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Overactive BladderNCT03516292

Assessment of Potential Biomarkers in Women With Symptoms of Overactive Bladder and Pelvic Organ Prolapse

An observational study of Overactive Bladder, run by Aristotle University Of Thessaloniki 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The objective of this study is to investigate the role of certain biomarkers in the initial assessment of women with overactive bladder (OAB). Nerve Growth Factor (NGF) levels, measured in urine samples, and bladder wall thickness (BWT), determined by two-dimensional transvaginal ultrasound, are two of those markers. Read more about this study

Who is it for?
Ages 18 to 100 years, women only
Conditions the study is for
Overactive Bladder
What is being tested?
Urinary Nerve Growth Factor
How many people
108 participants
Where
1 siteGreece
Study dates
29 Jan 2018to 30 Dec 2022
Phase
Observational
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 to 100 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women that visited outpatients Gynecology Department, 1st Department Obstetrics and Gynecology, Aristotle University of Thessaloniki, General Hospital Papageorgiou of Thessaloniki, complaining for vaginal prolapse and possible concomitant urinary problems.

Who may be able to join

  • Adult women that are able to communicate and understand comprehensively Greek Language and present vaginal prolapse problems.

Who cannot join

  • Male patients as well children will be excluded.
  • Women that have already operated once for pelvic organ prolapse.

Trial locations and contacts

1 site in 1 country.

Sofia Tsiapakidou, PhDc contact

6946321158 ext. +30

sofiatsiapakidou@gmail.com

Greece1 site, 1 recruiting
  • Aristotle University of Thessaloniki

    Thessaloniki, Central Macedonia, 54124

    Sofia Tsiapakidou, 6946321158, sofiatsiapakidou@gmail.com

    Recruiting

Other trials in Greece

About this study

Official title: Potential Biomarkers in the Study of Overactive Bladder in Women

The objective of this study is to investigate the role of certain biomarkers in the initial assessment of women with overactive bladder (OAB). Nerve Growth Factor (NGF) levels, measured in urine samples, and bladder wall thickness (BWT), determined by two-dimensional transvaginal ultrasound, are two of those markers. The investigators hypothesize that the pre-operative determination of these biomarkers in women suffering from genital prolapse and overactive bladder could lead to a more accurate prognosis of the post-operative course of overactive bladder symptoms in women undergoing surgical treatment of prolapse.

Read the detailed description

Pelvic organ prolapse Pelvic organ prolapse (POP) is a clinical condition that, although it is not life-threatening, significantly affects patients' quality of life. POP affects more than 30% of females in the general population. Among those, the majority is free of symptoms and do not need any medical assistance. However, according to US statistics, almost 20% of women will be candidates for some type of surgery to restore POP during their lifetime.

Urinary incontinence Urinary incontinence (UI) is used to describe any loss of urine through the urethra. It is a common patient complaint but not a specific disease. UI significantly affects patients' quality of life. UI is classified in 3 subtypes: stress UI (SUI) (loss of urine on effort, coughing etc.), urgency UI (UUI) (loss of urine involuntary and combined by urgency) and mixed UI (MUI) (combination of the two). UUI is the second most common type of UI in women, and it is estimated that 20-40% of women who visit outpatient clinic healthcare services have UUI. Regarding women with SUI, the surgical intervention by using a tension free vaginal tape is a successful method. Considering females with UUI, the pharmacological treatment is a long-lasting and effective alternative.

Pathophysiology of overactive bladder in women with POP Few evidence exist regarding the etiology of OAB in women with POP. POP itself is considered an important mechanism for the development of OAB. Several studies have suggested that patients with POP have a lower peak of maximum flow rate (Q max) during urination compared to patients without concomitant prolapse. In addition, the average flow rate (Q ave) in women with detrusor overactivity appears to be lower as well. It is possible that obstructive urination is involved in the creation of the detrusor overactivity in patients with POP . In studies with patients who underwent POP surgery, had improvement of OAB symptoms, and the urinary flow rates were mainly improved postoperatively.

The first theory that attempts to explain how prolapse induces the OAB symptoms is the possible damage of bladder nerve pathways that happens in women with obstructive voiding. In these patients, hypersensitivity and decreased secretion of acetylcholine (Ach), which is the major neurotransmitter of the urinary bladder, was found in comparison to asymptomatic patients. Ischemia and bladder wall hypoxia caused by bladder dilatation and contractions may play an important role in this damaged neural pathway in cases of prolapse and obstructive urination.

