Quo Vadis Urogynecology 2020 - Innovative Treatment Concepts for Urinary Incontinence and Pelvic Organ Prolapse

As pelvic organ prolapse is associated with a chronic muscle weakness, the transition between prolapse stages up to and including pronounced pelvic organ prolapse is fluid and patients may not always feel much discomfort. Mild prolapse of the uterus or vaginal wall with no additional symptoms (no residual urine, no disorders of micturition, no foreign body sensation, no pain, no infections) does not automatically require treatment. However, given the fact that prolapse often progresses, patients should be encouraged to try prophylactic measures (lifestyle changes, avoid lifting and carrying heavy loads, stool regulation, etc.). Even in cases with pronounced pelvic organ prolapse, patients should first be treated conservatively. This is particularly the case when patients have moderate prolapse or patients are not seriously affected. This also applies to so-called prophylactic surgery (“it could get worse”, “you might be too old for surgery later on”). Younger women with mild prolapse often only need supportive measures when they do sports or other forms of physical activity. Even patients unwilling to have surgery and older patients with multiple morbidities can benefit from non-surgical measures. Conservative therapy including topical estrogen application, repositioning of the prolapse using modern silicon pessaries, and professional pelvic floor training can help to stabilize pelvic structures. Repositioning of the prolapse with the help of a pessary may also uncover hidden incontinence and is therefore an important diagnostic aspect of surgical planning. Pessaries usually serve to bridge the time to surgery but can also be used for longer periods without any problems. To avoid ulcerations, pessary use should always be accompanied by topical hormone treatment and regular checks are necessary. There are many different surgical strategies used to rectify vaginal or uterine prolapse. Fixation of the prolapsed vaginal vault or uterus can be done using an abdominal or vaginal approach. The focus here is on ensuring sufficient anchoring of the middle vaginal compartment to the supporting structures of the lesser pelvis. For many years, vaginal prolapse surgery used a vaginal approach, but this has changed in recent years and the number of surgical options has increased significantly. Surgical treatment of pelvic organ prolapse requires a detailed examination of the patient and a carefully weighing up of different aspects, including the choice of the most appropriate surgical method and the best approach ( Table 1 ). Table 1  Factors affecting the choice of surgical approach in prolapse surgery. The patientʼs state of health; merely considering the patientʼs age is not sufficient Existing anatomical and functional defects in the pelvic floor area Intraoperative and postoperative risks of the chosen surgical method The success rates of specific methods Is the patient still sexually active? The patientʼs wishes and needs in terms of outcome and quality of life The physicianʼs technical skill and experience in carrying out specific surgical techniques

A vaginal procedure is still considered the best approach to rectify pelvic floor defects. All of the relevant structures can be reached with this approach, which also offers the option of administering regional anesthesia. Adequate reconstruction is usually possible using well-established fixation techniques and autologous tissue. Apical fixation of the uterus or vaginal vault to the sacrospinous ligaments results in sufficient stability. However, the procedure results in a slight dorsal shift of the vagina to a lower position rather than the more optimal, slightly higher, physiological S1-2 position. This surgical method is particularly suitable for older patients with a sufficiently long vaginal vault. It is associated with low morbidity rates and rapid recovery. A vaginal approach is also preferred when treating patients with previous laparotomies. The slight rightward deviation of the new vaginal anchoring which occurs with the unilateral Amreich-Richter procedure has almost no negative impact on patientsʼ sexuality. The success rate of this method in the international literature is 35 – 81%; recurrence of cystocele has been reported in up to 25% of cases 14 . When fixation to the sacrospinous ligaments (SSL) was compared with fixation to the uterosacral ligaments (SUL), no difference in success rates was found at follow-up after 2 years (60.5% SSL vs. 59.2% SUL) 15 . Unfortunately, the standard and routinely performed procedure is often still vaginal hysterectomy with simultaneous anterior and posterior colporrhaphy. Careful analysis of the location of the defect followed by reconstruction the specific defect would be far more effective. Hysterectomy is usually not necessay. Rectification of a small, completely asymptomatic rectocele is often carried out but offers no benefits and should be a thing of the past 16 . The primary focus of surgical repair should be stable fixation of the apical segment. In many cases, achieving sufficient elongation of the anterior and posterior vaginal wall can make anterior or posterior colporrhaphy procedures unnecessary. The decision whether to opt for sacrospinous fixation or fixation using a modified McCall culdoplasty with incorporation and shortening of the uterosacral ligaments is usually based on tissue quality and the extent of prolapse.

