Bladder ExstrophyNCT07794540
Early Versus Delayed Closure of Bladder Exstrophy in Female Patients
A study testing Early Primary Single-Stage Closure and Delayed Primary Single-Stage Closure in people with Bladder Exstrophy, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial summary
This study compared two timings for primary single-stage surgery in female newborns with classic bladder exstrophy. Participants were randomly assigned to surgery within 72 hours of birth or at 6 to 12 weeks of age. Both groups received the same surgical repair and standardized perioperative care. Read more about this study
- Who is it for?
- Ages 0 to 2 days, women only
- Conditions the study is for
- Bladder Exstrophy
- What is being tested?
- Early Primary Single-Stage Closure and Delayed Primary Single-Stage Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jan 2021to 15 Mar 2026
- 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 0 to 2 days
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Phenotypic female neonates presenting with classic bladder exstrophy within the first 48 hours of life
- Met the protocol-defined minimum birth-weight requirement
- Gestational age of at least 34 weeks
- Clinically stable and fit for general anaesthesia
- Written informed consent provided by a parent or legal guardian
Who cannot join
- Cloacal exstrophy, an exstrophy variant, or isolated epispadias
- Previous bladder or abdominal-wall surgery
- Life-threatening congenital anomaly
- Uncontrolled sepsis
- Coagulopathy
- Cardiorespiratory instability precluding surgery within the assigned window
- Parent or legal guardian unable or unwilling to comply with follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Single-Stage Early Versus Delayed Closure of Bladder Exstrophy in Female Patients: A Randomized Controlled Trial
This study compared two timings for primary single-stage surgery in female newborns with classic bladder exstrophy. Participants were randomly assigned to surgery within 72 hours of birth or at 6 to 12 weeks of age. Both groups received the same surgical repair and standardized perioperative care. The main outcome was successful closure of the bladder and abdominal wall 30 days after surgery. The study also evaluated wound dehiscence, surgical-site infection, urinary fistula, blood transfusion, reoperation, readmission, hospital stay, and adverse events.
Read the detailed description
Eligible phenotypic female neonates who presented with classic bladder exstrophy within the first 48 hours of life and met the prespecified clinical and anaesthetic criteria were enrolled through consecutive sampling. After written consent and baseline assessment, participants were randomized in a 1:1 ratio using a computer-generated sequence with randomly varying block sizes and stratification by centre. Allocation was implemented through sequentially numbered sealed envelopes prepared independently of recruitment.
Participants assigned to early closure underwent primary single-stage repair within 72 hours of birth. Participants assigned to delayed closure underwent the same repair at 6 to 12 weeks of age. Before delayed surgery, the exposed bladder plate was cleaned with sterile saline and covered with a clear non-adherent pad, while hydration and weight gain were monitored. The operation included closure of the bladder and posterior urethra and reconstruction of the lower abdominal wall, pelvic floor, and female external genitalia. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension. Perioperative care was standardized in both groups.
Participants were assessed on postoperative days 7, 14, and 30. Successful bladder closure on postoperative day 30 required an intact deep bladder and abdominal-wall closure without full-thickness wound dehiscence, urinary fistula, or urinary leakage requiring repeat closure or urinary diversion. Secondary outcomes were wound dehiscence, surgical-site infection, urinary fistula, blood transfusion, reoperation, readmission, hospital stay, and adverse events. The primary analysis followed the intention-to-treat principle.
- Conditions
- Bladder Exstrophy
- Being tested
- Early Primary Single-Stage Closure, Delayed Primary Single-Stage Closure
- Keywords
- Classic Bladder Exstrophy, Primary Bladder Closure, Single-Stage Repair, Early Closure, Delayed Closure, Female Neonates, Wound Dehiscence
- Medical subject headings
- Bladder Exstrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Primary Single-Stage ClosureProcedure or surgery
Primary single-stage closure performed within 72 hours of birth. The procedure included closure of the bladder and posterior urethra and reconstruction of the lower abdominal wall, pelvic floor, and female external genitalia during one anaesthetic. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension.
