Antispasmodic Drug for Diagnosis Proximal Tubal Occlusion on Hysterosalpingography
Condition: Tubal Obstruction
MeSH terms: Fallopian Tube Diseases
Study type: Interventional

Summary: 
      This study finds premedication Hyoscine-N-butylbromide before hysterosalpingography have a
      potential effect for diagnosis of proximal tubal obstruction in infertile women. The
      investigators did a double-blind, randomized placebo-controlled trial
    

Detailed description: 
      Infertility is a common gynecologic problem in reproductive medicine. The causes of female
      infertile can divided into ovulatory dysfunction, tubal and pelvic pathology, unexplained
      infertility and unusual problems. About 30-35% of case of infertility are caused by the tubal
      factor and tubal disease is an important cause of infertility and should be specifically
      excluded(1). Methods for evaluation of the fallopian tube pathology include the
      Hysterosalpingography(HSG), Saline infusion sonography(SIS) and Laparoscopy with
      chromopertubation etc(2-3).

      Laparoscopy with chromopertubation is considered the definitive test for evaluating tubal
      disease and allows for the detection of other intraabdominal causes of infertility. However,
      laparoscopy is expensive, time consuming, limited in some centers, and unpleasant for the
      patient. More importantly many patients have anesthetic and surgical complications that
      require hospital admission(4). Therefore, HSG has been most commonly used for routine
      screening in infertility for evaluation of tubal patency. It is a simple, noninvasive and
      inexpensive technique. HSG is the standard first-line test to evaluate tubal patency(5-7).

      HSG is an X-ray procedure that is used to view the inside of the uterus and fallopian tubes.
      HSG for investigating tubal patency has moderate sensitivity 65% but excellent specificity
      83% in the infertile population. The PPV and NPV of HSG are 38% and 94%, respectively(8-9).
      However, it can have a false positive diagnosis if the HSG indicates occlusion, there may be
      a good chance 60% that the tubes are actually patent, and if the HSG demonstrates patency
      there is a little chance 5% that the tubes are occluded(10). There are several factors
      leading to a false diagnosis of tubal occlusion by using HSG. The most common factor cited is
      a cornual spasm(11), there could simply be a resistance difference between the two tubes(12)
      and the other factor are an existing of mucous plug at proximal part of the fallopian
      tube(13).

      Diagnostic laparoscope performed after HSG showed a decrease in the rate of diagnoses of
      initial tubal occlusion by 40-60%(14-16). There are studies about repeat HSG 1 month later in
      patients whom HSG showed proximal tubal blockage, showed tubal patency about 60%(17). And
      there are many studies about administration of an antispasmodic or analgesic drug to
      distinguish tubal spasm from tubal occlusion during HSG. Such as Glucagon, Hyoscine
      butylbromide, ASA, Terbutaline, Diazepam, Fenoterol and Mitamizole etc(18-21). There is only
      one prospective study about hyoscine butylbromide use after tubal occlusion occur during HSG,
      showed that appears to be safe and effective drug to relieve proximal tubal obstruction by
      80%(22).

      Hyoscine-N-butylbromide(Buscopan®), an antispasmodic drug commonly used for relief of smooth
      muscle spasms and can use to relieve genito-urinary spasm. Hyoscine exerts a spasmolytic
      action, peripheral anticholinergic effects result from a ganglion-blocking action within the
      visceral wall as well as from anti-muscarinic activity, could decrease pain during uterine
      cramping. And about relief tubal obstruction in HSG procedure, no previous studies
      investigate compared its efficacy in randomized double-blind controlled trial. And there are
      inexpensive, safe with minimal side effects, then there are studies reported hyoscine can
      relieve dysmenorrhea too(23-24).

      In Thailand, reported that one of the most common causes of female infertility is tubal
      pathology which accounted for 27% of the cases(25). And at Infertile clinic of
      Songklanagarind Hospital, mostly use HSG for standard first-line to evaluate tubal patency.
      We hypothesized that Hyoscine-N-butylbromide use before HSG can relieve the tubal occlusion
      that not true occlusion. It is possible to decrease the false positive rate of diagnosis of
      tubal occlusion cause from cornual spasm. So it can apply to use to decrease the necessity of
      laparoscopy with chromopertubation for definitive test tubal occlusion or repeated. And it
      will also reduce the medical cost of further more expensive investigation and medical
      complication.
    

Intervention name(s): hysterosalpingography
Intervention type(s): Procedure
Intervention description(s): Starting procedure by using largest appropriate speculum for maximum cervical exposure. Cleanse the cervix with povidone iodine. A tenaculum was applied to the anterior cervix to help for stabilization and counter-traction. Then insert a sterile Rubin's cannula into the cervix uteri. A scout radiograph of the pelvis was obtained with the catheter in place before contrast material was instilled. After that the water soluble contrast media was slowly instilled through the cannula appropriate volume range 10-15 ml., with fluoroscopic images obtained intermittently to evaluate the uterus, fallopian tubes and tubal patency
Other intervention name(s): HSG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hysterosalpingography; antispasmodic drug; infertile women