Extraction form for project: SGS 2022 Enabling Technologies

Design Details

1. Extracted copublications
Provide citation id (eg, PMID) or other study information for sources of extracted data other than the primary article (eg, protocol article, secondary publications, ClinicalTrials.gov)
2. Study Design
3. Directionality
If unclear or other, explain
4. Study dates
Years that the study was conducted (or that the technologies were used). Just the years. If only a single year, just enter this in Start Year (don't repeat in End Year). If not reported, enter "<" the publication year (eg, if published in 2018, enter "<2018").
Start Year
End Year
5. Funding sources
If industry provided devices etc. for free, count this as industry funding.
6. Study country
If one or more countries is not in list, check "Other" and enter the list (ideally in alphabetical order). If study done in multiple European countries, no need to also check or list the individual countries.
7. Inclusion criteria (specific to GYN surgery)
Describe eligibility criteria related to GYN procedure and vaginal surgical enabling technology use. Enter other eligibility criteria in next section. Be concise. Use well-understood abbreviations. If you copy and paste, please go back and edit/clean up
8. Inclusion criteria, other
As needed, describe other eligibility criteria (not related to GYN procedure or vaginal surgical enabling technology use). Skip if n/a. Be concise. Use well-understood abbreviations. Omit non-salient feature (e.g., informed consent, language). If you copy and paste, please go back and edit/clean up
9. Exclusion criteria
Do not repeat, or be redundant with, inclusion criteria. Be concise. Use well-understood abbreviations. Omit non-salient features. OK to leave this blank if nothing unique to add.
10. Centers (number)
If not explicitly reported, use your best judgment.
11. Surgical teams (number)
If not explicitly reported, use your best judgment.
12. Comments/Notes
13. SECONDARY REVIEWER: Name
Your name (if you are the secondary reviewer)
14. SECONDARY REVIEWER: Corrections to DESIGN DETAILS
List corrections (from your perspective) pertinent to this section/tab. You don't need to list trivial corrections (like typos; except maybe number typos).
15. SECONDARY REVIEWER: Corrections to RESULTS
List corrections (from your perspective) pertinent to the extracted results, including things like comparisons and measures used. You don't need to list trivial corrections (like typos; except maybe number typos).
16. SECONDARY REVIEWER: Complete and checked
For all sections. Secondary reviewer should check the "COMPLETE" box when done. Sunil (or his assignee) will check the FINALIZED box when all set. If there are issues, write a few words to capture them.
2ary review COMPLETE
Extraction FINALIZED

Arms

Arm NameArm Description
Suture capturing deviceCapio

Arm Details

1. Specific technology
Name or other identifier of technology, if not fully described by the Arm Name (not the description of the technology)
Suture capturing device
2. Technology description
Description and/or details about technology. Be concise. Omit if nothing additional is necessary.
Suture capturing device
3. Other comments/notes
Suture capturing device
4. SECONDARY REVIEWER: Corrections to ARMS or ARMS DETAILS
List corrections (from your perspective) pertinent to the extracted arm list or name of arms or arm details. You don't need to list trivial corrections (like typos; except maybe number typos).
Suture capturing device

