Prospective Long-term Evaluation of the Efficacy and Safety of Calistar S for Transvaginal Pelvic Organ Prolapse Repair

Pelvic Organ Prolapse Clinical Trial

— CASPO  

Official title:

Prospective, Multicenter, 60 Months, Single Arm Cohort Study to Evaluate the Efficacy and Safety of the Ultra-Light-Weight Mesh CAlistar S in Transvaginal Pelvic Organ Prolapse Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821142
• Other study ID #: CaS_Pro
• Status: Recruiting
• Phase: N/A
• Start date: March 10, 2021
• Est. completion date: March 10, 2028

Study information

• Verified date: May 2022
• Source: Promedon
• Contact: Philipp Schelhorn
• Phone: 00498031900400
• Email: trials.de[@]promedon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective long-term evaluation of the performance and safety of Calistar S for transvaginal pelvic organ prolapse repair in women with anterior POP with or without apical vaginal involvement

Description:

Calistar S Single Incision Pelvic Organ Prolapse (POP) Repair System is intended for transvaginal reestablishment and reinforcement of the physiologic anatomy of the female pelvic floor in non-fertile women with anterior pelvic organ prolapse with or without apical vaginal wall involvement in both, recurrent pelvic organ prolapse and primary pelvic organ prolapse when other surgical procedures are expected to fail (i.e. complex primary prolapse).

The treatment kit consists of the lightweight mesh, two single-use introducers and 3 tissue anchoring system (TAS) anchors for fixation to the sacrospinous ligament. The product is approved in accordance with the CE Directive 93/42/EEC.

The utilization of synthetic implants in POP repair became increasingly popular in the last decade. The cumulative success rate of synthetic implants in anterior compartment repair is as high as up to 93%.However, meshes have been recently scrutinized due to high adverse event reporting after unreflected utilization of meshes which raised concerns of patients safety; furthermore taking into account the complexity of adverse event mesh management. This led to a vanishing of various meshes in transvaginal POP repair. Nevertheless, the further development of light weight meshes, the experience of the surgeon and the assessment and patients selection are well known factors reducing the rate of adverse events significantly.

Therefore, in the current trial the efficacy and safety of calistar S in a highly selected patient population will be evaluated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: March 10, 2028
• Est. primary completion date: March 10, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria Non-fertile women > 18 years1 2. Symtomatic anterior prolapse with or without apical vaginal wall involvement according POP-Q score = 2. (Corresponding to Aa, Ba = -1 and where applicable C = -1/2 TVL ).

3. Subjects with recurrent prolapse or complex primary prolapse are eligible for the study.

4. Scheduled mesh-augmented anterior POP repair with Calistar S 5. Signed inform consent

Exclusion criteria

1. Fertile women

2. Patients with active or latent infection of the vagina, cervix or uterus

3. Patients with previous or current vaginal, cervical or uterine cancer

4. Previous, current or planned pelvic radiation therapy

5. Known allergy to polypropylene

7. Subject is unable or unwilling to complete questionnaires (either self-administered, assisted or interviewed) and/or to follow scheduled visits and/or to sign informed consent

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Transvaginal mesh for anterior pelvic organ prolapse repair
synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population

Locations

Country	Name	City	State
Germany	St. Hedwig Hospital	Berlin
Germany	Helios Hospital Erfurt, Department of gynaecology	Erfurt	Thüringen
Germany	Evangelic Diakonie Hospital	Freiburg
Germany	St. Elisabeth-Hospital Leipzig	Leipzig
Germany	Hospital Tettnang	Tettnang
Germany	University Hospital Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Promedon

Country where clinical trial is conducted

Germany, 

References & Publications (16)

Barber MD, Kuchibhatla MN, Pieper CF, Bump RC. Psychometric evaluation of 2 comprehensive condition-specific quality of life instruments for women with pelvic floor disorders. Am J Obstet Gynecol. 2001 Dec;185(6):1388-95. — View Citation

Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7). Am J Obstet Gynecol. 2005 Jul;193(1):103-13. — View Citation

Bump RC, Mattiasson A, Bø K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. — View Citation

Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S. P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct. 2005 May-Jun;16(3):176-81; discussion 181. Epub 2004 Oct 21. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation

Hendrix SL, Clark A, Nygaard I, Aragaki A, Barnabei V, McTiernan A. Pelvic organ prolapse in the Women's Health Initiative: gravity and gravidity. Am J Obstet Gynecol. 2002 Jun;186(6):1160-6. — View Citation

Lenz F, Stammer H, Brocker K, Rak M, Scherg H, Sohn C. Validation of a German version of the P-QOL Questionnaire. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jun;20(6):641-9. doi: 10.1007/s00192-009-0809-x. Epub 2009 Feb 13. — View Citation

