Pelvic Organ Prolapse
Conditions
Brief summary
Pelvic organ prolapse repair involves conservative treatments and surgical treatments. Conservative treatments are for patients with moderate prolapse. Treatment of symptomatic prolapse remains essentially surgical. According to detailed medical history and a thorough physical exam, surgical techniques may be performed by high abdominal, low vaginal or mixed routes with or without the use of a reinforcing implant. Restorelle Direct Fix is indicated for transvaginal anterior and posterior surgical repair either as mechanical support or as reinforcement of pelvic floor defects. Advantages and disadvantages of vaginal prostheses are known but only limited data have been reported on the use of Restorelle® in the treatment of pelvic organ prolapse. This study is designed to collect data on the safety and efficacy of Restorelle® Direct Fix in pelvic organ prolapse repair.
Detailed description
Between January 2013 and December 2016, in the participating centers, all adult women who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis are eligible. Collected data are about the peri-operative period and the data available at the last consultation.
Interventions
PROCEDUREpelvic organ prolapse repair
Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.
Sponsors
Coloplast A/S
Groupe Hospitalier de la Rochelle Ré Aunis
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 18 * woman who underwent surgery to repair pelvic organ prolapse (recurrent or not) through the vagina with the addition of anterior and/or posterior Restorelle Direct Fix prosthesis * informed and not opposed to the use of her data
Exclusion criteria
* Opposed to the use of her data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding | up to 30 days after surgery | Perioperative morbidity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Late Complications | up to 4 years after surgery | self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other |
| Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | preoperative, within 48 hours before surgery | 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) |
| Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | up to 4 years after surgery | 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) |
| Number of Patients With Preoperative Urinary Signs | within 4 weeks before surgery | urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence |
| Number of Patients With Postoperative Urinary Signs | up to 4 years after surgery | urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence |
| Number of Patients With Preoperative Digestive Signs | within 4 weeks before surgery | dyschezia, incontinence |
| Number of Patients With Early Complications | up to 30 days after surgery | Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery |
| Number of Patients With Preoperative Active Sexuality | within 4 weeks before surgery | Patients reporting active sexuality |
| Number of Patients With Preoperative Dyspareunia | within 4 weeks before surgery | Patients reporting pain |
| Number of Patients With Postoperative Active Sexuality | up to 4 years after surgery | Patients reporting active sexuality |
| Number of Patients With Postoperative Dyspareunia | up to 4 years after surgery | Patients reporting pain |
| Preoperative Score at Numeric Pain Rating Scale | Within 48 hours before surgery | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) |
| Postoperative Score at Numeric Pain Rating Scale | up to 48 hours after surgery | The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable) |
| Number of Patients With Postoperative Digestive Signs | up to 4 years after surgery | dyschezia, incontinence |
Countries
France
Participant flow
Recruitment details
Between January 2013 and December 2016, in 10 secondary and tertiary French care centres
Pre-assignment details
Patients were excluded if they did not attend their follow up visit within 30 days of surgery.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 272 |
| Total | 272 |
Baseline characteristics
| Characteristic | Pelvic Organ Prolapse Repair | — |
|---|---|---|
| Age, Continuous | 70 years | — |
| Body mass index | 24.8 kg/m^2 | — |
| Hormone replacement therapy | 68 Participants | — |
| Parity | 2 children | — |
| Post menopause | 257 Participants | — |
| Previous hysterectomy | 58 Participants | — |
| Previous incontinence surgery | 25 Participants | — |
| Previous pelvic organ prolapse surgery | 51 Participants | — |
| Procedure Anterior Restorelle® Direct FixTM alone | 95 Participants | — |
| Procedure Concomitant hysterectomy | 46 Participants | — |
| Procedure Concomitant other surgery | 42 Participants | — |
| Procedure Concomitant posterior Restorelle® Direct FixTM | 63 Participants | — |
| Procedure Concomitant sub urethral sling | 64 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 272 participants | — |
| Sex: Female, Male Female | 272 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 272 |
| other Total, other adverse events | 136 / 272 |
| serious Total, serious adverse events | 14 / 272 |
Outcome results
Primary
Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
Perioperative morbidity
Time frame: up to 30 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding | 6 Participants |
Secondary
Number of Patients With Early Complications
Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery
Time frame: up to 30 days after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Early Complications | 43 Participants |
Secondary
Number of Patients With Late Complications
self-catheterization, recurrent urinary tract infections, de novo urinary stress incontinence, chronic pain, vaginal prosthesis exposure, prolapse recurrence, secondary surgery, other
Time frame: up to 4 years after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Late Complications | 43 Participants |
Secondary
Number of Patients With Postoperative Active Sexuality
Patients reporting active sexuality
Time frame: up to 4 years after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Postoperative Active Sexuality | 41 Participants |
Secondary
Number of Patients With Postoperative Digestive Signs
dyschezia, incontinence
Time frame: up to 4 years after surgery
Population: Data was collected retrospectively and few bowel symptom descriptions were not available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Postoperative Digestive Signs | Dyschezia | 6 Participants |
