NCT04417413 is a clinical trial of Fotona ProlapLase in Cystocele, sponsored by Aleksandra Novakov Mikic.

Who is sponsoring NCT04417413?

NCT04417413 is sponsored by Aleksandra Novakov Mikic.

What drugs are being tested in NCT04417413?

Interventions in NCT04417413: Fotona ProlapLase.

What condition does NCT04417413 study?

NCT04417413 studies Cystocele, Pelvic Organ Prolapse, Stress Urinary Incontinence.

Is NCT04417413 still recruiting?

NCT04417413 is currently completed. Last updated 13 November 2020.

Last reviewed 2020-11-13 · How we verify

NCT04417413

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.

Completed Last updated 13 November 2020

What this trial tests

trial testing Fotona ProlapLase in Cystocele in 41 participants. Completed in 31 December 2019.

Timeline

1 October 2019

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Aleksandra Novakov Mikic
Status	Completed
Study type	OBSERVATIONAL
Enrollment	41
Start date	1 October 2019
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	1 location across Serbia

Drugs / interventions tested

Fotona ProlapLase

Conditions studied

Cystocele — all drugs for Cystocele →
Pelvic Organ Prolapse — all drugs for Pelvic Organ Prolapse →
Stress Urinary Incontinence — all drugs for Stress Urinary Incontinence →

Sponsor

Aleksandra Novakov Mikic

Who can join

18 and older, female only, with Cystocele or Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the study is to retrospectively collect the data on patients who underwent pelvic organ prolapse treatment using a non-ablative Er:YAG laser with SMOOTH mode and to conduct an objective evaluation of safety and efficacy of Er:YAG laser treatment. In a group of patients that have concomitant stress urinary incontinence symptoms, the effectiveness of the treatments on these symptoms will be evaluated as well.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Cystocele

Currently open trials in the same condition.

NCT06430931 — Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery · NA · recruiting
NCT05602246 — Study Comparing Transobturator Cystocele vs. Anterior Vaginal RepairS · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04417413 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aleksandra Novakov Mikic
Last refreshed: 13 November 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04417413.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing