Pelvic Organ ProlapseNCT05586984
Transvaginal Sacrospinous Hysteropexy Versus Laparoscopic Uterine Lateral Suspension
An observational study of Pelvic Organ Prolapse and Uterine Prolapse, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse, Uterine Prolapse
- What is being tested?
- Laparoscopic uterine lateral suspension and Transvaginal sacrospinous fixation
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Jul 2022to 31 Dec 2029
- Phase
- Observational
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pelvic organ prolapse, predominantly apical prolapse, who had not received a previous surgical correction, and is willing to receive a uterine-preserving surgery for pelvic organ prolapse.
Who may be able to join
- older than 21 years old.
- uterine prolapse stage 2 at least, defined by C point distal to -1cm by POP-Q system.
- patients willing to receive a uterine-preserving surgery for pelvic organ prolapse, and is suitable for anesthesia after evaluation.
- patients who had or had not received conservative treatments for pelvic organ prolapse.
- patients able and willing to finish the questionnaire evaluation.
Who cannot join
- patient who had received a previous hysterectomy, or is planning on concomitant hysterectomy in the surgery for pelvic organ prolapse.
- patient who had received a previous surgery for pelvic organ prolapse.
- patient with history of adverse events following a synthetic mesh.
- patients with chronic or acute pelvic pain.
- patients who had received abdominal or pelvic irradiation.
- patients who cannot receive either surgery due to comorbidity.
- patients pregnant or with future plan of pregnancy.
- patients with vaginal length less than 5cm.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan
Yu Fang Huang, MD, 886-6-2353535 ext. 3104, yufangh@ncku.edu.tw
About this study
Official title: A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension
Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse.
Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.
Read the detailed description
Pelvic organ prolapse can be treated either conservatively or surgically. Patients who are unsatisfied with conservative treatment or with severe symptoms often seek for surgical intervention. Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic sacrohysteropexy is the current trend for laparoscopic surgery, with small incisional wound, fast recovery, and low recurrence rate as advantages. However, laparoscopic sacrohysteropexy is often regarded as time consuming and ous sometimes hazard given the complexity of surgical technique and the anatomy of the presacral region. Few cases with severe complications such as vascular injuries, sacral nerve root injuries, and diskitis had been reported with laparoscopic sacrohysteropexy in previous studies.
Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, is therefore proposed in our study. The most significant benefits of this novel approach include safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy of laparoscopic lateral uterine suspension and compare with the transvaginal sacrospinous ligament fixation with native tissue repair. Other results include safety and adverse events of laparoscopic lateral uterine suspension in long term follow up.
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse
- Being tested
- Laparoscopic uterine lateral suspension, Transvaginal sacrospinous fixation
- Keywords
- Pelvic organ prolapse, Laparoscopic uterine lateral suspension, Transvaginal sacrospinous ligament fixation
- Medical subject headings
- Pelvic Organ Prolapse, Uterine Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic uterine lateral suspensionProcedure or surgery
Laparoscopic uterine lateral suspension done with four trocar sites. Fix a 1.5cm*32cm mesh to uterus at anterior lower segment and bilateral round ligaments by non-absorbable sutures (Surgilon 2-0, Ethicon, Norderstedt, Germany), and to lateral abdominal fascia by non-absorbable sutures (Prolene 1-0, Ethicon, Norderstedt, Germany). Reperitonization done to avoid mesh exposure in peritoneal cavity. Concomitant anterior and posterior colporrhaphy may be performed.
Transvaginal sacrospinous fixationProcedure or surgery
Transvaginal sacrospinous fixation done by hand suturing uterus to right sacrospinous ligament with non-absorbable suture (Prolene 1-0, Ethicon, Norderstedt, Germany). Concomitant anterior and posterior colporrhaphy may be performed.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic uterine lateral suspension | Laparoscopic uterine lateral suspension for apical prolapse. Concomitant anterior and posterior colporrhaphy may be performed. Receives: Procedure: Laparoscopic uterine lateral suspension | |
| Transvaginal sacrospinous fixation | Uterus-preserving transvaginal sacrospinous fixation for apical prolapse. Concomitant anterior and posterior colporrhaphy may be performed. Receives: Procedure: Transvaginal sacrospinous fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Composite outcome of subjective and objective recurrence of uterine prolapse.
Measured: 5 years
Secondary outcomes (4)
Anatomical outcome
Comparison of total vaginal length (TVL), Ba, Bp points defined by POP-Q system.
Measured: 5 years
Functional outcome
Comparison of urination and defecation functions by Pelvic floor disability index-20 (PFDI-20).
Measured: 5 years
Sexual function outcome
Comparison of sexual function by Female Sexual Function Index (FSFI).
Measured: 5 years
Urodynamic outcome
Comparison of post residual urine amount, uroflowmetry, and 1-hour pad test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start26 Jul 2022
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (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.
