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Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS (STARS)

Primary Purpose

Pelvic Organ Prolapse, Cystocele, Cystocele and Incomplete Uterovaginal Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Transobturator cystocele repair
Anterior colporrhaphy
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Quality of life, TOCR, Anterior vaginal wall repair, Transobturator cystocele repair

Eligibility Criteria

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

Inclusion Criteria: (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1) Age ≥ 50 years Symptom bulge Ability to speak Czech or English Exclusion Criteria: Malignancy

Sites / Locations

  • Faculty of Medicine in Hradec Kralove, Charles University
  • Medical Faculty, Ostrava University
  • Hospital Pardubice Region, Inc.
  • Faculty of Medicine in Pilsen, Charles UniversityRecruiting
  • Hospital na Bulovce, 1st Medical Faculty, Charles University
  • Tomas Bata Regional Hospital in Zlin
  • Košice Medical University
  • Trenčianska univerzita Alexandra Dubčeka

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transobturator cystocele repair (TOCR)

standard anterior colporrhaphy (anterior repair - AR)

Arm Description

The technique of TOCR was published previously including a video [Kalis et al. Trans-obturator cystocele repair (TOCR) of level 2 paravaginal defect. Int Urogynecol J. 2020, 31(11):2435-38. doi:10.1007/s00192-020-04337-x]. The anterior vaginal wall is incised in the midline and the pubocervical fascia is dissected to open the paravaginal space towards the ATFP and the fascia of the obturator internus muscle. 3-4 continuous non-locking stitches of non-absorbable suture 1-0 Ti-Cron™ braided polyester are taken into the pubocervical fascia and threaded using Shirodkar needles through skin incisions in genitofemoral sulci passing through the full thickness of the obturator membrane, obturator internus muscle. After closure of the vaginal skin incision, both ends of the Ti-Cron™ sutures are tied ensuring the obliteration of the paravaginal defect. Indometacin rectal suppository 100 mg is inserted transrectally for early postoperative pain management.

The anterior vaginal wall is incised in the midline from the level of the bladder neck up to vaginal apex or anterior vaginal fornix. The bladder is sharply dissected from the vaginal wall with pubocervical fascia attached to the bladder wall. The fascia is approximated in the midline with several simple interrupted 0 polyglactin 910 sutures or equivalent. The surplus of distended vaginal epithelium is trimmed. The vaginal incision is closed using a continuous non-locking polyglactin 910 2-0 suture or equivalent. Indometacin rectal suppository 100 mg is inserted transrectally for early postoperative pain management.

Outcomes

Primary Outcome Measures

Anatomic failure
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. pelvic organ prolpase quantification (POPQ) point Ba, or C of > -1)

Secondary Outcome Measures

Composite surgery failure
Composite measure requiring at least one from the following: 1. anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of > 0), 2. subjective failure (presence of bothersome vaginal bulge symptoms), or 3. pessary or surgical retreatment for pelvic organ prolapse
2-year composite surgery failure
Composite measure requiring at least one from the following: 1. anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of > 0), 2. subjective failure (presence of bothersome vaginal bulge symptoms), or 3. pessary or surgical retreatment for pelvic organ prolapse
2-year anatomic failure
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. POPQ point Ba, or C of > -1)
Complication rate
Number of complications Dindo-Clavien Grade > 2
Pain after the surgery
visual analog scale (VAS) ≥ 3 (range 0-10, higher is worse)
Subjective perception of improvement
Patient global impression of improvement (PGI-I) ≤ 2 (range 1-7, higher is worse)
2-year subjective perception of improvement
PGI-I ≤ 2 (range 1-7, higher is worse)
Patient satisfaction
Subjectively assessed by the patient on a scale 0 - 100%. Satisfaction with the surgery ≥ 80 %.
De novo stress urinary incontinence (SUI)
Any new stress leaks of urine reported by the patient ≥ once a week, or treatment
De novo overactive bladder (OAB)
de novo OAB ≥ once a week, or treatment
Change in quality of life - urinary incontience
assessed by Urinary Distress Inventory (UDI-6) score, range 0-100, higher is worse
Change in quality of life - prolapse bother
assessed by Pelvic Organ Prolapse Distress Inventory (POPDI-6) score, range 0-100, higher is worse
Change in quality of life - anorectal problems
assessed by Colorectal-Anal Distress Inventory (CRADI-8) score,range 0-100, higher is worse.
Change in quality of sexual life
assessed by Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) single summary score in sexually active women (higher is better)
Change in severity of urinary incontinence
assessed by International Consultation of Incontinence Questionnaire - Short Form (ICIQ-UI SF) score (0-21, higher is worse)