Sample Characteristics

1. No. enrolled
Enrolled or initially included (before dropouts, missing data). Particularly for retrospective studies, may be same as number analyzed. Check NR/unclear if NR.
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No.
NR
2. Surgical indication(s)
For each indication, enter percent (0-100%), not the proportion (0-1). Calculate % from n/N. Confirm that %ages add to 100%. If the %age is NR for given indications, enter NR for those indications. If a listed indication is not included (ie, 0%), leave blank. (Remember that the indications may be listed in the Methods, not the Results). You can skip the Definition column (for specific or all indications). Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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DefinitionPercentage (%)% NR
Bleeding abnormality
Endometriosis
Adenomyosis
Adnexal mass
Cervical dysplasia
Pelvic pain etc.
Prolapse, pelvic organ
Endom Intra Neop (EIN)
BRCA positive
Other 1
Other 2
Other 3
Other 4
Other 5
Difference between groups
3. Surgical procedures
If the procedures are identical in both groups (eg, 100% one procedure) OR if they don't report % within each study group, please ONLY complete the TOTAL section. First click the procedure(s), then enter the percent (0-100%, not proportion [0-1]). If you select either of the "OTHER" options, name these.
Suture capturing device
4. Age
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
5. BMI
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
6. Race/Ethnicity
Extract or calculate % (0-100%), not proportion (0-1). Skip not relevant or not reported rows. For "Other" categories, Enter description and %. For example: Indian 42%. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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NR
White (all)
White, non-Hispanic
Black/AA (all)
Black/AA, non-Hispanic
Hispanic/Latina
Asian (all)
Other 1
Other 2
Other 3
Other 4
Difference between groups
7. Parity
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
8. No. vaginal births
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
Suture capturing device
Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
9. No. cesarean sections
No need to complete more than one row. Note that full range might be derived from eligibility criteria. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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Mean (SD)
Median (IQR)
Median (full range)
NR
Difference between groups
10. Comorbidities
List with %ages or other numerical data, as feasible. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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Comorbidities
Differences between groups
11. Prior surgeries
List with %ages or other numerical data, as feasible. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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Surgeries
Differences between groups
12. Uterine size (or weight)
PREOPERATIVE size, including weight. No need to complete more than one row. Select units in the first row. Include ONLY NUMBERS in (one of) the next 3 rows. Check NR if necessary. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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Units
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
13. Adnexal mass (or cyst size)
Complete only if adnexal surgery, otherwise, skip. PREOPERATIVE mass. No need to complete more than one row. Select units in the first row. Include ONLY NUMBERS in (one of) the next 3 rows. Check NR if necessary. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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Units
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
14. Pelvic/vaginal pain
PREOPERATIVE. Select tool/measure in the first row. If not VAS, name the tool. If CATEGORICAL, define the pain category and in next row(s), enter %age (0-100%). Include ONLY NUMBERS in (one of) the next 3 rows. Check NR if necessary (even if indication does not have a pain component). Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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Tool/Measure
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
15. QoL
PREOPERATIVE. Select questionnaire in the first row; check all tick boxes in first row and answer each: Min-Max: enter range of possible scores; Best QoL = min or max?: enter "min" or "max" to say whether the lowest or highest possible score corresponds to best QoL. Include ONLY NUMBERS in (one of) the next 3 rows. Check NR if necessary. Answer the LAST ROW only once and only in the Total section (not per arm). Omit the last row for single group studies (or if NR for overall question). Otherwise, note "No difference", P value (if <0.05), or explanation of any perceived difference.
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Questionnaire
Mean (SD)
Median (IQR)
Median (full range)
NR
Differences between groups
16. Comments/Notes
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17. SECONDARY REVIEWER: Corrections to SAMPLE CHARACTERISTICS
List corrections (from your perspective) pertinent to the extracted sample characteristics. You don't need to list trivial corrections (like typos; except maybe number typos).
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Outcomes

