Diagnosis and Therapy of Female Genital Malformations (Part 1). Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/052, May 2019)

Abstract

Objectives Female genital malformations may take the form of individual entities, they may involve neighboring organs or they may occur in the context of complex syndromes. Given the anatomical structures of the vulva, vagina, uterus and adnexa, the clinical picture of malformations may vary greatly. Depending on the extent of the malformation, organs of the urinary system or associated malformations may also be involved.

Methods This S2k-guideline was developed by representative members from different medical specialties and professions as part of the guidelines program of the DGGG, SGGG and OEGGG. The recommendations and statements were developed using a structured consensus process with neutral moderation and voted on.

Recommendations The guideline is the first comprehensive presentation of the symptoms, diagnosis and treatment options for female genital malformations. Additional chapters on classifications and transition were included.

Key words

guideline - genital malformation - genital reconstruction - MRKH - vaginal septum - subseptate uterus - bladder exstrophy - cloacal malformation

I  Guideline Information

Guidelines program of the DGGG, OEGGG and SGGG

For information on the guidelines program, please refer to the end of this guideline.

Citation format

Diagnosis and Therapy of Female Genital Malformations (Part 1). Guideline of the DGGG, OEGGG and SGGG (S2k Level, AWMF Registry Number 015/052, May 2019). Geburtsh Frauenheilk 2021; 2021; 81: 1307–1328

Guideline documents

The complete German-language long version of this guideline and a slide version of these guidelines as well as a list of the conflicts of interest of all of the authors are available on the homepage of the AWMF: http://www.awmf.org/leitlinien/detail/ll/015-052.html

Guideline authors

See [Tables 1] and [2].

Table 1 Lead author and/or coordinating guideline author.

Author	AWMF professional society
Prof. Dr. Peter Oppelt	Arbeitsgemeinschaft gynäkologische Endoskopie in DGGG [Gynecologic Endoscopy Working Group of the DGGG], Österreichische Gesellschaft für Gynäkologie & Geburtshilfe [Austrian Society of Gynecology and Obstetrics]

Table 2 Contributing guideline authors.

Author Mandate holder	DGGG working groups/AWMF/non-AWMF professional society/organization/association
Binder Helge, Prof. Dr.	Arbeitsgemeinschaft gyn. Endoskopie in DGGG [Gynecologic Endoscopy Working Group of the DGGG]
Birraux Jacques, Dr.	Schweizerische Gesellschaft für Kinderchirurgie [Swiss Society for Pediatric Surgery]
Brucker Sara, Prof. Dr.	Arbeitsgemeinschaft gyn. Endoskopie in DGGG [Gynecologic Endoscopy Working Group of the DGGG]
Dingeldein Irene, Dr.	Schweizerische Gesellschaft für Gynäkologie und Geburtshilfe [Swiss Society of Gynecology and Obstetrics]
Draths Ruth, Dr.	Schweizerische Arbeitsgemeinschaft für Kinder- und Jugendgynäkologie [Swiss Working Group on Pediatric and Adolescent Gynecology]
Eckoldt Felicitas, Prof. Dr.	Deutsche Gesellschaft für Kinderchirurgie [German Society for Pediatric Surgery]
Füllers Ulrich, Dr.	Arbeitsgemeinschaft gyn. Endoskopie in DGGG [Gynecologic Endoscopy Working Group of the DGGG]
Hiort Olaf, Prof. Dr.	Deutsche Gesellschaft für Kinder- und Jugendmedizin [German Society of Pediatrics and Adolescent Medicine]
Hoffmann Dorit, Dr.	Schweizerische Gesellschaft für Pädiatrie [Swiss Society of Pediatrics]
Hoopmann Markus, PD Dr.	Arbeitsgemeinschaft für Ultraschalldiagnostik in DGGG [Working Group for Ultrasound Diagnostics in the DGGG]
Hucke Jürgen, Prof. Dr.	Arbeitsgemeinschaft gyn. Endoskopie in DGGG [Gynecologic Endoscopy Working Group of the DGGG]
Korell Matthias, PD Dr.	Arbeitsgemeinschaft gyn. Endoskopie in DGGG [Gynecologic Endoscopy Working Group of the DGGG]
Kühnert Maritta, Prof. Dr.	Arbeitsgemeinschaft Geburtshilfe & Pränatalmedizin in DGGG [Obstetrics and Prenatal Medicine Working Group of the DGGG]
Ludwikowski Barbara, PD Dr.	Deutsche Gesellschaft für Kinderchirurgie [German Society for Pediatric Surgery]
Mentzel Hans-Joachim, Prof. Dr.	Gesellschaft für Pädiatrische Radiologie [Society for Pediatric Radiology]
OʼDey Dan mon, PD Dr.	Deutsche Gesellschaft der Plastischen, Rekonstruktiven und Ästhetischen Chirurgen [Geman Society of Plastic, Reconstructive and Aesthetic Surgeons]
Rall Katharina, Dr.	AG Kinder- und Jugendgynäkologie in DGGG [Pediatric and Adolescent Gynecology Working Group of the DGGG]
Riccabona Michael, Univ.-Prof. Dr.	Gesellschaft für Pädiatrische Radiologie [Society for Pediatric Radiology]
Rimbach Stefan, PD Dr.	Arbeitsgemeinschaft gyn. Endoskopie in DGGG [Gynecologic Endoscopy Working Group of the DGGG]
Schäffeler Norbert, Dr.	Deutsches Kollegium für Psychosomatische Medizin [German Collegium of Psychosomatic Medicine]
Shavit Sandra, Dr.	Schweizerische Gesellschaft für Kinderchirurgie [Swiss Society for Pediatric Surgery]
Stein Raimund, Prof. Dr.	Deutsche Gesellschaft für Urologie [German Society of Urology]
Utsch Boris, PD Dr.	Deutsche Gesellschaft für Kinder- und Jugendmedizin [German Society of Pediatrics and Adolescent Medicine]
Wenzl Rene, Prof. Dr.	Österreichische Gesellschaft für Gynäkologie & Geburtshilfe [Austrian Society of Gynecology and Obstetrics]
Wieacker Peter, Prof. Dr.	Deutsche Gesellschaft für Humangenetik [German Society of Human Genetics]
Zeino Mazen, Dr.	Schweizerische Gesellschaft für Kinderurologie [Swiss Society for Pediatric Urology]