Median suspension of a prolapsed vaginal vault, cervix or uterus using an abdominal approach can consist of sacrocolpopexy, cervicosacropexy or hysterosacropexy with attachment to the longitudinal anterior ligament below the sacral promontory at the S2 level or laterally with fixation to lateral pelvic wall structures. Because of the longer distance, a synthetic implant (prolene, polyvinylidene fluoride [PVDF] etc.) is used in most cases ( Table 3 ) 27 . Table 3  Various techniques used in abdominal-endoscopic prolapse surgery 27 . Median suspension of the vaginal vault, cervix or uterus to the longitudinal anterior ligament at the level of the sacral promontory or S1/S2 level Lateral anchoring of uterus or vaginal vault to the rectal fascia using a mesh while avoiding the area of the sacral promontory Laparoscopic pectopexy with bilateral fixation of the vagina or cervix to the iliopectineal ligaments at the S2 level Bilateral vaginal fixation using laparoscopic vaginosacropexy (laVASA) or laparoscopic cervicosacropexy (laCESA) with mesh placement, repair of the uterosacral ligaments, and fixation to the prevertebral fascia at the S1 level Endoscopic procedures are modifications of conventional open surgery procedures: all of the important steps in the reconstruction are carried out in the same way as in open surgery 28 . The postoperative success rates for open surgery and laparoscopic procedures are therefore equivalent 29 . Endoscopic procedures require special surgical skills, and the operating time is usually longer. On the other hand, patients benefit from the advantages of laparoscopy which include better cosmetic results, faster recovery times and a shorter hospital stay. Because of the longer operating time, older patients and patients with comorbidities should generally be treated using a vaginal approach. There is now sufficient data to compare the results of an abdominal approach with those of vaginal surgery. A recent Cochrane analysis of the treatment of apical prolapse compared outcomes after vaginal and abdominal surgery in 600 patients from 6 RCT studies 30 . After abdominal surgery, 7% of patients still reported a feeling of heaviness in the vagina; the figure for vaginal surgery was 14% (7 – 27%) (RR: 2.11). Recurrence was more common after vaginal surgery (31 – 63% vs. 23% after sacrocolpopexy, RR: 1.89). Surgery for recurrence was more common following vaginal surgery (5 – 18%, RR: 2.28) compared to abdominal procedures (4%). There were no significant differences in the occurrence of stress urinary incontinence after prolapse repair. Dyspareunia was more common in the group treated with vaginal surgery (RR: 2.53). In recent years, new open and laparoscopic techniques have been developed which do not repair the prolapse through median fixation in the sacral area or promontory but through fixation to the lateral pelvic wall. Possible cases for whom this method would be suitable are obese patients or patients with extensive adhesions which make it difficult to access the middle of the longitudinal anterior ligament. In pectopexy procedures, the iliopectineal ligament is used for lateral fixation as is also the case in colposuspension or lateral repair 31 . The CESA/VASA procedure aims to repair prolapsed uterosacral ligaments and restore them to their physiological position. This is done by bilateral lengthening for a defined length instead of single unilateral median suspension. Elevation of the uterus/vaginal vault and the bladder floor should significantly reduce the urinary urge symptoms. In a recent study, 120 women with prolapse and urinary incontinence had an endoscopic CESA/VASA procedure; in addition to a mean operating time of 88 minutes and a mean patient age of 66 years, urinary urge incontinence was resolved in in 65% of all cases, with only 4 cases requiring a repeat of apical fixation 32 . However, these data were only subjective, based on the responses to a questionnaire. Both procedures are still in their experimental stages and should be carried out by experienced laparoscopic surgeons in the context of medical studies because of the higher possibility of complications. New, robot-assisted, minimally invasive surgical systems have now also found their way into gynecological surgery and pelvic floor procedures. The Da Vinci surgical system from Intuitive offers a greater range of motion and dexterity and a higher resolution without movement artefacts, improving precision during dissection. The currently available data on sacrocolpopexy procedures report equivalent success rates and a good safety profile. New and still experimental surgical techniques should only be used under study conditions. Affected women should be informed in detail about the lack of scientific data, the lack of medium and long-term results, and established alternative techniques. Because of the complexity of the treatment options, women with pelvic floor dysfunction should be treated by certified specialists in pelvic floor centers. The opportunities for professional interdisciplinary cooperation and the range of expertise should ensure the best possible treatment of a complex and chronic problem.