Mant J, Painter R, Vessey M. Epidemiology of genital prolapse: observations from the Oxford Family Planning Association Study. Br J Obstet Gynaecol. 1997 May;104(5):579-85. — View Citation

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. — View Citation

Practice Bulletin No. 176: Pelvic Organ Prolapse. Obstet Gynecol. 2017 Apr;129(4):e56-e72. doi: 10.1097/AOG.0000000000002016. — View Citation

Risk factors for genital prolapse in non-hysterectomized women around menopause. Results from a large cross-sectional study in menopausal clinics in Italy. Progetto Menopausa Italia Study Group. Eur J Obstet Gynecol Reprod Biol. 2000 Dec;93(2):135-40. — View Citation

Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Epub 2003 Jul 25. Erratum in: Int Urogynecol J Pelvic Floor Dysfunct. 2004 May-Jun;15(3):219. — View Citation

Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol. 2007 Mar 15;165(6):710-8. Epub 2006 Dec 20. — View Citation

Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain. 2001 Jan;89(2-3):295-300. — View Citation

Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286. — View Citation

Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients with Cure of pelvic organ prolapse	Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components	24 months
Secondary	Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up	Differences between Baseline and Follow-Up result of the questionnaire of each patient regarding Quality of life and the correlating domains will be evaluated. P-QoL, Score: 0-100, the higher the score, the higher the impact of prolapse symptoms and the lower quality of life.	Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Change of sexual life according the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire in comparison between Baseline and follow-up	Differences between Baseline and Follow-Up result of each patient regarding Sexual life and the correlating domains will be evaluated. PISQ-IR, Score: 0-100, the higher the score, the higher the impact of prolapse symptoms and the higher the impact on sexual life.	Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Change of pain according Visual Analog Scale of Pain in comparison between baseline, postoperative and follow-up	Differences of pain-evaluation between Baseline and Follow-Up of each patient will be evaluated. Wong Baker Pain Scale, Score: 0 - 10, The higher the score, the higher the pain.	Baseline, 24-48h postoperatively, 6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Patients subjective evaluation of satisfaction with surgery according the Patient Global Impression of Improvement	Evaluation of the improvement of POP after the operation assed by the Patient Global Impression of Improvement of each patient. PGI-I, Score: 7 Likert scale from: very much better to very much worse,	6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Patient subjective evaluation of POP severity according the Global Impression of Severity	Evaluation of severity categorization by assing the Patient Global Impression of Severity of each patient at Baseline. Score. 4 Likert scale, from no impact to very much impact. A	Baseline
Secondary	Change of quality of life according the EQ-5L-5D in comparison between baseline and follow-up	Evaluation of Quality of life assessed by the EQ-5L-5D and evaluation of differences between Baseline and Follow-Up of each patient regarding health related Quality of life. Two scores: a) 5 Likert scale from no problems to extreme problems. b) self administered quality of life in scale 0 - 100, the higher the score the better the quality of life.	Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Anatomical success according the number of patients with anterior vaginal wall at or above the hymen and no decent of apical vaginal wall at or greater than half of the total vanilla lengths	Anatomical success defined by the number of patients with the anterior vaginal wall at or above the hymen (Aa and Ba = 0 ) and separately no decent of apical vaginal wall at or greater than half of the total vaginal lengths (C < -½ TVL).	6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Number of patients with necessity of repeated surgery due to recurrent anterior or apical Number of patients with Repeat surgery due to symptomatic recurrence of anterior or apical POP	Number of patients with necessity of repeated surgery due to recurrent anterior or apical POP.	6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Safety of Calistar S according the number of adverse events	Safety of Calistar S according the assessment of total amount of adverse events	intraoperative, postoperative, 6 weeks, and 6, 12, 24, 36, 48, 60 months and unscheduled visits
Secondary	Exposure and anatomical-failure free survival	Estimation of exposure- and anatomical-failure free survival according Kaplan meier	12, 24, 36, 48, 60 months
Secondary	Number of patients with further surgery for stress urinary incontinence	To assess the number of patients with further surgery for stress urinary incontinence.	6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Change of urinary incontinence according the ICIQ-UI-Sf in comparison between baseline and follow-up	The international Consultation of Incontinence Questionnaire - Urinary Incontinence - Short Form (ICIQ-UI-SF) is a validated questionnaire to asses urinary incontinence. Score 0-21, overall score with greater values indicating increased symptom severity	Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Change of overactive bladder symptoms according the ICIQ-OAB in comparison between baseline and follow-up	The International Consultation of Incontinence Questionnaire - Overacitve bladder (ICIQ-OAB) is a validated questionnaire.. 0-16 overall score with greater values indicating increased symptom severity	Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
Secondary	Cure in short-, mid-, and longterm follow-up	Number of patients accomplishing the composite outcome at remaining follow-up times	6 weeks and 6, 12, 36, 48, 60 months