The guideline was moderated by Dr. med. Monika Nothacker (AWMF-certified guideline moderator).

II  Guideline Application

Purpose and objectives

This guideline aims to present feasible diagnostic and therapeutic approaches for patients with congenital malformations of the female genital tract.

Targeted areas of patient care

1. Hospital care

2. Outpatient care

3. Day-patient care

4. Senior consultant/medical specialist care

Target user group/target audience

This guideline is addressed to the following groups of persons:

• Practice-based gynecologists

• Hospital-based gynecologists

• Practice-based physicians of pediatric and adolescent medicine

• Hospital-based physicians of pediatric and adolescent medicine

• Practice-based pediatric surgeons

• Hospital-based pediatric surgeons

• Practice-based physicians for pediatric radiology

• Hospital-based physicians for pediatric radiology

• Practice-based pediatric urologists

• Hospital-based pediatric urologists

• Practice-based physicians of psychosomatic medicine and psychologists

• Hospital-based physicians of psychosomatic medicine and psychologists

The guideline also aims to provide information to other medical professionals who care for female patients with genital malformations, e.g., nurses.

Adoption and period of validity

The validity of this guideline was confirmed by the executive boards/heads of the participating medical professional societies, working groups, organizations and associations as well as the boards of the DGGG, the DGGG guidelines commission, the SGGG and the OEGGG in the 4th quarter of 2019 and was thus approved in its entirety. This guideline is valid from 1st May 2019 through to 30th May 2024. Because of the contents of this guideline, this period of validity is only an estimate.

III  Methodology

Basic principles

The method used to prepare this guideline was determined by the class to which this guideline was assigned. The AWMF Guidance Manual (version 1.0) has set out the respective rules and requirements for different classes of guidelines. Guidelines are differentiated into lowest (S1), intermediate (S2), and highest (S3) class. The lowest class is defined as consisting of a set of recommendations for action compiled by a non-representative group of experts. In 2004, the S2 class was divided into two subclasses: a systematic evidence-based subclass (S2e) and a structural consensus-based subclass (S2k). The highest S3 class combines both approaches.