Full Information

First Posted
October 23, 2022
Last Updated
February 11, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT05602246
Brief Title
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Acronym
STARS
Official Title
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

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

5. Study Description

Brief Summary
Surgical correction of the prolapse in the anterior compartment remains one of the major challenges in urogynecology. Paravaginal defect in level II of vaginal fixation results in the majority of cystoceles. Clinically, these defects are often combined and/or may be bilateral. Hence, careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome. Several surgical techniques and approaches have been used for cystocele repair. After the ban on transvaginal meshes, the interest in native tissue repair has risen. Paravaginal defect repair is an effective surgery for paravaginal defect reconstruction. There is a current trend to utilize transvaginal surgery instead of more invasive transabdominal surgery. A novel method of transvaginal paravaginal defect repair - TOCR (transobturator cystocele repair) was suggested. The principle objective of the present trial is to compare its efficacy and safety to preexisting method of native tissue cystocele repair.
Detailed Description
Pelvic organ prolapse (POP) has a negative impact on the quality of life of affected women and anterior compartment defects remain the most challenging to repair. It was reported that a women has almost a 1 in 5 risk of needing any kind of POP surgery in her lifetime, with anterior wall repair accounting for 40.6% of all of these. Depending on the structures affected, cystocele can be secondary to defects at: A) Level I vaginal support, provided by the uterosacral and cardinal ligaments or B) Level II vaginal support, mainly provided by the pubocervical fascia. Level II defects can be midline or lateral (paravaginal) depending on whether the fascia is weak at the midline or detached from its lateral attachment to the arcus tendineus fasciae pelvis (ATFP). Clinically, these defects are often combined and/or may be bilateral. Hence, careful assessment and individualized planning of the surgical procedure is essential to optimize cystocele repair outcome. Several surgical techniques and approaches have been used for cystocele repair. These involve native tissue and the use of mesh implanted transvaginally and / or transabdominally.The mainstay for the vaginal repair of a level I defects is to anchor the uterine cervix or vaginal vault to the sacrospinous or the anterior longitudinal ligaments. However, proper restoration of a level II defect is more complex. Although, a classical anterior colporrhaphy might be suitable to correct an isolated midline weakness in the endopelvic fascia, it is suboptimal, on its own, for the repair an associated lateral defect, which is a common association. Indeed, De Lancey reported that paravaginal defects (PVDs) were diagnosed in 89% of women undergoing surgery for cystocele and stress urinary incontinence. Although a variety of techniques for paravaginal defect repair (PVDR) have been suggested, several of these are now not feasible in many countries following the FDA's ban on transvaginal mesh manufacture, sale and distribution. Therefore, currently there are attempts to utilize minimally invasive approaches and modern devices in PVDR native tissue repair. Applying this principle, e.g. Capio Suture Capturing Device (Boston Scientific) has been proposed to re-attach the vagina to the ATFP using two to four non-absorbable sutures. However, based on anatomical observation, the ATFP is thin its superior part and thicker inferiorly. This is an issue that might affect the reliability of identifying and ensuring a secure anchorage to the ATFP when solely using a transvaginal route. Recently a novel. Technique of PVDR, called transobturator cystocele repair has been published. However, as the technique was described recently, no follow-up data have been reported to support its practice. The aim of this randomized controlled trial (RCT) is to compare the novel TOCR and standard anterior colporrhaphy (AR) regarding their safety, efficacy and quality-of-life improvement in a one-year follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse, Cystocele, Cystocele and Incomplete Uterovaginal Prolapse
Keywords
Pelvic organ prolapse, Quality of life, TOCR, Anterior vaginal wall repair, Transobturator cystocele repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
