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Female sterilization: Prognosis for simplified outpatient procedures
CONTRACEPTION
FEMALE STERILIZATION:
PROGNOSIS FOR SIMPLIFIED
OUTPATIENT PROCEDURES Diana Schneider Johnson, Ph.D. Department of Physiology Medical College of Virginia Richmond, Virginia 23225 INTRODUCTION This report is a summary of a conference held at Airlie Mouse, Virginia, on December 2-3, 1971, in order to assess the current status of female sterilization procedures and to determine the most promising research approaches for the development of simplified sterilization techniques for The workshop was organized by Gordon W. Duncan use in less developed countries. and Richard D. Falb of the Battelle Population Study Center and supported by the United States Agency for International Development (AID). The workshop was organized on the assumption that the perfection of safe, simple procedures for female sterilization would significantly affect the direction and impact of family planning programs. The medical concern with the continuing reassessment of current pharmacologic contraceptive programs, the characteristics of effective fertility control measures and the resurging world-wide interest in the application of sterilization procedures warrant a critical appraisal of the contributions that can be expected from outpatient sterilization procedures and what efforts are yet required to achieve these expectations. The workshop was divided into sessions designed to: 1) describe the role of female sterilization in family planning programs and the impact that the availability of practical outpatient sterilization procedures would have on such programs; establish the criteria for practical outpatient procedures, with particular emphasis on the specific requirements imposed by consideration of their application in lesser developed countries; characterize the training procedures necessary to support sterilization programs; 2) comment on the anatomy, physiology, biochemistry and bioengineering of the oviduct and uterus as they pertain to sterilization procedures; 3) systematically review the currently available and contemplated sterilization techniques and their supportive instrumentation, with separate consideration of transabdominal and of transvaginal/cervical approaches; 4) critically assess the advantages, disadvantages and limitations of each procedure as compared to the previously established performance criteria; identify potential medical, mechanical and engineering contributions to correct the deficiencies of existent technology; establish logical research and development programs to achieve practical outpatient sterilization procedures. The proceedings of this meeting will be published by Academic Press in Prognosis for Simplified Outpatient Procedures, the Spring as Female Sterilization: edited by G. W. Duncan, R. D. Falb and J. J. Speidel.
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Dr. John Cutler (University of Pittsburgh School of Public Health), the conference moderator, opened the meeting by noting that there is a scarcity of trained physicians as well as other medical support personnel Therefore, research and backup equipment in the less developed countries. is needed to develop simplified procedures for use under a wide variety of conditions. ,J. Joseph Spcidel (AID) discussed the role of female sterilization in family planning programs. At the present time, female sterilization has only a modest role in the organized family planning programs of most countries. A primary reason for this is the administrative restrictions which are placed on the availability of sterilization. Kequirements for high age and parity, as in the “rule of 120” (age x parity = 120)) thus limit the demographic impact of female sterilization. There is strong evidence that the individual acceptance of sterilization is high, and that many people will use sterilization where there are no barriers to its avallabi lity. Although irreversability has been thought to be a major the high acceptance rates in impediment to acceptance of sterilization, some countries and low rate of requests for reversal suggest that this is Most users consider sterilization as a procedure to be not the case. used to terminate childbearing rather than as a means of spacing children. The need for hospitalization and attendant pain and scarring may be more serious barriers , and the enthusiasm of the medical community is critical. At present, lack of medical care infrastructure is the key impediment to further extension of this method in many countries. With these factors in mind , sterilization procedures should be evaluated on the basis of: Practicality. Sophisticated techniques such 3s laparoscopy and 1. culdoscopy may diminish the need for hospitalization, but this may be counterbalanced by equipment costs, maintenance requirements and the need for greater skill on the part of the doctor. f’ermanence has a great practical advantage in that it is only necessary to reach the target This is highly important where skilled medical personnel population once. are scarce. In addition, while initial costs are high, they can be amortized over the patient’s rcproductivc lifetime, as opposed to the continuing cxpensc of operating 3 family planning program. Demographic Impact. Impact is detcrmincd by prevalence of use, 2. effectiveness and the age and parity of the acceptor. At the present time, prevalence of use is low, effectiveness is high, and the age and parity of the acceptor are higher than would be desirable. _ Safety and Side Effects. Steri lization procedures have those side 3. -7 effects generally associated with minor abdominal surgery, and the mortality rate of 25/100,000 is low when considered over the reproductive life span. This rate is much lower than maternal death rates in most less developed countries.
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‘The most successful strategy for will be the development of new
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Highest priority should be placed on research and acceptable techniques. to develop simplified sterilization technology which can realistically be made available within the scope of family planning delivery systems in less Simplification and improvement of current medically developed countries. dependent means of female sterilization is important, but the ultimate goal is the development of means that are not dependent upon scarce medical personnel or facilities. Although the full potential of female sterilization in family planning it seems likely that this method is adequately programs cannot be predicted, acceptable to individual women and could therefore become a demographically effective means of fertility control for use in family planning programs. Jaroslav Hulka (University of North Carolina) discussed fundamental features of the anatomy and physiology of the fallopian tubes that must be The fallopian tubes considered when designing new methods of sterilization. are sources of secretions which flow toward both the uterus and the peritoneal cavity via the fimbria, and are also highly motile and contractile structures. Their physiology must be kept in mind when considering occlusion of the tubes. Since the reproductive organs utilize transport in two directions, both to transport sperm toward the fimbria and ova toward the uterus, a form of sterilization which blocked transport in one direction might be effective. It was suggested that transabdominal postpartum sterilization should be more widely practiced, Individual acceptance is high at this time, and the operative technique is simplified since the tubes are close to the abdominal wall.
