Pelvic Organ ProlapseNCT06260436
Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse
An observational study of Pelvic Organ Prolapse, run by Assiut University at 1 site in Egypt.
Trial summary
. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2021to 30 Dec 2024
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: female cases at women health hospital at assuit university
Who may be able to join
- Age; greater than or equal to 18 years
- women with urogenital prolapse grade 3 or more
- indicated for surgical repair for pelvic organ prolapse
- Willing and able to sign an informed consent
- Willing to comply with the study protocol
Who cannot join
- Anti-incontinence surgery
- Lower urinary tract anomaly
- Active urinary tract infections
- Bladder tumor.
- Bladder stones
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assuit University
Asyut, Assuit, 2063045
tharwat gl mohamed, 01151166826, tharwat.fares3@gmail.com
tht tg mohamed, 01017941889, tharwat.fares3@gmail.com
About this study
Official title: Questionnaire About The Incidence of Lower Urinary Tract Symptoms Among a Sample of Women Before and After Surgical Correction of Uterine Prolapse and Impact on Quality of Life
. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest.
Read the detailed description
Pelvic organs prolapse (POP) is defined as the downward descent of the pelvic organs resulting in protrusion of the vagina and/or uterine cervix. POP and overactive bladder (OAB) often co-exist. The International Continence Society defines OAB as "urgency with or without urge incontinence, usually with frequency and nocturia" Of women with symptomatic pelvic organ prolapse, 13-39% experience voiding dysfunction (VD).
The aim of the study is to determine the effect of prolapse surgery on voiding function. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire.
Non-responders will send a reminder after three weeks and if the non-responders still failed to respond were eventually asked to complete a short form comprising questions on urgency and incontinence. This procedure followed guidelines outlined by the local ethical committee. The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest. stress incontinence according to the International Continence Society defined as leakage caused by exertion (coughing or sneezing, moving, or lifting) and urge incontinence as leakage associated with urgency.
- Conditions
- Pelvic Organ Prolapse
- 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.
| Study group | Role | What they receive |
|---|---|---|
| pelvic organ prolapse patients with lower urinary tract symptoms | this group for patient who have pelvic organ prolapse and lower urinary tract symptoms | |
| pelvic organ prolapse patients without lower urinary tract symptoms | this group for patient who have pelvic organ prolapse but do not have any lower urinary tract symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms
the effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms will be checked through a validated questionnaire before and after surgical correction
Measured: 3 months
Secondary outcomes (1)
effect of surgical correction of pelvic organ prolapse on the quality of life
the questionnaire will check the effect of surgical correction of pelvic organ prolapse on quality of life
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start30 May 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tharwat Gamal Mohammed Ibrahim, Assiut University
- Investigators
- tharwat gm mohamed, Principal investigator, Assiut UniversityMustafa mb bahlool, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06260436
- Sponsor's protocol ID
- Tharwat gamal Mohamed
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no data can be shared
Publications
Baessler K, O'Neill SM, Maher CF, Battistutta D. Australian pelvic floor questionnaire: a validated interviewer-administered pelvic floor questionnaire for routine clinic and research. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):149-58. doi: 10.1007/s00192-008-0742-4. Epub 2008 Oct 29.
PubMed 18958382
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Questionnaire About The Incidence of Lower Urinary Tract Symptoms Among a Sample of Women Before and After Surgical Correction of Uterine Prolapse and Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT06260436
- Acronym / sponsor ID
- Tharwat gamal Mohamed
- Conditions
- Pelvic Organ Prolapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 May 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 15 Feb 2024 (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.
. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest.
Detailed description
Pelvic organs prolapse (POP) is defined as the downward descent of the pelvic organs resulting in protrusion of the vagina and/or uterine cervix. POP and overactive bladder (OAB) often co-exist. The International Continence Society defines OAB as "urgency with or without urge incontinence, usually with frequency and nocturia" Of women with symptomatic pelvic organ prolapse, 13-39% experience voiding dysfunction (VD).
The aim of the study is to determine the effect of prolapse surgery on voiding function. The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire.
Non-responders will send a reminder after three weeks and if the non-responders still failed to respond were eventually asked to complete a short form comprising questions on urgency and incontinence. This procedure followed guidelines outlined by the local ethical committee. The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest. stress incontinence according to the International Continence Society defined as leakage caused by exertion (coughing or sneezing, moving, or lifting) and urge incontinence as leakage associated with urgency.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pelvic organ prolapse patients with lower urinary tract symptoms | – | –this group for patient who have pelvic organ prolapse and lower urinary tract symptoms |
| pelvic organ prolapse patients without lower urinary tract symptoms | – | –this group for patient who have pelvic organ prolapse but do not have any lower urinary tract symptoms |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- female cases at women health hospital at assuit university
Key inclusion criteria (5 listed)
- Age; greater than or equal to 18 years
- women with urogenital prolapse grade 3 or more
- indicated for surgical repair for pelvic organ prolapse
- Willing and able to sign an informed consent
- Willing to comply with the study protocol
Key exclusion criteria (5 listed)
- Anti-incontinence surgery
- Lower urinary tract anomaly
- Active urinary tract infections
- Bladder tumor.
- Bladder stones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms
Time frame: 3 months
the effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms will be checked through a validated questionnaire before and after surgical correction
1 secondary outcome
effect of surgical correction of pelvic organ prolapse on the quality of life
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Results publication: PubMed 18958382Baessler K, O'Neill SM, Maher CF, Battistutta D. Australian pelvic floor questionnaire: a validated interviewer-administered pelvic floor questionnaire for routine clinic and research. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Feb;20(2):149-58. doi: 10.1007/s00192-008-0742-4. Epub 2008 Oct 29.
- Individual participant dataSharing planned: No. no data can be shared
Related trials for Pelvic Organ Prolapse
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
Active, not recruitingObservational study
i-Stitch for Bilateral Sacrospinous Ligament Fixation (SSLF)
Pelvic Organ Prolapse, Genital Prolapse
Recruiting
Safety and Performance of a Pelvic Floor Mesh Implant for Laparoscopic Sacrocolpopexy (ProGYNious)
Pelvic Organ Prolapse (POP), Synthetic Mesh
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
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.
tharwat gm mohamed principal investigator
Assiut University
Mustafa mb bahlool, professor study director
Assiut 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 Pelvic Organ Prolapse, run by Assiut 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 5 inclusion and 5 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 21 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact tharwat gl mohammed (01151166826, tharwat.fares3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms (time frame: 3 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 NCT06260436, which also lists 1 linked publication.
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 21 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.