An observational study in Uterine Prolapse Without Vaginal Wall Prolapse, sponsored by Pop Medical Solutions. Completed at 15 sites in 3 countries. Open to female participants aged 36 Years to 84 Years. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Pop Medical Solutions · Observational
The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.
93 studies on the registry are indexed under Prolapse; 9 are open to participants now.
This study's enrollment of 60 is below the median of 150 across 27 observational studies indexed under Prolapse.
Browse Prolapse studies →Pop Medical Solutions is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who are undergoing surgical treatment for uterine prolapse.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System.
Device: NeuGuide™ System
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.
Also known as: transvaginal sacrospinous ligament fixation
A composite of the Pelvic Organ Prolapse Quantification (POP-Q) C point score, patient-rated symptom of vaginal bulging after vaginal colpopexy performed using the NeuGuide™ and the absence of further surgical therapy for uterine prolapse.
Primary composite performance outcome
Time frame: 12 months
The number of device / procedure related Serious Adverse Events (SAE).
Primary safety of surgical implantation as reflected by adverse events
Time frame: 30 days
The number of Serious Adverse Events and Adverse Events.
Primary safety of NeuGuide treatment as reflected by adverse events
Time frame: 12 months
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical performance of the NeuGuide treatment
Time frame: one month
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical performance of the NeuGuide treatment
Time frame: 6 months
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical of the NeuGuide treatment
Time frame: 12 months
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical performance of the NeuGuide treatment outcome
Time frame: 24 months
Change in mean POP-Q C point score from baseline (cm).
Secondary anatomical performance of the NeuGuide treatment
Time frame: 36 months
Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence.
Secondary performance: durability of the NeuGuide treatment
Time frame: 36 months
Number of subjects in whom the primary symptomatic reason for repair of prolapse persists.
Secondary symptomatic performance of the NeuGuide treatment
Time frame: 12 months
The time utilization of staff performing the NeuGuide procedure.
Secondary outcome: Cost performance of the procedure
Time frame: one month
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Time frame: Baseline
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Time frame: one month
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Time frame: 12 months
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Time frame: 24 months
The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen
Secondary outcome: POP-Q Stage Score.
Time frame: 36 months
Plan to share: No — There is no plan to make individual participant data a available to other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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