Prolapse; FemaleKIDSNCT03878056
Cost-effectiveness Comparison Between Vaginal Versus Robotic Mesh Surgery for Apical Prolapse: Prospective, Cohort Study
An observational study of Prolapse; Female, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Cost-effectiveness, safety, outcomes and diagnostic development in advanced apical female genital prolapse reconstructive surgery by vaginal and robotic-assisted mesh surgery. A multicenter, prospective, parallel, cohort, comparative study between the vaginal and robotic-assisted mesh surgery including 200 patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Prolapse; Female
- What is being tested?
- Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific
- Type of treatment
- Medical device
- How many people
- 147 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to 30 Nov 2021
- Phase
- Observational
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with apical prolapse and suffering prolapse symptoms.
Who may be able to join
- Posthysterectomy prolapse of the vaginal apex, with or without cystocele/rectocele, where the vaginal apex descends at least 50% of the total vaginal length
- Uterine prolapse, with or without cystocele/rectocele, where the leading edge of the cervix descends at least 50% of the total vaginal length and TVL minus point C= ≤ 2 cm
- Prolapse specific pelvic symptom of pelvic heaviness and/or vaginal bulging
- Reproductive years in the past (biologically or reproductive decision)
- Being able to make an informed consent on participation
- Physically and cognitively capable of participating in the required follow-up
- No exclusion criteria fulfilled
Who cannot join
- Posthysterectomy prolapse of the vaginal apex where the vaginal apex descends less than 50% of the total vaginal length regardless of whether a cystocele/rectocele is present or not
- Uterine prolapse, with or without cystocele, where the leading edge of the cervix descends less than 50% of the total vaginal length
- If cervix elongation is present corresponding to: TVL minus point C= >2 cm without uterine prolapse.
- If prolapse specific pelvic symptoms of pelvic heaviness and/or vaginal bulging are not present
- Previous or current pelvic organ cancer (regardless of treatment)
- Severe rheumatic disease
Show all 11Show fewer
- Insulin treated severe diabetes mellitus
- Connective tissue disorders (SLE, Sjögrens syndrome, Marfans syndrome, Ehlers Danlos, collagenosis, polymyositis or rheumatic myalgia)
- Current systemic steroid treatment
- Other clinically relevant pelvic disorders for which surgery is indicated including stress urinary incontinence.
- Decision to perform prolapse surgery using other medical devices/mesh
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Division of Obstetrics and Gynecology, Department of Clinical Sciences, Karolinska Institutet Danderyd University Hospital
Stockholm, 18288
About this study
Official title: Cost-effectiveness Analysis and Patient Safety After Apical Prolapse Surgery by Mesh Via Different Approaches; Vaginal or Robotic-assisted: Multicenter, Prospective Parallel Cohort Study
Cost-effectiveness, safety, outcomes and diagnostic development in advanced apical female genital prolapse reconstructive surgery by vaginal and robotic-assisted mesh surgery.
A multicenter, prospective, parallel, cohort, comparative study between the vaginal and robotic-assisted mesh surgery including 200 patients.
Read the detailed description
Pelvic organ prolapse (POP) is a common condition and may be disabling and limiting quality of life (QoL) among aging women. POP may arise in the anterior (cystocele), posterior (rectocele) and middle compartment (apical POP) of the vagina. Apical POP includes descent of uterus or vaginal vault (if uterus was previously removed). The lifetime risk of undergoing a single operation for POP or urinary incontinence by age 80 is 11%. In Sweden, the risk to undergo 2 pelvic floor surgery is about 130 000 women. Traditional Surgical repairs of POP using native connective tissues are commonly used but the risk for POP recurrence is high if apical prolapse is present (ca 60%). Thus, minimal invasive surgical approaches by apical trans-vaginal mesh (A-TVM) and robotic sacral colpopexy (RSC) to support the vaginal apex (middle compartment) are in progress. 1 Evidence show effectivity and improved QoL after surgery.
Vaginal and robotic accesses may be available to many patients. Vaginal approach may allow surgeon to perform surgery for all POP compartments and perineal injury in one single surgery opportunity. Contra-indications for general anesthesia and some abdominal diseases or conditions may dismiss the robotic surgery. In contrast, all patients can be operated via the vaginal approach except for patient unwellness. Thus, a direct low cost of vaginal surgery may be possible. In the other hand, costs for robotic surgery are high. Whether or not this may be reflected on cost-effectiveness based on QoL improvement after surgery has not yet been studied.