The second theory focuses on the bladder detrusor muscle. The urinary bladder is a hollow sac-like cavity connected with the ureters, where the urine is collected, and a funnel extension, the bladder neck connected to the urethra. The urinary bladder is lined with transitional epithelial tissue that is able to stretch significantly to accommodate large volumes of urine. The main part of the wall is formed by smooth muscle layers provide the urinary bladder with its ability to expand and contract. It is commonly referred to as the detrusor muscle. In cases where there is a reduction in the cell-site electrical activity propagation or in the cell membrane instability, the transmission of the cell-to-cell electrical activity signal is activated. As a result, the detrusor muscle becomes hypersensitive and the patient develops OAB symptoms.

According to the third theory, changes in the spinal reflexes are the cause of the OAB. In experimental animal studies, bladder obstruction has been shown to cause hypertrophy of the afferent neurons and is accompanied by increased expression of NGF in the bladder wall. Also, it was shown that obstruction is accompanied to a certain extent by a reduction in neuronal excitability leading to a more pronounced spinal reflex that could contribute to the development of OAB.

Other possible pathophysiological mechanisms of OAB in women suffering from POP is the dilatation of the bladder wall, which commonly appears in POP and which can induce receptor stimulation resulting in contractions of the detrusor muscle Finally, a large sized vaginal prolapse can drop down the bladder neck and the most common symptom is UI. This mechanism is known to cause detrusor overactivity (DO).

The role of biomarkers in the diagnosis and monitoring of overactive bladder A. The bladder wall thickness (BWT) There are numerous studies linking the increase in bladder wall thickness (BWT) with the symptoms of the OAB. It appears that BWT is affected by the increased muscle work that occurs due to DO. In several studies, ultrasound transvaginal scanning of the detrusor muscle over 5mm is significantly associated with OAB symptomatology. Finally, there is little evidence of altering the BWT in women with OAB after treatment with anticholinergics. To conclude, there are no studies to investigate BWT in women with POP and OAB symptoms.

  1. Neurotrophic Growth Factor (NGF) Neurotrophins are responsible for the maintenance and the control of bladder nerve stimulation threshold and appear to be involved in the pathophysiology of the OAB symptoms. NGF is produced by urothelium and smooth muscles of the detrusor muscle and its urine levels seems to rise in OAB patients and to fall after a successful treatment. In studies where the objective was to investigate the role of NGF in the pathophysiology of lower urinary tract symptoms, it was found that urinary NGF levels were consistently low in asymptomatic women. In similar studies in patients with lower urinary tract symptoms, urinary NGF levels were found to be elevated. Finally, in studies in which the symptoms of OAB were successfully treated, urinary NGF levels were reduced. There are also no studies to investigate urinary NGF levels in women with prolapse and coexisting bladder symptomatology.

Are symptoms of OAB improved after treatment for POP? In literature, there are still no sufficient high quality studies to address this question. There is only one study with Stage I prolapse patients and a smaller group with Stage II prolapse, all of which had proven symptoms of OAB and urodynamically documented DO. After conservative pharmacological treatment with tolterodine, only 14.1% of Stage I patients and 39.2% of Stage II patients continued to experience OAB symptoms. This study showed an improvement in OAB in patients with vaginal prolapse (relative risk-RR) of 2.55, but improvement in women without prolapse was much higher (RR 7.09). The difference could be explained in some extent because of the fact that OAB is provoked by vaginal prolapse itself and continues to exist despite conservative treatment. In the other hand, there are more than 12 studies in the literature showing that symptoms of OAB are improved after surgical treatment for vaginal prolapse, including de novo overactive bladder postoperatively.

Detrusor overactivity (DO) The presence of vaginal prolapse appears to be a risk factor for the DO, since in urodynamic studies appear to co-exist at a rate of 10-50%. The majority of studies show improvement of DO activity after surgical repair of vaginal prolapse. Overall, it appears that there is a high probability of disappearance of DO after surgery, but these results do not seem to be verified in cases of concomitant OAB.