SURGICAL STERILIZATION PROCEDURES The use of culdoscopy as a sterilization procedure was discussed by Martin Clyman (New York City), Alfonso Gutierrez Najar (Mexico City) and William Little (Miami), who have been developing outpatient procedures using this technique. The procedure involves penetration of the vaginal cul-de-sac and insertion of the culdoscope for visualization, after which the fallopian tubes are either severed via a modified Pomeroy technique (Clyman, Little), or clamped with hemoclips (Gutierrez Najar). The pre- and postoperative treatments used by these physicians differ, as do contraindications, analgesia, instruments, etc., but their procedures are basically quite similar. Dr. Clyman considers the presence of a mass in the cul-de-sac to be the major contraindication, and procedes if there is adequate mobility of the tubes. Most of Dr. Gutierrez Najar’s patients are from the postabortion or postpartum clinics, and therefore generally have free pelvic mobility; the pelvis and cul-de-sac must be clear of pathology for the operation to proceed. The clip technique involves tubal closure that is tight enough to prevent free passage but loose enough to prevent necrosis. This procedure has been used on over 4000 patients, of whom 1305 have been reculdoscoped for observation, Of 1112 treated with this method, there were only 9 failures and 3 pregnancies, with few complications. The majority of failures were due to incompletely closed clips. Dr. Little
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those patients who show any pelvic pathology and who might require future hysterectomy, as well as obese patients in whom bowel tissue becomes a problem, diabetics, and patients with respiratory or cardiovascular disease. He worhs with an indigent population with a high incidence of pelvic inflammatory disease (PID) and other pathologies (10% have significant adhesive disease). Significant complications were seen in 7 of 190 patients. Culdoscop~ has significant advantages over other procedures. It can be done as an outpatient procedure and does not require general anesthesia. This reduces the required number of trained physicians from 2 to 1, since an anesthesiologist is not required. Patient acceptance is high because of the lack of a hospitalization requirement, high effectiveness, minimal discomfort and the lack of a visible scar. It has the significant disadvantage of requiring at least some training in abdominal surgery. The procedure may be difficult for many physicians to learn, as most abdominal surgery is initiated with the patient in the pronc position, while culdoscopy requires that the peritoneal cavity be entered from below, with the patient in a knee-chest position. excludes
Clifford R. Wheclcss (Johns tloJ>kins Ilospital, Baltimore) has developed a single incision laparoscopic technique that can be performed with local anesthesia. I’he development of this procedure was designed to 1) reduce hospitalization time to less than 24 hours, 2) require less than 30 minutes operating time, 3) require the skill of the average physician, 4) have results comparable with those of other techniques of tubal ligation, and 4 pilot study in the Maryland farnil) 5) cost les than $100 per Jlatient. planning clinics showed that all requirements hut (3) could be met; surgical experience 118s needed for successful use of the technique. Cost was also Dr. Wheeless also higher than was desirable ($150 instead of $100 j. successfully introduced this technique at the State ‘Yaternity Hospital in Knthmandu, Nepa I, under much more difficult conditions. The USC of local anesthesia was made Jlossible by the use of a oneincision technique, in which the cauterization instrument is inserted through an operating pore in the laparoscope. The patient is sedated and a cannula is placed into the uterus to maintain the reproductive organs in the desired Jlosition. The abdomen is Jn-epped with Iodine solution, the umbilicus injected with lidocainc, a 2 mm incision is made in the umbilicus, and the peritoneal cavity is filled with 2 liters of COz. The incision is then The pelvis is thoroughly widened to 1 cm and the laparoscope inserted. inspected prior to cauterization of the fallopian tubes using the cutting current of the instrument, which is not painful because it produces a 3rd degree burn which hills the nerve. The patient is warned to expect slight It is pain, which appears to he similar to that involved in 11111placement. hoped that :I clip> holder similar to that used in culdoscopy ryill be developed in the near future; this would simplify the technique and reduce the ‘L‘hcminimal extent of concern for reversibility opcrnt i ye sk i 11 norg required. in an ncccptable sterilization procedure was indicated by the observation that onlv one of 2000 patients has rcqucstcd xssistancc in re-establishing her fertllitv.
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Hospital, Pittsburgh), Leonard Laufe (The Western Pennsylvania Columbus Laboratories) described Craig Hassler and Brenton Lower (Battelle preliminary studies with loose fitting or balloon type silicone rubber fimbrial caps designed to provide reversible sterilization. The caps were placed over the fimbriated end of one fallopian tube in rabbits via laparotomy , and were anchored to the broad ligament; the second uterine horn was used as a control for each animal. With the cap in place, Subsequent implantations occurred only in the noncapped uterine horn. removal of the cap and remating led to normal pregnancy and implantations These preliminary results indicate that the fimbrial in both uterine horns. However, the cap approach to reversible sterilization may be feasible. procedure as it is now employed does require abdominal surgery for both The which limits its use at the present time. placement and removal, concept of a fimbrial covering does seem to be a reasonable approach and eventually might be accomplished via a single transcervical injection of a time-controlled setting polymer which would set as it reached the It might also be feasible to use a biodegradable compound ends of the tube. for such a procedure.
