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Urinary IncontinencePhase 2/3NCT05112718

Platelet Rich Plasma in Women With Urinary Incontinence

A Phase 2/3 study testing Platelet Rich Plasma Injections and Normal Saline Injections in people with Urinary Incontinence and Stress Urinary Incontinence, run by National and Kapodistrian University of Athens at 1 site in Greece.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion or on sneezing or coughing. Platelet-rich plasma (PRP) is an autologous solution of human plasma containing various growth factors witch enhance regeneration and healing process. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Platelet Rich Plasma Injections and Normal Saline Injections
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteGreece
Study dates
1 Jul 2021to Dec 2022
Phase
Phase 2/3
Are there results?
None posted in the registry

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

  • Adult women with stress urinary incontinence

Who cannot join

  • pregnancy,
  • history of active malignant pathology,
  • mental disorders making them unable to give consent,
  • undiagnosed abnormal uterine bleeding,
  • genitourinary fistula,
  • anti-incontinence surgery,
  • pelvic organ prolapse stage > 2 according to POP-Q system

Trial locations and contacts

1 site in 1 country.

Stavros Athanasiou, Professor contact

+306944478555

stavros.athanasiou@gmail.com

Greece1 site, 1 recruiting

  • Urogynecological Unit of Alexandra Hospital

    Athens, 11528

    Stavros Athanasiou, Prof., +306944478555, stavros.athanasiou@gmail.com

    Themos Grigoriadis, As. Prof., +306948741306, tgregos@yahoo.com

    Recruiting

Other trials in Greece

About this study

Official title: The Use of Platelet Rich Plasma (PRP) as a Treatment of the Female Stress Urinary Incontinence

Stress urinary incontinence (SUI) is defined as involuntary loss of urine on effort or physical exertion or on sneezing or coughing. Platelet-rich plasma (PRP) is an autologous solution of human plasma containing various growth factors witch enhance regeneration and healing process. The aim of this study is to evaluate the efficacy and safety of PRP in the treatment of the female SUI.

Being tested
Platelet Rich Plasma Injections, Normal Saline Injections
Keywords
incontinence, urinary incontinence, stress urinary incontinence, platelet rich plasma, PRP,, outpatient treatment, nonsurgical treatment
Medical subject headings
Urinary Incontinence, Urinary Incontinence, Stress

What participants receive

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

  • Platelet Rich Plasma InjectionsBiological

    PRP injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal).

    The participants will receive 2 PRP injections at 4-6-week intervals. Xylocaine gel 2% is applied to the distal anterior vaginal wall 20 minutes before injections.

  • Normal Saline InjectionsOther

    Normal saline injected into 9 sites of the distal anterior one-third of the vagina using a small 30-gauge needle. The injections were performed at 10, 12 and 2 o'clock in 3 different levels of the urethra 1-2 cm apart (distal, mid and proximal).

    The participants will receive 2 injections at 4-6-week intervals.

Study groups in NCT05112718
Study groupRoleWhat they receive
Platelet Rich PlasmaExperimentalThe patients who receive PRP injections
Receives: Biological: Platelet Rich Plasma Injections
Normal SalineSham comparatorThe patients who receive normal saline
Receives: Other: Normal Saline Injections

What is being measured

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

  1. Stress urinary incontinence symptoms

    International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS) Number of items: 12

    Question items:

    Nocturia,Urgency, Bladder pain, Frequency, Hesitancy, Straining, Intermittency, Urge urinary incontinence, Frequency of urinary incontinence, Stress urinary incontinence, Unexplained urinary incontinence, Nocturnal enuresis

    Completion time: 4-5 minutes

    Scoring:

    0-16 filling symptoms subscale 0-12 voiding symptoms subscale 0-20 incontinence symptoms subscale 0-48 where all subscale scores are added. Bother scales are not incorporated in the overall score but indicate impact of individual symptoms for the patient

    Higher scores indicate greater impact of individual symptoms for the patient.

    Measured: 6-12 months

Secondary outcomes (4)

  1. Impact of urinary incontinence on the quality of life

    King's Health Questionnaire (KHQ)

    Description: The KHQ is an assessment of health-related quality of life related to a specific condition.