The prerequisite for successful treatment is careful evaluation of the individual defect and the patientʼs symptoms of urinary incontinence and/or pelvic organ prolapse. This must include assessment of the patientʼs state of health and anesthetic risk profile. It is also important to discover the patientʼs wishes to understand the surgical and conservative treatment options and alternatives in order to offer her a realistic explanation of the individual concepts. The gold standard for treating stress incontinence remains the placement of a suburethral sling. If this option is not available, a pubovaginal sling procedure, colposuspension or intraurethral injection can be good alternatives. When carrying out a surgical repair of pelvic organ prolapse, the specific defects, the overall constellation and the patientʼs specific expectations need to be combined into a personalized concept which explores the different vaginal and abdominal/endoscopic options including autologous tissue reconstruction and the use of alloplastic material. A vaginal approach is useful for older patients, patients with posterior apical defects, patients requiring fast and non-invasive therapy, and sexually inactive patients. The results are equivalent and offer the benefit of local/regional anesthesia and shorter operating times. Abdominal and laparoscopic approaches are more suitable for younger women, patients with anterior apical defects, patients who tolerate general anesthesia, and sexually active patients. Surgical prolapse repair can often be carried out with preservation of the uterus.

In the overwhelming majority of prolapse operations, simultaneous hysterectomy is not indicated. As clearly stated in the current S3-guideline on hysterectomy procedures, extirpation of the uterus during prolapse surgery must be specifically indicated, which is usually not the case ( Table 2 ) 17 . Table 2  Contraindications for uterus-preserving prolapse repair 17 . Symptomatic myomas, adenomyosis, endometrial abnormalities Recent or previous cervical pathology Abnormal or postmenopausal bleeding Tamoxifen therapy Familial BRCA 1 and 2 risk Status post hereditary nonpolyposis colorectal cancer with 40 – 50% lifetime risk of endometrial cancer Regular gynecological follow-up not assured Uterine preservation is only contraindicated in very specific cases 18 . Preserving the uterus/cervix reduces the rate of surgical suspension failure. Recent randomized studies have shown that fixation combined with uterine preservation is superior even at follow-up after 5 years (87% success rate with sacrospinous hysteropexy vs. 76% success rate with vaginal hysterectomy and uterosacral ligament fixation) 19 . This has been confirmed in recent meta-analyses which showed equivalent outcomes with lower operating times and fewer complications if the uterus was preserved 20 . In recent years, various insertion aids were developed for the minimally invasive, tension-free fixation of the cervix to both sacrospinous ligaments. A narrow synthetic band, about 1 cm wide and 8 cm long, is transfixed to the anterior cervix and extended from the front above the vesicouterine ligament towards the sacrospinous ligament where it is fixed in place using an insertion aid. This achieves excellent and reliable suspension and leaves the cervix accessible for later cytological controls. The anterior compartment which is also usually involved can be repaired using a fascial graft. The limited alloplastic materials used are not in contact with vaginal tissue, making erosion very rare. This operation has been carried out since 2017 in our hospital and monitored under study conditions (Splentis ® , Promedon, Cordoba, Argentina). With around 300 interventions performed and a mean operating time of 22 minutes, the procedure has high subjective and objective success rates and almost no intraoperative and postoperative complications.