NON-SURGICALSTERILIZATION PROCEDURES Santiago) discussed the use of Jaime Zipper (University of Chile, quinacrine as an occlusive agent for the human fallopian tube. Animal studies showed that quinacrine application to one uterine horn occludes the lumen as the result of a granulomatous reaction, that the effects of quinacrine are potentiated by the addition of other agents, and that The potentiation estrogen or progesterone prevents the quinacrine effect. drugs and metal ions was highly of quinacrine action by various hormones, and no good model for the human has been found variable between species, This latter point was a concern of several participants, to date. particularly from the standpoint that the animal models may provide too severe a test and result in potentially useful clinical methods being In a series of 500 human subjects, who have been followed discarded. a single transcervical application of quinacrine was for up to 4 years, found to produce occlusion in 66% of the patients. This fairly low effectiveness was increased to 92% when quinacrine was administered on Zinc chelating agents and zinc competitors such two separate occasions. as copper were found to be the most effective potentiators for quinncrine It has been postulated that the effect of quinacrine action in the human. results from binding to DNA, and that this binding is dependent on the endometrial zinc concentration. Future studies will be directed toward improving the effectiveness of until the method is more than 95% effective with one quinacrine treatment, This procedure shows great potential for mass programs, as application. it is even simpler than IUD insertion and takes only 2-3 minutes to complete. which has none of the prohlems It involves a transcervical approach, attendant uponacurgical procedure; therefore it could be readily utilized as an outpatient procedure that could be performed by paramedical personnel.
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Columbus and I(. I,. I’avkov (liattelle 1:31b, G. A. Grodc described the potential USC of rapidly polymerizing tissue rhe ideal occluding adhesive was tubal occluding agents. determined to he one that would form primary covalent bonds with functional It was suggested that such 3 material must be groups in body tissues. and it must be nontoxic biodegradable and replaced by regcncrating tissue, An adhcsivc system consistin?, of gelr~tin-rcsorcinoland non cnrcinogcn i c formaldehyde best fulfi 1 led these critcri a. ‘I‘his materi;ll has been anil acts by bonding to tissue extensively tested in man!~ anininl tissues, When used for surfii cal bonding, the original incision heals protein. after i-0 months :~nd the adhcsivc is displ:iccd h!, regener:lting tissue. The time required for setting of the material is 2 function of ptl and thcrcfore cas i I!, control led, and it is of jlart icular value for bleeding or csuding tissue or tissue \,ith ;I mricos:il lxycr. It products some irritation and granulomatous tissue formation, ih i ch coilld bc advantageous for l)lochade of the f:11 lopinn tube. I’rclimin:iry 5tudics with rabbits utilized and resulted in ;I firm r~dhesion to the tissue 2 lq~aroscopi c procwltrre, and :i 1:icL of‘ prC>gnancy in the treated horn, indicating the feasibility lhc go;‘1 in an\ futrlrc rtorh with human subiccts wi 11 be of the aj’pr”:lch. appl i cat ion vi:1 ;i t~anscervi c‘:, 1 apprnnch. \ preliminary dclivcry system for th ii matcri al has Ihew clc\-clop~~il, hut ha4 not !‘et been tested in hum:ln suhj ccts Richard
Ii.
Lnhoratorics) adhesives as
lior;lce 1.. Ihom~~son (1)enver C;cneral Ilospi t:rl) discussed several tfchniqucs of transccrvical oviduct occlusion that arc in various stages of expcrimentntion. t’c~raform~ildei~\~rle in :d~solutc eth:lnol w’ns inserted into the cornual region of monhcys v; ;I la~~:rrotomy. ‘l’hi s combination w:js found to sloaly dissol\-c in the uterine musculature, producing 3 chronic irritation rfsul till: in the formation of a granulomcltow reaction and subscqucnt tubal closure It is not possible to prc’dict the results on human patients from l’rehystcrectom)paticr1t.s will /JC’ tested, using a curved, blunt this study. c:innul;i &signed for the introduction oi‘ sclcrosing agents into the uterine cornu3 I’w’ii additional trnnscervi cal ;ipproache.s have been electrocautery and the :ippl ic:itj on of c\.unoncri 1 ate tissue udhcsivcs into the lumen of the fallopi:n1 tube. it ‘is technically ciifficult to exactly localize the olwnini: of the f;~llopinn tube and to force material into the lumen. .\ contwit pressure technique iius devclopc~! for this purposf, which utilizes ;I curved uterine cnnnula whose distal end except for the tip is surrounded ‘I’hCTfi I led by ;I rubber buIloon that can be inflated via a small tube. balloon scrvcs :IC; :I seal for the cndomctr‘ial cavity, except in the arca of the tii, of the cnnnula. l’hc cannul:~ i5 aLl_iusted until it is in proper pro?timIty to the tubal ori Cite. l’tiis instrument lbill he further modified so th:It ,/ measured :>mount of tissue adhes~vc c‘:~n be jntroduccd. \n cup;~nJi~q cautery clcvicc hr15 been clcrigned khi ch can be introduced
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damage can be produced. be necessary in order to
Extension determine
of this work to human subjects will the effectiveness of these techniques.
