Stress Urinary IncontinenceNCT06044987
Effect of Cystocele Repair With Trans Obturator Tape VS. Trans Obturator Tape Alone on Stress Urinary Incontinence.
A study testing Trans Obturator Tape Procedure (TOT) and Cystocele Repair in people with Stress Urinary Incontinence, run by Al-Mustafa University College at 1 site in Iraq.
Trial summary
The goal of this interventional study is to compare the effect of Concurrent cystocele repair and trans obturator tape (TOT) and TOT alone in a sample of Iraqi Female participants with diagnosed stress urinary incontinence and cystocele. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Trans Obturator Tape Procedure (TOT) and Cystocele Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteIraq
- Study dates
- 1 Sep 2021to 1 Sep 2022
- Phase
- Interventional
- 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients.
- Pure stress and/or stress-predominant mixed urinary incontinence (MUI) associated with cystocele.
- Had not undergone a previous SUI surgery.
- BMI less than 35 kg/m2
Who cannot join
- Patients out of the age limit.
- Patients refused to participate in the study.
- Severe comorbid disease (heart failure HYHA class II and above, etc.).
- Patients with a previous surgical history of transvaginal mesh.
- Patients suffering detrusor overactivity.
- Patients diagnosed with the female genital system or urinary bladder Malignancies.
- Patients diagnosed with the presence of neurological disorders that caused voiding dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Concurrent Cystocele Repair on Transobturator Tape in Patients With Stress Urinary Incontinence - A Comparative Study
The goal of this interventional study is to compare the effect of Concurrent cystocele repair and trans obturator tape (TOT) and TOT alone in a sample of Iraqi Female participants with diagnosed stress urinary incontinence and cystocele. The main questions to answer are:
1-What are the effects of the tested Interventions on the outcomes measured by The Pelvic Organ Prolapse Quantification (POP-Q) System?
Read more
- What are the effects of the tested Interventions on the degree of pelvic organ prolapse?
- What are the effects of the tested Interventions on the frequency, severity, and effect of Stress urinary incontinence on the quality of life of the patients?
- What are the effects of the tested Interventions on the impact of lower urinary tract symptoms on the quality of the patient's life?
Female Patients diagnosed with SUI indicated for intervention were divided into 2 groups
Group I: (n=49) offered TOT alone
Group II: (n=49) offered concurrent TOT and Cystocele Repair
Patients were then followed up and evaluated using The Pelvic Organ Prolapse Quantification (POP-Q) System, The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and the King Health Questionnaire (KHQ). The efficacy of both procedures and their impact on SUI and quality of life was measured.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Trans Obturator Tape Procedure (TOT), Cystocele Repair
- Keywords
- Urinary Incontinence, Stress, Cystocele, Trans Obturator Tape, Pelvic Organ Prolapse
- Medical subject headings
- Urinary Incontinence, Stress, Cystocele, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans Obturator Tape Procedure (TOT)Procedure or surgery
Done under Spinal anesthesia in the dorsal lithotomy position.
Cystocele RepairProcedure or surgery
Done under Spinal anesthesia in the dorsal lithotomy position..
| Study group | Role | What they receive |
|---|---|---|
| Group I (TOT alone) | Active comparator | 49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure Receives: Procedure: Trans Obturator Tape Procedure (TOT) |
| Group II (TOT+ Cystocele Repair) | Experimental | 49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair. Receives: Procedure: Trans Obturator Tape Procedure (TOT); Procedure: Cystocele Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Pelvic organ Prolapse (POP-Q)
Assessed using the pelvic organ prolapse quantification system, in which it classified into:
- Stage 0: No prolapse is observed
- Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen
- Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen
- Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm
- Stage 4: vaginal eversion has taken place or eversion to with 2cm of TVL
Measured: At baseline, and at 9 months
Frequency, severity, and effect of urine incontinence on quality of life.
Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The score runs from "0 to 21", with higher values indicating more severe illness
Measured: At baseline, and at 9 months
Secondary outcomes (1)
Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.
Assessed using the King Health Questionnaire (KHQ). It contains ten patient-rated domains. Each score value from 0% (best outcome) to 100% (worst outcome), except for Q10 from "0 to 30" with 30 being the worst.
