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

NCT03821142 | Active Not Recruiting

• 1 other identifier: CaS_Pro
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 6

Brief 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

Conditions

Pelvic Organ Prolapse

Keywords

surgical mesh; surgery; Therapy; pelvic floor disorders; cystocele

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up

  Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months

• Change of sexual life according the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire in comparison between Baseline and follow-up

  Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months

• Change of pain according Visual Analog Scale of Pain in comparison between baseline, postoperative and follow-up

  Baseline, 24-48h postoperatively, 6 weeks and 6, 12, 24, 36, 48, 60 months

• Patients subjective evaluation of satisfaction with surgery according the Patient Global Impression of Improvement

  6 weeks and 6, 12, 24, 36, 48, 60 months

• Patient subjective evaluation of POP severity according the Global Impression of Severity

  Baseline

Study Arms (1)

Calistar S

EXPERIMENTAL

Single arm cohort trial

Device: Transvaginal mesh for anterior pelvic organ prolapse repair

Interventions

Transvaginal mesh for anterior pelvic organ prolapse repair DEVICE

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

Calistar S

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Subjects with recurrent prolapse or complex primary prolapse are eligible for the study.
• \. Scheduled mesh-augmented anterior POP repair with Calistar S 5. Signed inform consent

You may not qualify if:

• Fertile women
• Patients with active or latent infection of the vagina, cervix or uterus
• Patients with previous or current vaginal, cervical or uterine cancer
• Previous, current or planned pelvic radiation therapy
• Known allergy to polypropylene
• \. 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

Sponsors & Collaborators

• Promedon: lead

Study Sites (6)

Helios Hospital Erfurt, Department of gynaecology

Erfurt, Thuringia, Germany

Location

St. Hedwig Hospital

Berlin, Germany

Location

Evangelic Diakonie Hospital

Freiburg im Breisgau, Germany

Location

St. Elisabeth-Hospital Leipzig

Leipzig, Germany

Location

Hospital Tettnang

Tettnang, Germany

Location

University Hospital Tübingen

Tübingen, Germany

Location

Related Publications (16)

• 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. doi: 10.1016/S0029-7844(97)00058-6.

  PMID: 9083302 BACKGROUND

• 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.

  PMID: 24807341 BACKGROUND

• 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.

  PMID: 24463674 BACKGROUND

• 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. doi: 10.1067/mob.2002.123819.

  PMID: 12066091 BACKGROUND

• 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. doi: 10.1111/j.1471-0528.1997.tb11536.x.

  PMID: 9166201 BACKGROUND

• 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.

  PMID: 11074133 BACKGROUND

• 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. doi: 10.1067/mob.2001.118659.

  PMID: 11744914 BACKGROUND

• 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. doi: 10.1016/j.ajog.2004.12.025.

  PMID: 16021067 BACKGROUND

• 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.

  PMID: 19214361 BACKGROUND

• 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. doi: 10.1007/s00192-004-1225-x. Epub 2004 Oct 21.

  PMID: 15875234 BACKGROUND

• 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. doi: 10.1007/s00192-003-1063-2. Epub 2003 Jul 25.

  PMID: 12955337 BACKGROUND

• Wong DL, Baker CM. Smiling faces as anchor for pain intensity scales. Pain. 2001 Jan;89(2-3):295-300. doi: 10.1016/s0304-3959(00)00375-4. No abstract available.

  PMID: 11291631 BACKGROUND

• Bump RC, Mattiasson A, Bo 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. doi: 10.1016/s0002-9378(96)70243-0.

  PMID: 8694033 BACKGROUND

• 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. doi: 10.1093/aje/kwk052. Epub 2006 Dec 20.

  PMID: 17182981 BACKGROUND

• 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. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

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

  PMID: 28333818 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse; Pelvic Floor Disorders; Cystocele

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases

Study Officials

• Gert Naumann, PD Dr.habil.

  Helios Hospital Erfurt

  PRINCIPAL INVESTIGATOR

• Ralf Tunn, Prof.Dr.

  St. Hedwig Hospital

  PRINCIPAL INVESTIGATOR

• Dirk Watermann, Prof.Dr.

  Evangelic Diakonie Hospital

  PRINCIPAL INVESTIGATOR

• Birgit Henne, Dr.med.

  St. Elisabeth-Hospital Leipzig

  PRINCIPAL INVESTIGATOR

• Christl Reisenauer, Prof.Dr.med.

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

• Christian Fünfgeld, Dr.med.

  Hospital Tettnang

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Blinded POP-Q Examination: The POP-Q examination will be performed by a physician different to the corresponding surgeon
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Calistar S Single Incision POP System

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 29, 2019
• Study Start: March 10, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6)