Restorelle: Smartmesh Technology in Pelvic Floor Repair Procedures

• Sponsor: Groupe Hospitalier de la Rochelle Ré Aunis (Other)
• Overall Status: Completed
• CT.gov ID: NCT03098641
• Collaborator: Coloplast A/S (Industry)
• Enrollment: 272
• Locations: 16
• Actual Duration (Months): 4.9
• Patients Per Site: 17
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Procedure: 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.

Study Design

• Study Type: Observational
• Actual Enrollment: 272 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Transvaginal Treatment of Anterior and Apical Genital Prolapses Using an Ultra Lightweight Mesh: Restorelle® Direct FixTM: a Retrospective Study on Feasibility and Morbidity.
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: Sep 26, 2017
• Actual Study Completion Date: Sep 26, 2017

Outcome Measures

Primary Outcome Measures

1. Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding [up to 30 days after surgery]

   Perioperative morbidity

Secondary Outcome Measures

1. Number of Patients With Early Complications [up to 30 days after surgery]

   Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery

2. 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

3. 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)

4. 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)

5. Number of Patients With Preoperative Urinary Signs [within 4 weeks before surgery]

   urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence

6. Number of Patients With Postoperative Urinary Signs [up to 4 years after surgery]

   urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence

7. Number of Patients With Preoperative Digestive Signs [within 4 weeks before surgery]

   dyschezia, incontinence

8. Number of Patients With Postoperative Digestive Signs [up to 4 years after surgery]

   dyschezia, incontinence

9. Number of Patients With Preoperative Active Sexuality [within 4 weeks before surgery]

   Patients reporting active sexuality

10. Number of Patients With Preoperative Dyspareunia [within 4 weeks before surgery]

    Patients reporting pain

11. Number of Patients With Postoperative Active Sexuality [up to 4 years after surgery]

    Patients reporting active sexuality

12. Number of Patients With Postoperative Dyspareunia [up to 4 years after surgery]

    Patients reporting pain

13. 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)

14. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CH Dunkerque	Grande Synthe		France
2	Groupe Hospitalier de la Rochelle Ré Aunis	La Rochelle		France
3	Clinique Saint Ame	Lambres-lez-Douai		France
4	CH de Laon	Laon		France
5	Clinique Jules Verne	Nantes		France
6	CHU Nîmes	Nimes		France
7	Hôpital des Diaconesses	Paris		France
8	Hôpital Kremlin-Bicêtre	Paris		France
9	CH de Cornouaille	Quimper		France
10	Clinique St Michel et St Anne	Quimper		France
11	Polyclinique de Courlancy	Reims		France
12	Clinique la Sagesse	Rennes		France
13	CH Robert Pax	Sarreguemines		France
14	Agyl	Strasbourg		France
15	Hôpital Foch	Suresnes		France
16	Hôpitaux du Léman	Thonon les Bains		France

Sponsors and Collaborators

• Groupe Hospitalier de la Rochelle Ré Aunis
• Coloplast A/S

Investigators

• Study Director: Philippe Ferry, MD, Groupe Hospitalier de la Rochelle Ré Aunis

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 20, 2016
• Informed Consent Form - Mar 3, 2017

More Information

Additional Information:

• Association Française de Normalisation (AFNOR). Norme Française (NF) S 94-801 implants de renfort mis en place par voie vaginale pour cure d'incontinence urinaire d'effort et/ou de prolapsus des organes pelviens. Essais pré-cliniques et essais cliniques

Publications

• Khunda A, Vashisht A, Cutner A. New procedures for uterine prolapse. Best Pract Res Clin Obstet Gynaecol. 2013 Jun;27(3):363-79. doi: 10.1016/j.bpobgyn.2012.12.004. Epub 2013 Jan 5. Review.
• Le Normand L, Cosson M, Cour F, Deffieux X, Donon L, Ferry P, Fatton B, Hermieu JF, Marret H, Meurette G, Cortesse A, Wagner L, Fritel X. [Clinical practice guidelines: Summary of recommendations for first surgical treatment of female pelvic organ prolapse by 5 French academic societies: AFU, CNGOF, SIFUD-PP, SNFCP, and SCGP]. Prog Urol. 2016 Jul;26 Suppl 1:S1-7. doi: 10.1016/S1166-7087(16)30424-9. Review. French.
• Lousquy R, Costa P, Delmas V, Haab F. [Update on the epidemiology of genital prolapse]. Prog Urol. 2009 Dec;19(13):907-15. doi: 10.1016/j.purol.2009.09.011. Epub 2009 Nov 4. Review. French.
• Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Marjoribanks J. Transvaginal mesh or grafts compared with native tissue repair for vaginal prolapse. Cochrane Database Syst Rev. 2016 Feb 9;2:CD012079. doi: 10.1002/14651858.CD012079. Review.
• Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
• Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL. Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997 Apr;89(4):501-6.
• Persu C, Chapple CR, Cauni V, Gutue S, Geavlete P. Pelvic Organ Prolapse Quantification System (POP-Q) - a new era in pelvic prolapse staging. J Med Life. 2011 Jan-Mar;4(1):75-81. Epub 2011 Feb 25.