This guideline has been classified as: S2k

Grading of recommendations

The grading of evidence based on the systematic search, selection, evaluation and synthesis of an evidence base which is then used to grade recommendations is not envisaged for S2k guidelines. The different individual statements and recommendations are only differentiated linguistically, not by the use of symbols ([Table 3]):

Table 3 Grading of recommendations (based on Lomotan et al., Qual Saf Health Care 2010).

Description of binding character	Expression
Strong recommendation with highly binding character	must/must not
Regular recommendation with moderately binding character	should/should not
Open recommendation with limited binding character	may/may not

Statements

Expositions or explanations of specific facts, circumstances or problems without any direct recommendations for action included in this guideline are referred to as “statements”. It is not possible to provide any information about the grading of evidence for these statements.

Achieving consensus and level of consensus

At structured NIH-type consensus-based conferences (S2k/S3 level), authorized participants attending the session vote on draft statements and recommendations. The process is as follows. A recommendation is presented, its contents are discussed, proposed changes are put forward, and finally, all proposed changes are voted on. If a consensus (> 75% of votes) is not achieved, there is another round of discussions, followed by a repeat vote. Finally, the extent of consensus is determined based on the number of participants ([Table 4]).

Table 4 Level of consensus based on extent of agreement.

Symbol	Level of consensus	Extent of agreement in percent
+++	Strong consensus	> 95% participants agree
++	Consensus	> 75 – 95% participants agree
+	Majority agreement	> 50 – 75% participants agree
–	No consensus	< 51% participants agree

Expert consensus

As the term already indicates, this refers to consensus decisions taken specifically with regard to recommendations/statements issued without a prior systematic search of the literature (S2k) or where evidence is lacking (S2e/S3). The term “expert consensus” (EC) used here is synonymous with terms used in other guidelines such as “good clinical practice” (GCP) or “clinical consensus point” (CCP). The strength of the recommendation is graded as previously described in the chapter on the grading of recommendations; it is only expressed semantically (“must”/“must not” or “should”/“should not” or “may”/“may not”) without the use of symbols.

IV  Guideline

1  Epidemiology

The data on the epidemiology of genital malformations tended to be older and was usually obtained from retrospective studies and case reports [1], [2].

2  Etiology of anomalies of the Mullerian ducts

3  Classification

For many years, the standard classification of malformations was the classification of the American Fertility Society (AFS). The variation in the presentations of malformations led to the development of the VCUAM classification [3] and the ESHRE/ESGE classification [4]. Both classifications are based on anatomical structures. It is important in this context to also take associated malformations into account.

4  Diagnosis

5  Transition

5.1  Introduction and definition

5.2  Associated malformations

5.3  Multidisciplinary team

5.4  The specific objectives of the transition period

6  Malformations of the vulva

Recreation of the form and function of the external female genitalia is based on re-establishing their morphological features [5].

Because of the complexity of possible anatomical impairments, in addition to general surgery, reconstructive surgery of the external female genitalia must also include specialized procedures to achieve the optimal outcome [6].

7  Malformations of the vagina

7.1  Vaginal septa

(ESHRE/ESGE Class V1 – 3; VCUAM V1 – 5)

7.1.1  Longitudinal non-obstructive septum (V1)

(ESHRE/ESGE Class V1; VCUAM V2)

7.1.1.1  Diagnosis

A speculum examination is usually indispensable to make a definitive diagnosis of longitudinal vaginal septum.

In more than 87% of cases, vaginal septa are associated with uterine malformations. The patient must also be examined for anomalies of the kidney and urinary tract system, which are often also present in these patients [7], [8].

7.1.1.2  Therapy

The treatment of choice consists of dissection of the septum using two long straight clamps.

7.1.2  Longitudinal obstructive vaginal septum

(ESHRE/ESGE Class V2; VCUAM V5a)

7.1.2.1  Diagnosis

A speculum examination is indispensable to obtain a definitive diagnosis of obstructive longitudinal septum, most of which are located in the vicinity of the cervix, and to decide on the appropriate therapeutic approach. Hematocolpos and in some cases hematometra on the obstructed side are visible on ultrasound imaging as well as kidney anomalies in many cases. In recent years, 3D sonography has become increasingly important for diagnosis [9], [10].

Magnetic resonance imaging (MRI) may be useful to obtain a differential diagnosis of different obstructive malformations [11], [12].

7.1.2.2  Therapy

Treatment consists of resection of the septum, with tissue at the protruding site first aspirated with a cannula followed by sharp resection of part of the septum. It is important to avoid stenosis.

