Pelvic Organ ProlapseSTARSNCT05602246
Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
A study testing Transobturator cystocele repair and Anterior colporrhaphy in people with Pelvic Organ Prolapse and Cystocele, run by Charles University, Czech Republic at 8 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Cystocele, Cystocele and Incomplete Uterovaginal Prolapse
- What is being tested?
- Transobturator cystocele repair and Anterior colporrhaphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Dec 2022to 1 Nov 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1)
- Age ≥ 50 years
- Symptom bulge
- Ability to speak Czech or English
Who cannot join
- Malignancy
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
Czechia6 sites, 6 recruiting
- Not yet recruiting
Faculty of Medicine in Hradec Kralove, Charles University
Hradec Králové, 500 05
Ondřej Dvořák, MD PhD, dvorino@centrum.cz
- Not yet recruiting
Medical Faculty, Ostrava University
Ostrava-Poruba, 708 52
Olga Szabová, MD, olga.szabova@fno.cz
- Not yet recruiting
Hospital Pardubice Region, Inc.
Pardubice, 530 03
Germund Hensel, MD, germund.hensel@nempk.cz
- Recruiting
Faculty of Medicine in Pilsen, Charles University
Pilsen, 30000
Zdenek Rusavy, MD PhD, +420377105440, rusavyz@fnplzen.cz
- Not yet recruiting
Hospital na Bulovce, 1st Medical Faculty, Charles University
Prague, 18000
Petr Hubka, MD PhD, petr.hubka@bulovka.cz
- Not yet recruiting
Tomas Bata Regional Hospital in Zlin
Zlín, 762 75
Zdeněk Adamík, MD, zdenek.adamik@icloud.com
Slovakia2 sites, 2 recruiting
- Not yet recruiting
Košice Medical University
Košice, 040 11
Peter Urdzík, prof. MD Ph.D., peter.urdzik@upjs.sk
- Not yet recruiting
Trenčianska univerzita Alexandra Dubčeka
Trenčín, 911 01
Matej Vidoman, MD, vidoman.matej@gmail.com
About this study
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.
Read the 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.
- Being tested
- Transobturator cystocele repair, Anterior colporrhaphy
- Keywords
- Pelvic organ prolapse, Quality of life, TOCR, Anterior vaginal wall repair, Transobturator cystocele repair
- Medical subject headings
- Pelvic Organ Prolapse, Cystocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transobturator cystocele repairProcedure or surgery
Also called TOCR
Novel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse.
Anterior colporrhaphyProcedure or surgery
Also called Anterior repair
The traditional transvaginal surgery for cystocele treatment used as a comparator in the study
| Study group | Role | What they receive |
|---|---|---|
| Transobturator cystocele repair (TOCR) | Experimental | 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. Receives: Procedure: Transobturator cystocele repair |
| standard anterior colporrhaphy (anterior repair - AR) | Active comparator | 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. Receives: Procedure: Anterior colporrhaphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anatomic failure
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. pelvic organ prolpase quantification (POPQ) point Ba, or C of > -1)
Measured: 1 year
Secondary outcomes (15)
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
Measured: 1 year
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
Measured: 2 years
2-year anatomic failure
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. POPQ point Ba, or C of > -1)
Measured: 2 years
Complication rate
Number of complications Dindo-Clavien Grade > 2
Measured: 1 year
Pain after the surgery
visual analog scale (VAS) ≥ 3 (range 0-10, higher is worse)
Measured: Postoperative day 14
Subjective perception of improvement
Patient global impression of improvement (PGI-I) ≤ 2 (range 1-7, higher is worse)
Measured: 1 year
2-year subjective perception of improvement
PGI-I ≤ 2 (range 1-7, higher is worse)
Measured: 2 years
Patient satisfaction
Subjectively assessed by the patient on a scale 0 - 100%. Satisfaction with the surgery ≥ 80 %.
Measured: 1 year
De novo stress urinary incontinence (SUI)
Any new stress leaks of urine reported by the patient ≥ once a week, or treatment
Measured: 1 year
De novo overactive bladder (OAB)
de novo OAB ≥ once a week, or treatment
Measured: 1 year
Change in quality of life - urinary incontience
assessed by Urinary Distress Inventory (UDI-6) score, range 0-100, higher is worse
Measured: 1 year
Change in quality of life - prolapse bother
assessed by Pelvic Organ Prolapse Distress Inventory (POPDI-6) score, range 0-100, higher is worse
Measured: 1 year
Change in quality of life - anorectal problems
assessed by Colorectal-Anal Distress Inventory (CRADI-8) score,range 0-100, higher is worse.
Measured: 1 year
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)
Measured: 1 year
Change in severity of urinary incontinence
assessed by International Consultation of Incontinence Questionnaire - Short Form (ICIQ-UI SF) score (0-21, higher is worse)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start1 Dec 2022
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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 Charles University, Czech RepublicThe 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
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 592 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zdenek Rusavy, Charles University, Czech Republic
- Investigators
- Vladimir Kalis, prof. MD PhD, Study chair, Faculty of Medicine in Plzen, Charles UniversityKhaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG, Study director, Faculty of Medicine in Plzen, Charles UniversityZdenek Rusavy, assoc. prof. MD PhD, Principal investigator, Faculty of Medicine in Plzen, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602246
- Sponsor's protocol ID
- STARS
- Acronym
- STARS
- Status last verified
- Mar 2026
- First submitted
- 23 Oct 2022
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24842118Otcenasek 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.
