score on a scale |
| Laparoscopic Burch Colposuspension | Bowel Symptoms | 6.7 score on a scale |
Number of Participants With Surgical Complication
Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system.
Time frame: 3 months following study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Surgical Complication | 3 Participants |
| Laparoscopic Burch Colposuspension | Number of Participants With Surgical Complication | 5 Participants |
Number of Participants With Urinary Retention
Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization
Time frame: 3 months following study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Urinary Retention | 1 Participants |
| Laparoscopic Burch Colposuspension | Number of Participants With Urinary Retention | 3 Participants |
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).
Time frame: 3 months following study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Urinary Tract Infection | 2 Participants |
| Laparoscopic Burch Colposuspension | Number of Participants With Urinary Tract Infection | 1 Participants |
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
Time frame: 3 months following study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participants With Urinary Urgency Incontinence | 1 Participants |
| Laparoscopic Burch Colposuspension | Number of Participants With Urinary Urgency Incontinence | 2 Participants |
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?
Time frame: 3 months following study intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control | Number of Participate With Urinary Frequency | 2 Participants |
| Laparoscopic Burch Colposuspension | Number of Participate With Urinary Frequency | 4 Participants |
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.
Time frame: 3 months following study intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Pelvic Organ Prolapse Symptoms | 8.3 score on a scale |
| Laparoscopic Burch Colposuspension | Pelvic Organ Prolapse Symptoms | 2.1 score on a scale |
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.
Time frame: 3 months following study intervention
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Sexual Function | 10.5 score on a scale |
| Laparoscopic Burch Colposuspension | Sexual Function | 12.0 score on a scale |