In summary, there is a large number of women suffering from POP and UI problems. There is the possibility to repair surgically both conditions in case of SUI with high rates of success. In case of UUI, the surgical repair of vaginal prolapse shows up to 50% improvement in UI postoperatively. However, it is not yet investigated whether there are some specific biomarkers that could help to assess and predict patients with POP and UUI who would be benefit by a surgical intervention.

Being tested
Urinary Nerve Growth Factor
Keywords
overactive bladder, biomarker, nerve growth factor, vaginal prolapse, urinary incontinence
Medical subject headings
Urinary Bladder, Overactive, Hereditary Sensory and Autonomic Neuropathies, Uterine Prolapse, Urinary Incontinence

What participants receive

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

  • Urinary Nerve Growth FactorDiagnostic test

    Also called Bladder Wall Thickness, Bladder Neck Mobility, Clinical Assessment of Subjective Vaginal and Urinary Symptoms

    The subjective patient's discomfort regarding the vaginal prolapse problems and urinary incontinency symptoms will be assessed through the following questionnaires: (a) ICIQ-OAB (b) ICIQ FLUTS (c) ICIQ-VS. Determination of the bladder neck of urethra in midsagittal plane using a transvaginal two-dimensional ultrasound machine at lithotomy position in rest (point OA) and on Valsalva maneuver (point OB). Bladder Neck Mobility is defined as the difference from point OA to OB. BWT is determined and measured as the hypoechoic layer between two hyperechoic layers that is recognized as the urothelium and the perivesical tissue using a transvaginal two-dimensional ultrasound machine at lithotomy position. The measurement is performed with a bladder volume <30 ml and is taken place in 3 different bladder sites: (a) the thickest part of the bladder triangle, (b) the dome of the bladder in the midline, (c) the anterior wall of the bladder. NGF will be measured in urine sample.

Study groups in NCT03516292
Study groupRoleWhat they receive
OAB-POP groupAs an Observational Case-Control Study, the participants will divided in two groups depending whether they suffer from overactive bladder symptoms or not. All participants will have POP.
Receives: Diagnostic Test: Urinary Nerve Growth Factor
POP only groupAs an Observational Case-Control Study, the participants will divided in two groups depending whether they suffer from overactive bladder symptoms or not. All participants will have POP.
Receives: Diagnostic Test: Urinary Nerve Growth Factor

What is being measured

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

  1. Urinary NGF as a biomarker for OAB symptoms in women with POP

    Determination of urinary NGF levels' change as a reliable prognostic factor for the treatment of OAB in women with POP before and after surgical repair

    Measured: Two samples will be taken at the time of recruitment (Month 0) at three months post-operatively (Month 3).

  2. Urinary NGF as a biomarker for OAB symptoms in women with POP

    Determination of urinary NGF levels' change as a reliable prognostic factor for the treatment of OAB in women with POP before and after surgical repair.

    Measured: Two samples will be taken at the time of recruitment (Month 0) and at the 1 years follow up appointment post-operatively (Month 12)

Secondary outcomes (1)
  1. BWT as a biomarker for OAB symptoms in women with POP

    Determination of BWT's change as a reliable prognostic factor for the treatment of OAB in women with POP.

    Measured: Ultrasound will take place before surgery repair (Month 0) at three months post-operatively (Month 3).

Timeline

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

  1. First posted4 May 2018
  2. Study start29 Jan 2018
  3. Primary completion30 Jan 2022 (estimated)
  4. Study completion30 Dec 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
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03516292
Sponsor's protocol ID
411/29.03.2018
Status last verified
Dec 2021
First submitted
22 Apr 2018
Last updated
13 Dec 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • de Boer TA, Salvatore S, Cardozo L, Chapple C, Kelleher C, van Kerrebroeck P, Kirby MG, Koelbl H, Espuna-Pons M, Milsom I, Tubaro A, Wagg A, Vierhout ME. Pelvic organ prolapse and overactive bladder. Neurourol Urodyn. 2010;29(1):30-9. doi: 10.1002/nau.20858.

    PubMed 20025017
  • de Boer TA, Kluivers KB, Withagen MI, Milani AL, Vierhout ME. Predictive factors for overactive bladder symptoms after pelvic organ prolapse surgery. Int Urogynecol J. 2010 Sep;21(9):1143-9. doi: 10.1007/s00192-010-1152-y. Epub 2010 Apr 24.