The effects of endometrial cryocoagulation and its potential as a sterilization method were described by William Droegemueller (University Homogeneous ablation of the endometrium of Colorado School of Medicine). Intrauterine should result in sterilization due to end organ failure. cryosurgery was performed following diagnostic dilatation and curettage in 6 women scheduled for hysterectomies. A separate 4-6 minute freezethaw cycle was applied to 4 uterine areas, using a probe with a linear freezing surface of 3 cm whose distal 1 cm contained an insulator. The results of this preliminary study were encouraging; morbidity was minimal, and endometrial coagulation necrosis was accomplished without myometrial damage. A second group of 16 patients with dysfunctional uterine bleeding were treated with endometrial probes designed to damage the entire endometrium. Ten of the patients were amenorrheic for the 6-8 week interval before hysterectomy. There was a sharp demarcation between the coagulated tissue and the normal myometrium. The procedure was performed under paracervical block anesthesia in 2 patients, suggesting that it could be adapted for use as an outpatient procedure. However, some endometrial tissue persisted in all patients, and More recent experiments use problems were encountered with the probe. Of 11 patients on whom nitrous oxide rather than Freon as the cryogen. cryosurgery was tested with this device, 3 were free of residual endometrial tissue as evidenced by review of serial histologic sections from the hysterectomy, but all remaining 8 patients showed residual endometrium in the fundal or cornual regions. Future experiments will be directed toward the development of more effective probes to place the cryogen in close proximity to the entire endometrial lining and the determination of the long-term regenerative and functional reproductive capacity of the endometrium. James Newell (Palo Alto, California) described preliminary studies on hysteroscope visualization for use in uterotubal occlusion, with the ultimate goal of performing sterilization on an outpatient basis. A flexible bronchoscope with photographic capability and a cold light source has been used; it has a diameter of 5 mm, contains a light channel, viewing objective lens and a biopsy channel, and is used in conjunction with a dextran solution. Although the length (57 cm) and flexibility makes the instrument unwieldy and is longer than the ideal cannulizing catheters, it is always possible to locate the cornual regions when tip placement is known. It is also easy to identify the cornual region with the rigid hysteroscope now in use in Japan. Successful permanent closure of the fallopian tubes under hysteroscope visualization has been reported in 76 of 84 cases by Mohri and Mohri, although their method of electrocoagulation could be further refined. Once an appropriate hysteroscope has been obtained, tubal occlusion will be attempted by cauterizing 1 cm regions in the intramural portion of the fallopian tubes with semi-rigid olive or filiform cauterizing tip having a 1 mm diameter, and using a spark-gap
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current. If this current is applied at high power coagulating electric and for a short time, the depth of coagulation should be limited, and Blockade during secondary hemorrhage and tissue damage minimized. fibrosis should be provided by edema and spasm. IMAGING TECtfiVIQlJES ‘The available options for imaging the female reproductive system were Imaging must discussed by John Deichman (Battelle Northwest Laboratories). be an integral part of the sterilization technique, whether the procedure is invasive or noninvasive, or whether it utilizes a mechanical, electrical, chemical, ultrasonic or thermal procedure. Dr. Deichman felt that the imaging technique must never be more complex than the sterilization procedure; for example, a noninvasive technique would have to use a noninvasive or no imaging technique. Of the many possible sources of illumination and techniques of imaging, some are quite incompatible with the imaging requirements for the female reproductive system. Possible non-invasive illuminating sources include ultrasound (pulseecho methods, ultrasonic holography) and X-rays (radiography, fluororadiography) Invasive while invasive techniques may in addition utilize light sources. techniques now utilize the culdoscope, laparoscope, fiber optics, etc. Development of a screen presentation, such as on a video monitor, could provide greater freedom for the sterilization team and would eliminate the need for a cumbersome eye piece.
CONCLUSIONS The available culdoscopic and laparoscopic procedures are already in These techniques use on an outpatient basis in a limited number of clinics. are highly acceptable to patients and only a low morbidity is associated with them. The major disadvantage of these procedures is that, at their present stage of development, they require a good deal of skill and prior training They would in abdominal surgery, and significant instrument repair support. be greatly simplified by the development of an improved tubal clip and forceps for culdoscopic use, as well as by the development of instrumentation Simplification of so that the clip technique could be used in laparoscopy. these surgical techniques can be expected to increase their utility in less developed countries. However, a scarcity of physicians in these countries limits their use. The various transcervical approaches described at this meeting show promise for future use on a widespread basis, but they all require fairly Dr. Zipper’s studies with quinacrine as extensive development and testing. a tubal occluding agent need to be pursued in order to increase the The use of tissue adhesives effectiveness of a single administration. and paraformaldehyde as occluding agents needs to be extended to patients, and shows promise of being a fairly simple, nontoxic method of occlusion.
