Pelvic Organ ProlapseMERITNCT04480671
Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy
A study testing Level III support procedure, Minimally Invasive Sacrocolpopexy and Transperineal ultrasound of the Pelvic Floor in people with Pelvic Organ Prolapse, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Level III support procedure, Minimally Invasive Sacrocolpopexy and Transperineal ultrasound of the Pelvic Floor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2020to 25 Jul 2024
- 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
- Female subjects with pelvic organ prolapse (POP)
- Planning a surgical repair of POP with minimally invasive sacrocolpopexy
- Preoperative resting genital hiatus measure between 4.0 and 7.5cm
- Exclusion Criteria: subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above
- Note: we will NOT exclude patients based on prior surgical history (including prior posterior colporrhaphy)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Impact of Level III Support Procedure on Normalization of Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy: a Randomized Controlled Trial
This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus.
An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Level III support procedure, Minimally Invasive Sacrocolpopexy, Transperineal ultrasound of the Pelvic Floor
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Level III support procedureProcedure or surgery
A level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy.
Minimally Invasive SacrocolpopexyProcedure or surgery
All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.
Transperineal ultrasound of the Pelvic FloorOther
Subjects from either arm will be invited to participate in this exploratory arm of the study. If they choose to participate, they will have a preoperative ultrasound performed and an ultrasound performed at the time of their 6 month visit.
| Study group | Role | What they receive |
|---|---|---|
| Sacrocolpopexy | Other | This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair. Receives: Procedure: Minimally Invasive Sacrocolpopexy; Other: Transperineal ultrasound of the Pelvic Floor |
| Sacrocolpopexy and concomitant level III support procedure | Active comparator | This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy. Receives: Procedure: Level III support procedure; Procedure: Minimally Invasive Sacrocolpopexy; Other: Transperineal ultrasound of the Pelvic Floor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enlarged Genital Hiatus at 6 months postoperatively
Proportion of subjects with enlarged genital hiatus on pelvic exam
Measured: 6 months postoperatively
Secondary outcomes (6)
Composite prolapse recurrence
Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary.
Measured: 12 months
Subjective prolapse recurrence
Any symptomatic recurrence of prolapse on questionnaire
Measured: 24 months
Dyspareunia postoperatively
Incidence of pain with sex (dyspareunia), ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)].This questionnaire indicates worse pain with sex with higher score.
Measured: 6, 12 months postoperatively
Sexual Function postoperatively
Assessment of sexual function, ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)]. This questionnaire helps us determine what impact pelvic organ prolapse has on sexual activity.
Measured: 6, 12 months postoperatively
Pelvic Floor Distress Inventory Change
Measurement of pelvic floor distress change, using the Pelvic Floor Distress Inventory questionnaire (PFDI-20) which is a validated questionnaire used for pelvic floor disorders and their impact on patient quality of life.
Measured: baseline, 6, 12 months postoperatively
Levator Hiatal Area
Measurement of the levator hiatus on transperineal ultrasound
Measured: baseline, 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start26 Aug 2020
- Primary completion2 Feb 2023
- Study completion25 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Glass Clark, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480671
- Sponsor's protocol ID
- STUDY19110286
- Acronym
- MERIT
- Status last verified
- Sep 2024
- First submitted
- 17 Dec 2019
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers
Publications
Bradley MS, Askew AL, Vaughan MH, Kawasaki A, Visco AG. Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus. Am J Obstet Gynecol. 2018 May;218(5):514.e1-514.e8. doi: 10.1016/j.ajog.2018.01.046. Epub 2018 Feb 6.
PubMed 29425837Nosti PA, Umoh Andy U, Kane S, White DE, Harvie HS, Lowenstein L, Gutman RE. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):33-7. doi: 10.1097/SPV.0000000000000036.
PubMed 24368486Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 May;206(5):435.e1-5. doi: 10.1016/j.ajog.2012.01.035. Epub 2012 Feb 1.
PubMed 22397900Vaughan MH, Siddiqui NY, Newcomb LK, Weidner AC, Kawasaki A, Visco AG, Bradley MS. Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension. Obstet Gynecol. 2018 Jun;131(6):1137-1144. doi: 10.1097/AOG.0000000000002593.