Visualising synthetic implants i.e. POP mesh and the Tension-Free Vaginal Tape (TVT) implant for urinary incontinence (UI) by ultrasonography (US) has been a subject for some studies. Using US, localisation of the TVT in correlation to urinary bladder neck and how close to urethra may explain outcomes after TVT surgery. Given its importance, knowledge of how mesh anatomical position may influence outcomes, it may be useful in further POP surgery development. Our results indicate that US can be used and is reproducible in mapping of A-TVM (manuscript).
Growing need worldwide is to have more cost-effective and safe health care. Cost-effectiveness, safety, outcomes, POP-recurrence and effects on pelvic floor dysfunction have not yet been directly compared between vaginal and robotic mesh surgery for apical POP.
Topic: Cost-Effectiveness (Vaginal vs robotic POP mesh surgery), QoL, safety and outcomes.
- Conditions
- Prolapse; Female
- Being tested
- Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal: UpholdTM Lite Vaginal Support - Boston ScientificDevice
Also called Robotic: Artisyn® Y-Shaped Mesh - Ethicon
Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal mesh | Vaginal surgery (UpholdTM Lite Vaginal Support, Boston Scientific) Receives: Device: Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific | |
| Robotic sacral colpopexy | Robotic surgery (Artisyn® Y-Shaped Mesh - Ethicon) Receives: Device: Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-effectiveness measurements and comparison between vaginal and robotic mesh surgery for apical prolapse
Cost-effectiveness analysis: cost-effectiveness will be evaluated by comparing the vaginal approach with the robotic approach in term of incremental costs and incremental benefits (measured by QALYs gained).15 The incremental cost-effectiveness ratio (ICER) gives the marginal cost for each additional QALY gained by treating a patient using the robotic approach compared to the vaginal approach. To evaluate cost-effectiveness, the ICER must be compared with a reference willingness to pay (WTP) value. Sweden has no such official number, but the National Institute of Clinical Excellence (NICE) in the United Kingdom states a willingness to pay between 20,000 - 30,000 British pounds. If the ICER is below this threshold, the robotic approach will be considered cost-effective compared to the vaginal approach.
Measured: Changes from baseline an up to 1, 5 and 10 years
Secondary outcomes (11)
Measurement of anatomical outcomes by Pelvic Organ Prolapse Quantification system (POP-Q): vaginal mesh utero-/colpopexy vs Robotic Sacral Colpopexy
Grading of genital prolapse will be performed using the pelvic organ prolapse quantification (POP-Q) system which is a quantitative method for the assessment of vaginal topography and conforms to the standards recommended by the International Continence Society as described by Bump et al. (Am J Obstetrics Gynecology1996). Postoperative examinations are to be performed by the trial gynecologist with the patient in a supine position. Prolapse of the middle compartment equivalent to, or more, than 50% of the total vaginal length (TVL) (i.e. point C positioned at, or distal to, a point between the hymen and half the total vaginal length) is required for inclusion of a patient in the trial.
Measured: Changes from baseline an up to 3 months, 1, 5 and 10 years
Measurement of generic quality of Life (QoL) by The 15D instrument of health-related quality of Life (15D): vaginal mesh utero-/colpopexy vs Robotic Sacral
The 15D is a generic, comprehensive, self-administered, 15-dimensional, preference-based questionnaire. The 15D includes 15-dimensions: mobility, vision, hearing, breathing, sleeping, eating, speech (communication), excretion, usual activity, mental function, discomfort, depression, distress, vitality, and sexual functions. Each dimension has five descriptive levels to choose from. The 15D can be used as a profile and a single index score measure. The valuation system is based on the application of multi-attribute utility theory. The single index or utility score represents the generic health-related quality of life on a maximum value of 1 (full health) to lower bound of 0 (being dead). From the 15D, the generic minimal important change (MIC) can be calculated to indicate improvement or deterioration. Also, he quality adjusted life-year (QALY) is evaluated using the estimated 15D values preoperative and after surgery.
Measured: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of pelvic floor symptoms by Pelvic Floor Distress Inventory (PFDI-20): vaginal mesh utero-/colpopexy vs Robotic Sacral
The PFDI-20 is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms. It is a short-form version of the Pelvic Floor Distress Inventory. The questionnaire has been validated for use in pelvic reconstructive surgery and has proven sensitive to change.
The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions.