| Pelvic Organ Prolapse Repair | Number of Patients With Postoperative Digestive Signs | Faecal incontinence | 3 Participants |
Secondary
Number of Patients With Postoperative Dyspareunia
Patients reporting pain
Time frame: up to 4 years after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Postoperative Dyspareunia | 3 Participants |
Secondary
Number of Patients With Postoperative Urinary Signs
urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Time frame: up to 4 years after surgery
Population: Data was collected retrospectively and few bladder symptom descriptions were not available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Postoperative Urinary Signs | Stress urinary incontinence | 48 Participants |
| Pelvic Organ Prolapse Repair | Number of Patients With Postoperative Urinary Signs | Overactive bladder | 24 Participants |
| Pelvic Organ Prolapse Repair | Number of Patients With Postoperative Urinary Signs | Voiding dysfunction | 13 Participants |
Secondary
Number of Patients With Preoperative Active Sexuality
Patients reporting active sexuality
Time frame: within 4 weeks before surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Preoperative Active Sexuality | 94 Participants |
Secondary
Number of Patients With Preoperative Digestive Signs
dyschezia, incontinence
Time frame: within 4 weeks before surgery
Population: Data was collected retrospectively and few bowel symptom descriptions were not available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Preoperative Digestive Signs | Dyschezia | 21 Participants |
| Pelvic Organ Prolapse Repair | Number of Patients With Preoperative Digestive Signs | Faecal incontinence | 13 Participants |
Secondary
Number of Patients With Preoperative Dyspareunia
Patients reporting pain
Time frame: within 4 weeks before surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Preoperative Dyspareunia | 16 Participants |
Secondary
Number of Patients With Preoperative Urinary Signs
urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Time frame: within 4 weeks before surgery
Population: Data was collected retrospectively and few bladder symptom descriptions were not available
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pelvic Organ Prolapse Repair | Number of Patients With Preoperative Urinary Signs | Stress urinary incontinence | 97 Participants |
| Pelvic Organ Prolapse Repair | Number of Patients With Preoperative Urinary Signs | Overactive bladder | 103 Participants |
| Pelvic Organ Prolapse Repair | Number of Patients With Preoperative Urinary Signs | Voiding dysfunction | 118 Participants |
| Pelvic Organ Prolapse Repair | Number of Patients With Preoperative Urinary Signs | Occult urinary incontinence | 48 Participants |
Secondary
Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
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)
Time frame: up to 4 years after surgery
Population: Data was collected retrospectively and few pelvic organ prolapse stage were not available
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Cystocele | Stage 0 | 128 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Cystocele | Stage 1 | 54 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Cystocele | Stage 2 | 24 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Cystocele | Stage 3 | 0 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Cystocele | Stage 4 | 1 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Apex | Stage 0 | 188 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Apex | Stage 1 | 6 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Apex | Stage 2 | 7 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Apex | Stage 3 | 0 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Apex | Stage 4 | 1 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Rectocele | Stage 0 | 174 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Rectocele | Stage 1 | 14 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Rectocele | Stage 2 | 10 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Rectocele | Stage 3 | 2 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery | Rectocele | Stage 4 | 0 Participants |
Secondary
Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
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)
Time frame: preoperative, within 48 hours before surgery
Population: Data was collected retrospectively and few pelvic organ prolapse stage were not available
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Apex | Stage 3 | 37 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Cystocele | Stage 0 | 0 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Cystocele | Stage 1 | 1 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Cystocele | Stage 2 | 61 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Cystocele | Stage 3 | 169 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Cystocele | Stage 4 | 39 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Apex | Stage 0 | 78 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Apex | Stage 2 | 64 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Apex | Stage 4 | 12 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Rectocele | Stage 0 | 115 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Rectocele | Stage 1 | 86 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Rectocele | Stage 2 | 61 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Rectocele | Stage 4 | 4 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Apex | Stage 1 | 75 Participants |
| Pelvic Organ Prolapse Repair | Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery | Rectocele | Stage 3 | 5 Participants |
Secondary
Postoperative Score at Numeric Pain Rating Scale
The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Time frame: up to 48 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Organ Prolapse Repair | Postoperative Score at Numeric Pain Rating Scale | 0.46 units on a scale | Standard Deviation 0.56 |
Secondary
Preoperative Score at Numeric Pain Rating Scale
The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Time frame: Within 48 hours before surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pelvic Organ Prolapse Repair | Preoperative Score at Numeric Pain Rating Scale | 7.3 units on a scale | Standard Deviation 1.9 |