Pelvic Organ ProlapseNCT05420831
Comparison of Vaginal and Laparoscopic Apical Fixation Techniques for Pelvic Organ Prolapse Treatment
A study testing Vaginal and Laparoscopic in people with Pelvic Organ Prolapse, run by Saint Petersburg State University, Russia at 1 site in Russia.
Trial summary
This is a prospective randomized controlled study, designed to compare efficacy and safety of two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous hysteropexy (SSHP) with synthetic mesh and laparoscopic sacrohysteropexy (LSHP), and the impact of the surgery on quality of life. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Vaginal and Laparoscopic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteRussia
- Study dates
- 9 Sep 2022to 9 May 2025
- 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 45 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is a woman with anterior and apical compartment pelvic organ prolapse
- The age of a subject is 45-80 years
- Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C>=0 according to POP-Q classification)
- The subject gave written consent to participate in the study
- The subject is able to evaluate the risks of the treatment and make an independent decision on participation in the study
- The subject is able to fill up validated questionnaires and come to the control visit after the surgery
Who cannot join
- The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious disease
- The subject had prior surgery for POP, stress urinary incontinence (SUI) or hysterectomy
- The subject has history of pelvic cancer
- The subject has chronic pelvic pain
- The subject has cervical elongation
- The subject has severe obesity (BMI > 30)
Show all 12Show fewer
- The subject has postoperative scars/suspected adhesions in the ares of surgical access to the abdomen
- The subject has gynecological diseases (recurrent uterine bleeding, endometrial hyperplasia, the presence of atypical cells in cervical smears, adenomyosis, multiple uterine myoma)
- The subject has urinary incontinence
- The subject is planning pregnancy
- The subject is unable to visit postoperative check-ups
- Refusal from participation.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Saint-Petersburg State University Hospital
Saint Petersburg, 190103
About this study
Official title: Comparison the Effectiveness and Safety of Vaginal and Laparoscopic Apical Fixation Techniques Using a Synthetic Mesh for Pelvic Organ Prolapse Treatment. A Randomized Controlled Study
This is a prospective randomized controlled study, designed to compare efficacy and safety of two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous hysteropexy (SSHP) with synthetic mesh and laparoscopic sacrohysteropexy (LSHP), and the impact of the surgery on quality of life.
Read the detailed description
BACKGROUND POP remains a widespread condition, that significantly affects patients' quality of life. The estimated incidence of POP in women varies from 10% in young age to 40% after menopause. Apical defect is the least frequent of all types of POP and occurs in 5-15% of patients, however apical support is crucial to maintaining normal anatomy of the pelvic floor.
Although the uterus itself is not the cause of POP, hysterectomy is the most common surgery for POP. However there is a growing interest in uterine-sparing surgical techniques because a lot of women express a desire to preserve uterus.
There are various techniques for uterine-sparing apical repair, including abdominal (laparoscopic or robotic) and vaginal apical fixation. SSHP is the most studied method of apical fixation and was originally performed with sutures. The use of transvaginal mesh for SSHP is discussable in conjunction with numerous reports of complications and wariness towards synthetic materials use. Some authors though reported of comparable effectiveness and high safety of SSHP using mesh. Due to the lack of the reliable evidence, to date there are no consensus about optimal method of hysteropexy, as LSHP is not without its drawbacks and complications.
PREOPERATIVE ASSESSMENT All patients who meet eligibility criteria will undergo a preoperative assessment: medical history, physical and vaginal examination, assessing pelvic organ prolapse according to Pelvic Organ Prolapse Quantification System (POP-Q). All patients will complete questionnaires validated in Russia: Pelvic Floor Disability Index (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, short form (PISQ-SF), Patient Global Impression of Improvement (PGI-I).
MATERIALS AND METHODS The investigators hypothesis is that SSHP is non-inferior to LSHP in terms of recurrence rate and complications. The sample size was calculated assuming an objective cure rate of 92% as described in literature. With a power of 80%, a level of 0,05 and the non-inferiority margin at 15%, the sample size is 92 patients. The investigators assume a drop-out rate of 10%, thus a total of 102 participants will be included in the study.
