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Sexual Function DisturbancesNCT03087565

Urinary and Sexual Functions After Subtotal Versus Total Abdominal Hysterectomy

A study testing subtotal hystrectomy and Total hystrectomy in people with Sexual Function Disturbances and Urinary Function Disorders, run by Cairo University at 1 site in Egypt.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

All hysterectomies were performed intrafascially using the clamp-cut-ligate method as described by (Jones, 2003); Careful examination under anesthesia. Catheterization by N. 18 Foley's catheter and its balloon Filled with 10-ml saline.A transverse lower abdominal incision (Pfannenstiel incision) ranging from 8-12 cm… Read more about this study

Who is it for?
Ages 35 to 50 years, women only
What is being tested?
subtotal hystrectomy and Total hystrectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteEgypt
Study dates
1 Apr 2017to Dec 2017
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 35 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • An age over 35 and below 50 years.
  • Menstruating women.
  • No symptomatic uterine prolapse. .
  • Normal cervical smears.
  • Benign lesions.
  • Active sexual life.
  • Functioning ovaries.

Who cannot join

  • Known endometriosis.
  • Overt neurological or psychiatric disorder.
  • Candidate for vaginal hysterectomy.
  • Use of hormone replacement therapy.
  • Oophorectomy.

Trial locations and contacts

1 site in 1 country.

Ashraf Eldaly, MD contact

eldalyashraf@gmail.com

Egypt1 site, 1 recruiting
  • Kasr Alainy medical school

    Cairo, Cairo Governorate, 12151

    Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com

    Recruiting

Other trials in Egypt

About this study

All hysterectomies were performed intrafascially using the clamp-cut-ligate method as described by (Jones, 2003);

Careful examination under anesthesia.

Read more

Catheterization by N. 18 Foley's catheter and its balloon Filled with 10-ml saline.A transverse lower abdominal incision (Pfannenstiel incision) ranging from 8-12 cm through which the abdomen is opened in layers.

During subtotal hysterectomy procedure, the corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures.

During total hysterectomy procedure, the urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done using a finger pushed gently against the cervix rather than against the bladder. Sharp dissection using Metzenbaum scissors is performed in patients with previous cesarean sections, with upward traction on the bladder peritoneum and the uterine fundus stretched tightly out of the pelvis, the tips of the Metzenbaum scissors rest lightly on the fascia overlying the cervix with small bites to develop a tissue plane, dissecting the bladder from the anterior cervix.

Revision of all pedicles to ensure hemostasis.

Intraoperative antibiotics (1 gm of a 3rd generation cephalosporin + 0.5 gm metronidazole).

The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination in the pathology Unit.

Read the detailed description

All hysterectomies were performed intrafascially using the clamp-cut-ligate method as described by (Jones, 2003);

Careful examination under anesthesia.

Catheterization by N. 18 Foley's catheter and its balloon Filled with 10-ml saline.

A transverse lower abdominal incision (Pfannenstiel incision) ranging from 8-12 cm through which the abdomen is opened in layers.

During subtotal hysterectomy procedure, the corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. . The cervical stump is closed using vicryl 0 sutures.

During total hysterectomy procedure, the urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done using a finger pushed gently against the cervix rather than against the bladder. Sharp dissection using Metzenbaum scissors is performed in patients with previous cesarean sections, with upward traction on the bladder peritoneum and the uterine fundus stretched tightly out of the pelvis, the tips of the Metzenbaum scissors rest lightly on the fascia overlying the cervix with small bites to develop a tissue plane, dissecting the bladder from the anterior cervix.

Revision of all pedicles to ensure hemostasis.

Intraoperative antibiotics (1 gm of a 3rd generation cephalosporin + 0.5 gm metronidazole).

The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination in the pathology Unit.

Post-operative care;

After ensuring complete recovery, the patient was transferred to the ward with close follow up of the vital signs every 15 minutes till stable, then every 2 hours for 24 hours, then every 8 hours till discharge.

Postoperative antibiotics (1 gm of a 3rd generation cephalosporin + 0.5 gm metronidazole) were given eight hourly for 24 hours then stopped (Hager, 2003).

Postoperative analgesics (Non-steroidal anti-inflammatory drugs) were given eight hourly for 24 hours then if needed

Intravenous fluids were given for the 1st 8 hours postoperative and then fluid diet was allowed with early ambulation and deep breathing (Horowitz and Basil, 2003).

The urinary catheter was removed 24 hours postoperatively.

Upon discharge, the patients were advised to resume work and sexual intercourse only after 4 weeks . An appointment was given to the patients to be seen 6 months after the operation.

Pre- and post-operative evaluation

The patients were interviewed and examined preoperatively and 6 months postoperative.

  1. Urinary function was evaluated before surgery and 6 months afterward using;
  2. Subjective questionnaire to detect urinary Symptoms including:
  3. Diurnal frequency of micturition (voids >6 times a day).
  4. Nocturia (waking at night more than one time to void).
  5. Urge urinary incontinence. (urine leakage related to a feeling of urgency).
  6. Stress urinary incontinence. (urine leakage related to physical activity, coughing or sneezing).
  7. Dysuria (stinging/burning sensation).
  8. Hesitancy (difficulty in initiating micturition).
  9. Reduction of the stream (compared to previous performance).
  10. Sensation of incomplete bladder emptying.
  11. Haematuria.
  12. Physical examination:

Stress test: With the bladder near full, the patient was asked to cough vigorously while watching for leakage of urine .

Evaluate levator ani muscle function by asking the patient to tighten her "vaginal muscles".

  1. Objective urodynamic studies: urodynamic evaluation was done for all participants in the study. All urodynamic studies were performed using ANDROMEDA M00101-2 ELLIPSE.