592 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transobturator cystocele repair (TOCR)
Arm Type
Experimental
Arm Description
The technique of TOCR was published previously including a video [Kalis et al. Trans-obturator cystocele repair (TOCR) of level 2 paravaginal defect. Int Urogynecol J. 2020, 31(11):2435-38. doi:10.1007/s00192-020-04337-x]. The anterior vaginal wall is incised in the midline and the pubocervical fascia is dissected to open the paravaginal space towards the ATFP and the fascia of the obturator internus muscle. 3-4 continuous non-locking stitches of non-absorbable suture 1-0 Ti-Cron™ braided polyester are taken into the pubocervical fascia and threaded using Shirodkar needles through skin incisions in genitofemoral sulci passing through the full thickness of the obturator membrane, obturator internus muscle. After closure of the vaginal skin incision, both ends of the Ti-Cron™ sutures are tied ensuring the obliteration of the paravaginal defect. Indometacin rectal suppository 100 mg is inserted transrectally for early postoperative pain management.
Arm Title
standard anterior colporrhaphy (anterior repair - AR)
Arm Type
Active Comparator
Arm Description
The anterior vaginal wall is incised in the midline from the level of the bladder neck up to vaginal apex or anterior vaginal fornix. The bladder is sharply dissected from the vaginal wall with pubocervical fascia attached to the bladder wall. The fascia is approximated in the midline with several simple interrupted 0 polyglactin 910 sutures or equivalent. The surplus of distended vaginal epithelium is trimmed. The vaginal incision is closed using a continuous non-locking polyglactin 910 2-0 suture or equivalent. Indometacin rectal suppository 100 mg is inserted transrectally for early postoperative pain management.
Intervention Type
Procedure
Intervention Name(s)
Transobturator cystocele repair
Other Intervention Name(s)
TOCR
Intervention Description
Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.
Intervention Type
Procedure
Intervention Name(s)
Anterior colporrhaphy
Other Intervention Name(s)
Anterior repair
Intervention Description
The traditional transvaginal surgery for cystocele treatment used as a comparator in the study
Primary Outcome Measure Information:
Title
Anatomic failure
Description
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. pelvic organ prolpase quantification (POPQ) point Ba, or C of > -1)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Composite surgery failure
Description
Composite measure requiring at least one from the following: 1. anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of > 0), 2. subjective failure (presence of bothersome vaginal bulge symptoms), or 3. pessary or surgical retreatment for pelvic organ prolapse
Time Frame
1 year
Title
2-year composite surgery failure
Description
Composite measure requiring at least one from the following: 1. anatomic failure (Pelvic Organ Prolapse Quantification point Ba, Bp, or C of > 0), 2. subjective failure (presence of bothersome vaginal bulge symptoms), or 3. pessary or surgical retreatment for pelvic organ prolapse
Time Frame
2 years
Title
2-year anatomic failure
Description
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. POPQ point Ba, or C of > -1)
Time Frame
2 years
Title
Complication rate
Description
Number of complications Dindo-Clavien Grade > 2
Time Frame
1 year
Title
Pain after the surgery
Description
visual analog scale (VAS) ≥ 3 (range 0-10, higher is worse)
Time Frame
Postoperative day 14
Title
Subjective perception of improvement
Description
Patient global impression of improvement (PGI-I) ≤ 2 (range 1-7, higher is worse)
Time Frame
1 year
Title
2-year subjective perception of improvement
Description
PGI-I ≤ 2 (range 1-7, higher is worse)
Time Frame
2 years
Title
Patient satisfaction
Description
Subjectively assessed by the patient on a scale 0 - 100%. Satisfaction with the surgery ≥ 80 %.
Time Frame
1 year
Title
De novo stress urinary incontinence (SUI)
Description
Any new stress leaks of urine reported by the patient ≥ once a week, or treatment
Time Frame
1 year
Title
De novo overactive bladder (OAB)
Description
de novo OAB ≥ once a week, or treatment
Time Frame
1 year
Title
Change in quality of life - urinary incontience
Description
assessed by Urinary Distress Inventory (UDI-6) score, range 0-100, higher is worse
Time Frame
1 year
Title
Change in quality of life - prolapse bother
Description
assessed by Pelvic Organ Prolapse Distress Inventory (POPDI-6) score, range 0-100, higher is worse
Time Frame
1 year
Title
Change in quality of life - anorectal problems
Description