Measured: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Ultrasound measurement of mesh length in cm and mapping of mesh in correlation to bladder and urethra: vaginal mesh utero-/colpopexy vs Robotic Sacral
2D, 3D ultrasound mapping of prolapse mesh length in cm and mesh position from the urinary bladder neck and urethra as measured in cm. Further, to investigate if mesh position correlate to urinary incontinence and/or bladder emptying difficulties (urinary retention).
Measured: Ultrasound measurements at 1, 5 and 10 years after surgery
Measurement of generic QoL by health related quality of life by EuroQol 5-dimensions questionnaire (EQ-5D): vaginal mesh utero-/colpopexy vs Robotic Sacral
The EQ-5D questionnaire is used to assess the health condition. It is an instrument to be used to measure generic quality of life in a similar way to 15D, and will be used to measure adjusted quality of life (QALYs). Similar to the 15D, the questionnaire results are mapped to a single utility value.
Measured: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of life impact in women with pelvic floor disorders by Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7): vaginal mesh utero-/colpopexy vs Robotic Sacral
The PFIQ-7 is an abridged version of the PFIQ and is used to assess life impact in women with pelvic floor disorders. The PFIQ-7 summary score is calculated by adding the scores from the 3 scales together to obtain the summary score (range 0-300).
Measured: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of sexual function by Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12): vaginal mesh utero-/colpopexy vs Robotic Sacral
The validated PISQ-12 is a condition-specific, 12-item questionnaire on sexual function, with ordinal response alternatives based on a 5-point Likert scale. The PISQ-12 correlates well with other sexual health questionnaires and has shown sensitivity to change after pelvic reconstructive surgery and predictability of scores using the unabridged PISQ (31 items). The specific questions can be combined to form a score where higher scores indicate better sexual function. The maximum PISQ-12 score is 48. The twelve questions of the PISQ-12 can be divided into three domains: behavioral-emotive, partner-related and physical.
Measured: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
VAS scale is a numeric rating scale and ranges from 0-10 (each digit is 1cm) where 0 indicates no and 10 indicates maximum, digits between 0-10 indicate degree of pain.
Measured: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of urinary incontinence by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
VAS scale is a numeric rating scale and ranges from 0-10 (each digit is 1cm) where 0 indicates no and 10 indicates maximum, digits between 0-10 indicate degree of severity of urinary incontinence. VAS scale for urinary incontinence: 0 indicate no urinary incontinence whereas 10 indicates maximal or severe urinary incontinence.
Measured: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of patient satisfaction by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
VAS scale is a numeric rating scale and ranges from 0-10 (each digit is 1cm) where 0 indicates no and 10 indicates maximum, digits between 0-10 indicate degree of satisfaction after mesh surgery. VAS scale for patient satisfaction: 0 indicates no satisfaction whereas 10 indicates maximal satisfaction.
Measured: Assessment after operation: 15 days, 3,6&9 months, 1-5 and 10 years
Measurement of patient recommendation to other patients to undergo same surgery if they suffer apical prolapse (assessed by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
VAS scale is a numeric rating scale and ranges from 0-10 (each digit is 1cm) where 0 indicates no and 10 indicates maximum, digits between 0-10 indicate degree of satisfaction. VAS scale for patient recommendation to other patients to undergo same surgery if they suffer apical prolapse: 0 indicates no recommendation whereas 10 indicates maximal recommendation.
Measured: Assessment after operation: 15 days, 3,6&9 months, 1-5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prolapse; FemaleStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Morcos, Karolinska Institutet
- Investigators
- Edward Morcos, MD, PhD, Principal investigator, Karolinska Institutet Danderyds Sjukhus (KIDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878056
- Sponsor's protocol ID
- Dnr: 2017/1988-31, 2018/380-32
- Acronym
- KIDS
- Status last verified
- Apr 2022
- First submitted
- 14 Feb 2019
- Last updated
- 8 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Poutakidis G, Geale K, Morcos E. Quality-Adjusted Life-Years Outcome 1 Year After Surgery by Robotics-Assisted Sacral Hystero-Colpopexy Versus Vaginal Mesh for Pelvic Organ Prolapse Repair. Int Urogynecol J. 2026 Jan;37(1):161-173. doi: 10.1007/s00192-025-06242-7. Epub 2025 Aug 13.