TypeDomainSpecific measurement (i.e., tool/definition/specific outcome)PopulationsTimepoints
CategoricalCx: NeuropathyButtock pain
  • All Participants
  • one week post op
  • 6 weeks post op
  • 12 months post op
CategoricalPatient satisfaction - subjective successdefined by a response of ‘much better’ or ‘very much better’ on the condition change question on the electronic personal assessment questionnaire – pelvic floor (ePAQ-PF)
  • All Participants
  • 12 months post op
CategoricalCx: Recurrent prolapse - objective successdefined as point C at or above the midvaginal point on examination using POP-Q
  • All Participants
  • Post-op
ContinuousSurgery: OR timeaverage time taken to performthe sacrospinous ligament fixation using the capio, all unilateral
  • All Participants
  • Intra-op
CategoricalEBL <50 mL
  • All Participants
  • Intraop
CategoricalSurgery: Procedure successProlapse no longer present at 12 months
  • All Participants
  • 12 months
CategoricalSurgery: Procedure successPreoperative vaginal pain no longer present at 12 months
  • All Participants
  • 12 months
CategoricalSurgery: Procedure successPreoperative vaginal problems in general (pain, capacity, prolapse) no longer present at 12 months
  • All Participants
  • 12 months
CategoricalSurgery: Procedure successPreoperative urinary problems in general (pain, voiding issues, OAB, SUI) no longer present at 12 months
  • All Participants
  • 12 months
CategoricalSurgery: Procedure successPreoperative OAB no longer present at 12 months
  • All Participants
  • 12 months
CategoricalSurgery: Procedure successPreoperative SUI no longer present at 12 months
  • All Participants
  • 12 months
CategoricalSurgery: Procedure successPreoperative bowel problems in general (irritable, constipation, evacuation, incontinence) no longer present at 12 months
  • All Participants
  • 12 months
CategoricalSurgery: Procedure successPreoperative sexual problems in general (urinary, bowel, vaginal, dyspareunia, QOL) no longer present at 12 months
  • All Participants
  • 12 months
CategoricalSurgery: Procedure successPreoperative dyspareunia no longer present at 12 months
  • All Participants
  • 12 months
CategoricalCx: De novo pelvic floor problemsDe novo vaginal pain at 12 months
  • All Participants
  • 12 months
CategoricalCx: De novo pelvic floor problemsDe novo vaginal problems in general (pain, capacity, prolapse) at 12 months
  • All Participants
  • 12 months
CategoricalCx: De novo pelvic floor problemsDe novo urinary problems in general (pain, voiding issues, OAB, SUI) at 12 months
  • All Participants
  • 12 (mo)
CategoricalCx: De novo pelvic floor problemsDe novo OAB at 12 months
  • All Participants
  • 12 months
CategoricalCx: De novo pelvic floor problemsDe novo SUI at 12 months
  • All Participants
  • 12 months
CategoricalCx: De novo pelvic floor problemsDe novo bowel problems in general (irritable, constipation, evacuation, incontinence) at 12 months
  • All Participants
  • 12 months
CategoricalCx: De novo pelvic floor problemsDe novo sexual problems in general (urinary, bowel, vaginal, dyspareunia, QOL) at 12 months
  • All Participants
  • 12 months
CategoricalCx: De novo pelvic floor problemsDe novo dyspareunia at 12 months
  • All Participants
  • 12 months
ContinuousPOPQ measurementsPOPQ Point Aa
  • All Participants
  • Baseline
  • 6 weeks
  • 12 months or beyond
ContinuousPOPQ measurementsPOPQ Point Ba
  • All Participants
  • Basline
  • 6 weeks
  • 12 months or beyond
ContinuousPOPQ measurementsPOPQ Point C
  • All Participants
  • Baseline
  • 6 weeks
  • 12 months or beyond
ContinuousPOPQ measurementsPOPQ Point GH
  • All Participants
  • Baseline
  • 6 weeks
  • 12 months or beyond
ContinuousPOPQ measurementsPOPQ Point PB
  • All Participants
  • Baseline
  • 6 weeks
  • 12 months or beyond
ContinuousPOPQ measurementsPOPQ Point TVL
  • All Participants
  • Baseline
  • 6 weeks
  • 12 months or beyond
ContinuousPOPQ measurementsPOPQ Point Ap
  • All Participants
  • Baseline
  • 6 weeks
  • 12 months or beyond
ContinuousPOPQ measurementsPOPQ Point Bp
  • All Participants
  • Baseline
  • 6 weeks
  • 12 months or beyond