• Responsible Party: Groupe Hospitalier de la Rochelle Ré Aunis
• ClinicalTrials.gov Identifier: NCT03098641
• Other Study ID Numbers: 2016/P05/179
• First Posted: Apr 4, 2017
• Last Update Posted: Jun 3, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse

Study Results

Participant Flow

Recruitment Details	Between January 2013 and December 2016, in 10 secondary and tertiary French care centres
Pre-assignment Detail	Patients were excluded if they did not attend their follow up visit within 30 days of surgery.

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Period Title: Overall Study
STARTED	272
COMPLETED	220
NOT COMPLETED	52

Baseline Characteristics

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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 Participants	272
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	70
Sex: Female, Male (Count of Participants)
Female	272 100%
Male	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
France	272 100%
Body mass index (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]	24.8
Parity (children) [Median (Full Range) ]
Median (Full Range) [children]	2
Post menopause (Count of Participants)
Count of Participants [Participants]	257 94.5%
Hormone replacement therapy (Count of Participants)
Count of Participants [Participants]	68 25%
Previous hysterectomy (Count of Participants)
Count of Participants [Participants]	58 21.3%
Previous pelvic organ prolapse surgery (Count of Participants)
Count of Participants [Participants]	51 18.8%
Previous incontinence surgery (Count of Participants)
Count of Participants [Participants]	25 9.2%
Procedure (Count of Participants)
Anterior Restorelle® Direct FixTM alone	95 34.9%
Concomitant hysterectomy	46 16.9%
Concomitant posterior Restorelle® Direct FixTM	63 23.2%
Concomitant sub urethral sling	64 23.5%
Concomitant other surgery	42 15.4%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With a Composite Outcome : Bladder Wound, Rectum Wound, Abnormal Bleeding
Description	Perioperative morbidity
Time Frame	up to 30 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	272
Count of Participants [Participants]	6 2.2%

2. Secondary Outcome

Title	Number of Patients With Early Complications
Description	Urinary retention, urinary tract infection, hematoma, ureteral complication, second surgery
Time Frame	up to 30 days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	272
Count of Participants [Participants]	43 15.8%

3. Secondary Outcome

Title	Number of Patients With Late Complications
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	220
Count of Participants [Participants]	43 15.8%

4. Secondary Outcome

Title	Pelvic Organ Prolapse Quantification (POP-Q) Exam Before Surgery
Description	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

Outcome Measure Data

Analysis Population Description

Data was collected retrospectively and few pelvic organ prolapse stage were not available

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	272
Stage 0	0 0%
Stage 1	1 0.4%
Stage 2	61 22.4%
Stage 3	169 62.1%
Stage 4	39 14.3%
Stage 0	78 28.7%
Stage 1	75 27.6%
Stage 2	64 23.5%
Stage 3	37 13.6%
Stage 4	12 4.4%
Stage 0	115 42.3%
Stage 1	86 31.6%
Stage 2	61 22.4%
Stage 3	5 1.8%
Stage 4	4 1.5%

5. Secondary Outcome

Title	Pelvic Organ Prolapse Quantification (POP-Q) Exam After Surgery
Description	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

Outcome Measure Data

Analysis Population Description

Data was collected retrospectively and few pelvic organ prolapse stage were not available

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	220
Stage 0	128 47.1%
Stage 1	54 19.9%
Stage 2	24 8.8%
Stage 3	0 0%
Stage 4	1 0.4%
Stage 0	188 69.1%
Stage 1	6 2.2%
Stage 2	7 2.6%
Stage 3	0 0%
Stage 4	1 0.4%
Stage 0	174 64%
Stage 1	14 5.1%
Stage 2	10 3.7%
Stage 3	2 0.7%
Stage 4	0 0%

6. Secondary Outcome

Title	Number of Patients With Preoperative Urinary Signs
Description	urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Time Frame	within 4 weeks before surgery