PubMed 26800142Arenholt 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.
PubMed 27640064Arenholt 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.
PubMed 30506182de 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.
PubMed 19924370Ward 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.
PubMed 18060976Chinthakanan O, Miklos JR, Moore RD. Laparoscopic Paravaginal Defect Repair: Surgical Technique and a Literature Review. Surg Technol Int. 2015 Nov;27:173-83.
PubMed 26680393Delancey 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.
PubMed 12114894Holt 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.
PubMed 31034366Leffler 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.
PubMed 11483901Kalis 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.
PubMed 32494957Jelovsek 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.
PubMed 33039390Delacroix 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/s00192-022-05092-x. Epub 2022 Feb 28.
PubMed 35226145
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS
- ClinicalTrials.gov ID
- NCT05602246
- Acronym / sponsor ID
- STARS / STARS
- Keywords
- Pelvic organ prolapse, Quality of life, TOCR, Anterior vaginal wall repair, Transobturator cystocele repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 592 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2034 (estimated)
- First posted
- 2 Nov 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Transobturator cystocele repair (TOCR) | Experimental | Procedure: Transobturator cystocele repairThe 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. |
| standard anterior colporrhaphy (anterior repair - AR) | Active comparator | Procedure: Anterior colporrhaphyThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (at least) 2nd stage prolapse of the anterior compartment (Ba ≥ -1)
- Age ≥ 50 years
- Symptom bulge
- Ability to speak Czech or English
Key exclusion criteria (1 listed)
- Malignancy
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 |
|---|---|---|
| Transobturator cystocele repairAlso: TOCRNovel transvaginal surgical reconstruction of anterior compartment pelvic organ prolapse. | Procedure or surgery | Transobturator cystocele repair (TOCR) |
| Anterior colporrhaphyAlso: Anterior repairThe traditional transvaginal surgery for cystocele treatment used as a comparator in the study | Procedure or surgery | standard anterior colporrhaphy (anterior repair - AR) |
Primary outcome
Anatomic failure
Time frame: 1 year
Anterior compartment pelvic organ prolapse stage ≥ 2( i.e. pelvic organ prolpase quantification (POPQ) point Ba, or C of > -1)
15 secondary outcomes
Composite surgery failure
Time frame: 1 year
2-year composite surgery failure
Time frame: 2 years
2-year anatomic failure
Time frame: 2 years
Complication rate
Time frame: 1 year
Pain after the surgery
Time frame: Postoperative day 14
Subjective perception of improvement
Time frame: 1 year
2-year subjective perception of improvement
Time frame: 2 years
Patient satisfaction
Time frame: 1 year
De novo stress urinary incontinence (SUI)
Time frame: 1 year
De novo overactive bladder (OAB)
Time frame: 1 year
Change in quality of life - urinary incontience
Time frame: 1 year
Change in quality of life - prolapse bother
Time frame: 1 year
Change in quality of life - anorectal problems
Time frame: 1 year
Change in quality of sexual life
Time frame: 1 year
Change in severity of urinary incontinence
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 24842118Lowenstein 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.
- Background: PubMed 26800142Otcenasek 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.
- Background: PubMed 27640064Arenholt 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.
- Background: PubMed 30506182Arenholt 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.
- Background: PubMed 19924370de 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.
- Background: PubMed 18060976Ward 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.
- Background: PubMed 26680393Chinthakanan O, Miklos JR, Moore RD. Laparoscopic Paravaginal Defect Repair: Surgical Technique and a Literature Review. Surg Technol Int. 2015 Nov;27:173-83.
- Background: PubMed 12114894Delancey 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.
- Background: PubMed 31034366Holt 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.
- Background: PubMed 11483901Leffler 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.
- Background: PubMed 32494957Kalis 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.
- Background: PubMed 33039390Jelovsek 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.
- Individual participant dataSharing planned: Undecided
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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.
Vladimir Kalis, prof. MD PhD study chair
Faculty of Medicine in Plzen, Charles University
Khaled MK Ismail, MBBCh, MSc, MD, PhD, FRCOG study director
Faculty of Medicine in Plzen, Charles University
Zdenek Rusavy, assoc. prof. MD PhD principal investigator
Faculty of Medicine in Plzen, Charles University
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transobturator cystocele repair and Anterior colporrhaphy in people with Pelvic Organ Prolapse and Cystocele, run by Charles University, Czech Republic at 8 sites in 2 countries.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Czechia, Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vladimir Kalis, prof. MD PhD (+420377105228, kalisv@fnplzen.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anatomic failure (time frame: 1 year). 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 NCT05602246, which also lists 13 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 19 Mar 2026.