Outcome Details

1. Comments/Notes
Cx: Neuropathy
Patient satisfaction - subjective success
Cx: Recurrent prolapse - objective success
Surgery: OR time
EBL <50 mL
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
2. SECONDARY REVIEWER: Corrections to OUTCOMES or OUTCOME DETAILS
List corrections (from your perspective) pertinent to the extracted outcome list or name or definition of outcomes, or time points, or outcome details. You don't need to list trivial corrections (like typos; except maybe number typos).
Cx: Neuropathy
Patient satisfaction - subjective success
Cx: Recurrent prolapse - objective success
Surgery: OR time
EBL <50 mL
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Surgery: Procedure success
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
Cx: De novo pelvic floor problems
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements
POPQ measurements

Risk of Bias Assessment

1. Study Design
Answer this question to allow program to select the right questions for you.
2. Clarity: Discrepancies
Was the article free of discrepancies (eg, between text and tables)? Add note if No (High concern)
3. Clarity: Population
Were patient eligibility criteria sufficiently clear? Add note if No (High concern).
4. Clarity: Intervention (technology) and Comparator
Were the technology and comparator sufficiently clearly described? Add note if No (High concern).
5. Clarity: Outcomes
Were the outcomes adequately defined without problem. Add note if No (High concern). Not every outcome requires an explicit definition (e.g., length of hospital stay).
6. Clarity: Setting
Was the setting sufficiently clearly defined (e.g., the surgical team)? Add note if No (High concern). Not every outcome requires an explicit definition (e.g., length of hospital stay).
7. Random sequence generation
Selection bias (biased allocation to interventions) due to inadequate generation of a randomized sequence. If they say only "randomized" this says nothing about the random sequence generation (select Unclear and enter "NR"). There is a low risk of selection bias if the investigators describe a random component in the sequence generation process such as: referring to a random number table, using a computer random number generator, coin tossing, shuffling cards or envelopes, throwing dice, drawing of lots, minimization (minimization may be implemented without a random element, and this is considered to be equivalent to being random). There is a high risk of selection bias if the investigators describe a non-random component in the sequence generation process, such as: sequence generated by odd or even date of birth, date (or day) of admission, hospital or clinic record number; or allocation by judgement of the clinician, preference of the participant, results of a laboratory test or a series of tests, or availability of the intervention. ADD NOTE IF UNCLEAR (usually "NR") OR HIGH ROB.
Rating
8. Allocation concealment
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment. This usually not reported (select Unclear and enter "NR"). There is a low risk of selection bias if the participants and investigators enrolling participants could not foresee assignment because one of the following, or an equivalent method, was used to conceal allocation: central allocation (including telephone, web-based and pharmacy-controlled randomization); sequentially numbered drug containers of identical appearance; or sequentially numbered, opaque, sealed envelopes. There is a high risk of bias if participants or investigators enrolling participants could possibly foresee assignments and thus introduce selection bias, such as allocation based on: using an open random allocation schedule (e.g. a list of random numbers); assignment envelopes were used without appropriate safeguards (e.g. if envelopes were unsealed or non-opaque or not sequentially numbered); alternation or rotation; date of birth; case record number; or other explicitly unconcealed procedures. ADD NOTE IF UNCLEAR (usually enter "NR) OR HIGH ROB.
Rating
9. Blinding of participants and personnel
