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Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence

Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03841513
Acronym
MICRO
Enrollment
50
Registered
2019-02-15
Start date
2019-01-29
Completion date
2022-09-27
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Dysfunction, Pelvic Organ Prolapse, Sexual Dysfunction, Urinary Incontinence,Stress, Urinary Incontinence, Urge

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

Friends of Prentice
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

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

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Number of Participants With Stress Urinary Incontinence3 months following study interventionRate 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

MeasureTime frameDescription
Number of Participate With Urinary Frequency3 months following study interventionValues 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 Retention3 months following study interventionRate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization
Number of Participants With Urinary Tract Infection3 months following study interventionRate 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 Incontinence3 months following study interventionRate 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 Symptoms3 months following study interventionCompare 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 Function3 months following study interventionCompare 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 Complication3 months following study interventionCompare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system.
Pelvic Organ Prolapse Symptoms3 months following study interventionCompare 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

ArmCount
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
Total50

Baseline characteristics

CharacteristicTotalLaparoscopic Burch ColposuspensionControl
Age, Continuous64 years66 years61 years
Baseline POP-Q Stage3 stage3 stage3 stage
BMI25.4 kg/m^225.6 kg/m^225.1 kg/m^2
CRADI18.8 score on a scale14.1 score on a scale23.4 score on a scale
PISQ-1214.5 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
POPDI41.7 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 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
White
46 Participants24 Participants22 Participants
Sex: Female, Male
Female
50 Participants26 Participants24 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
UDI24.0 score on a scale25.0 score on a scale22.9 score on a scale

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
3 / 245 / 26
other
Total, other adverse events
0 / 240 / 26
serious
Total, serious adverse events
0 / 240 / 26

Outcome results

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: * 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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Stress Urinary Incontinence10 Participants
Laparoscopic Burch ColposuspensionNumber of Participants With Stress Urinary Incontinence13 Participants
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.

Time frame: 3 months following study intervention

ArmMeasureValue (MEDIAN)
ControlBowel Symptoms6.3 score on a scale
Laparoscopic Burch ColposuspensionBowel Symptoms6.7 score on a scale
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Surgical Complication3 Participants
Laparoscopic Burch ColposuspensionNumber of Participants With Surgical Complication5 Participants
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

Time frame: 3 months following study intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Urinary Retention1 Participants
Laparoscopic Burch ColposuspensionNumber of Participants With Urinary Retention3 Participants
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).

Time frame: 3 months following study intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Urinary Tract Infection2 Participants
Laparoscopic Burch ColposuspensionNumber of Participants With Urinary Tract Infection1 Participants
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: * 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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participants With Urinary Urgency Incontinence1 Participants
Laparoscopic Burch ColposuspensionNumber of Participants With Urinary Urgency Incontinence2 Participants
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?

Time frame: 3 months following study intervention

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
ControlNumber of Participate With Urinary Frequency2 Participants
Laparoscopic Burch ColposuspensionNumber of Participate With Urinary Frequency4 Participants
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.

Time frame: 3 months following study intervention

ArmMeasureValue (MEDIAN)
ControlPelvic Organ Prolapse Symptoms8.3 score on a scale
Laparoscopic Burch ColposuspensionPelvic Organ Prolapse Symptoms2.1 score on a scale
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.

Time frame: 3 months following study intervention

ArmMeasureValue (MEDIAN)
ControlSexual Function10.5 score on a scale
Laparoscopic Burch ColposuspensionSexual Function12.0 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026