PubMed 29742664Carter-Brooks CM, Lowder JL, Du AL, Lavelle ES, Giugale LE, Shepherd JP. Restoring Genital Hiatus to Normative Values After Apical Suspension Alone Versus With Level 3 Support Procedures. Female Pelvic Med Reconstr Surg. 2019 May/Jun;25(3):226-230. doi: 10.1097/SPV.0000000000000528.
PubMed 29210807Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23.
PubMed 31449806
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Level III Support Procedure on Normalization of Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04480671
- Acronym / sponsor ID
- MERIT / STUDY19110286
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 25 Jul 2024 (actual)
- First posted
- 21 Jul 2020 (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.
This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus.
An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacrocolpopexy | Other | Procedure: Minimally Invasive Sacrocolpopexy, Other: Transperineal ultrasound of the Pelvic FloorThis group will only receive the sacrocolpopexy for their pelvic organ prolapse repair. |
| Sacrocolpopexy and concomitant level III support procedure | Active comparator | Procedure: Level III support procedure, Procedure: Minimally Invasive Sacrocolpopexy, Other: Transperineal ultrasound of the Pelvic FloorThis randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy. |
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)
- Female subjects with pelvic organ prolapse (POP)
- Planning a surgical repair of POP with minimally invasive sacrocolpopexy
- Preoperative resting genital hiatus measure between 4.0 and 7.5cm
- Exclusion Criteria: subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above
- Note: we will NOT exclude patients based on prior surgical history (including prior posterior colporrhaphy)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Level III support procedureA level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy. | Procedure or surgery | Sacrocolpopexy and concomitant level III support procedure |
| Minimally Invasive SacrocolpopexyAll study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse. | Procedure or surgery | Sacrocolpopexy, Sacrocolpopexy and concomitant level III support procedure |
| Transperineal ultrasound of the Pelvic FloorSubjects from either arm will be invited to participate in this exploratory arm of the study. If they choose to participate, they will have a preoperative ultrasound performed and an ultrasound performed at the time of their 6 month visit. | Other | Sacrocolpopexy, Sacrocolpopexy and concomitant level III support procedure |
Primary outcome
Enlarged Genital Hiatus at 6 months postoperatively
Time frame: 6 months postoperatively
Proportion of subjects with enlarged genital hiatus on pelvic exam
6 secondary outcomes
Composite prolapse recurrence
Time frame: 12 months
Subjective prolapse recurrence
Time frame: 24 months
Dyspareunia postoperatively
Time frame: 6, 12 months postoperatively
Sexual Function postoperatively
Time frame: 6, 12 months postoperatively
Pelvic Floor Distress Inventory Change
Time frame: baseline, 6, 12 months postoperatively
Levator Hiatal Area
Time frame: baseline, 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 29425837Bradley MS, Askew AL, Vaughan MH, Kawasaki A, Visco AG. Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus. Am J Obstet Gynecol. 2018 May;218(5):514.e1-514.e8. doi: 10.1016/j.ajog.2018.01.046. Epub 2018 Feb 6.
- Background: PubMed 24368486Nosti PA, Umoh Andy U, Kane S, White DE, Harvie HS, Lowenstein L, Gutman RE. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):33-7. doi: 10.1097/SPV.0000000000000036.
- Background: PubMed 22397900Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 May;206(5):435.e1-5. doi: 10.1016/j.ajog.2012.01.035. Epub 2012 Feb 1.
- Background: PubMed 29742664Vaughan MH, Siddiqui NY, Newcomb LK, Weidner AC, Kawasaki A, Visco AG, Bradley MS. Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension. Obstet Gynecol. 2018 Jun;131(6):1137-1144. doi: 10.1097/AOG.0000000000002593.
- Background: PubMed 29210807Carter-Brooks CM, Lowder JL, Du AL, Lavelle ES, Giugale LE, Shepherd JP. Restoring Genital Hiatus to Normative Values After Apical Suspension Alone Versus With Level 3 Support Procedures. Female Pelvic Med Reconstr Surg. 2019 May/Jun;25(3):226-230. doi: 10.1097/SPV.0000000000000528.
- Background: PubMed 31449806Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Level III support procedure, Minimally Invasive Sacrocolpopexy and Transperineal ultrasound of the Pelvic Floor in people with Pelvic Organ Prolapse, run by University of Pittsburgh 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 0 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: finished, as of the sponsor's last update on 1 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enlarged Genital Hiatus at 6 months postoperatively (time frame: 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04480671, which also lists 6 linked publications.
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 1 Oct 2024.