Trial Outcomes & Findings for Smartmesh Technology in Pelvic Floor Repair Procedures (NCT NCT03098641)
NCT ID: NCT03098641
Last Updated: 2023-11-13
Results Overview
Perioperative morbidity
Recruitment status
COMPLETED
Target enrollment
272 participants
Primary outcome timeframe
up to 30 days after surgery
Results posted on
2023-11-13
Participant Flow
Between January 2013 and December 2016, in 10 secondary and tertiary French care centres
Patients were excluded if they did not attend their follow up visit within 30 days of surgery.
Participant milestones
| Measure |
Pelvic Organ Prolapse Repair
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Overall Study
STARTED
|
272
|
|
Overall Study
COMPLETED
|
220
|
|
Overall Study
NOT COMPLETED
|
52
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pelvic Organ Prolapse Repair
n=272 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Age, Continuous
|
70 years
n=272 Participants
|
|
Sex: Female, Male
Female
|
272 Participants
n=272 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=272 Participants
|
|
Region of Enrollment
France
|
272 participants
n=272 Participants
|
|
Body mass index
|
24.8 kg/m^2
n=272 Participants
|
|
Parity
|
2 children
n=272 Participants
|
|
Post menopause
|
257 Participants
n=272 Participants
|
|
Hormone replacement therapy
|
68 Participants
n=272 Participants
|
|
Previous hysterectomy
|
58 Participants
n=272 Participants
|
|
Previous pelvic organ prolapse surgery
|
51 Participants
n=272 Participants
|
|
Previous incontinence surgery
|
25 Participants
n=272 Participants
|
|
Procedure
Anterior Restorelle® Direct FixTM alone
|
95 Participants
n=272 Participants
|
|
Procedure
Concomitant hysterectomy
|
46 Participants
n=272 Participants
|
|
Procedure
Concomitant posterior Restorelle® Direct FixTM
|
63 Participants
n=272 Participants
|
|
Procedure
Concomitant sub urethral sling
|
64 Participants
n=272 Participants
|
|
Procedure
Concomitant other surgery
|
42 Participants
n=272 Participants
|
PRIMARY outcome
Timeframe: up to 30 days after surgeryPerioperative morbidity
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=272 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
|
6 Participants
|
SECONDARY outcome
Timeframe: up to 30 days after surgeryUrinary retention, urinary tract infection, hematoma, ureteral complication, second surgery
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=272 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Early Complications
|
43 Participants
|
SECONDARY outcome
Timeframe: up to 4 years after surgeryself-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=220 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Late Complications
|
43 Participants
|
SECONDARY outcome
Timeframe: preoperative, within 48 hours before surgeryPopulation: Data was collected retrospectively and few pelvic organ prolapse stage were not available
Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=272 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Apex · Stage 0
|
78 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Apex · Stage 1
|
75 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Apex · Stage 2
|
64 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Apex · Stage 3
|
37 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Cystocele · Stage 1
|
1 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Cystocele · Stage 2
|
61 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Cystocele · Stage 3
|
169 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Cystocele · Stage 4
|
39 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Cystocele · Stage 0
|
0 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Apex · Stage 4
|
12 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Rectocele · Stage 0
|
115 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Rectocele · Stage 1
|
86 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Rectocele · Stage 2
|
61 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Rectocele · Stage 3
|
5 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Rectocele · Stage 4
|
4 Participants
|
SECONDARY outcome
Timeframe: up to 4 years after surgeryPopulation: Data was collected retrospectively and few pelvic organ prolapse stage were not available
Pelvic organ prolapse quantification (POP-Q) Staging Criteria Prolapse is staged using POP-Q criteria that can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=220 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Cystocele · Stage 0
|
128 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Cystocele · Stage 1
|
54 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Cystocele · Stage 2
|
24 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Cystocele · Stage 3
|
0 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Cystocele · Stage 4
|
1 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Apex · Stage 0
|
188 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Apex · Stage 1
|
6 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Apex · Stage 2
|
7 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Apex · Stage 3
|
0 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Apex · Stage 4
|
1 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Rectocele · Stage 0
|
174 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Rectocele · Stage 1
|
14 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Rectocele · Stage 2
|
10 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Rectocele · Stage 3
|
2 Participants
|
|
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Rectocele · Stage 4
|
0 Participants
|
SECONDARY outcome
Timeframe: within 4 weeks before surgeryPopulation: Data was collected retrospectively and few bladder symptom descriptions were not available
urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=272 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Preoperative Urinary Signs
Stress urinary incontinence
|
97 Participants
|
|
Number of Patients With Preoperative Urinary Signs
Overactive bladder
|
103 Participants
|
|
Number of Patients With Preoperative Urinary Signs
Voiding dysfunction
|
118 Participants
|
|
Number of Patients With Preoperative Urinary Signs
Occult urinary incontinence
|
48 Participants
|
SECONDARY outcome
Timeframe: up to 4 years after surgeryPopulation: Data was collected retrospectively and few bladder symptom descriptions were not available
urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=220 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Postoperative Urinary Signs
Stress urinary incontinence
|
48 Participants
|
|
Number of Patients With Postoperative Urinary Signs
Overactive bladder
|
24 Participants
|
|
Number of Patients With Postoperative Urinary Signs
Voiding dysfunction
|
13 Participants
|
SECONDARY outcome
Timeframe: within 4 weeks before surgeryPopulation: Data was collected retrospectively and few bowel symptom descriptions were not available
dyschezia, incontinence
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=272 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Preoperative Digestive Signs
Dyschezia
|
21 Participants
|
|
Number of Patients With Preoperative Digestive Signs
Faecal incontinence
|
13 Participants
|
SECONDARY outcome
Timeframe: up to 4 years after surgeryPopulation: Data was collected retrospectively and few bowel symptom descriptions were not available
dyschezia, incontinence
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=220 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Postoperative Digestive Signs
Dyschezia
|
6 Participants
|
|
Number of Patients With Postoperative Digestive Signs
Faecal incontinence
|
3 Participants
|
SECONDARY outcome
Timeframe: within 4 weeks before surgeryPatients reporting active sexuality
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=198 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Preoperative Active Sexuality
|
94 Participants
|
SECONDARY outcome
Timeframe: within 4 weeks before surgeryPatients reporting pain
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=87 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Preoperative Dyspareunia
|
16 Participants
|
SECONDARY outcome
Timeframe: up to 4 years after surgeryPatients reporting active sexuality
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=122 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Postoperative Active Sexuality
|
41 Participants
|
SECONDARY outcome
Timeframe: up to 4 years after surgeryPatients reporting pain
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=40 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Number of Patients With Postoperative Dyspareunia
|
3 Participants
|
SECONDARY outcome
Timeframe: Within 48 hours before surgeryThe numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=65 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Preoperative Score at Numeric Pain Rating Scale
|
7.3 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: up to 48 hours after surgeryThe numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Outcome measures
| Measure |
Pelvic Organ Prolapse Repair
n=162 Participants
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Postoperative Score at Numeric Pain Rating Scale
|
0.46 units on a scale
Standard Deviation 0.56
|
Adverse Events
Pelvic Organ Prolapse Repair
Serious events: 14 serious events
Other events: 136 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pelvic Organ Prolapse Repair
n=272 participants at risk
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Renal and urinary disorders
Ureteral injury
|
0.74%
2/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Urinary tract infection
|
0.74%
2/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Postoperative haematoma
|
0.74%
2/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
3rd degree vaginal prolapse
|
3.2%
7/220 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Adverse local tissue reaction around prosthesis
|
0.91%
2/220 • The median follow-up was 3 months ranging from 1 to 36 months
|
Other adverse events
| Measure |
Pelvic Organ Prolapse Repair
n=272 participants at risk
Adult women who had vaginal repair of pelvic organ prolapse (recurrent or not) planned with anterior Restorelle® Direct FixTM mesh (with or without posterior mesh)
|
|---|---|
|
Renal and urinary disorders
Bladder injury
|
1.1%
3/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Rectal injury
|
0.37%
1/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Urinary retention postoperative
|
7.0%
19/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Pain
|
37.9%
103/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Urinary tract infection
|
5.5%
15/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Postoperative haematoma
|
2.2%
6/272 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Chronic pain
|
3.2%
7/220 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Adverse local tissue reaction around prosthesis
|
3.6%
8/220 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Medical device site granuloma
|
2.7%
6/220 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Incontinence
|
4.5%
10/220 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
1st degree vaginal prolapse
|
1.8%
4/220 • The median follow-up was 3 months ranging from 1 to 36 months
|
|
Renal and urinary disorders
Dyspareunia
|
0.45%
1/220 • The median follow-up was 3 months ranging from 1 to 36 months
|
Additional Information
Dr Philippe Ferry
Groupe Hospitalier de la Rochelle Ré Aunis
Phone: +33 5 46 45 50 50
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place