Trial Outcomes & Findings for Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence (NCT NCT03841513)

NCT ID: NCT03841513

Last Updated: 2025-08-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 3 months following study intervention
• Results posted on: 2025-08-26

Participant Flow

Participant milestones

Measure	Control Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	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.
Overall Study STARTED	24	26
Overall Study COMPLETED	24	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence

Baseline characteristics by cohort

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.	Total n=50 Participants Total of all reporting groups
Age, Continuous	61 years n=5 Participants	66 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	26 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
BMI	25.1 kg/m^2 n=5 Participants	25.6 kg/m^2 n=7 Participants	25.4 kg/m^2 n=5 Participants
Baseline POP-Q Stage	3 stage n=5 Participants	3 stage n=7 Participants	3 stage n=5 Participants
POPDI	47.7 scores on a scale STANDARD_DEVIATION 23.0 • n=5 Participants	35.7 scores on a scale STANDARD_DEVIATION 24.3 • n=7 Participants	41.7 scores on a scale STANDARD_DEVIATION 23.6 • n=5 Participants
CRADI	23.4 score on a scale n=5 Participants	14.1 score on a scale n=7 Participants	18.8 score on a scale n=5 Participants
UDI	22.9 score on a scale n=5 Participants	25.0 score on a scale n=7 Participants	24.0 score on a scale n=5 Participants
PISQ-12	13.8 score on a scale STANDARD_DEVIATION 5.8 • n=5 Participants	15.1 score on a scale STANDARD_DEVIATION 6.2 • n=7 Participants	14.5 score on a scale STANDARD_DEVIATION 6.0 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Number of Participants With Stress Urinary Incontinence	10 Participants	13 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Number of Participants With Urinary Urgency Incontinence	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 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?"

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Number of Participate With Urinary Frequency	2 Participants	4 Participants

SECONDARY outcome

Timeframe: 3 months following study intervention

Rate of Urinary Retention, defined as a post void residual greater than 150 mL obtained via straight catheterization

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Number of Participants With Urinary Retention	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Number of Participants With Urinary Tract Infection	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Pelvic Organ Prolapse Symptoms	8.3 score on a scale Interval 0.0 to 11.9	2.1 score on a scale Interval 0.0 to 12.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Bowel Symptoms	6.3 score on a scale Interval 0.0 to 17.2	6.7 score on a scale Interval 0.0 to 24.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Sexual Function	10.5 score on a scale Interval 8.8 to 15.2	12.0 score on a scale Interval 11.0 to 17.0

SECONDARY outcome

Timeframe: 3 months following study intervention

Compare rate of intraoperative and short-term surgical complications, as defined by the Dindo classification system.

Outcome measures

Measure	Control n=24 Participants Patients in this arm will undergo standard laparoscopic or robotic sacrocolpopexy, without the addition of a laparoscopic/robotic Burch colposuspension	Laparoscopic Burch Colposuspension n=26 Participants 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.
Number of Participants With Surgical Complication	3 Participants	5 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Laparoscopic Burch Colposuspension

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Tsung Mou

TMC

Phone: 6176365890

Email: tmou@tuftsmedicalcenter.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place