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Previous studies of uterotubal cautery have not proven successful in with or without hysteroscope humans ; however, newer techniques, The use of endometrial visualization, may prove more successful. cryocoagulation may prove feasible; however, a means of complete ablation is not yet available. Further development of imaging techniques such as hysteroscopy and ultrasonic holography should facilitate the development of various transcervical approaches to sterilization. The participants were in general agreement that a two-pronged approach towards research in sterilization techniques is necessary. Those techniques that are presently available must be simplified in order In addition, to make their use practical for the average physician. completely new and simpler methods are required that could ultimately Methods requiring a transcervical be used by paramedical personnel. approach rather than involving penetration of the peritoneal cavity would lend themselves more readily to use by paramedical personnel. The need for incorporating sterilization procedures in general and specifically outpatient procedures - into family planning programs was established. The assembled participants, including program directors as well as medical and bioengineering professionals, all evidenced optimism that the required improvements in technology would be forthcoming
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FEMALE STERILIZATION:
PROGNOSIS FOR SIMPLIFIED
OUTPATIENT PROCEDURES Diana Schneider Johnson, Ph.D. Department of Physiology Medical College of Virginia Richmond, Virginia 23225 INTRODUCTION This report is a summary of a conference held at Airlie Mouse, Virginia, on December 2-3, 1971, in order to assess the current status of female sterilization procedures and to determine the most promising research approaches for the development of simplified sterilization techniques for The workshop was organized by Gordon W. Duncan use in less developed countries. and Richard D. Falb of the Battelle Population Study Center and supported by the United States Agency for International Development (AID). The workshop was organized on the assumption that the perfection of safe, simple procedures for female sterilization would significantly affect the direction and impact of family planning programs. The medical concern with the continuing reassessment of current pharmacologic contraceptive programs, the characteristics of effective fertility control measures and the resurging world-wide interest in the application of sterilization procedures warrant a critical appraisal of the contributions that can be expected from outpatient sterilization procedures and what efforts are yet required to achieve these expectations. The workshop was divided into sessions designed to: 1) describe the role of female sterilization in family planning programs and the impact that the availability of practical outpatient sterilization procedures would have on such programs; establish the criteria for practical outpatient procedures, with particular emphasis on the specific requirements imposed by consideration of their application in lesser developed countries; characterize the training procedures necessary to support sterilization programs; 2) comment on the anatomy, physiology, biochemistry and bioengineering of the oviduct and uterus as they pertain to sterilization procedures; 3) systematically review the currently available and contemplated sterilization techniques and their supportive instrumentation, with separate consideration of transabdominal and of transvaginal/cervical approaches; 4) critically assess the advantages, disadvantages and limitations of each procedure as compared to the previously established performance criteria; identify potential medical, mechanical and engineering contributions to correct the deficiencies of existent technology; establish logical research and development programs to achieve practical outpatient sterilization procedures. The proceedings of this meeting will be published by Academic Press in Prognosis for Simplified Outpatient Procedures, the Spring as Female Sterilization: edited by G. W. Duncan, R. D. Falb and J. J. Speidel.
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Dr. John Cutler (University of Pittsburgh School of Public Health), the conference moderator, opened the meeting by noting that there is a scarcity of trained physicians as well as other medical support personnel Therefore, research and backup equipment in the less developed countries. is needed to develop simplified procedures for use under a wide variety of conditions. ,J. Joseph Spcidel (AID) discussed the role of female sterilization in family planning programs. At the present time, female sterilization has only a modest role in the organized family planning programs of most countries. A primary reason for this is the administrative restrictions which are placed on the availability of sterilization. Kequirements for high age and parity, as in the “rule of 120” (age x parity = 120)) thus limit the demographic impact of female sterilization. There is strong evidence that the individual acceptance of sterilization is high, and that many people will use sterilization where there are no barriers to its avallabi lity. Although irreversability has been thought to be a major the high acceptance rates in impediment to acceptance of sterilization, some countries and low rate of requests for reversal suggest that this is Most users consider sterilization as a procedure to be not the case. used to terminate childbearing rather than as a means of spacing children. The need for hospitalization and attendant pain and scarring may be more serious barriers , and the enthusiasm of the medical community is critical. At present, lack of medical care infrastructure is the key impediment to further extension of this method in many countries. With these factors in mind , sterilization procedures should be evaluated on the basis of: Practicality. Sophisticated techniques such 3s laparoscopy and 1. culdoscopy may diminish the need for hospitalization, but this may be counterbalanced by equipment costs, maintenance requirements and the need for greater skill on the part of the doctor. f’ermanence has a great practical advantage in that it is only necessary to reach the target This is highly important where skilled medical personnel population once. are scarce. In addition, while initial costs are high, they can be amortized over the patient’s rcproductivc lifetime, as opposed to the continuing cxpensc of operating 3 family planning program. Demographic Impact. Impact is detcrmincd by prevalence of use, 2. effectiveness and the age and parity of the acceptor. At the present time, prevalence of use is low, effectiveness is high, and the age and parity of the acceptor are higher than would be desirable. _ Safety and Side Effects. Steri lization procedures have those side 3. -7 effects generally associated with minor abdominal surgery, and the mortality rate of 25/100,000 is low when considered over the reproductive life span. This rate is much lower than maternal death rates in most less developed countries.
-1
increasing
156
Role and Yced for rechnology. the prevalence of sterilization
‘The most successful strategy for will be the development of new
FEBRUARY
1972
VOL. 5 NO. 2
CONTRACEPTION
Highest priority should be placed on research and acceptable techniques. to develop simplified sterilization technology which can realistically be made available within the scope of family planning delivery systems in less Simplification and improvement of current medically developed countries. dependent means of female sterilization is important, but the ultimate goal is the development of means that are not dependent upon scarce medical personnel or facilities. Although the full potential of female sterilization in family planning it seems likely that this method is adequately programs cannot be predicted, acceptable to individual women and could therefore become a demographically effective means of fertility control for use in family planning programs. Jaroslav Hulka (University of North Carolina) discussed fundamental features of the anatomy and physiology of the fallopian tubes that must be The fallopian tubes considered when designing new methods of sterilization. are sources of secretions which flow toward both the uterus and the peritoneal cavity via the fimbria, and are also highly motile and contractile structures. Their physiology must be kept in mind when considering occlusion of the tubes. Since the reproductive organs utilize transport in two directions, both to transport sperm toward the fimbria and ova toward the uterus, a form of sterilization which blocked transport in one direction might be effective. It was suggested that transabdominal postpartum sterilization should be more widely practiced, Individual acceptance is high at this time, and the operative technique is simplified since the tubes are close to the abdominal wall.