assessed by Colorectal-Anal Distress Inventory (CRADI-8) score,range 0-100, higher is worse.
Time Frame
1 year
Title
Change in quality of sexual life
Description
assessed by Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) single summary score in sexually active women (higher is better)
Time Frame
1 year
Title
Change in severity of urinary incontinence
Description
assessed by International Consultation of Incontinence Questionnaire - Short Form (ICIQ-UI SF) score (0-21, higher is worse)
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1) Age ≥ 50 years Symptom bulge Ability to speak Czech or English Exclusion Criteria: Malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Kalis, prof. MD PhD
Phone
+420377105228
Email
kalisv@fnplzen.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Zdenek Rusavy, assoc. prof. MD PhD
Phone
+420377105440
Email
rusavyz@fnplzen.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Kalis, prof. MD PhD
Organizational Affiliation
Faculty of Medicine in Plzen, Charles University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Khaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG
Organizational Affiliation
Faculty of Medicine in Plzen, Charles University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Zdenek Rusavy, assoc. prof. MD PhD
Organizational Affiliation
Faculty of Medicine in Plzen, Charles University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine in Hradec Kralove, Charles University
City
Hradec Králové
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ondřej Dvořák, MD PhD
Email
dvorino@centrum.cz
Facility Name
Medical Faculty, Ostrava University
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olga Szabová, MD
Email
olga.szabova@fno.cz
Facility Name
Hospital Pardubice Region, Inc.
City
Pardubice
ZIP/Postal Code
530 03
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Germund Hensel, MD
Email
germund.hensel@nempk.cz
Facility Name
Faculty of Medicine in Pilsen, Charles University
City
Pilsen
ZIP/Postal Code
30000
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdenek Rusavy, MD PhD
Phone
+420377105440
Email
rusavyz@fnplzen.cz
Facility Name
Hospital na Bulovce, 1st Medical Faculty, Charles University
City
Praha
ZIP/Postal Code
18000
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Hubka, MD PhD
Email
petr.hubka@bulovka.cz
Facility Name
Tomas Bata Regional Hospital in Zlin
City
Zlín
ZIP/Postal Code
762 75
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zdeněk Adamík, MD
Email
zdenek.adamik@icloud.com
Facility Name
Košice Medical University
City
Košice
ZIP/Postal Code
040 11
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Urdzík, prof. MD Ph.D.
Email
peter.urdzik@upjs.sk
Facility Name
Trenčianska univerzita Alexandra Dubčeka
City
Trenčín
ZIP/Postal Code
911 01
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matej Vidoman, MD
Email
vidoman.matej@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24842118
Citation
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Results Reference
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PubMed Identifier
26800142
Citation
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Results Reference
background
PubMed Identifier
27640064
Citation
Arenholt LTS, Pedersen BG, Glavind K, Glavind-Kristensen M, DeLancey JOL. Paravaginal defect: anatomy, clinical findings, and imaging. Int Urogynecol J. 2017 May;28(5):661-673. doi: 10.1007/s00192-016-3096-3. Epub 2016 Sep 17.
Results Reference
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PubMed Identifier
30506182
Citation
Arenholt LTS, Pedersen BG, Glavind K, Greisen S, Bek KM, Glavind-Kristensen M. Prospective evaluation of paravaginal defect repair with and without apical suspension: a 6-month postoperative follow-up with MRI, clinical examination, and questionnaires. Int Urogynecol J. 2019 Oct;30(10):1725-1733. doi: 10.1007/s00192-018-3807-z. Epub 2018 Dec 1.
Results Reference
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PubMed Identifier
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Citation
de Tayrac R, Boileau L, Fara JF, Monneins F, Raini C, Costa P. Bilateral anterior sacrospinous ligament suspension associated with a paravaginal repair with mesh: short-term clinical results of a pilot study. Int Urogynecol J. 2010 Mar;21(3):293-8. doi: 10.1007/s00192-009-1036-1.
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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result

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Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

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