PubMed 40801945Poutakidis G, Falconer C, Altman D, Johannesson U, Zhang A, Ericson C, Stenberg M, Altrock S, Morcos E. Pelvic Organ Prolapse Repair Using Robotic-Assisted Sacral Hysterocolpopexy vs Vaginal Surgery with the Uphold System: 1-Year Clinical Outcomes. Int Urogynecol J. 2025 Mar;36(3):585-597. doi: 10.1007/s00192-024-06017-6. Epub 2025 Jan 8.
PubMed 39776188
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis and Patient Safety After Apical Prolapse Surgery by Mesh Via Different Approaches; Vaginal or Robotic-assisted: Multicenter, Prospective Parallel Cohort Study
- ClinicalTrials.gov ID
- NCT03878056
- Acronym / sponsor ID
- KIDS / Dnr: 2017/1988-31, 2018/380-32
- Conditions
- Prolapse; Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Mar 2019 (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.
Cost-effectiveness, safety, outcomes and diagnostic development in advanced apical female genital prolapse reconstructive surgery by vaginal and robotic-assisted mesh surgery.
A multicenter, prospective, parallel, cohort, comparative study between the vaginal and robotic-assisted mesh surgery including 200 patients.
Detailed description
Pelvic organ prolapse (POP) is a common condition and may be disabling and limiting quality of life (QoL) among aging women. POP may arise in the anterior (cystocele), posterior (rectocele) and middle compartment (apical POP) of the vagina. Apical POP includes descent of uterus or vaginal vault (if uterus was previously removed). The lifetime risk of undergoing a single operation for POP or urinary incontinence by age 80 is 11%. In Sweden, the risk to undergo 2 pelvic floor surgery is about 130 000 women. Traditional Surgical repairs of POP using native connective tissues are commonly used but the risk for POP recurrence is high if apical prolapse is present (ca 60%). Thus, minimal invasive surgical approaches by apical trans-vaginal mesh (A-TVM) and robotic sacral colpopexy (RSC) to support the vaginal apex (middle compartment) are in progress. 1 Evidence show effectivity and improved QoL after surgery.
Vaginal and robotic accesses may be available to many patients. Vaginal approach may allow surgeon to perform surgery for all POP compartments and perineal injury in one single surgery opportunity. Contra-indications for general anesthesia and some abdominal diseases or conditions may dismiss the robotic surgery. In contrast, all patients can be operated via the vaginal approach except for patient unwellness. Thus, a direct low cost of vaginal surgery may be possible. In the other hand, costs for robotic surgery are high. Whether or not this may be reflected on cost-effectiveness based on QoL improvement after surgery has not yet been studied.
Visualising synthetic implants i.e. POP mesh and the Tension-Free Vaginal Tape (TVT) implant for urinary incontinence (UI) by ultrasonography (US) has been a subject for some studies. Using US, localisation of the TVT in correlation to urinary bladder neck and how close to urethra may explain outcomes after TVT surgery. Given its importance, knowledge of how mesh anatomical position may influence outcomes, it may be useful in further POP surgery development. Our results indicate that US can be used and is reproducible in mapping of A-TVM (manuscript).
Growing need worldwide is to have more cost-effective and safe health care. Cost-effectiveness, safety, outcomes, POP-recurrence and effects on pelvic floor dysfunction have not yet been directly compared between vaginal and robotic mesh surgery for apical POP.
Topic: Cost-Effectiveness (Vaginal vs robotic POP mesh surgery), QoL, safety and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal mesh | – | Device: Vaginal: UpholdTM Lite Vaginal Support - Boston ScientificVaginal surgery (UpholdTM Lite Vaginal Support, Boston Scientific) |
| Robotic sacral colpopexy | – | Device: Vaginal: UpholdTM Lite Vaginal Support - Boston ScientificRobotic surgery (Artisyn® Y-Shaped Mesh - Ethicon) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with apical prolapse and suffering prolapse symptoms.
Key inclusion criteria (7 listed)
- Posthysterectomy prolapse of the vaginal apex, with or without cystocele/rectocele, where the vaginal apex descends at least 50% of the total vaginal length
- Uterine prolapse, with or without cystocele/rectocele, where the leading edge of the cervix descends at least 50% of the total vaginal length and TVL minus point C= ≤ 2 cm
- Prolapse specific pelvic symptom of pelvic heaviness and/or vaginal bulging
- Reproductive years in the past (biologically or reproductive decision)
- Being able to make an informed consent on participation
Key exclusion criteria (11 listed)
- Posthysterectomy prolapse of the vaginal apex where the vaginal apex descends less than 50% of the total vaginal length regardless of whether a cystocele/rectocele is present or not
- Uterine prolapse, with or without cystocele, where the leading edge of the cervix descends less than 50% of the total vaginal length
- If cervix elongation is present corresponding to: TVL minus point C= >2 cm without uterine prolapse.
