Pelvic Organ ProlapseCASPONCT03821142

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

A study testing Transvaginal mesh for anterior pelvic organ prolapse repair in people with Pelvic Organ Prolapse, run by Promedon at 6 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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 Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pelvic Organ Prolapse
What is being tested?: Transvaginal mesh for anterior pelvic organ prolapse repair
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 6 sitesGermany
Study dates: 10 Mar 2021to Oct 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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
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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Germany6 sites

St. Hedwig Hospital
Berlin
Helios Hospital Erfurt, Department of gynaecology
Erfurt, Thuringia
Evangelic Diakonie Hospital
Freiburg im Breisgau
St. Elisabeth-Hospital Leipzig
Leipzig
Hospital Tettnang
Tettnang
University Hospital Tübingen
Tübingen

Other trials in Germany

About this study

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

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

Read the detailed 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.

Conditions: Pelvic Organ Prolapse
Being tested: Transvaginal mesh for anterior pelvic organ prolapse repair
Keywords: surgical mesh, surgery, Therapy, pelvic floor disorders, cystocele
Medical subject headings: Pelvic Organ Prolapse, Pelvic Floor Disorders, Cystocele

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03821142
Study group	Role	What they receive
Calistar S	Experimental	Single arm cohort trial Receives: Device: Transvaginal mesh for anterior pelvic organ prolapse repair

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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,
Measured: 6 weeks and 6, 12, 24, 36, 48, 60 months
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
Measured: Baseline
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.
Measured: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
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).
Measured: 6 weeks and 6, 12, 24, 36, 48, 60 months
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.
Measured: 6 weeks and 6, 12, 24, 36, 48, 60 months
Safety of Calistar S according the number of adverse events
Safety of Calistar S according the assessment of total amount of adverse events
Measured: intraoperative, postoperative, 6 weeks, and 6, 12, 24, 36, 48, 60 months and unscheduled visits
Exposure and anatomical-failure free survival
Estimation of exposure- and anatomical-failure free survival according Kaplan meier
Measured: 12, 24, 36, 48, 60 months
Number of patients with further surgery for stress urinary incontinence
To assess the number of patients with further surgery for stress urinary incontinence.
Measured: 6 weeks and 6, 12, 24, 36, 48, 60 months
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
Measured: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
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
Measured: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
Cure in short-, mid-, and longterm follow-up
Number of patients accomplishing the composite outcome at remaining follow-up times
Measured: 6 weeks and 6, 12, 36, 48, 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 2021Oct 2029

First posted29 Jan 2019
Study start10 Mar 2021
Primary completionOct 2026 (estimated)
Study completionOct 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Calistar S Single Incision POP System
Masking: None (open label)
Enrolment: 180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03821142
Sponsor's protocol ID: CaS_Pro
Acronym: CASPO
Status last verified: Nov 2024
First submitted: 10 Jan 2019
Last updated: 22 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 9083302
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.
PubMed 24807341
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.
PubMed 24463674
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.
PubMed 12066091
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.
PubMed 9166201
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.
PubMed 11074133
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.
PubMed 11744914
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.
PubMed 16021067
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.
PubMed 19214361
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.
PubMed 15875234
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.
PubMed 12955337
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.
PubMed 11291631
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.
PubMed 8694033
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.
PubMed 17182981
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.
PubMed 15273542

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pelvic Organ Prolapse trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03821142
Acronym / sponsor ID: CASPO / CaS_Pro
Conditions: Pelvic Organ Prolapse
Keywords: surgical mesh, surgery, Therapy, pelvic floor disorders, cystocele
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 180 participants (estimated)
Lead sponsor: PromedonIndustry (pharma, biotech, devices)
Study start: 10 Mar 2021 (actual)
Primary completion: Oct 2026 (estimated)
Study completion: Oct 2029 (estimated)
First posted: 29 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Calistar S Single Incision POP System

Arm	Type	Receives
Calistar S	Experimental	Device: Transvaginal mesh for anterior pelvic organ prolapse repairSingle arm cohort trial

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transvaginal mesh for anterior pelvic organ prolapse repairsynthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population	Device	Calistar S

Primary outcome

Number of Patients with Cure of pelvic organ prolapse
Time frame: 24 months
Number of patients accomplishing the composite endpoint after 24 months including anatomic, subjective and retreatment components

14 secondary outcomes

Change of prolapse specific quality of life according the validated Questionnaire Prolapse quality of life questionnaire in comparison between baseline and follow-up
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 weeks and 6, 12, 24, 36, 48, 60 months
Patient subjective evaluation of POP severity according the Global Impression of Severity
Time frame: Baseline
Change of quality of life according the EQ-5L-5D in comparison between baseline and follow-up
Time frame: Baseline, 6 weeks and 6, 12, 24, 36, 48, 60 months
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
Time frame: 6 weeks and 6, 12, 24, 36, 48, 60 months
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
Time frame: 6 weeks and 6, 12, 24, 36, 48, 60 months
Safety of Calistar S according the number of adverse events
Time frame: intraoperative, postoperative, 6 weeks, and 6, 12, 24, 36, 48, 60 months and unscheduled visits
Exposure and anatomical-failure free survival
Time frame: 12, 24, 36, 48, 60 months
Number of patients with further surgery for stress urinary incontinence
Time frame: 6 weeks and 6, 12, 24, 36, 48, 60 months
Change of urinary incontinence according the ICIQ-UI-Sf in comparison between baseline and follow-up
Time frame: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
Change of overactive bladder symptoms according the ICIQ-OAB in comparison between baseline and follow-up
Time frame: Baseline 6 weeks and 6, 12, 24, 36, 48, 60 months
Cure in short-, mid-, and longterm follow-up
Time frame: 6 weeks and 6, 12, 36, 48, 60 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Background: PubMed 9083302Olsen 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.
Background: PubMed 24807341Wu 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.
Background: PubMed 24463674Wu 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.
Background: PubMed 12066091Hendrix 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.
Background: PubMed 9166201Mant 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.
Background: PubMed 11074133Risk 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.
Background: PubMed 11744914Barber 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.
Background: PubMed 16021067Barber 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.
Background: PubMed 19214361Lenz 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.
Background: PubMed 15875234Digesu 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.
Background: PubMed 12955337Rogers 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.
Background: PubMed 11291631Wong 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gert Naumann, PD Dr.habil. principal investigator

Helios Hospital Erfurt

Ralf Tunn, Prof.Dr. principal investigator

St. Hedwig Hospital

Dirk Watermann, Prof.Dr. principal investigator

Evangelic Diakonie Hospital

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transvaginal mesh for anterior pelvic organ prolapse repair in people with Pelvic Organ Prolapse, run by Promedon at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients with Cure of pelvic organ prolapse (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03821142, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2024.