Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse

Vaginal Vault Prolapse Clinical Trial

Official title:

Comparison of Vaginal Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04172896
• Other study ID #: Pro00022633
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: September 2021

Study information

• Verified date: November 2019
• Source: The Methodist Hospital System
• Contact: Danny Mounir, MD
• Phone: 713-363-7592
• Email: dmmounir[@]houstonmethodist.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-hysterectomy vaginal vault prolapse is a common pelvic floor disorder described as descent of the vaginal apex after hysterectomy. The incidence of post-hysterectomy vault prolapse has been reported to follow 11.6% of hysterectomies performed for prolapse and 1.8% for other benign diseases. The majority of surgical repairs to correct post-hysterectomy vault prolapse are approached via a transvaginal route. A common transvaginal procedure to correct vaginal vault prolapse is the uterosacral ligament suspension. Traditionally, the uterosacral ligaments have been accessed intraperitoneally to perform the vaginal suspension. More recently, an extraperitoneal approach has been utilized with good results. There is limited evidence comparing the the two approaches. Thus, the objectives of this study are to compare compare operative time, hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches.

Description:

This is a single-center, randomized, single-blind surgical trial of women with post-hysterectomy vaginal vault prolapse desiring surgical treatment. The purpose of this study is to compare outcomes of vaginal intraperitoneal uterosacral ligament suspensions and vaginal extraperitoneal uterosacral ligament suspensions for the treatment of post-hysterectomy vaginal vault prolapse. The primary objective will be to compare operative time between the two approaches. Secondary objectives of the trial will be to compare hospital stay, cost, surgical success, and other perioperative outcomes between the two approaches through 12 months using assessments at six weeks, six months, and twelve months.

The study will include subjects with stage 1-4 pelvic organ prolapse and descent of the vaginal apex at least ½ way into vaginal canal (defined as POPQ Point C ≥ -TVL/2) that desire vaginal surgical management for post-hysterectomy vaginal vault prolapse. Subjects enrolled into the trial will be randomized to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension with a 1:1 allocation using a computer-generated randomization schedule. Patients will be blinded to their allocation. Patients in both groups will receive the same standard of care for vaginal procedures as it currently exists in out practice. This involves the standard anesthetics and opioid medications intraoperatively. Randomization will be revealed to the surgeons in the operating room once the patient is under general anesthesia.

Intraoperative data to be collected will include, operative time (minutes from surgical incision time to surgery end time), estimated blood loss (ml), intraoperative complications, and concurrent surgical procedures.

Preoperative and postoperative clinical measures to be collected will include POPQ examination points and scores from three validated questionnaires (Pelvic Floor Disability Index (PFDI-20) questionnaire, Pelvic Floor Impact Questionnaires (PFIQ-7) and the Pelvic and Incontinence Sexual Questionnaire (PISQ-12)). Postoperative clinical measures will be collected at six week, six month, and twelve month post-operative visits.

Surgical success or failure will be evaluated as a dichotomous composite outcome(objective measures (POPQ examination points) and subjective measures(validated questionnaires) at six week, six month, and twelve month post-operative visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women who are 18 years of age or greater

• English speaking

• Stage 1 or greater post-hysterectomy vaginal vault prolapse

• Descent of vaginal apex at least ½ way into vaginal canal (defined as POPQ Point C = -TVL/2)

• Vaginal surgery for prolapse is planned, including a vaginal apical suspension procedure

Exclusion Criteria:

• Non-English speaking or not able to provide informed consent

• Combined surgical cases with other surgical specialties

• Women unable to follow up postoperatively

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Post-Hysterectomy Vaginal Vault Prolapse
• Prolapse
• Prolapse, Vaginal
• Uterine Prolapse
• Vaginal Vault Prolapse

Intervention

Procedure:
• Intraperitoneal Uterosacral Ligament Suspension
Vaginal intraperitoneal uterosacral ligament suspension performed by transfixing the ligament, intraperitoneally, in the intermediate portion (at the level of or above ischial spine plane) with three delayed absorbable 0 sutures, performed bilaterally (three sutures per side; six sutures total).
• Extraperitoneal Uterosacral Ligament Suspension
Vaginal extraperitoneal uterosacral ligament suspension performed by transfixing the ligament, extraperitoneally, in the intermediate portion (at the level of or above ischial spine plane) using a suture capturing device with two delayed absorbable 0 sutures, performed bilaterally (two sutures per side; four sutures total).