- If prolapse specific pelvic symptoms of pelvic heaviness and/or vaginal bulging are not present
- Previous or current pelvic organ cancer (regardless of treatment)
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 |
|---|---|---|
| Vaginal: UpholdTM Lite Vaginal Support - Boston ScientificAlso: Robotic: Artisyn® Y-Shaped Mesh - EthiconApical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy | Device | Robotic sacral colpopexy, Transvaginal mesh |
Primary outcome
Cost-effectiveness measurements and comparison between vaginal and robotic mesh surgery for apical prolapse
Time frame: Changes from baseline an up to 1, 5 and 10 years
Cost-effectiveness analysis: cost-effectiveness will be evaluated by comparing the vaginal approach with the robotic approach in term of incremental costs and incremental benefits (measured by QALYs gained).15 The incremental cost-effectiveness ratio (ICER) gives the marginal cost for each additional QALY gained by treating a patient using the robotic approach compared to the vaginal approach. To evaluate cost-effectiveness, the ICER must be compared with a reference willingness to pay (WTP) value. Sweden has no such official number, but the National Institute of Clinical Excellence (NICE) in the United Kingdom states a willingness to pay between 20,000 - 30,000 British pounds. If the ICER is below this threshold, the robotic approach will be considered cost-effective compared to the vaginal approach.
11 secondary outcomes
Measurement of anatomical outcomes by Pelvic Organ Prolapse Quantification system (POP-Q): vaginal mesh utero-/colpopexy vs Robotic Sacral Colpopexy
Time frame: Changes from baseline an up to 3 months, 1, 5 and 10 years
Measurement of generic quality of Life (QoL) by The 15D instrument of health-related quality of Life (15D): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of pelvic floor symptoms by Pelvic Floor Distress Inventory (PFDI-20): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Ultrasound measurement of mesh length in cm and mapping of mesh in correlation to bladder and urethra: vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Ultrasound measurements at 1, 5 and 10 years after surgery
Measurement of generic QoL by health related quality of life by EuroQol 5-dimensions questionnaire (EQ-5D): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of life impact in women with pelvic floor disorders by Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of sexual function by Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of Pain by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of urinary incontinence by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Changes from baseline an up to15 days, 3,6&9 months, 1-5 and 10 years
Measurement of patient satisfaction by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Assessment after operation: 15 days, 3,6&9 months, 1-5 and 10 years
Measurement of patient recommendation to other patients to undergo same surgery if they suffer apical prolapse (assessed by patient self-reporting Visual analogue scale (VAS-scale): vaginal mesh utero-/colpopexy vs Robotic Sacral
Time frame: Assessment after operation: 15 days, 3,6&9 months, 1-5 and 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Derived from this study: PubMed 40801945Poutakidis G, Geale K, Morcos E. Quality-Adjusted Life-Years Outcome 1 Year After Surgery by Robotics-Assisted Sacral Hystero-Colpopexy Versus Vaginal Mesh for Pelvic Organ Prolapse Repair. Int Urogynecol J. 2026 Jan;37(1):161-173. doi: 10.1007/s00192-025-06242-7. Epub 2025 Aug 13.
- Derived from this study: PubMed 39776188Poutakidis G, Falconer C, Altman D, Johannesson U, Zhang A, Ericson C, Stenberg M, Altrock S, Morcos E. Pelvic Organ Prolapse Repair Using Robotic-Assisted Sacral Hysterocolpopexy vs Vaginal Surgery with the Uphold System: 1-Year Clinical Outcomes. Int Urogynecol J. 2025 Mar;36(3):585-597. doi: 10.1007/s00192-024-06017-6. Epub 2025 Jan 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. This study is not recruiting at the moment.
Edward Morcos, MD, PhD principal investigator
Karolinska Institutet Danderyds Sjukhus (KIDS)
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 Prolapse; Female, run by Karolinska Institutet at 1 site in Sweden.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 8 Apr 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cost-effectiveness measurements and comparison between vaginal and robotic mesh surgery for apical prolapse (time frame: Changes from baseline an up to 1, 5 and 10 years). 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 NCT03878056, which also lists 2 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 8 Apr 2022.