Vaginal Vault ProlapseNCT04172896
Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse
A study testing Intraperitoneal Uterosacral Ligament Suspension and Extraperitoneal Uterosacral Ligament Suspension in people with Vaginal Vault Prolapse and Post-Hysterectomy Vaginal Vault Prolapse, run by The Methodist Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Vault Prolapse, Post-Hysterectomy Vaginal Vault Prolapse, Prolapse, Vaginal
- What is being tested?
- Intraperitoneal Uterosacral Ligament Suspension and Extraperitoneal Uterosacral Ligament Suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-English speaking or not able to provide informed consent
- Combined surgical cases with other surgical specialties
- Women unable to follow up postoperatively
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Danny Mounir, MD, 337-298-0964, dmmounir@houstonmethodist.org
About this study
Official title: Comparison of Vaginal Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse: A Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Intraperitoneal Uterosacral Ligament Suspension, Extraperitoneal Uterosacral Ligament Suspension
- Keywords
- Pelvic Reconstructive Surgery, Prolapse Surgery
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraperitoneal Uterosacral Ligament SuspensionProcedure or surgery
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 SuspensionProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal Group | Active comparator | Vaginal intraperitoneal uterosacral ligament suspension group Receives: Procedure: Intraperitoneal Uterosacral Ligament Suspension |
| Extraperitoneal Group | Active comparator | Vaginal extraperitoneal uterosacral ligament suspension group Receives: Procedure: Extraperitoneal Uterosacral Ligament Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time (minutes)
Minutes from surgical incision time to surgery end time
Measured: Day of surgery
Secondary outcomes (16)
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
Measured: 6 week
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
Measured: 6 month
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
Measured: 12 month
Hospital length of stay (hours)
Time period between hospital admission and discharge for the surgical encounter
Measured: Up to 7 days
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.
Measured: Up to 7 days
Estimated blood loss (ml)
Mutual estimation by the surgeon and anesthesiologist
Measured: Day of surgery
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.
Measured: 6 week
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.
Measured: 6 week
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.
Measured: 6 month
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.
Measured: 12 month
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.
Measured: 6 week
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.
Measured: 6 month
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.
Measured: 12 month
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.
Measured: 6 month
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.
Measured: 12 month
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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Nov 2019
- Primary completionSep 2020 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Vault ProlapseStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a two-arm parallel design. Participants will be randomly assigned to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danny Mounir, The Methodist Hospital Research Institute
- Investigators
- Tristi Muir, MD, Principal investigator, The Methodist Hospital Research InstituteDanny Mounir, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172896
- Sponsor's protocol ID
- Pro00022633
- Status last verified
- Nov 2019
- First submitted
- 14 Nov 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vaginal Intraperitoneal and Extraperitoneal Uterosacral Ligament Suspensions for Post-Hysterectomy Vaginal Vault Prolapse: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04172896
- Acronym / sponsor ID
- Pro00022633
- Keywords
- Pelvic Reconstructive Surgery, Prolapse Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a two-arm parallel design. Participants will be randomly assigned to either vaginal intraperitoneal or extraperitoneal uterosacral ligament suspension.
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal Group | Active comparator | Procedure: Intraperitoneal Uterosacral Ligament SuspensionVaginal intraperitoneal uterosacral ligament suspension group |
| Extraperitoneal Group | Active comparator | Procedure: Extraperitoneal Uterosacral Ligament SuspensionVaginal extraperitoneal uterosacral ligament suspension group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Non-English speaking or not able to provide informed consent
- Combined surgical cases with other surgical specialties
- Women unable to follow up postoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraperitoneal Uterosacral Ligament SuspensionVaginal 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). | Procedure or surgery | Intraperitoneal Group |
| Extraperitoneal Uterosacral Ligament SuspensionVaginal 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). | Procedure or surgery | Extraperitoneal Group |
Primary outcome
Operative time (minutes)
Time frame: Day of surgery
Minutes from surgical incision time to surgery end time
16 secondary outcomes
Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 week postoperative visit
Time frame: 6 week
Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 6 month postoperative visit
Time frame: 6 month
Percent of participants with surgical "success" or "failure" as a dichotomous outcome at the 12 month postoperative visit
Time frame: 12 month
Hospital length of stay (hours)
Time frame: Up to 7 days
Surgical encounter total direct costs ($)
Time frame: Up to 7 days
Estimated blood loss (ml)
Time frame: Day of surgery
Frequency of perioperative complications (%)
Time frame: 6 week
Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 week postoperative visit
Time frame: 6 week
Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 6 month postoperative visit
Time frame: 6 month
Mean Pelvic Floor Disability Index (PFDI-20) questionnaire score at the 12 month postoperative visit
Time frame: 12 month
Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 week postoperative visit
Time frame: 6 week
Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 6 month postoperative visit
Time frame: 6 month
Mean Pelvic Floor Impact (PFIQ-7) questionnaire score at the 12 month postoperative visit
Time frame: 12 month
Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 6 month postoperative visit
Time frame: 6 month
Mean Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) score at the 12 month postoperative visit
Time frame: 12 month
Mean postoperative numerical rating scale (NRS) score of pain intensity at 1 week after surgery
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Vaginal Vault Prolapse
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Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
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Vaginal Vault Native Tissue Suspension
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Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
Recruiting
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Prolapse, Vaginal Vault
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Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tristi Muir, MD principal investigator
The Methodist Hospital Research Institute
Danny Mounir, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraperitoneal Uterosacral Ligament Suspension and Extraperitoneal Uterosacral Ligament Suspension in people with Vaginal Vault Prolapse and Post-Hysterectomy Vaginal Vault Prolapse, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danny Mounir, MD (713-363-7592, dmmounir@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (minutes) (time frame: Day of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.