Performance bias due to knowledge of the allocated interventions by participants during the study. There is a low risk of performance bias if blinding of participants and key study personnel was ensured and it was unlikely that the blinding could have been broken. If unblinded, enter HIGH RoB even if blinding would have been impossible (the RoB still exists). If no mention of blinding use your judgment, erring on the side of unblinded. ADD NOTE ONLY IF there's something atypical beyond lack of blinding.
Rating
10. Blinding of outcome assessor
Detection bias due to knowledge of the allocated interventions by outcome assessors. There is LOW risk of detection bias if the blinding of the outcome assessment was ensured and it was unlikely that the blinding could have been broken. Note that most outcomes of interest could have been assessed by blinded outcome assessors (except, possibly patient-reported or surgeon-reported outcomes; which are addressed by the question about patient/provider blinding). ADD NOTE ONLY IF there's something atypical beyond lack of blinding (of if there was differential blinding for different outcomes). Use your judgment if blinding information was not reported.
Rating
11. Incomplete outcome data
Attrition bias due to amount, nature or handling of incomplete outcome data. There is a LOW risk of attrition bias if there were No missing outcome data; if attrition was <20% and reasons for missing outcome data were unlikely to be related to the true outcome and missing outcome data were BALANCED in % loss, with similar reasons for missing data across groups. ADD NOTE IF UNCLEAR OR HIGH RoB.
Rating
12. Selective Reporting
Reporting bias due to selective outcome reporting. This may be difficult to judge. There is LOW risk of reporting bias if the study protocol is available and all of the study’s pre-specified (primary and secondary) outcomes that are of interest in the review have been reported in the pre-specified way, or if the study protocol is not available but it is clear that the published reports include all expected outcome, including those that were pre-specified (convincing text of this nature may be uncommon). There is a HIGH risk of reporting bias if not all of the study’s pre-specified primary outcomes have been reported; one or more primary outcomes is reported using measurements, analysis methods or subsets of the data (e.g. subscales) that were not pre-specified; one or more reported primary outcomes were not pre-specified (unless clear justification for their reporting is provided, such as an unexpected adverse effect); one or more outcomes of interest in the review are reported incompletely so that they cannot be entered in a meta-analysis; the study report fails to include results for a key outcome that would be expected to have been reported for such a study. ADD NOTE IF UNCLEAR OR HIGH RoB.
Rating
13. Intention-to-treat-analysis
Bias due to incomplete reporting and analysis according to group allocation. There is low risk of bias if all randomized patients were reported/analyzed in the group to which they were allocated by randomization. Either with intention-to-treat methods or if there were no dropouts (all analyzed). Note that authors' use of the term ITT does not at all guarantee that ITT methods were used. ADD NOTE ONLY if something unusual.
Rating
14. Representativeness of the cases
LOW RoB if all eligible cases with outcome of interest over a defined period of time OR all cases in a defined catchment area OR all cases in a defined service OR a random sample of those cases; no concern about biased selection of patients. ADD NOTE IF UNCLEAR OR HIGH RoB.
Rating
15. Selection of Controls
LOW RoB if Controls were selected from the same source population as the cases AND essentially the same eligibility criteria (except for intervention). HIGH RoB if Controls were selected from a different source population that was not completely comparable OR different basic eligibility criteria. ADD NOTE IF UNCLEAR OR HIGH ROB.
Rating
16. Other Bias
Bias due to problems not covered elsewhere in the table. If yes (High RoB), describe them in the Notes.There is a LOW risk of bias if the study appears to be free of other sources of bias not addressed elsewhere
Rating

