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

Primary Purpose

Vaginal Vault Prolapse, Post-Hysterectomy Vaginal Vault Prolapse, Prolapse, Vaginal

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraperitoneal Uterosacral Ligament Suspension
Extraperitoneal Uterosacral Ligament Suspension
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Vault Prolapse focused on measuring Pelvic Reconstructive Surgery, Prolapse Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Houston Methodist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intraperitoneal Group

Extraperitoneal Group

Arm Description

Vaginal intraperitoneal uterosacral ligament suspension group

Vaginal extraperitoneal uterosacral ligament suspension group

Outcomes

Primary Outcome Measures

Operative time (minutes)
Minutes from surgical incision time to surgery end time

Secondary Outcome Measures

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
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
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
Hospital length of stay (hours)
Time period between hospital admission and discharge for the surgical encounter
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.
Estimated blood loss (ml)
Mutual estimation by the surgeon and anesthesiologist
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).

Full Information

First Posted
November 14, 2019
Last Updated
November 19, 2019
Sponsor
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04172896
Brief Title
Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse
Official Title
Comparison of Vaginal Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Vault Prolapse, Post-Hysterectomy Vaginal Vault Prolapse, Prolapse, Vaginal
Keywords
Pelvic Reconstructive Surgery, Prolapse Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a two-arm parallel design. Participants will be randomly assigned to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension.
Masking
Participant
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraperitoneal Group
Arm Type
Active Comparator
Arm Description
Vaginal intraperitoneal uterosacral ligament suspension group
Arm Title
Extraperitoneal Group
Arm Type
Active Comparator
Arm Description
Vaginal extraperitoneal uterosacral ligament suspension group
Intervention Type
Procedure
Intervention Name(s)
Intraperitoneal Uterosacral Ligament Suspension
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Extraperitoneal Uterosacral Ligament Suspension
Intervention Description
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).
Primary Outcome Measure Information:
Title
Operative time (minutes)
Description
Minutes from surgical incision time to surgery end time
Time Frame
Day of surgery
Secondary Outcome Measure Information:
Title
Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 week postoperative visit
Description
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
Time Frame
6 week
Title
Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 month postoperative visit
Description
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
Time Frame
6 month
Title
Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 12 month postoperative visit
Description
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
Time Frame
12 month
Title
Hospital length of stay (hours)
Description
Time period between hospital admission and discharge for the surgical encounter
Time Frame
Up to 7 days
Title
Surgical encounter total direct costs ($)
Description
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.
Time Frame
Up to 7 days
Title
Estimated blood loss (ml)
Description
Mutual estimation by the surgeon and anesthesiologist
Time Frame
Day of surgery
Title
Frequency of perioperative complications (%)
Description
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.
Time Frame
6 week
Title
Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 week postoperative visit
Description
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.
Time Frame
6 week
Title
Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 month postoperative visit
Description
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.
Time Frame
6 month
Title
Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 12 month postoperative visit
Description
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.
Time Frame
12 month
Title
Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 week postoperative visit
Description
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.
Time Frame
6 week
Title
Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 month postoperative visit
Description
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.
Time Frame
6 month
Title
Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 12 month postoperative visit
Description
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.
Time Frame
12 month
Title
Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 6 month postoperative visit
Description
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.
Time Frame
6 month
Title
Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 12 month postoperative visit
Description
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.
Time Frame
12 month
Title
Mean postoperative numerical rating scale (NRS) score of pain intensity at 1 week after surgery
Description
Postoperative pain is measured by the numeric rating scale (NRS 0-10; 0, no pain; 10, worst pain imaginable).
Time Frame
1 week

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients with post-hysterectomy vaginal vault prolapse
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danny Mounir, MD
Phone
713-363-7592
Email
dmmounir@houstonmethodist.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nickie Griffin, BS
Phone
713-363-7592
Email
ngriffin@houstonmethodist.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tristi Muir, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Danny Mounir, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danny Mounir, MD
Phone
337-298-0964
Email
dmmounir@houstonmethodist.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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