This year, the COVID-19 pandemic has almost completely eclipsed many, predominantly benign disorders. Particularly older and more vulnerable patients are currently shying away from visiting their GP or attending outpatient clinics to receive the necessary treatment for pronounced pelvic floor dysfunction, even though some patients are dealing with serious problems which are reducing their quality of life. This article aims to motivate all colleagues to direct affected women to seek appropriate and adequate treatment and encourage their proactive cooperation. The aim of this paper is to provide an update on the different methods available to treat urinary incontinence and pelvic organ prolapse and present the risks involved and the chances of success. With a prevalence of 30 – 35 percent in all women from the age of 50 years and above, pelvic floor disorders with pelvic organ prolapse and urinary incontinence are among the most common disorders in women and are associated with serious restrictions of everyday life and a reduced quality of life and sexual health. The female pelvic floor must fulfil two complex but contrary purposes; outside pregnancy and delivery, it functions as a firm caudal end of the abdominal cavity with regulated evacuation functions and a flexible sexual organ. Complex biochemical changes occur during pregnancy and in childbirth which enable tissues to become extraordinarily flexible and elastic but also to largely recover their previous condition post partum. This double function may lead to an increasing impairment of bladder function in later life with the loss of regulated muscular fixation and connective tissue anchoring and, consequently, displacement of the vagina, bladder or rectum outside the pelvic cavity. The urethral closure mechanism also becomes weaker following the decrease in hormone activity; the consequence can be stress urinary incontinence with involuntary loss of urine when coughing or sneezing or during physical activities. The symptoms associated with overactive bladder have a particularly severe impact on quality of life as patients suffer from urinary urgency and/or urinary urge incontinence. An individualized, differentiated, diagnostic investigation is essential for the successful treatment of such complex disorders of pelvic floor function as urinary incontinence and pelvic organ prolapse. Recording all distressing symptoms and assessing the patientʼs psychological stress together with a urogynecological examination which includes various function tests are easy to carry out and are not associated with any major technical costs.

According to the current guideline, reconstruction of the anterior compartment through plication of the endopelvic fascia has a cumulative success rate of 63% (30 – 100%), making it a good option for the primary treatment of pelvic organ prolapse 21 . After many years of experience in general surgery in treating abdominal hernias and using synthetic meshes to manage hernias, alloplastic materials have also found their way into urogynecology. Because of the favorable material properties of large pore monofilament polypropylene, this alloplastic material is widely used in the pelvic floor region. Vaginal surgery with placement of an alloplastic mesh performed by a surgeon with a lot of experience in pelvic floor surgery can still be a very successful option with many benefits and acceptable risks, if the procedure is performed in patients with the right indication and after carefully weighing up all of the benefits and drawbacks. Benefits include shorter operating times and lower morbidity rates. Meta-analyses have confirmed the efficacy of this approach, which has significantly better anatomical outcomes compared to autologous tissue repair. Subjective improvement and a better quality of life have been reported both with and without mesh use. More re-operations occur because of erosion or de novo incontinence 22 . In view of the ongoing discussions about the benefits and drawbacks and recent FDA warnings, synthetic mesh devices should only be used in cases with recurrence or very pronounced prolapse where the remaining tissue is unstable and/or the patient has suffered levator avulsion 23 ,  24 . If mesh insertion is combined with simultaneous hysterectomy, the risk of mesh erosion is 5 times higher; it is 6 times higher for inverted T colpotomy 25 . If the procedure includes mesh placement, then preserving the uterus and minimizing the extent of the colpotomy significantly reduces this complication. Particular care must be taken when treating women with immune deficiency, diabetes mellitus or pronounced hormone deficiency atrophy. Sexually active women must be informed about the potential for dyspareunia. The current generation of single incision meshes are introduced through a single vaginal incision and placed using special insertion devices directly, under palpatory or optical control of the relevant landmarks, into the medial sacrospinous ligament at the sciatic spine with no blind passage. The first analysis of single-incision mesh placement (Calistar S, Promedon) in 107 women (98.1% postmenopausal) with prolapse recurrence (87%) or complex primary prolapse (13%) at follow-up after 18.5 months reported an anatomical success rate of 98% and 92% subjective satisfaction rate. With a mean operating time of 38 minutes, there were no intraoperative complications and no incidences of postoperative pain syndrome. Six women had vaginal mesh erosion, and all of them were treated conservatively with topical application of estrogen 26 .