Outcome Measure Data

Analysis Population Description

Data was collected retrospectively and few bladder symptom descriptions were not available

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	272
Stress urinary incontinence	97 35.7%
Overactive bladder	103 37.9%
Voiding dysfunction	118 43.4%
Occult urinary incontinence	48 17.6%

7. Secondary Outcome

Title	Number of Patients With Postoperative Urinary Signs
Description	urinary stress incontinence, overactive bladder, dysuria, masked urinary incontinence
Time Frame	up to 4 years after surgery

Outcome Measure Data

Analysis Population Description

Data was collected retrospectively and few bladder symptom descriptions were not available

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	220
Stress urinary incontinence	48 17.6%
Overactive bladder	24 8.8%
Voiding dysfunction	13 4.8%

8. Secondary Outcome

Title	Number of Patients With Preoperative Digestive Signs
Description	dyschezia, incontinence
Time Frame	within 4 weeks before surgery

Outcome Measure Data

Analysis Population Description

Data was collected retrospectively and few bowel symptom descriptions were not available

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	272
Dyschezia	21 7.7%
Faecal incontinence	13 4.8%

9. Secondary Outcome

Title	Number of Patients With Postoperative Digestive Signs
Description	dyschezia, incontinence
Time Frame	up to 4 years after surgery

Outcome Measure Data

Analysis Population Description

Data was collected retrospectively and few bowel symptom descriptions were not available

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	220
Dyschezia	6 2.2%
Faecal incontinence	3 1.1%

10. Secondary Outcome

Title	Number of Patients With Preoperative Active Sexuality
Description	Patients reporting active sexuality
Time Frame	within 4 weeks before surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	198
Count of Participants [Participants]	94 34.6%

11. Secondary Outcome

Title	Number of Patients With Preoperative Dyspareunia
Description	Patients reporting pain
Time Frame	within 4 weeks before surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	87
Count of Participants [Participants]	16 5.9%

12. Secondary Outcome

Title	Number of Patients With Postoperative Active Sexuality
Description	Patients reporting active sexuality
Time Frame	up to 4 years after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	122
Count of Participants [Participants]	41 15.1%

13. Secondary Outcome

Title	Number of Patients With Postoperative Dyspareunia
Description	Patients reporting pain
Time Frame	up to 4 years after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	40
Count of Participants [Participants]	3 1.1%

14. Secondary Outcome

Title	Preoperative Score at Numeric Pain Rating Scale
Description	The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Time Frame	Within 48 hours before surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	65
Mean (Standard Deviation) [units on a scale]	7.3 (1.9)

15. Secondary Outcome

Title	Postoperative Score at Numeric Pain Rating Scale
Description	The numeric pain rating scale ranges from 0 (no pain) to 10 (worst pain imaginable)
Time Frame	up to 48 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
Measure Participants	162
Mean (Standard Deviation) [units on a scale]	0.46 (0.56)

Adverse Events

Time Frame	The median follow-up was 3 months ranging from 1 to 36 months
Arm/Group Title	Pelvic Organ Prolapse Repair
Arm/Group Description	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)
All Cause Mortality
	Pelvic Organ Prolapse Repair
	Affected / at Risk (%)	# Events
Total	0/272 (0%)
Serious Adverse Events
	Pelvic Organ Prolapse Repair
	Affected / at Risk (%)	# Events
Total	14/272 (5.1%)
Renal and urinary disorders
Ureteral injury	2/272 (0.7%)
Urinary tract infection	2/272 (0.7%)
Postoperative haematoma	2/272 (0.7%)
3rd degree vaginal prolapse	7/220 (3.2%)
Adverse local tissue reaction around prosthesis	2/220 (0.9%)
Other (Not Including Serious) Adverse Events
	Pelvic Organ Prolapse Repair
	Affected / at Risk (%)	# Events
Total	136/272 (50%)
Renal and urinary disorders
Bladder injury	3/272 (1.1%)
Rectal injury	1/272 (0.4%)
Urinary retention postoperative	19/272 (7%)
Pain	103/272 (37.9%)
Urinary tract infection	15/272 (5.5%)
Postoperative haematoma	6/272 (2.2%)
Chronic pain	7/220 (3.2%)
Adverse local tissue reaction around prosthesis	8/220 (3.6%)
Medical device site granuloma	6/220 (2.7%)
Incontinence	10/220 (4.5%)
1st degree vaginal prolapse	4/220 (1.8%)
Dyspareunia	1/220 (0.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.