Urogenital ProlapseurodynaemicsNCT04980196
Is Preoperative Urodynamics Essential for Women With Pelvic Organ Prolapse
An observational study of Urogenital Prolapse, run by Alexandria University at 1 site in Egypt.
Trial summary
urodynamic investigation when added in the diagnostic work-up of women with lower urinary tract dysfunction with POP is debatable. This study was planned to determine the usefulness of preoperative urodynamic study in improving urological outcome following surgery in women with pelvic organ prolapse and urinary tract… Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Urogenital Prolapse
- What is being tested?
- urodynaemic studies
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2020to 1 May 2021
- 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 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: performed in Shatby Maternity University hospital, which is considered the largest hospital in Alexandria city in Egypt offering obstetrical and gynecological services for more than three millions females
Who may be able to join
- pelvic organ prolapse associated with lower urinary tract dysfunction.
Who cannot join
- are those who had previous surgery for urinary incontinence, or experienced neurological disorder such as multiple sclerosis or spinal cord injuries were not included. Or had complicated medical disease that made the patient unfit for anesthesia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Shatby Maternity University Hospital
Alexandria, El-Khartoum Square, 21131
About this study
Official title: Is Urodynamic Study an Essential Step in Preoperative Evaluation of Women With Pelvic Organ Prolapse With Urinary Tract Dysfunction: Prospective Comparative Study
urodynamic investigation when added in the diagnostic work-up of women with lower urinary tract dysfunction with POP is debatable.
This study was planned to determine the usefulness of preoperative urodynamic study in improving urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.
Read the detailed description
60 patients, fulfilled the selection criteria were counseled and informed about the trial protocol and a written consent according to declaration of Helsinki was signed. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to group (1) or group (2). Each group consisted of 30 patients. All participants had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging. Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed. Only patients allocated for group 1 were subjected to urodynamic studies before surgical intervention and then corrective procedures for POP had been done .The Urodynamic studies carried out were : uroflowmetry and cystometry. The Uroflowmetry was performed by the gravimeter method, where maximum flow rate, average flow rate, voided volume and residual urine was measured. Maximum flow rate ≤15 ml/sec, and/or residual urine of more than 50 ml or 10% of voided volume in a bladder filled with a minimum of 150 ml was taken as cut off to detect abnormal voiding. Cystometric parameters which indicated normal bladder function were first desire to void between 150 and 200 ml, capacity (taken as strong desire to void) of greater than 400 ml, detrusor pressure rise on filling of less than 15 mm H2O per 500 ml infused, absence of detrusor contractions, no leakage on coughing, no significant pain on filling and finally a detrusor pressure rises on voiding (maximum voiding pressure) of less than 50 cm H2O, with a peak flow rate of more than 15 ml/s for a voided volume over 150 ml. Urodynamic stress incontinence was diagnosed when urethral leakage was seen with increased abdominal pressure, in the absence of detrusor contractions. Detrusor over activity was diagnosed when the patient has involuntary detrusor contractions during filling with or without leakage which may be spontaneous or provoked. All participants were followed-up with same questionnaire and clinical examination after 12 weeks post operatively.
- Conditions
- Urogenital Prolapse
- Being tested
- urodynaemic studies
- Keywords
- pelvic organ prolapse,, Urodynamics
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urodynaemic studiesDiagnostic test
The Urodynamic studies carried out were : uroflowmetry and cystometry. The Uroflowmetry was performed by the gravimetric method Detrusor over activity was diagnosed when the patient has involuntary detrusor contractions during filling with or without leakage which may be spontaneous or provoked,
| Study group | Role | What they receive |
|---|---|---|
| (1) URODYNAEMICS GROUP | 30 patients allocated for group (1) had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging .Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed. And to urodynamic studies were performed before surgical intervention and then corrective procedures for POP had been done uroflowmetry and cystometry. All participants were followed-up with same questionnaire and clinical examination after 12 weeks post -operatively Receives: Diagnostic Test: urodynaemic studies | |
| (2)NON URODYNAMICS GROUP | 30 patients allocated for group (2) had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging .Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed and then corrective procedures for POP had been done.All participants were followed-up with same questionnaire and clinical examination after 12 weeks post-- operatively |
What is being measured
The primary outcome is the main question the study is designed to answer.
urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.
persistence of urinary incontinence
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start20 Sep 2020
- Primary completion30 Dec 2020
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urogenital ProlapseStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervit Sersy, Alexandria University
- Investigators
- Mervat AM Elsersy, MD, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980196
- Sponsor's protocol ID
- 0304824
- Acronym
- urodynaemics
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all individual participant data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Urodynamic Study an Essential Step in Preoperative Evaluation of Women With Pelvic Organ Prolapse With Urinary Tract Dysfunction: Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT04980196
- Acronym / sponsor ID
- urodynaemics / 0304824
- Conditions
- Urogenital Prolapse
- Keywords
- pelvic organ prolapse,, Urodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 28 Jul 2021 (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.
urodynamic investigation when added in the diagnostic work-up of women with lower urinary tract dysfunction with POP is debatable.
