Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Pelvic Organ Prolapse Clinical Trial

— STARS  

Official title:

Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602246
• Other study ID #: STARS
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: February 2023
• Source: Charles University, Czech Republic
• Contact: Vladimir Kalis, prof. MD PhD
• Phone: +420377105228
• Email: kalisv[@]fnplzen.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 592
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Hernia
• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Transobturator cystocele repair
Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.
• Anterior colporrhaphy
The traditional transvaginal surgery for cystocele treatment used as a comparator in the study

Locations

Country	Name	City	State
Czechia	Faculty of Medicine in Hradec Kralove, Charles University	Hradec Králové
Czechia	Medical Faculty, Ostrava University	Ostrava-Poruba
Czechia	Hospital Pardubice Region, Inc.	Pardubice
Czechia	Faculty of Medicine in Pilsen, Charles University	Pilsen
Czechia	Hospital na Bulovce, 1st Medical Faculty, Charles University	Praha
Czechia	Tomas Bata Regional Hospital in Zlin	Zlín
Slovakia	Košice Medical University	Košice
Slovakia	Trencianska univerzita Alexandra Dubceka	Trencín

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Countries where clinical trial is conducted

Czechia,  Slovakia, 

References & Publications (13)

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. — View 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. — View Citation

Chinthakanan O, Miklos JR, Moore RD. Laparoscopic Paravaginal Defect Repair: Surgical Technique and a Literature Review. Surg Technol Int. 2015 Nov;27:173-83. — View 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. — View Citation

Delacroix C, Allegre L, Chatziioannidou K, Gerard A, Fatton B, de Tayrac R. Anterior bilateral sacrospinous ligament fixation with concomitant anterior native tissue repair: a pilot study. Int Urogynecol J. 2022 Dec;33(12):3519-3527. doi: 10.1007/s00192-0 — View Citation

Delancey JO. Fascial and muscular abnormalities in women with urethral hypermobility and anterior vaginal wall prolapse. Am J Obstet Gynecol. 2002 Jul;187(1):93-8. doi: 10.1067/mob.2002.125733. — View Citation

Holt E. US FDA rules manufacturers to stop selling mesh devices. Lancet. 2019 Apr 27;393(10182):1686. doi: 10.1016/S0140-6736(19)30938-9. No abstract available. Erratum In: Lancet. 2019 May 25;393(10186):2124. — View Citation

Jelovsek JE, Gantz MG, Lukacz E, Sridhar A, Zyczynski H, Harvie HS, Dunivan G, Schaffer J, Sung V, Varner RE, Mazloomdoost D, Barber MD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Success and failure are dynamic, recurrent event states after surgical treatment for pelvic organ prolapse. Am J Obstet Gynecol. 2021 Apr;224(4):362.e1-362.e11. doi: 10.1016/j.ajog.2020.10.009. Epub 2020 Oct 8. — View Citation

Kalis V, Kovarova V, Rusavy Z, Ismail KM. Trans-obturator cystocele repair of level 2 paravaginal defect. Int Urogynecol J. 2020 Nov;31(11):2435-2438. doi: 10.1007/s00192-020-04337-x. Epub 2020 Jun 3. — View Citation

Leffler KS, Thompson JR, Cundiff GW, Buller JL, Burrows LJ, Schon Ybarra MA. Attachment of the rectovaginal septum to the pelvic sidewall. Am J Obstet Gynecol. 2001 Jul;185(1):41-3. doi: 10.1067/mob.2001.116366. — View Citation

Lowenstein E, Ottesen B, Gimbel H. Incidence and lifetime risk of pelvic organ prolapse surgery in Denmark from 1977 to 2009. Int Urogynecol J. 2015 Jan;26(1):49-55. doi: 10.1007/s00192-014-2413-y. Epub 2014 May 20. — View Citation

Otcenasek M, Gauruder-Burmester A, Haak LA, Grill R, Popken G, Baca V. Paravaginal defect: A new classification of fascial and muscle tears in the paravaginal region. Clin Anat. 2016 May;29(4):524-9. doi: 10.1002/ca.22694. Epub 2016 Feb 14. — View Citation

Ward RM, Sung VW, Clemons JL, Myers DL. Vaginal paravaginal repair with an AlloDerm graft: Long-term outcomes. Am J Obstet Gynecol. 2007 Dec;197(6):670.e1-5. doi: 10.1016/j.ajog.2007.08.067. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomic failure	Anterior compartment pelvic organ prolapse stage = 2( i.e. pelvic organ prolpase quantification (POPQ) point Ba, or C of > -1)	1 year
Secondary	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	1 year
Secondary	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 years
Secondary	2-year anatomic failure	Anterior compartment pelvic organ prolapse stage = 2( i.e. POPQ point Ba, or C of > -1)	2 years
Secondary	Complication rate	Number of complications Dindo-Clavien Grade > 2	1 year
Secondary	Pain after the surgery	visual analog scale (VAS) = 3 (range 0-10, higher is worse)	Postoperative day 14
Secondary	Subjective perception of improvement	Patient global impression of improvement (PGI-I) = 2 (range 1-7, higher is worse)	1 year
Secondary	2-year subjective perception of improvement	PGI-I = 2 (range 1-7, higher is worse)	2 years
Secondary	Patient satisfaction	Subjectively assessed by the patient on a scale 0 - 100%. Satisfaction with the surgery = 80 %.	1 year
Secondary	De novo stress urinary incontinence (SUI)	Any new stress leaks of urine reported by the patient = once a week, or treatment	1 year
Secondary	De novo overactive bladder (OAB)	de novo OAB = once a week, or treatment	1 year
Secondary	Change in quality of life - urinary incontience	assessed by Urinary Distress Inventory (UDI-6) score, range 0-100, higher is worse	1 year
Secondary	Change in quality of life - prolapse bother	assessed by Pelvic Organ Prolapse Distress Inventory (POPDI-6) score, range 0-100, higher is worse	1 year
Secondary	Change in quality of life - anorectal problems	assessed by Colorectal-Anal Distress Inventory (CRADI-8) score,range 0-100, higher is worse.	1 year
Secondary	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)	1 year
Secondary	Change in severity of urinary incontinence	assessed by International Consultation of Incontinence Questionnaire - Short Form (ICIQ-UI SF) score (0-21, higher is worse)	1 year