All enrolled patients will be randomly assigned to SSHP or LSHP treatment groups in equal ratio the day before the surgery, using computer randomization.
All data will be collected by medical staff not involved in treatment. Collected pre- and postoperative data will be anonymized using unique codes, that patients will receive immediately after randomization.
All surgical interventions will be performed by 3 qualified surgeons. Postoperative follow-up will be performed 6, 12 and 24 months after surgery by 2 researchers, who will be blinded about the type of intervention.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Vaginal, Laparoscopic
- Keywords
- sacrohysteropexy, pelvic organ prolapse, apical prolapse, vaginal repair, vaginal mesh, sacrospinous fixation
- 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.
VaginalProcedure or surgery
Sacrospinous hysteropexy using the synthetic mesh
LaparoscopicProcedure or surgery
Laparoscopic Sacrohysteropexy
| Study group | Role | What they receive |
|---|---|---|
| Sacrospinous fixation of the vaginal apex with the synthetic mesh | Active comparator | Not described Receives: Procedure: Vaginal |
| Laparoscopic sacrocolpopexy | Active comparator | Not described Receives: Procedure: Laparoscopic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective cure rate
The patient is considered cured if there is no prolapse beyond the hymen and the cervix is above -1 cm according to POP-Q (0-1 stage)
Measured: 24 months (2 years)
Secondary outcomes (4)
Satisfaction with the surgery
Measured through the Patient Global Impression of Improvement questionnaire (PGI-I), validated in Russia. The patient marks the number that best describes her post-operative condition, compared with how it was before surgery. The score ranges from 1 (very much better) to 7 (very much worse).
Measured: Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
The impact of treatment on sexual function
Measured through the scoring of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) validated in Russia. The scale evaluates sexual function in patients with urinary incontinence and/or POP. The responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Items 1 - 4 are reversely scored and a total of 48 is the maximum score. The higher scores indicate better sexual function.
Measured: Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
The impact of treatment on the quality of life
Measured through the Pelvic Floor Disability Index (PFDI-20), validated in Russia. The item includes 20 questions. The score ranges from 0 to 300. The higher the score, the worse the outcome.
Measured: Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
Observed complications
Presence of any adverse effects such as: bleeding requiring blood transfusion, haematoma, organ perforation, nerve injury, vaginal scarring and shortening, wound infection, urinary tract infection, pelvic pain, mesh extrusion in the vagina, mesh erosion into the urinary tract, dyspareunia de novo, de novo urgency, atonic bladder, de novo stress urinary incontinence
Measured: Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start9 Sep 2022
- Primary completion2 Aug 2023
- Study completion9 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Petersburg State University, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shkarupa Dmitry, Saint Petersburg State University, Russia
- Investigators
- Dmitry Shkarupa, MD, PhD, Study chair, Saint Petersburg State University, Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420831
- Sponsor's protocol ID
- Vaginal_or_laparoscopic
- Status last verified
- Dec 2023
- First submitted
- 18 May 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effectiveness and Safety of Vaginal and Laparoscopic Apical Fixation Techniques Using a Synthetic Mesh for Pelvic Organ Prolapse Treatment. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05420831
- Acronym / sponsor ID
- Vaginal_or_laparoscopic
- Conditions
- Pelvic Organ Prolapse
- Keywords
- sacrohysteropexy, pelvic organ prolapse, apical prolapse, vaginal repair, vaginal mesh, sacrospinous fixation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Saint Petersburg State University, RussiaUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 2 Aug 2023 (actual)
- Study completion
- 9 May 2025 (estimated)
- First posted
- 15 Jun 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.
This is a prospective randomized controlled study, designed to compare efficacy and safety of two methods of apical fixation in patients with pelvic organ prolapse (POP) - sacrospinous hysteropexy (SSHP) with synthetic mesh and laparoscopic sacrohysteropexy (LSHP), and the impact of the surgery on quality of life.
Detailed description
BACKGROUND POP remains a widespread condition, that significantly affects patients' quality of life. The estimated incidence of POP in women varies from 10% in young age to 40% after menopause. Apical defect is the least frequent of all types of POP and occurs in 5-15% of patients, however apical support is crucial to maintaining normal anatomy of the pelvic floor.
