STARS: Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05602246
Collaborator
(none)
592
1
2
36
16.4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transobturator cystocele repair
  • Procedure: Anterior colporrhaphy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
592 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Transobturator cystocele repair (TOCR)

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.

Procedure: Transobturator cystocele repair
Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.
Other Names:
  • TOCR
  • Active Comparator: standard anterior colporrhaphy (anterior repair - AR)

    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.

    Procedure: Anterior colporrhaphy
    The traditional transvaginal surgery for cystocele treatment used as a comparator in the study
    Other Names:
  • Anterior repair
  • Outcome Measures

    Primary Outcome Measures

    1. Anatomic failure [1 year]

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

    Secondary Outcome Measures

    1. Composite surgery failure [1 year]

      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. 2-year composite surgery failure [2 years]

      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

    3. 2-year anatomic failure [2 years]

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

    4. Complication rate [1 year]

      Dindo-Clavien Grade > 2

    5. Pain after the surgery [Postoperative day 14]

      visual analog scale (VAS) ≥ 3

    6. Subjective perception of improvement [1 year]

      Patient global impression of improvement (PGI-I) ≤ 2

    7. 2-year subjective perception of improvement [2 years]

      PGI-I ≤ 2

    8. Patient satisfaction [1 year]

      Subjectively assessed by the patient on a scale 0 - 100%. Satisfaction with the surgery ≥ 80 %.

    9. De novo stress urinary incontinence (SUI) [1 year]

      Any new stress leaks of urine reported by the patient ≥ once a week, or treatment

    10. De novo overactive bladder (OAB) [1 year]

      de novo OAB ≥ once a week, or treatment

    11. Change in quality of life - urinary incontience [1 year]

      assessed by Urinary Distress Inventory (UDI-6) score, range 0-100, higher is worse

    12. Change in quality of life - prolapse bother [1 year]

      assessed by Pelvic Organ Prolapse Distress Inventory (POPDI-6) score, range 0-100, higher is worse

    13. Change in quality of life - anorectal problems [1 year]

      assessed by Colorectal-Anal Distress Inventory (CRADI-8) score,range 0-100, higher is worse.

    14. Change in quality of sexual life [1 year]

      assessed by Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) single summary score in sexually active women (higher is better)

    15. Change in severity of urinary incontinence [1 year]

      assessed by International Consultation of Incontinence Questionnaire - Short Form (ICIQ-UI SF) score (0-21, higher is worse)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Obstetrics and Gynecology, Charles University Hospital Pilsen Czechia 30460

    Sponsors and Collaborators

    • Charles University, Czech Republic

    Investigators

    • Study Chair: Vladimir Kalis, prof. MD PhD, Faculty of Medicine in Plzen, Charles University
    • Study Director: Khaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG, Faculty of Medicine in Plzen, Charles University
    • Principal Investigator: Zdenek Rusavy, assoc. prof. MD PhD, Faculty of Medicine in Plzen, Charles University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Zdenek Rusavy, assoc. prof. MD PhD, Charles University, Czech Republic
    ClinicalTrials.gov Identifier:
    NCT05602246
    Other Study ID Numbers:
    • STARS
    First Posted:
    Nov 2, 2022
    Last Update Posted:
    Nov 2, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Zdenek Rusavy, assoc. prof. MD PhD, Charles University, Czech Republic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 2, 2022