Delayed Primary Single-Stage ClosureProcedure or surgery
Primary single-stage closure performed at 6 to 12 weeks of age using the same operative checklist and repair. Before surgery, the exposed bladder plate was cleaned with sterile saline and covered with a clear non-adherent pad, with monitoring of hydration and weight gain. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension.
| Study group | Role | What they receive |
|---|---|---|
| Early Closure | Experimental | Participants underwent primary single-stage closure within 72 hours of birth. Receives: Procedure: Early Primary Single-Stage Closure |
| Delayed Closure | Active comparator | Participants underwent primary single-stage closure at 6 to 12 weeks of age. Receives: Procedure: Delayed Primary Single-Stage Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Bladder Closure at Postoperative Day 30
Number and percentage of participants with an intact deep bladder and abdominal-wall closure without full-thickness abdominal wound dehiscence, urinary fistula, or urinary leakage requiring repeat closure or urinary diversion on or before postoperative day 30.
Measured: Postoperative day 30
Secondary outcomes (8)
Wound Dehiscence Within 30 Days
Number and percentage of participants with partial or complete, superficial or deep disruption of the operative wound within 30 days after surgery.
Measured: From surgery through postoperative day 30
Surgical-Site Infection Within 30 Days
Number and percentage of participants with inflammatory signs at the operative site, with or without purulent discharge or positive culture, requiring antibiotic or surgical treatment within 30 days after surgery.
Measured: From surgery through postoperative day 30
Urinary Fistula Within 30 Days
Number and percentage of participants with continuous urinary leakage from the wound or another site after surgery, confirmed clinically or by imaging and requiring continued drainage or intervention.
Measured: From surgery through postoperative day 30
Blood Transfusion
Number and percentage of participants who received a blood transfusion during the operative or perioperative period.
Measured: From the start of surgery through hospital discharge, up to 30 days after surgery
Reoperation Within 30 Days
Number and percentage of participants who underwent a repeat surgical procedure related to the primary closure within 30 days after surgery.
Measured: From surgery through postoperative day 30
Readmission Within 30 Days
Number and percentage of participants readmitted to hospital within 30 days after surgery.
Measured: From discharge through postoperative day 30
Hospital Stay
Duration of the index postoperative hospital stay, measured in days from surgery to discharge.
Measured: From surgery to hospital discharge, up to 30 days after surgery
Any Adverse Event Within 30 Days
Number and percentage of participants with at least one recorded adverse event within 30 days after surgery.
Measured: From surgery through postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start28 Jan 2021
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder ExstrophyStudies 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
- Model description
- Participants were assigned in a 1:1 ratio to primary single-stage closure within 72 hours of birth or at 6 to 12 weeks of age.
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sajjad Ali, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794540
- Sponsor's protocol ID
- KTH-BE-RCT-2021-2026
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Single-Stage Early Versus Delayed Closure of Bladder Exstrophy in Female Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07794540
- Acronym / sponsor ID
- KTH-BE-RCT-2021-2026
- Conditions
- Bladder Exstrophy
- Keywords
- Classic Bladder Exstrophy, Primary Bladder Closure, Single-Stage Repair, Early Closure, Delayed Closure, Female Neonates, Wound Dehiscence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 31 Aug 2026 (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.
This study compared two timings for primary single-stage surgery in female newborns with classic bladder exstrophy. Participants were randomly assigned to surgery within 72 hours of birth or at 6 to 12 weeks of age. Both groups received the same surgical repair and standardized perioperative care. The main outcome was successful closure of the bladder and abdominal wall 30 days after surgery. The study also evaluated wound dehiscence, surgical-site infection, urinary fistula, blood transfusion, reoperation, readmission, hospital stay, and adverse events.
Detailed description
Eligible phenotypic female neonates who presented with classic bladder exstrophy within the first 48 hours of life and met the prespecified clinical and anaesthetic criteria were enrolled through consecutive sampling. After written consent and baseline assessment, participants were randomized in a 1:1 ratio using a computer-generated sequence with randomly varying block sizes and stratification by centre. Allocation was implemented through sequentially numbered sealed envelopes prepared independently of recruitment.