Although the uterus itself is not the cause of POP, hysterectomy is the most common surgery for POP. However there is a growing interest in uterine-sparing surgical techniques because a lot of women express a desire to preserve uterus.
There are various techniques for uterine-sparing apical repair, including abdominal (laparoscopic or robotic) and vaginal apical fixation. SSHP is the most studied method of apical fixation and was originally performed with sutures. The use of transvaginal mesh for SSHP is discussable in conjunction with numerous reports of complications and wariness towards synthetic materials use. Some authors though reported of comparable effectiveness and high safety of SSHP using mesh. Due to the lack of the reliable evidence, to date there are no consensus about optimal method of hysteropexy, as LSHP is not without its drawbacks and complications.
PREOPERATIVE ASSESSMENT All patients who meet eligibility criteria will undergo a preoperative assessment: medical history, physical and vaginal examination, assessing pelvic organ prolapse according to Pelvic Organ Prolapse Quantification System (POP-Q). All patients will complete questionnaires validated in Russia: Pelvic Floor Disability Index (PFDI-20), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, short form (PISQ-SF), Patient Global Impression of Improvement (PGI-I).
MATERIALS AND METHODS The investigators hypothesis is that SSHP is non-inferior to LSHP in terms of recurrence rate and complications. The sample size was calculated assuming an objective cure rate of 92% as described in literature. With a power of 80%, a level of 0,05 and the non-inferiority margin at 15%, the sample size is 92 patients. The investigators assume a drop-out rate of 10%, thus a total of 102 participants will be included in the study.
All enrolled patients will be randomly assigned to SSHP or LSHP treatment groups in equal ratio the day before the surgery, using computer randomization.
All data will be collected by medical staff not involved in treatment. Collected pre- and postoperative data will be anonymized using unique codes, that patients will receive immediately after randomization.
All surgical interventions will be performed by 3 qualified surgeons. Postoperative follow-up will be performed 6, 12 and 24 months after surgery by 2 researchers, who will be blinded about the type of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacrospinous fixation of the vaginal apex with the synthetic mesh | Active comparator | Procedure: Vaginal |
| Laparoscopic sacrocolpopexy | Active comparator | Procedure: Laparoscopic |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is a woman with anterior and apical compartment pelvic organ prolapse
- The age of a subject is 45-80 years
- Leading point of prolapse is at the level of the hymen or distal to the hymen (Ba, C>=0 according to POP-Q classification)
- The subject gave written consent to participate in the study
- The subject is able to evaluate the risks of the treatment and make an independent decision on participation in the study
Key exclusion criteria (12 listed)
- The subject has an active urinary tract infection or skin infection in the region of surgery or acute infectious disease
- The subject had prior surgery for POP, stress urinary incontinence (SUI) or hysterectomy
- The subject has history of pelvic cancer
- The subject has chronic pelvic pain
- The subject has cervical elongation
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 |
|---|---|---|
| VaginalSacrospinous hysteropexy using the synthetic mesh | Procedure or surgery | Sacrospinous fixation of the vaginal apex with the synthetic mesh |
| LaparoscopicLaparoscopic Sacrohysteropexy | Procedure or surgery | Laparoscopic sacrocolpopexy |
Primary outcome
Objective cure rate
Time frame: 24 months (2 years)
The patient is considered cured if there is no prolapse beyond the hymen and the cervix is above -1 cm according to POP-Q (0-1 stage)
4 secondary outcomes
Satisfaction with the surgery
Time frame: Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
The impact of treatment on sexual function
Time frame: Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
The impact of treatment on the quality of life
Time frame: Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
Observed complications
Time frame: Measured postoperatively at intervals of 6, 12 and 24 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
Dmitry Shkarupa, MD, PhD study chair
Saint Petersburg State University, Russia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal and Laparoscopic in people with Pelvic Organ Prolapse, run by Saint Petersburg State University, Russia at 1 site in Russia.
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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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 Russia. 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?
Results are not available in the source record.
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?
Objective cure rate (time frame: 24 months (2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2023.