Results

Categorical


Cx: Neuropathy (Buttock pain)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
one week post op
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
SD
p value
6 weeks post op
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
SD
p value
12 months post op
Total (N analyzed)
Odds Ratio (OR)
Events
95% CI low (OR)
Percentage
95% CI high (OR)
SD
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Patient satisfaction - subjective success (defined by a response of ‘much better’ or ‘very much better’ on the condition change question on the electronic personal assessment questionnaire – pelvic floor (ePAQ-PF))

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months post op
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: Recurrent prolapse - objective success (defined as point C at or above the midvaginal point on examination using POP-Q)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Post-op
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

EBL <50 mL

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Intraop
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Surgery: Procedure success (Prolapse no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Surgery: Procedure success (Preoperative vaginal pain no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Surgery: Procedure success (Preoperative vaginal problems in general (pain, capacity, prolapse) no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Surgery: Procedure success (Preoperative urinary problems in general (pain, voiding issues, OAB, SUI) no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Surgery: Procedure success (Preoperative OAB no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Surgery: Procedure success (Preoperative SUI no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device
vs.
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Odds Ratio (OR)
Saved!
95% CI low (OR)
Saved!
95% CI high (OR)
Saved!

Surgery: Procedure success (Preoperative bowel problems in general (irritable, constipation, evacuation, incontinence) no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Surgery: Procedure success (Preoperative sexual problems in general (urinary, bowel, vaginal, dyspareunia, QOL) no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Surgery: Procedure success (Preoperative dyspareunia no longer present at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: De novo pelvic floor problems (De novo vaginal pain at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: De novo pelvic floor problems (De novo vaginal problems in general (pain, capacity, prolapse) at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: De novo pelvic floor problems (De novo urinary problems in general (pain, voiding issues, OAB, SUI) at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 (mo)
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: De novo pelvic floor problems (De novo OAB at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: De novo pelvic floor problems (De novo SUI at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: De novo pelvic floor problems (De novo bowel problems in general (irritable, constipation, evacuation, incontinence) at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: De novo pelvic floor problems (De novo sexual problems in general (urinary, bowel, vaginal, dyspareunia, QOL) at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Cx: De novo pelvic floor problems (De novo dyspareunia at 12 months)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
12 months
Total (N analyzed)
Mean Difference (MD)
Events
95% CI low (MD)
Percentage
95% CI high (MD)
SD
SD (MD)
p value (MD)
Odds Ratio (OR)
95% CI low (OR)
95% CI high (OR)
p value
Within Arm ComparisonsNet Comparisons
Suture capturing device

Continuous


Surgery: OR time (average time taken to performthe sacrospinous ligament fixation using the capio, all unilateral)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Intra-op
range
Mean Difference (MD)
Total (N analyzed)
95% CI low (MD)
Mean
95% CI high (MD)
SD
SD (MD)
Median
p value (MD)
25th percentile
75th percentile
Within Arm ComparisonsNet Comparisons
Suture capturing device

POPQ measurements (POPQ Point Aa)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
6 weeks
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
12 months or beyond
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device
Baseline
vs.
12 months or beyond
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Baseline
vs.
6 weeks
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)

POPQ measurements (POPQ Point Ba)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Basline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
6 weeks
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
12 months or beyond
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device
Basline
vs.
6 weeks
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Basline
vs.
12 months or beyond
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)

POPQ measurements (POPQ Point C)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
6 weeks
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
12 months or beyond
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device
Baseline
vs.
6 weeks
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Baseline
vs.
12 months or beyond
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)

POPQ measurements (POPQ Point GH)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
6 weeks
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
12 months or beyond
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device
Baseline
vs.
6 weeks
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Baseline
vs.
12 months or beyond
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)

POPQ measurements (POPQ Point PB)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
6 weeks
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
12 months or beyond
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device
Baseline
vs.
6 weeks
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Baseline
vs.
12 months or beyond
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)

POPQ measurements (POPQ Point TVL)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
6 weeks
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
12 months or beyond
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device
Baseline
vs.
6 weeks
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Baseline
vs.
12 months or beyond
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)

POPQ measurements (POPQ Point Ap)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
6 weeks
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
12 months or beyond
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device
Baseline
vs.
6 weeks
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Baseline
vs.
12 months or beyond
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)

POPQ measurements (POPQ Point Bp)

All Participants
Descriptive StatisticsBetween Arm Comparisons
Suture capturing device
Baseline
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
6 weeks
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
12 months or beyond
Total (N analyzed)
Mean Difference (MD)
Median
95% CI low (MD)
25th percentile
95% CI high (MD)
75th percentile
SD (MD)
p value (MD)
Within Arm ComparisonsNet Comparisons
Suture capturing device
Baseline
vs.
6 weeks
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)
Baseline
vs.
12 months or beyond
Mean Difference (MD)
Saved!
Net Mean Difference (NMD)
95% CI low (MD)
Saved!
95% CI low (NMD)
95% CI high (MD)
Saved!
95% CI high (NMD)
SD (MD)
Saved!
SD (NMD)
p value (MD)
Saved!
P value (NMD)