7.1.3  Imperforate hymen and transverse vaginal septum

(ESHRE/ESGE Class V3; VCUAM V1b)

7.1.3.1  Imperforate hymen

7.1.3.1.1  Diagnosis

Bulging of the hymen is visible on examination. Hematocolpos and in some cases hematometra are visible on ultrasound examination.

7.1.3.1.2  Therapy

Surgical correction is carried out with central incision of the hymen and resection, with placement of a bladder catheter in the vagina and laser or monopolar electrocautery. Most procedures use a cruciate or circular incision [12], [13].

7.1.3.2  Transverse vaginal septum

7.1.3.2.1  Diagnosis

The diagnosis is made based on speculum examination combined with ultrasound and, in some cases, MRI if required.

7.1.3.2.2  Therapy

Surgical treatment consists of excision of the septum. In complex cases and cases with a thick-walled septum, treatment must often be combined with an abdominal approach (laparoscopy or laparotomy) as well as flap reconstruction where necessary [14].

7.2  Vaginal aplasia

(ESHRE/ESGE Class V4; VCUAM V5b)

7.2.1  Diagnosis

The majority of cases have a blind vaginal dimple just a few centimeters in length and either uterine agenesis or a rudimentary uterus in the form of two aplastic uterine buds visible on ultrasound examination. Sonography of the kidneys may lead to the diagnosis of associated malformations. MRI may be used to detect additional associated malformations and characterize rudimentary Mullerian ducts [15], [16].

7.2.2  Therapy

The goal of therapy for vaginal aplasia is the creation of a sufficiently long and wide neovagina. Numerous conservative and surgical methods for the creation of a neovagina have been described in the literature. An overview of individual procedures is given in [Table 5].

Table 5 Overview of methods used to treat vaginal malformations.

Method	Advantages	Disadvantages	Complications
Non-surgical Frank self-dilation	No surgical risks, no surgical complications, no anesthesia	Protracted therapy, painful, requires maximum motivation and stringent guidance, continuous maintenance treatment is necessary as the neovagina has a tendency to shrink if the patient does not have regular sexual intercourse, length of the neovagina is rather small	Risk of using the wrong technique with dilation of the urethra, urethrovaginal/rectovaginal fistula, risk of prolapse
Surgical methods
1.  Creation of a neovagina through dissection of the area between the bladder and rectum (rectovesical tunneling) with a graft		Tendency to shrink, making regular dilation or regular sexual activity necessary postoperatively; in some cases, visible scar at the graft site (split-thickness skin graft), no lubrication to moderate lubrication, hair growth	Prolapse, fistulas, injury to the intestine and bladder, carcinoma development, formation of granulation tissue is common
1.1 McIndoe vaginoplasty and modifications	McIndoe procedure: relatively simple method, no abdominal approach required; can be used in cases with a functional uterus
1.2 Davydov procedure	Davydov procedure: good vaginal length, also possible in cases with genital scars from prior surgical procedures
2.  Creation of a neovagina by dissection of the area between the bladder and rectum (rectovesical tunneling) without a transplant/graft
2.1 Wharton-Sheares-George method	Relatively simple method when duct structures are visible, no abdominal approach required	Tendency to shrink, regular lifelong maintenance dilation or sexual activity required postoperatively, granulation tissue	Formation of cystoceles/rectoceles, dehiscence
3.  Flap reconstruction 3.1 Full-thickness skin transplants with flap reconstruction to form the vaginal lining 3.2 Vulvovaginal reconstruction	No abdominal approach required, primary wound healing, few stenoses, good success rates	Hair growth in the neovagina, discharge, fistulas, dyspareunia, scar formation at the graft/transplant site, non-physiological anatomy/angle of the neovagina	Flap necrosis, wound healing disorders, infection, incontinence, thromboembolisms, granulation tissue, prolapse
4.  Bowel vaginoplasty	Less likely to shrink, good lubrication, often does not require subsequent treatment with a vaginal mold	Complex surgical procedure, excessive malodorous discharge, dyspareunia, scar formation	Serious complications including mortality, bladder/bowel injury, infections, anastomotic insufficiency, ileum, tendency to prolapse, colitis, carcinoma development, granulation tissue
4.  Surgical dilation with traction 4.1 Vecchietti procedure with modifications 4.2 Balloon-based method	Good success rates, physiologically functional vaginal epithelium, good lubrication, no prolapse reported to date, short traction time, no long-term use of dilators required, can even be safely used in cases with a pelvic kidney	Special instruments required, requires sufficient analgesia during traction, postoperative treatment with a vaginal mold necessary for several months	Intestinal injury, bladder injury, granulation tissue

7.2.2.1  Non-surgical methods

This method of vaginal dilation, which is carried out by the patient herself, was first described in 1938 by Frank [17].