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time (minutes)	Minutes from surgical incision time to surgery end time	Day of surgery
Secondary	Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 week postoperative visit	Surgical failure defined as any of the following: (1) apical descent greater than one-third of the total vaginal length or anterior or posterior vaginal wall beyond the hymen (2) retreatment for prolapse or (3) bothersome vaginal bulge symptoms as indicated by an positive response to either "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?" or "Do you usually experience heaviness or dullness in the pelvic area?" in the Pelvic Floor Distress Inventory (PFDI-20), and any response other than "not at all" to the question "How much does this bother you?"; A subject will be considered a surgical failure if any ONE of the criteria above is met. Otherwise, a subject will be considered a surgical success	6 week
Secondary	Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 month postoperative visit	Surgical failure defined as any of the following: (1) apical descent greater than one-third of the total vaginal length or anterior or posterior vaginal wall beyond the hymen (2) retreatment for prolapse or (3) bothersome vaginal bulge symptoms as indicated by an positive response to either "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?" or "Do you usually experience heaviness or dullness in the pelvic area?" in the Pelvic Floor Distress Inventory (PFDI-20), and any response other than "not at all" to the question "How much does this bother you?"; A subject will be considered a surgical failure if any ONE of the criteria above is met. Otherwise, a subject will be considered a surgical success	6 month
Secondary	Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 12 month postoperative visit	Surgical failure defined as any of the following: (1) apical descent greater than one-third of the total vaginal length or anterior or posterior vaginal wall beyond the hymen (2) retreatment for prolapse or (3) bothersome vaginal bulge symptoms as indicated by an positive response to either "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?" or "Do you usually experience heaviness or dullness in the pelvic area?" in the Pelvic Floor Distress Inventory (PFDI-20), and any response other than "not at all" to the question "How much does this bother you?"; A subject will be considered a surgical failure if any ONE of the criteria above is met. Otherwise, a subject will be considered a surgical success	12 month
Secondary	Hospital length of stay (hours)	Time period between hospital admission and discharge for the surgical encounter	Up to 7 days
Secondary	Surgical encounter total direct costs ($)	The costs generated by each department of the hospital involved in the surgical patient care, including hospital preoperative, intraoperative, and postoperative costs. This comprises costs related to anesthesia, surgery, operating room, medication, laboratory (including blood transfusion), equipment, and room and board.	Up to 7 days
Secondary	Estimated blood loss (ml)	Mutual estimation by the surgeon and anesthesiologist	Day of surgery
Secondary	Frequency of perioperative complications (%)	A perioperative complication will be defined as any documented complication encountered intraoperatively through the sixth postoperative week. Complications include: visceral injury (bowel, bladder, or ureteral), need for blood transfusion, urinary tract infection (defined as patient symptoms with or without a positive urine culture that is treated with antibiotics), wound infection or abscess, readmission, and return to the operating room.	6 week
Secondary	Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 week postoperative visit	The degree of bother and distress (quality-of-life) caused by pelvic floor symptoms is measured by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.	6 week
Secondary	Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 month postoperative visit	The degree of bother and distress (quality-of-life) caused by pelvic floor symptoms is measured by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.	6 month
Secondary	Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 12 month postoperative visit	The degree of bother and distress (quality-of-life) caused by pelvic floor symptoms is measured by the pelvic floor disability index (PFDI-20) questionnaire. The PFDI-20 has 20 items within 3 scales of symptoms (total of 20 items). Each item produces a response of 0 to 4, the average response in each scale is multiplied by 25 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.	12 month
Secondary	Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 week postoperative visit	The life impact in women with pelvic floor disorders is measured by the pelvic floor impact (PFIQ-7) questionnaire. The PFIQ-7 consists of 7 items for each of 3 scales (total of 21 items) taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire.Each item produces a response of 0 to 3, the average response in each scale is multiplied by 100/3 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.	6 week
Secondary	Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 month postoperative visit	The life impact in women with pelvic floor disorders is measured by the pelvic floor impact (PFIQ-7) questionnaire. The PFIQ-7 consists of 7 items for each of 3 scales (total of 21 items) taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire.Each item produces a response of 0 to 3, the average response in each scale is multiplied by 100/3 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.	6 month
Secondary	Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 12 month postoperative visit	The life impact in women with pelvic floor disorders is measured by the pelvic floor impact (PFIQ-7) questionnaire. The PFIQ-7 consists of 7 items for each of 3 scales (total of 21 items) taken from the Urinary Impact Questionnaire, the Pelvic Organ Prolapse Impact Questionnaire, and the Colorectal-Anal Impact Questionnaire.Each item produces a response of 0 to 3, the average response in each scale is multiplied by 100/3 to obtain the scale score (range 0 to 100). The total score is the sum of the three scale score with a range of 0-300. Higher values indicate a greater degree of bother.	12 month
Secondary	Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 6 month postoperative visit	Sexual function in women with pelvic organ prolapse is measured by the PISQ-12. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.	6 month
Secondary	Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 12 month postoperative visit	Sexual function in women with pelvic organ prolapse is measured by the PISQ-12. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.	12 month
Secondary	Mean postoperative numerical rating scale (NRS) score of pain intensity at 1 week after surgery	Postoperative pain is measured by the numeric rating scale (NRS 0-10; 0, no pain; 10, worst pain imaginable).	1 week