SURGICAL STERILIZATION PROCEDURES The use of culdoscopy as a sterilization procedure was discussed by Martin Clyman (New York City), Alfonso Gutierrez Najar (Mexico City) and William Little (Miami), who have been developing outpatient procedures using this technique. The procedure involves penetration of the vaginal cul-de-sac and insertion of the culdoscope for visualization, after which the fallopian tubes are either severed via a modified Pomeroy technique (Clyman, Little), or clamped with hemoclips (Gutierrez Najar). The pre- and postoperative treatments used by these physicians differ, as do contraindications, analgesia, instruments, etc., but their procedures are basically quite similar. Dr. Clyman considers the presence of a mass in the cul-de-sac to be the major contraindication, and procedes if there is adequate mobility of the tubes. Most of Dr. Gutierrez Najar’s patients are from the postabortion or postpartum clinics, and therefore generally have free pelvic mobility; the pelvis and cul-de-sac must be clear of pathology for the operation to proceed. The clip technique involves tubal closure that is tight enough to prevent free passage but loose enough to prevent necrosis. This procedure has been used on over 4000 patients, of whom 1305 have been reculdoscoped for observation, Of 1112 treated with this method, there were only 9 failures and 3 pregnancies, with few complications. The majority of failures were due to incompletely closed clips. Dr. Little
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those patients who show any pelvic pathology and who might require future hysterectomy, as well as obese patients in whom bowel tissue becomes a problem, diabetics, and patients with respiratory or cardiovascular disease. He worhs with an indigent population with a high incidence of pelvic inflammatory disease (PID) and other pathologies (10% have significant adhesive disease). Significant complications were seen in 7 of 190 patients. Culdoscop~ has significant advantages over other procedures. It can be done as an outpatient procedure and does not require general anesthesia. This reduces the required number of trained physicians from 2 to 1, since an anesthesiologist is not required. Patient acceptance is high because of the lack of a hospitalization requirement, high effectiveness, minimal discomfort and the lack of a visible scar. It has the significant disadvantage of requiring at least some training in abdominal surgery. The procedure may be difficult for many physicians to learn, as most abdominal surgery is initiated with the patient in the pronc position, while culdoscopy requires that the peritoneal cavity be entered from below, with the patient in a knee-chest position. excludes
Clifford R. Wheclcss (Johns tloJ>kins Ilospital, Baltimore) has developed a single incision laparoscopic technique that can be performed with local anesthesia. I’he development of this procedure was designed to 1) reduce hospitalization time to less than 24 hours, 2) require less than 30 minutes operating time, 3) require the skill of the average physician, 4) have results comparable with those of other techniques of tubal ligation, and 4 pilot study in the Maryland farnil) 5) cost les than $100 per Jlatient. planning clinics showed that all requirements hut (3) could be met; surgical experience 118s needed for successful use of the technique. Cost was also Dr. Wheeless also higher than was desirable ($150 instead of $100 j. successfully introduced this technique at the State ‘Yaternity Hospital in Knthmandu, Nepa I, under much more difficult conditions. The USC of local anesthesia was made Jlossible by the use of a oneincision technique, in which the cauterization instrument is inserted through an operating pore in the laparoscope. The patient is sedated and a cannula is placed into the uterus to maintain the reproductive organs in the desired Jlosition. The abdomen is Jn-epped with Iodine solution, the umbilicus injected with lidocainc, a 2 mm incision is made in the umbilicus, and the peritoneal cavity is filled with 2 liters of COz. The incision is then The pelvis is thoroughly widened to 1 cm and the laparoscope inserted. inspected prior to cauterization of the fallopian tubes using the cutting current of the instrument, which is not painful because it produces a 3rd degree burn which hills the nerve. The patient is warned to expect slight It is pain, which appears to he similar to that involved in 11111placement. hoped that :I clip> holder similar to that used in culdoscopy ryill be developed in the near future; this would simplify the technique and reduce the ‘L‘hcminimal extent of concern for reversibility opcrnt i ye sk i 11 norg required. in an ncccptable sterilization procedure was indicated by the observation that onlv one of 2000 patients has rcqucstcd xssistancc in re-establishing her fertllitv.
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Hospital, Pittsburgh), Leonard Laufe (The Western Pennsylvania Columbus Laboratories) described Craig Hassler and Brenton Lower (Battelle preliminary studies with loose fitting or balloon type silicone rubber fimbrial caps designed to provide reversible sterilization. The caps were placed over the fimbriated end of one fallopian tube in rabbits via laparotomy , and were anchored to the broad ligament; the second uterine horn was used as a control for each animal. With the cap in place, Subsequent implantations occurred only in the noncapped uterine horn. removal of the cap and remating led to normal pregnancy and implantations These preliminary results indicate that the fimbrial in both uterine horns. However, the cap approach to reversible sterilization may be feasible. procedure as it is now employed does require abdominal surgery for both The which limits its use at the present time. placement and removal, concept of a fimbrial covering does seem to be a reasonable approach and eventually might be accomplished via a single transcervical injection of a time-controlled setting polymer which would set as it reached the It might also be feasible to use a biodegradable compound ends of the tube. for such a procedure.