7.2.2.2  Surgical methods

Creation of a neovagina with dissection of the area between the bladder and rectum (rectovesical tunneling) and transplantation.

7.2.2.2.1  McIndoe vaginoplasty and modifications

Tunneling to create the neovagina is extended to the peritoneum of the pouch of Douglas. A split-thickness skin transplant, usually taken from the patientʼs buttock or thigh, is used to cover the neovagina.

7.2.2.2.2  Davydov procedure

The original procedure has largely been superseded by a laparoscopic approach, which results in less blood loss and less postoperative pain, shorter hospital stays, quicker recovery times, and better cosmetic results [18], [19].

7.2.2.3  Surgical methods

Creation of a neovagina with dissection of the area between the bladder and rectum (rectovesical tunneling) without a transplant.

7.2.2.3.1  Wharton-Sheares-George method

The George modification of the Wharton-Sheares method [20] no longer requires primary coverage of the surgically created cavity with a (autologous or heterologous) tissue graft and thereby avoids the problems associated with such transplants.

7.2.2.4  Flap reconstruction

7.2.2.4.1  Full-thickness skin transplants with flap-plasty reconstruction for vaginal coverage

The problem with the majority of these methods is that they leave visible scars, keloids may form, and lubrication is insufficient.

7.2.2.4.2  Vulvovaginal reconstruction

Objections to the use of this method include the abnormal location of the neovagina, which is awkwardly angled for sexual intercourse, and the lack of lubrication in some cases.

7.2.2.5  Bowel vaginoplasty

After creation of a tunnel between the rectum and the bladder, an isolated bowel segment is brought to the neovagina and sutured at the introitus [21].

7.2.2.6  Surgical dilation with traction

Vecchietti procedure and modifications

By connecting an olive-shaped dilator via traction threads to a traction device positioned on the abdomen close to the lower edge of the navel (subumbilical or suprapubic location), traction can be increased every day, resulting in the creation of a neovagina with a length of 10 – 12 cm within the space of 4 – 7 days [22], [23].

8  Malformations of the cervix

8.1  Double cervix

(ESHRE/ESGE C1+2; VCUAM C1)

8.1.1  Special diagnostic work-up

Congenital cervical anomalies are extremely rare malformations.

A double cervix is the result of a complete Mullerian fusion defect at the level of the cervix. The diagnosis is based on clinical examination, imaging using ultrasound and MRI and invasive endoscopy.

8.1.2  Therapy

The therapeutic focus is on treating associated malformations of the vagina and uterus.

8.2  Cervical aplasia

(ESHRE/ESGE C3 + 4; VCUAM C2a/b)

8.2.1  Special diagnostic work-up

The full clinical picture of cervical aplasia is complete cervical agenesis. However, the literature also includes reports of obstructed cervix, cervical remnants, or a cord of connective tissue [24].

Depending on the type of malformation, symptoms may be primary amenorrhea or cryptomenorrhea with lower abdominal pain occurring at cyclical intervals in cases with obstructive malformation; symptoms may also be entirely lacking or consist only of primary sterility [25].

The diagnosis is made based on clinical examination, imaging using ultrasound and MRI and invasive endoscopy.

8.2.2  Therapy

Treatment consists of surgery, which may take the form of hysterectomy or reconstruction using a cervico-cervical or uterovaginal anastomosis [21], [26].

When deciding on the appropriate treatment, it is important to consider potential complications if the patients become pregnant, for example, associated disorders of placentation [27].

Conflict of Interest/Interessenkonflikt

The conflicts of interest of all of the authors are listed in the German-language long version of the guideline./Die Interessenkonflikte der Autoren sind in der Langfassung der Leitlinie aufgelistet.

• References/Literatur

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Publication History

Received: 28 March 2021
Received: 02 December 2020

Accepted: 28 March 2021

Article published online:
08 December 2021