Trial Outcomes & Findings for Calistar A vs. Calistar S - Comparative Cohort Retrospective Analysis of Single Incision POP Systems (NCT NCT03715803)

Results Overview

According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.

Recruitment status

COMPLETED

Target enrollment

217 participants

Primary outcome timeframe

Post-operative at 6 months

Results posted on

2020-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Calistar A Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Calistar S Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Overall Study STARTED	91	126
Overall Study COMPLETED	91	126
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Calistar A n=91 Participants Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Calistar S n=126 Participants Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses	Total n=217 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 9 • n=91 Participants	62 years STANDARD_DEVIATION 8 • n=126 Participants	62 years STANDARD_DEVIATION 8 • n=217 Participants
Sex: Female, Male Female	91 Participants n=91 Participants	126 Participants n=126 Participants	217 Participants n=217 Participants
Sex: Female, Male Male	0 Participants n=91 Participants	0 Participants n=126 Participants	0 Participants n=217 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Argentina	32 Participants n=91 Participants	71 Participants n=126 Participants	103 Participants n=217 Participants
Region of Enrollment Brazil	23 Participants n=91 Participants	19 Participants n=126 Participants	42 Participants n=217 Participants
Region of Enrollment Italy	29 Participants n=91 Participants	30 Participants n=126 Participants	59 Participants n=217 Participants
Region of Enrollment France	7 Participants n=91 Participants	6 Participants n=126 Participants	13 Participants n=217 Participants

PRIMARY outcome

Timeframe: Post-operative at 6 months

According to Barber criteria cure is defined if there are no points beyond the hymen (measure by POP-Q quantification), an absence of vaginal bulge symptoms and no re-treatment/interventions on year post procedure.

Outcome measures

Outcome measures
Measure	Calistar A n=91 Participants Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Calistar S n=126 Participants Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Percentage of Cured Participants According to Barber Criteria	82.42 percentage of cured patients	90.48 percentage of cured patients

SECONDARY outcome

Timeframe: Pre-operative and post-operative at 6 months

Assessment of POP with POP-Q quantification. Number of participants cured according to POP-Q quantification. Success criteria: POP-Q stage equal 0 or 1.

Outcome measures

Outcome measures
Measure	Calistar A n=91 Participants Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Calistar S n=126 Participants Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Percentage of Participants Cured According to Objective Measure (POP-Q Quantification)	82.42 percentage of cured patients	88.88 percentage of cured patients

SECONDARY outcome

Timeframe: Post-operative at 6 months

Patient satisfaction with the experience and the result of procedure will be evaluated with the "Patient Global Impression" questionnaire. This is a visual analogue scale range 1 (very much worse) - 5 (very much improved). A higher score a better outcome.

Outcome measures

Outcome measures
Measure	Calistar A n=91 Participants Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Calistar S n=126 Participants Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Quality of Life Status: Patient Global Impression Questionnaire	5 units on a scale Interval 1.0 to 5.0	5 units on a scale Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: Intra-operative and post-operative at 6 months

Population: Adverse events were presented in a separate section.

Register of adverse events. Clavien-Dindo classification

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-operative at 6 months

Quality of life assessed with "Pelvic Floor Distress Inventory (PFDI 20)" questionnaire to evaluate the impact of urinary, prolapse and colorectal distress post-operative. The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 (least distress) to 100 (greatest distress).

Outcome measures

Outcome measures
Measure	Calistar A n=91 Participants Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Calistar S n=126 Participants Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Quality of Life: PFDI 20	30.85 score on a scale Interval 0.0 to 91.1	19.4 score on a scale Interval 0.0 to 52.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-operative at 6 months

Quality of life assessed with "Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire (PISQ-12)" to evaluate sexual function in women with pelvic organ prolapse and/or urinary incontinence post-operative. Higher PISQ-12 scores indicate a better sexual function. Maximum score is 48.

Outcome measures

Outcome measures
Measure	Calistar A n=91 Participants Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Calistar S n=126 Participants Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Quality of Life: PISQ-12	0 score on a scale Interval 0.0 to 5.0	0 score on a scale Interval 0.0 to 13.0

Adverse Events

Calistar A

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Calistar S

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Calistar A n=91 participants at risk Calistar A mesh to treat anterior and apical POP Calistar A mesh to treat anterior and apical POP: Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses	Calistar S n=126 participants at risk Calistar S mesh to treat anterior and apical POP Calistar S mesh to treat anterior and apical POP: Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
Surgical and medical procedures Pain	6.6% 6/91 • Number of events 6 • All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S	4.8% 6/126 • Number of events 6 • All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S
Surgical and medical procedures Reoperation for prolapse	2.2% 2/91 • Number of events 2 • All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S	1.6% 2/126 • Number of events 2 • All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S
Surgical and medical procedures Mesh erosion	11.0% 10/91 • Number of events 10 • All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S	4.0% 5/126 • Number of events 5 • All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S
Renal and urinary disorders Urinary tract infection	13.2% 12/91 • Number of events 12 • All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S	0.79% 1/126 • Number of events 1 • All adverse events were collected within a FU of 24 mo (6-64 mo) for Ca A and 12 mo (6-36 mo) for Ca S

Additional Information

Dr. Agustín Sampietro

Universidad de Buenos Aires

Phone: +5491158336327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place