Participants assigned to early closure underwent primary single-stage repair within 72 hours of birth. Participants assigned to delayed closure underwent the same repair at 6 to 12 weeks of age. Before delayed surgery, the exposed bladder plate was cleaned with sterile saline and covered with a clear non-adherent pad, while hydration and weight gain were monitored. The operation included closure of the bladder and posterior urethra and reconstruction of the lower abdominal wall, pelvic floor, and female external genitalia. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension. Perioperative care was standardized in both groups.
Participants were assessed on postoperative days 7, 14, and 30. Successful bladder closure on postoperative day 30 required an intact deep bladder and abdominal-wall closure without full-thickness wound dehiscence, urinary fistula, or urinary leakage requiring repeat closure or urinary diversion. Secondary outcomes were wound dehiscence, surgical-site infection, urinary fistula, blood transfusion, reoperation, readmission, hospital stay, and adverse events. The primary analysis followed the intention-to-treat principle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned in a 1:1 ratio to primary single-stage closure within 72 hours of birth or at 6 to 12 weeks of age.
| Arm | Type | Receives |
|---|---|---|
| Early Closure | Experimental | Procedure: Early Primary Single-Stage ClosureParticipants underwent primary single-stage closure within 72 hours of birth. |
| Delayed Closure | Active comparator | Procedure: Delayed Primary Single-Stage ClosureParticipants underwent primary single-stage closure at 6 to 12 weeks of age. |
Who may qualify
- Ages
- 0 to 2 days
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Phenotypic female neonates presenting with classic bladder exstrophy within the first 48 hours of life
- Met the protocol-defined minimum birth-weight requirement
- Gestational age of at least 34 weeks
- Clinically stable and fit for general anaesthesia
- Written informed consent provided by a parent or legal guardian
Key exclusion criteria (7 listed)
- Cloacal exstrophy, an exstrophy variant, or isolated epispadias
- Previous bladder or abdominal-wall surgery
- Life-threatening congenital anomaly
- Uncontrolled sepsis
- Coagulopathy
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 |
|---|---|---|
| Early Primary Single-Stage ClosurePrimary single-stage closure performed within 72 hours of birth. The procedure included closure of the bladder and posterior urethra and reconstruction of the lower abdominal wall, pelvic floor, and female external genitalia during one anaesthetic. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension. | Procedure or surgery | Early Closure |
| Delayed Primary Single-Stage ClosurePrimary single-stage closure performed at 6 to 12 weeks of age using the same operative checklist and repair. Before surgery, the exposed bladder plate was cleaned with sterile saline and covered with a clear non-adherent pad, with monitoring of hydration and weight gain. Pelvic osteotomy was reserved for predefined anatomical findings or excessive closure tension. | Procedure or surgery | Delayed Closure |
Primary outcome
Successful Bladder Closure at Postoperative Day 30
Time frame: Postoperative day 30
Number and percentage of participants with an intact deep bladder and abdominal-wall closure without full-thickness abdominal wound dehiscence, urinary fistula, or urinary leakage requiring repeat closure or urinary diversion on or before postoperative day 30.
8 secondary outcomes
Wound Dehiscence Within 30 Days
Time frame: From surgery through postoperative day 30
Surgical-Site Infection Within 30 Days
Time frame: From surgery through postoperative day 30
Urinary Fistula Within 30 Days
Time frame: From surgery through postoperative day 30
Blood Transfusion
Time frame: From the start of surgery through hospital discharge, up to 30 days after surgery
Reoperation Within 30 Days
Time frame: From surgery through postoperative day 30
Readmission Within 30 Days
Time frame: From discharge through postoperative day 30
Hospital Stay
Time frame: From surgery to hospital discharge, up to 30 days after surgery
Any Adverse Event Within 30 Days
Time frame: From surgery through postoperative day 30
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 31 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Primary Single-Stage Closure and Delayed Primary Single-Stage Closure in people with Bladder Exstrophy, run by Khyber Teaching Hospital at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 31 Aug 2026. 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 Pakistan. 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?
Successful Bladder Closure at Postoperative Day 30 (time frame: Postoperative day 30). 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 31 Aug 2026.