- More trials run by National Cheng-Kung University HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Fang Huang, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586984
- Sponsor's protocol ID
- 111-NCKUH-CTC--IIT
- Status last verified
- Oct 2022
- First submitted
- 16 Oct 2022
- Last updated
- 21 Oct 2022
- 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 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Trial of Transvaginal Uterine Suspension With the New Minimally Invasive Uterine Suspension
- ClinicalTrials.gov ID
- NCT05586984
- Acronym / sponsor ID
- 111-NCKUH-CTC--IIT
- Conditions
- Pelvic Organ Prolapse, Uterine Prolapse
- Keywords
- Pelvic organ prolapse, Laparoscopic uterine lateral suspension, Transvaginal sacrospinous ligament fixation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Oct 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.
Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse.
Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, performed with expected safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy, long term safety, and adverse events of laparoscopic lateral uterine suspension and compare with the conventional transvaginal sacrospinous ligament fixation with native tissue repair.
Detailed description
Pelvic organ prolapse can be treated either conservatively or surgically. Patients who are unsatisfied with conservative treatment or with severe symptoms often seek for surgical intervention. Transvaginal or transabdominal surgeries are current choices of uterus-preserving surgeries for pelvic organ prolapse. Laparoscopic sacrohysteropexy is the current trend for laparoscopic surgery, with small incisional wound, fast recovery, and low recurrence rate as advantages. However, laparoscopic sacrohysteropexy is often regarded as time consuming and ous sometimes hazard given the complexity of surgical technique and the anatomy of the presacral region. Few cases with severe complications such as vascular injuries, sacral nerve root injuries, and diskitis had been reported with laparoscopic sacrohysteropexy in previous studies.
Laparoscopic lateral uterine suspension, a modified surgical approach of uterine suspension from bilateral abdominal wall fascia, is therefore proposed in our study. The most significant benefits of this novel approach include safety and simplicity of surgery besides advantages including small wound incision and fast recovery in laparoscopic surgeries. This trial aim to discuss the therapeutic efficacy of laparoscopic lateral uterine suspension and compare with the transvaginal sacrospinous ligament fixation with native tissue repair. Other results include safety and adverse events of laparoscopic lateral uterine suspension in long term follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic uterine lateral suspension | – | Procedure: Laparoscopic uterine lateral suspensionLaparoscopic uterine lateral suspension for apical prolapse. Concomitant anterior and posterior colporrhaphy may be performed. |
| Transvaginal sacrospinous fixation | – | Procedure: Transvaginal sacrospinous fixationUterus-preserving transvaginal sacrospinous fixation for apical prolapse. Concomitant anterior and posterior colporrhaphy may be performed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pelvic organ prolapse, predominantly apical prolapse, who had not received a previous surgical correction, and is willing to receive a uterine-preserving surgery for pelvic organ prolapse.
Key inclusion criteria (5 listed)
- older than 21 years old.
- uterine prolapse stage 2 at least, defined by C point distal to -1cm by POP-Q system.
- patients willing to receive a uterine-preserving surgery for pelvic organ prolapse, and is suitable for anesthesia after evaluation.
- patients who had or had not received conservative treatments for pelvic organ prolapse.
- patients able and willing to finish the questionnaire evaluation.
Key exclusion criteria (8 listed)
- patient who had received a previous hysterectomy, or is planning on concomitant hysterectomy in the surgery for pelvic organ prolapse.
- patient who had received a previous surgery for pelvic organ prolapse.
- patient with history of adverse events following a synthetic mesh.
- patients with chronic or acute pelvic pain.
- patients who had received abdominal or pelvic irradiation.
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 |
|---|---|---|
| Laparoscopic uterine lateral suspensionLaparoscopic uterine lateral suspension done with four trocar sites. Fix a 1.5cm*32cm mesh to uterus at anterior lower segment and bilateral round ligaments by non-absorbable sutures (Surgilon 2-0, Ethicon, Norderstedt, Germany), and to lateral abdominal fascia by non-absorbable sutures (Prolene 1-0, Ethicon, Norderstedt, Germany). Reperitonization done to avoid mesh exposure in peritoneal cavity. Concomitant anterior and posterior colporrhaphy may be performed. | Procedure or surgery | Laparoscopic uterine lateral suspension |
| Transvaginal sacrospinous fixationTransvaginal sacrospinous fixation done by hand suturing uterus to right sacrospinous ligament with non-absorbable suture (Prolene 1-0, Ethicon, Norderstedt, Germany). Concomitant anterior and posterior colporrhaphy may be performed. | Procedure or surgery | Transvaginal sacrospinous fixation |
Primary outcome
Recurrence
Time frame: 5 years
Composite outcome of subjective and objective recurrence of uterine prolapse.
4 secondary outcomes
Anatomical outcome
Time frame: 5 years
Functional outcome
Time frame: 5 years
Sexual function outcome
Time frame: 5 years
Urodynamic outcome
Time frame: 6 months
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 21 Oct 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse and Uterine Prolapse, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 5 inclusion and 8 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 21 Oct 2022. 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 Taiwan. 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 Yu Fang Huang, MD (886-6-2353535 ext. 3104, yufangh@ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 5 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 21 Oct 2022.