    PubMed 20419366
  • Rachaneni S, McCooty S, Middleton LJ, Parker VL, Daniels JP, Coomarasamy A, Verghese TS, Balogun M, Goranitis I, Barton P, Roberts TE, Deeks JJ, Latthe P; Bladder Ultrasound Study (BUS) Collaborative Group. Bladder ultrasonography for diagnosing detrusor overactivity: test accuracy study and economic evaluation. Health Technol Assess. 2016 Jan;20(7):1-150. doi: 10.3310/hta20070.

    PubMed 26806032
  • Seth JH, Sahai A, Khan MS, van der Aa F, de Ridder D, Panicker JN, Dasgupta P, Fowler CJ. Nerve growth factor (NGF): a potential urinary biomarker for overactive bladder syndrome (OAB)? BJU Int. 2013 Mar;111(3):372-80. doi: 10.1111/j.1464-410X.2012.11672.x.

    PubMed 23444927
  • 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
  • Forde JC, Davila JL, Marks BK, Epstein M, Tsui JF, Weiss JP, Blaivas JG. Urogynecological conditions associated with overactive bladder symptoms in women. Can Urol Assoc J. 2017 Mar-Apr;11(3-4):E83-E87. doi: 10.5489/cuaj.3962. Epub 2017 Mar 16.

    PubMed 28360952
  • Eapen RS, Radomski SB. Review of the epidemiology of overactive bladder. Res Rep Urol. 2016 Jun 6;8:71-6. doi: 10.2147/RRU.S102441. eCollection 2016.

    PubMed 27350947
  • Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

    PubMed 19941278
  • Bureau M, Carlson KV. Pelvic organ prolapse: A primer for urologists. Can Urol Assoc J. 2017 Jun;11(6Suppl2):S125-S130. doi: 10.5489/cuaj.4634.

    PubMed 28616110
  • Osman T. Stress incontinence surgery for patients presenting with mixed incontinence and a normal cystometrogram. BJU Int. 2003 Dec;92(9):964-8. doi: 10.1111/j.1464-410x.2003.04519.x.

    PubMed 14632856
  • Olivera CK, Meriwether K, El-Nashar S, Grimes CL, Chen CC, Orejuela F, Antosh D, Gleason J, Kim-Fine S, Wheeler T, McFadden B, Balk EM, Murphy M; Systematic Review Group for the Society of Gynecological Surgeons. Nonantimuscarinic treatment for overactive bladder: a systematic review. Am J Obstet Gynecol. 2016 Jul;215(1):34-57. doi: 10.1016/j.ajog.2016.01.156. Epub 2016 Feb 4.

    PubMed 26851599
  • Zargham M, Alizadeh F, Moayednia A, Haghdani S, Nouri-Mahdavi K. The role of pelvic organs prolapse in the etiology of urinary incontinence in women. Adv Biomed Res. 2013 Mar 6;2:22. doi: 10.4103/2277-9175.108010. eCollection 2013.

    PubMed 23977650
  • Long CY, Hsu SC, Sun DJ, Chen CC, Tsai EM, Su JH. Abnormal clinical and urodynamic findings in women with severe genitourinary prolapse. Kaohsiung J Med Sci. 2002 Dec;18(12):593-7.

    PubMed 12670034
  • Rosenzweig BA, Pushkin S, Blumenfeld D, Bhatia NN. Prevalence of abnormal urodynamic test results in continent women with severe genitourinary prolapse. Obstet Gynecol. 1992 Apr;79(4):539-42.

    PubMed 1553172
  • Coates KW, Harris RL, Cundiff GW, Bump RC. Uroflowmetry in women with urinary incontinence and pelvic organ prolapse. Br J Urol. 1997 Aug;80(2):217-21. doi: 10.1046/j.1464-410x.1997.00246.x.

    PubMed 9284191

Questions about this trial

What is this clinical trial studying?

An observational study of Overactive Bladder, run by Aristotle University Of Thessaloniki 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 2 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 13 Dec 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. 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?

Results are not available in the source record.

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

Contact Sofia Tsiapakidou, PhDc (6946321158 ext. +30, sofiatsiapakidou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary NGF as a biomarker for OAB symptoms in women with POP (time frame: Two samples will be taken at the time of recruitment (Month 0) at three months post-operatively (Month 3).). The study lists 2 primary outcomes in all. 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 NCT03516292, which also lists 43 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 13 Dec 2021.

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