NON-SURGICALSTERILIZATION PROCEDURES Santiago) discussed the use of Jaime Zipper (University of Chile, quinacrine as an occlusive agent for the human fallopian tube. Animal studies showed that quinacrine application to one uterine horn occludes the lumen as the result of a granulomatous reaction, that the effects of quinacrine are potentiated by the addition of other agents, and that The potentiation estrogen or progesterone prevents the quinacrine effect. drugs and metal ions was highly of quinacrine action by various hormones, and no good model for the human has been found variable between species, This latter point was a concern of several participants, to date. particularly from the standpoint that the animal models may provide too severe a test and result in potentially useful clinical methods being In a series of 500 human subjects, who have been followed discarded. a single transcervical application of quinacrine was for up to 4 years, found to produce occlusion in 66% of the patients. This fairly low effectiveness was increased to 92% when quinacrine was administered on Zinc chelating agents and zinc competitors such two separate occasions. as copper were found to be the most effective potentiators for quinncrine It has been postulated that the effect of quinacrine action in the human. results from binding to DNA, and that this binding is dependent on the endometrial zinc concentration. Future studies will be directed toward improving the effectiveness of until the method is more than 95% effective with one quinacrine treatment, This procedure shows great potential for mass programs, as application. it is even simpler than IUD insertion and takes only 2-3 minutes to complete. which has none of the prohlems It involves a transcervical approach, attendant uponacurgical procedure; therefore it could be readily utilized as an outpatient procedure that could be performed by paramedical personnel.
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Columbus and I(. I,. I’avkov (liattelle 1:31b, G. A. Grodc described the potential USC of rapidly polymerizing tissue rhe ideal occluding adhesive was tubal occluding agents. determined to he one that would form primary covalent bonds with functional It was suggested that such 3 material must be groups in body tissues. and it must be nontoxic biodegradable and replaced by regcncrating tissue, An adhcsivc system consistin?, of gelr~tin-rcsorcinoland non cnrcinogcn i c formaldehyde best fulfi 1 led these critcri a. ‘I‘his materi;ll has been anil acts by bonding to tissue extensively tested in man!~ anininl tissues, When used for surfii cal bonding, the original incision heals protein. after i-0 months :~nd the adhcsivc is displ:iccd h!, regener:lting tissue. The time required for setting of the material is 2 function of ptl and thcrcfore cas i I!, control led, and it is of jlart icular value for bleeding or csuding tissue or tissue \,ith ;I mricos:il lxycr. It products some irritation and granulomatous tissue formation, ih i ch coilld bc advantageous for l)lochade of the f:11 lopinn tube. I’rclimin:iry 5tudics with rabbits utilized and resulted in ;I firm r~dhesion to the tissue 2 lq~aroscopi c procwltrre, and :i 1:icL of‘ prC>gnancy in the treated horn, indicating the feasibility lhc go;‘1 in an\ futrlrc rtorh with human subiccts wi 11 be of the aj’pr”:lch. appl i cat ion vi:1 ;i t~anscervi c‘:, 1 apprnnch. \ preliminary dclivcry system for th ii matcri al has Ihew clc\-clop~~il, hut ha4 not !‘et been tested in hum:ln suhj ccts Richard
Ii.
Lnhoratorics) adhesives as
lior;lce 1.. Ihom~~son (1)enver C;cneral Ilospi t:rl) discussed several tfchniqucs of transccrvical oviduct occlusion that arc in various stages of expcrimentntion. t’c~raform~ildei~\~rle in :d~solutc eth:lnol w’ns inserted into the cornual region of monhcys v; ;I la~~:rrotomy. ‘l’hi s combination w:js found to sloaly dissol\-c in the uterine musculature, producing 3 chronic irritation rfsul till: in the formation of a granulomcltow reaction and subscqucnt tubal closure It is not possible to prc’dict the results on human patients from l’rehystcrectom)paticr1t.s will /JC’ tested, using a curved, blunt this study. c:innul;i &signed for the introduction oi‘ sclcrosing agents into the uterine cornu3 I’w’ii additional trnnscervi cal ;ipproache.s have been electrocautery and the :ippl ic:itj on of c\.unoncri 1 ate tissue udhcsivcs into the lumen of the fallopi:n1 tube. it ‘is technically ciifficult to exactly localize the olwnini: of the f;~llopinn tube and to force material into the lumen. .\ contwit pressure technique iius devclopc~! for this purposf, which utilizes ;I curved uterine cnnnula whose distal end except for the tip is surrounded ‘I’hCTfi I led by ;I rubber buIloon that can be inflated via a small tube. balloon scrvcs :IC; :I seal for the cndomctr‘ial cavity, except in the arca of the tii, of the cnnnula. l’hc cannul:~ i5 aLl_iusted until it is in proper pro?timIty to the tubal ori Cite. l’tiis instrument lbill he further modified so th:It ,/ measured :>mount of tissue adhes~vc c‘:~n be jntroduccd. \n cup;~nJi~q cautery clcvicc hr15 been clcrigned khi ch can be introduced
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damage can be produced. be necessary in order to
Extension determine
of this work to human subjects will the effectiveness of these techniques.