This study was planned to determine the usefulness of preoperative urodynamic study in improving urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.
Detailed description
60 patients, fulfilled the selection criteria were counseled and informed about the trial protocol and a written consent according to declaration of Helsinki was signed. Participants were randomly assigned following simple randomization procedures (computerized random numbers) to group (1) or group (2). Each group consisted of 30 patients. All participants had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging. Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed. Only patients allocated for group 1 were subjected to urodynamic studies before surgical intervention and then corrective procedures for POP had been done .The Urodynamic studies carried out were : uroflowmetry and cystometry. The Uroflowmetry was performed by the gravimeter method, where maximum flow rate, average flow rate, voided volume and residual urine was measured. Maximum flow rate ≤15 ml/sec, and/or residual urine of more than 50 ml or 10% of voided volume in a bladder filled with a minimum of 150 ml was taken as cut off to detect abnormal voiding. Cystometric parameters which indicated normal bladder function were first desire to void between 150 and 200 ml, capacity (taken as strong desire to void) of greater than 400 ml, detrusor pressure rise on filling of less than 15 mm H2O per 500 ml infused, absence of detrusor contractions, no leakage on coughing, no significant pain on filling and finally a detrusor pressure rises on voiding (maximum voiding pressure) of less than 50 cm H2O, with a peak flow rate of more than 15 ml/s for a voided volume over 150 ml. Urodynamic stress incontinence was diagnosed when urethral leakage was seen with increased abdominal pressure, in the absence of detrusor contractions. Detrusor over activity was diagnosed when the patient has involuntary detrusor contractions during filling with or without leakage which may be spontaneous or provoked. All participants were followed-up with same questionnaire and clinical examination after 12 weeks post operatively.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (1) URODYNAEMICS GROUP | – | Diagnostic Test: urodynaemic studies30 patients allocated for group (1) had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging .Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed. And to urodynamic studies were performed before surgical intervention and then corrective procedures for POP had been done uroflowmetry and cystometry. All participants were followed-up with same questionnaire and clinical examination after 12 weeks post -operatively |
| (2)NON URODYNAMICS GROUP | – | –30 patients allocated for group (2) had been thoroughly evaluated by history and examination. A standardized questionnaire was obtained to evaluate the symptoms of stress urinary incontinence, urge urinary incontinence and obstructive symptoms. Clinical staging of pelvic organ prolapse by POP Q Staging .Ultrasound examination had been also carried out to rule out any pelvic pathology. Patients had completed a 3-day bladder diary (frequency volume chart) to assist in arriving at an urodynamic diagnosis. Urinalysis was performed and then corrective procedures for POP had been done.All participants were followed-up with same questionnaire and clinical examination after 12 weeks post-- operatively |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- performed in Shatby Maternity University hospital, which is considered the largest hospital in Alexandria city in Egypt offering obstetrical and gynecological services for more than three millions females
Key inclusion criteria (1 listed)
- pelvic organ prolapse associated with lower urinary tract dysfunction.
Key exclusion criteria (1 listed)
- are those who had previous surgery for urinary incontinence, or experienced neurological disorder such as multiple sclerosis or spinal cord injuries were not included. Or had complicated medical disease that made the patient unfit for anesthesia.
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 |
|---|---|---|
| urodynaemic studiesThe Urodynamic studies carried out were : uroflowmetry and cystometry. The Uroflowmetry was performed by the gravimetric method Detrusor over activity was diagnosed when the patient has involuntary detrusor contractions during filling with or without leakage which may be spontaneous or provoked, | Diagnostic test | (1) URODYNAEMICS GROUP |
Primary outcome
urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction.
Time frame: 3months
persistence of urinary incontinence
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: Yes. all individual participant data that underlie results in a publication
Related trials for Urogenital Prolapse
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i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
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Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
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Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
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Pelvic Floor Muscle Training During Pregnancy
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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.
Mervat AM Elsersy, MD principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urogenital Prolapse, run by Alexandria University at 1 site in Egypt.
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 1 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: finished, as of the sponsor's last update on 6 Aug 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
urological outcome following surgery in women with pelvic organ prolapse and urinary tract dysfunction. (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2021.