Measured: At baseline, and after 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: After discussing this study with the investigators, it was decided to consider it a retrospective study rather than a clinical trial. Since we could not delete this record, we chose the termination status instead.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Mustafa University College
- Sponsor type
- University, hospital or other
- Collaborators
- Al-Sadr Teaching Hospital
- Responsible party
- Principal investigator, Hayder Adnan Fawzi, Al-Mustafa University College
- Investigators
- Hayder Adnan Fawzi, Ph.D, Study chair, Al-Mustafa University CollegeThaer Saleh Sabor Al-Omary, Ph.D, Principal investigator, Al-Sadr Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044987
- Sponsor's protocol ID
- A-202301
- Status last verified
- Feb 2025
- First submitted
- 13 Sep 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Concurrent Cystocele Repair on Transobturator Tape in Patients With Stress Urinary Incontinence - A Comparative Study
- ClinicalTrials.gov ID
- NCT06044987
- Acronym / sponsor ID
- A-202301
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Stress, Cystocele, Trans Obturator Tape, Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: After discussing this study with the investigators, it was decided to consider it a retrospective study rather than a clinical trial. Since we could not delete this record, we chose the termination status instead.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Al-Mustafa University CollegeUniversity, hospital or other
- Collaborators
- Al-Sadr Teaching Hospital
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 21 Sep 2023 (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 goal of this interventional study is to compare the effect of Concurrent cystocele repair and trans obturator tape (TOT) and TOT alone in a sample of Iraqi Female participants with diagnosed stress urinary incontinence and cystocele. The main questions to answer are:
1-What are the effects of the tested Interventions on the outcomes measured by The Pelvic Organ Prolapse Quantification (POP-Q) System?
- What are the effects of the tested Interventions on the degree of pelvic organ prolapse?
- What are the effects of the tested Interventions on the frequency, severity, and effect of Stress urinary incontinence on the quality of life of the patients?
- What are the effects of the tested Interventions on the impact of lower urinary tract symptoms on the quality of the patient's life?
Female Patients diagnosed with SUI indicated for intervention were divided into 2 groups
Group I: (n=49) offered TOT alone
Group II: (n=49) offered concurrent TOT and Cystocele Repair
Patients were then followed up and evaluated using The Pelvic Organ Prolapse Quantification (POP-Q) System, The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and the King Health Questionnaire (KHQ). The efficacy of both procedures and their impact on SUI and quality of life was measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (TOT alone) | Active comparator | Procedure: Trans Obturator Tape Procedure (TOT)49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure |
| Group II (TOT+ Cystocele Repair) | Experimental | Procedure: Trans Obturator Tape Procedure (TOT), Procedure: Cystocele Repair49 Female Patients diagnosed with Stress urinary incontinence and cystocele and offered repair by Trans obturator tape procedure concurrently with cystocele repair. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients.
- Pure stress and/or stress-predominant mixed urinary incontinence (MUI) associated with cystocele.
- Had not undergone a previous SUI surgery.
- BMI less than 35 kg/m2
Key exclusion criteria (7 listed)
- Patients out of the age limit.
- Patients refused to participate in the study.
- Severe comorbid disease (heart failure HYHA class II and above, etc.).
- Patients with a previous surgical history of transvaginal mesh.
- Patients suffering detrusor overactivity.
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 |
|---|---|---|
| Trans Obturator Tape Procedure (TOT)Done under Spinal anesthesia in the dorsal lithotomy position. | Procedure or surgery | Group I (TOT alone), Group II (TOT+ Cystocele Repair) |
| Cystocele RepairDone under Spinal anesthesia in the dorsal lithotomy position.. | Procedure or surgery | Group II (TOT+ Cystocele Repair) |
Primary outcome
Degree of Pelvic organ Prolapse (POP-Q)
Time frame: At baseline, and at 9 months
Assessed using the pelvic organ prolapse quantification system, in which it classified into: 1. Stage 0: No prolapse is observed 2. Stage 1: The most proximal portion of prolapse is greater than 1 cm above the level of the hymen 3. Stage 2: The most proximal portion of prolapse is found between 1 cm higher than hymen and 1cm beneath hymen 4. Stage 3: The most distal part of the prolapse extends more than 1cm beneath the hymen but no further than 2 cm 5. Stage 4: vaginal eversion has taken place or eversion to with 2cm of TVL
Frequency, severity, and effect of urine incontinence on quality of life.
Time frame: At baseline, and at 9 months
Assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF). The score runs from "0 to 21", with higher values indicating more severe illness
1 secondary outcome
Impact of lower urinary tract symptoms including urinary incontinence on health-related quality of life.
Time frame: At baseline, and after 9 months
Results and safety
The study was stopped early (reason given: After discussing this study with the investigators, it was decided to consider it a retrospective study rather than a clinical trial. Since we could not delete this record, we chose the termination status instead.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
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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.
Hayder Adnan Fawzi, Ph.D study chair
Al-Mustafa University College
Thaer Saleh Sabor Al-Omary, Ph.D principal investigator
Al-Sadr Teaching Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans Obturator Tape Procedure (TOT) and Cystocele Repair in people with Stress Urinary Incontinence, run by Al-Mustafa University College at 1 site in Iraq.
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 4 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: stopped early, as of the sponsor's last update on 19 Feb 2025. 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 Iraq. 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 was stopped early (reason given: After discussing this study with the investigators, it was decided to consider it a retrospective study rather than a clinical trial. Since we could not delete this record, we chose the termination status instead.). Results are not available in the source record.
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?
Degree of Pelvic organ Prolapse (POP-Q) (time frame: At baseline, and at 9 months). 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?
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 19 Feb 2025.