The following tests were done:

  1. Filling cystometry; the following parameters were evaluated and compared ; First desire to void (The point at which the woman first experiences an awareness of the need to empty her bladder). Maximum cystometric capacity (The point at which the woman can delay micturition no longer). Maximum detrusor pressure reached during filling phase.
  2. Uroflowmetry:

Where the maximum flow rate and the residual volume were identified.

Method

  1. The patient presented with a symptomatically full bladder. She voided spontaneously in a uroflow chair. Maximum flow rate and postvoid residual urine volume were obtained via a transurethral catheter.
  2. The microtransducer catheters were connected to the appropriate cables and to the tubing from the water pump.
  3. With the patient in the supine position on a urodynamic chair, the abdominal catheter was placed into the vagina . A dual microtransducer 6-French catheter with a filling port was then placed into the bladder . The patient was moved to a sitting position.
  4. After the catheters were appropriately placed, the subtraction was checked by asking the patient to cough. Cough-induced pressure spikes should be seen on the Pves and Pabd channels, but not on the true detrusor pressure channel.
  5. The urinary bladder was filled with normal saline at room temperature with a filling rate 50-100 ml/min. First desire to void and strong desire to void were recorded. Throughout the filling portion of the examination, the patient was asked to perform provocative activities, such as coughing and straining. The external urethral meatus was constantly observed for any involuntary urine loss.

Sexual function: The patients were interviewed before surgery and 6 months afterward and sexual function was evaluated using a subjective questionnaire measuring the following sexual variables :

  1. Libido (desire): It is described as perceiving sexual desire once a week or more, which is a subjective feeling state.
  2. Frequency of intercourse (once a week or more).
  3. Dyspareunia (painful coitus).
  4. Frequency of orgasm: the most intense pleasure followed by sudden release of the tension that has built up during excitement. It is described as (always or often).
  5. Sense of vaginal dryness.
  6. Satisfaction with sexual life (satisfied-not satisfied).

The patients were allowed to resume sexual intercourse 4 weeks after the operation.

Data collection included:

  1. Postoperative recording of operation time, intra-operative blood transfusion (if needed), length of hospital stay, and pathology of the removed uterus.
  2. Postoperative complications including pyrexia, vault haematoma, wound haematoma, wound infection, vaginal bleeding, need for blood transfusion, postoperative pain, cervical stump prolapse, and vaginal vault prolapse.
Being tested
subtotal hystrectomy, Total hystrectomy
Medical subject headings
Sexual Dysfunctions, Psychological

What participants receive

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

  • subtotal hystrectomyProcedure or surgery

    A transverse lower abdominal incision (Pfannenstiel incision) The corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures.

    Revision of all pedicles to ensure hemostasis. Intraoperative antibiotics . The abdomen is closed in layers; the wound is covered with a sterile dressing.

  • Total hystrectomyProcedure or surgery

    A transverse lower abdominal incision (Pfannenstiel incision) The urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Revision of all pedicles to ensure hemostasis.

    The abdomen is closed in layers; the wound is covered with a sterile dressing.

Study groups in NCT03087565
Study groupRoleWhat they receive
subtotal hystrectomyActive comparatorCareful examination under anesthesia. Catheterization by N. 18 Foley's catheter . A transverse lower abdominal incision (Pfannenstiel incision) . the corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures. Intraoperative antibiotics The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination .
Receives: Procedure: subtotal hystrectomy
Total hyterectomyActive comparatorexamination under anesthesia. Catheterization by N. 18 Foley's catheter A transverse lower abdominal incision (Pfannenstiel incision) The urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Blunt dissection is done . Sharp dissection using Metzenbaum scissors is performed in patients with previous cesarean sections Revision of all pedicles to ensure hemostasis. Intraoperative antibiotics The abdomen is closed in layers; the wound is covered with a sterile dressing. All specimens were sent for pathological examination .
Receives: Procedure: Total hystrectomy

What is being measured

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

  1. Filling cystometry

    The patient presented with a symptomatically full bladder. She voided spontaneously in a uroflow chair. Maximum flow rate and postvoid residual urine volume were obtained via a transurethral catheter. The microtransducer catheters were connected to the appropriate cables and to the tubing from the water pump. With the patient in the supine position on a urodynamic chair, the abdominal catheter was placed into the vagina. A dual microtransducer 6-French catheter with a filling port was then placed into the bladder. The patient was moved to a sitting position. After the catheters were appropriately placed, the subtraction was checked by asking the patient to cough. Cough-induced pressure spikes should be seen on the Pves and Pabd channels, but not on the true detrusor pressure channel.

    Measured: 6 months after operation

  2. Uroflowmetry

    The urinary bladder was filled with normal saline at room temperature with a filling rate 50-100 ml/min. First desire to void and strong desire to void were recorded. Throughout the filling portion of the examination, the patient was asked to perform provocative activities, such as coughing and straining. The external urethral meatus was constantly observed for any involuntary urine loss.

    Measured: 6 months after operation

Secondary outcomes (1)
  1. Sexual functions

    Satisfaction with sexual life (satisfied-not satisfied).

    Measured: 6 months after operation

Timeline

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

  1. First posted22 Mar 2017
  2. Study start1 Apr 2017
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03087565
Sponsor's protocol ID
162
Status last verified
Apr 2017
First submitted
11 Mar 2017
Last updated
12 Apr 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing subtotal hystrectomy and Total hystrectomy in people with Sexual Function Disturbances and Urinary Function Disorders, run by Cairo 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 7 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 12 Apr 2017. 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 Ahmed Maged, MD (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Filling cystometry (time frame: 6 months after operation). 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 12 Apr 2017.

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