    Format: 21 items about urinary tract symptoms yield scores in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy \& severity of symptoms).

    Scoring: Each item is rated using a 4 or 5 points likert scale. Domain scores range from 0 (best) to 100 (worst). There are 2 single-item domains (general health perceptions, and incontinence impact) and the severity of symptoms domain is scored using a scale from 0 (best) to 30 (worst).

    Measured: 6-12 months

  2. Assessment of urine loss (1-hr pad test)

    One-hour pad test standardized by International Continence Society (ICS):

    • started by putting one pre-weighted pad,
    • patient drinks 500 ml in <15 min- then sits or rests,
    • patient walks for 30 min,
    • patient performs the following activities: standing up from sitting, coughing vigorously, running on the spot for 1 min, bending to pick up an object from the floor, and washing hands in running water for 1min
    • the total amount of urine leaked is determined by weighing the pad.

    Interpretation:

    The upper limit of weight increase for the 1-hr test in continent women is 1.4 grams.

    A weight gain of less than 1.4 g during 1-hr test could be a result of sweating or vaginal discharge.

    An increase of 1-10 g is classified as representing mild incontinence, 11-50 g moderate and >50 g severe incontinence.

    Measured: 6-12 months

  3. Level of discomfort during injections (VAS score)

    The visual analog scale (VAS) is pain rating scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

    Measured: 6-12 months

  4. Patient Global Impression of Improvement

    The Patient Global Impression of Improvement (PGI-I) is a validated generic tool for assessment of the over-all improvement or deterioration that the patient may experience following the treatment.

    The PGI-I is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment on a scale from 1. Very much better to 7. Very much worse.

    Therefore, lower values correlate with increased satisfaction.

    Measured: 6-12 months

Timeline

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

  1. First posted9 Nov 2021
  2. Study start1 Jul 2021
  3. Primary completionMay 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112718
Sponsor's protocol ID
420/20-09-2019
Status last verified
Nov 2021
First submitted
26 Oct 2021
Last updated
9 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dawood AS, Salem HA. Current clinical applications of platelet-rich plasma in various gynecological disorders: An appraisal of theory and practice. Clin Exp Reprod Med. 2018 Jun;45(2):67-74. doi: 10.5653/cerm.2018.45.2.67. Epub 2018 Jun 29.

    PubMed 29984206

  • Alves R, Grimalt R. A Review of Platelet-Rich Plasma: History, Biology, Mechanism of Action, and Classification. Skin Appendage Disord. 2018 Jan;4(1):18-24. doi: 10.1159/000477353. Epub 2017 Jul 6.

    PubMed 29457008

  • Schreiber Pedersen L, Lose G, Hoybye MT, Elsner S, Waldmann A, Rudnicki M. Prevalence of urinary incontinence among women and analysis of potential risk factors in Germany and Denmark. Acta Obstet Gynecol Scand. 2017 Aug;96(8):939-948. doi: 10.1111/aogs.13149. Epub 2017 May 20.

    PubMed 28401541

  • Behnia-Willison F, Nguyen TTT, Norbury AJ, Mohamadi B, Salvatore S, Lam A. Promising impact of platelet rich plasma and carbon dioxide laser for stress urinary incontinence. Eur J Obstet Gynecol Reprod Biol X. 2019 Oct 22;5:100099. doi: 10.1016/j.eurox.2019.100099. eCollection 2020 Jan.

    PubMed 32021973

  • Grigoriadis T, Kalantzis C, Zacharakis D, Kathopoulis N, Prodromidou A, Xadzilia S, Athanasiou S. Platelet-Rich Plasma for the Treatment of Stress Urinary Incontinence-A Randomized Trial. Urogynecology (Phila). 2024 Jan 1;30(1):42-49. doi: 10.1097/SPV.0000000000001378. Epub 2023 Jun 1.

    PubMed 37493287

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Platelet Rich Plasma Injections and Normal Saline Injections in people with Urinary Incontinence and Stress Urinary Incontinence, run by National and Kapodistrian University of Athens at 1 site in Greece.

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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Stavros Athanasiou, Professor (+306944478555, stavros.athanasiou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress urinary incontinence symptoms (time frame: 6-12 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 NCT05112718, which also lists 5 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 9 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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