The effects of endometrial cryocoagulation and its potential as a sterilization method were described by William Droegemueller (University Homogeneous ablation of the endometrium of Colorado School of Medicine). Intrauterine should result in sterilization due to end organ failure. cryosurgery was performed following diagnostic dilatation and curettage in 6 women scheduled for hysterectomies. A separate 4-6 minute freezethaw cycle was applied to 4 uterine areas, using a probe with a linear freezing surface of 3 cm whose distal 1 cm contained an insulator. The results of this preliminary study were encouraging; morbidity was minimal, and endometrial coagulation necrosis was accomplished without myometrial damage. A second group of 16 patients with dysfunctional uterine bleeding were treated with endometrial probes designed to damage the entire endometrium. Ten of the patients were amenorrheic for the 6-8 week interval before hysterectomy. There was a sharp demarcation between the coagulated tissue and the normal myometrium. The procedure was performed under paracervical block anesthesia in 2 patients, suggesting that it could be adapted for use as an outpatient procedure. However, some endometrial tissue persisted in all patients, and More recent experiments use problems were encountered with the probe. Of 11 patients on whom nitrous oxide rather than Freon as the cryogen. cryosurgery was tested with this device, 3 were free of residual endometrial tissue as evidenced by review of serial histologic sections from the hysterectomy, but all remaining 8 patients showed residual endometrium in the fundal or cornual regions. Future experiments will be directed toward the development of more effective probes to place the cryogen in close proximity to the entire endometrial lining and the determination of the long-term regenerative and functional reproductive capacity of the endometrium. James Newell (Palo Alto, California) described preliminary studies on hysteroscope visualization for use in uterotubal occlusion, with the ultimate goal of performing sterilization on an outpatient basis. A flexible bronchoscope with photographic capability and a cold light source has been used; it has a diameter of 5 mm, contains a light channel, viewing objective lens and a biopsy channel, and is used in conjunction with a dextran solution. Although the length (57 cm) and flexibility makes the instrument unwieldy and is longer than the ideal cannulizing catheters, it is always possible to locate the cornual regions when tip placement is known. It is also easy to identify the cornual region with the rigid hysteroscope now in use in Japan. Successful permanent closure of the fallopian tubes under hysteroscope visualization has been reported in 76 of 84 cases by Mohri and Mohri, although their method of electrocoagulation could be further refined. Once an appropriate hysteroscope has been obtained, tubal occlusion will be attempted by cauterizing 1 cm regions in the intramural portion of the fallopian tubes with semi-rigid olive or filiform cauterizing tip having a 1 mm diameter, and using a spark-gap
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current. If this current is applied at high power coagulating electric and for a short time, the depth of coagulation should be limited, and Blockade during secondary hemorrhage and tissue damage minimized. fibrosis should be provided by edema and spasm. IMAGING TECtfiVIQlJES ‘The available options for imaging the female reproductive system were Imaging must discussed by John Deichman (Battelle Northwest Laboratories). be an integral part of the sterilization technique, whether the procedure is invasive or noninvasive, or whether it utilizes a mechanical, electrical, chemical, ultrasonic or thermal procedure. Dr. Deichman felt that the imaging technique must never be more complex than the sterilization procedure; for example, a noninvasive technique would have to use a noninvasive or no imaging technique. Of the many possible sources of illumination and techniques of imaging, some are quite incompatible with the imaging requirements for the female reproductive system. Possible non-invasive illuminating sources include ultrasound (pulseecho methods, ultrasonic holography) and X-rays (radiography, fluororadiography) Invasive while invasive techniques may in addition utilize light sources. techniques now utilize the culdoscope, laparoscope, fiber optics, etc. Development of a screen presentation, such as on a video monitor, could provide greater freedom for the sterilization team and would eliminate the need for a cumbersome eye piece.
CONCLUSIONS The available culdoscopic and laparoscopic procedures are already in These techniques use on an outpatient basis in a limited number of clinics. are highly acceptable to patients and only a low morbidity is associated with them. The major disadvantage of these procedures is that, at their present stage of development, they require a good deal of skill and prior training They would in abdominal surgery, and significant instrument repair support. be greatly simplified by the development of an improved tubal clip and forceps for culdoscopic use, as well as by the development of instrumentation Simplification of so that the clip technique could be used in laparoscopy. these surgical techniques can be expected to increase their utility in less developed countries. However, a scarcity of physicians in these countries limits their use. The various transcervical approaches described at this meeting show promise for future use on a widespread basis, but they all require fairly Dr. Zipper’s studies with quinacrine as extensive development and testing. a tubal occluding agent need to be pursued in order to increase the The use of tissue adhesives effectiveness of a single administration. and paraformaldehyde as occluding agents needs to be extended to patients, and shows promise of being a fairly simple, nontoxic method of occlusion.
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Previous studies of uterotubal cautery have not proven successful in with or without hysteroscope humans ; however, newer techniques, The use of endometrial visualization, may prove more successful. cryocoagulation may prove feasible; however, a means of complete ablation is not yet available. Further development of imaging techniques such as hysteroscopy and ultrasonic holography should facilitate the development of various transcervical approaches to sterilization. The participants were in general agreement that a two-pronged approach towards research in sterilization techniques is necessary. Those techniques that are presently available must be simplified in order In addition, to make their use practical for the average physician. completely new and simpler methods are required that could ultimately Methods requiring a transcervical be used by paramedical personnel. approach rather than involving penetration of the peritoneal cavity would lend themselves more readily to use by paramedical personnel. The need for incorporating sterilization procedures in general and specifically outpatient procedures - into family planning programs was established. The assembled participants, including program directors as well as medical and bioengineering professionals, all evidenced optimism that the required improvements in technology would be forthcoming
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