Asymptomatic stage 2 pelvic organ prolapse seldom progresses

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.

SCOTTSDALE, ARIZ. – Women with asymptomatic stage 2 pelvic organ prolapse can be reassured that it rarely progresses, according to the results of a study reported at the annual meeting of the Society of Gynecologic Surgery.

Investigators led by Dr. Peggy A. Norton, chief of urogynecology and pelvic reconstructive surgery at the University of Utah in Salt Lake City, performed a secondary analysis of the 597 women undergoing surgery for stress urinary incontinence in the randomized TOMUS (Trial of Mid-Urethral Slings) study. Analyses were based on the 291 women (49%) who also had stage 2 prolapse – a group for whom the need for repair has been a gray area.

The results showed that among the 189 women who had asymptomatic prolapse and did not have concomitant repair at the time of continence surgery, just 2% experienced progression to stage 3 prolapse after 6 years of follow-up. Moreover, none underwent surgery for the prolapse during that time.

This very low rate of progression was surprising, according to Dr. Norton, and noteworthy in that these women were being rigorously followed up in a trial.

"We would conclude that surgeons may counsel women with asymptomatic stage 2 prolapse that their prolapse is unlikely to progress or even unlikely to require surgery in the next 5-7 years. Said another way, it is not necessary to perform concomitant anterior prolapse surgery for asymptomatic stage 2 anterior prolapse when performing a mid-urethral sling for stress incontinence," she said at the annual scientific meeting of the Society of Gynecologic Surgeons, jointly sponsored by the American College of Surgeons.

In additional findings, among the 47 women who had symptomatic prolapse and did have concomitant repair at the time of their continence surgery, just 6% underwent another prolapse repair during follow-up (2 at 36 months and 1 at 48 months). The women who underwent another repair typically had a repeated anterior prolapse or an apical prolapse, but the numbers were too small to definitively pin down any pattern.

Invited discussant Dr. Jeffrey Mangel, director of the division of urogynecology and pelvic reconstructive surgery at the Metrohealth Medical Center, Cleveland, noted, "This is a very common clinical scenario; we see this every week – patients who have primary stress incontinence who have some mild degree of anterior wall prolapse – and the question is how to manage that."

"This was an impressive long-term surgical follow-up," he commented. However, "the surgical bias is there; that is, we know how we counsel patients can influence what patients decide to do or not to do in response to these milder degrees of symptoms and findings on anatomy.

"Were the patients in the TOMUS trial who had concurrent prolapse surgery (or not) evenly distributed across all the study sites, and were there any differences in stress incontinence outcomes in patients who had their prolapse repaired and those who didn’t?" Dr. Mangel asked.

There were some differences in surgical intervention across institutions, as might be expected in a multicenter trial, Dr. Norton said. The results for the whole trial population at 2 years of follow-up, previously reported, showed that concomitant repair did not adversely affect continence outcomes (N. Engl. J. Med. 2010;362:2066-76). "Doing a concomitant procedure didn’t increase the number of [adverse events]; it just changed the type of [adverse events] that we saw. But it didn’t change the primary outcome for stress urinary incontinence.

"I think we would all agree it is hard to improve in an asymptomatic patient, but how, given these findings, would you counsel a patient about symptomatic stage 2 anterior wall prolapse who is a candidate for a sling procedure with regard to concurrent repair of the prolapse?" Dr. Mangel asked.

"It has to be an individual discussion between the surgeon and the patient," Dr. Norton replied. "We have always told patients, have everything repaired at the time, while we are in there anyway. I think what’s changed for me is the minute we saw these results, I was able to say to patients, if we repair this stage 2 prolapse, you have about a 6%-7% chance that over the next couple of years, we’ll have to repair it again. And it seems like for patients who don’t have any bother, that none of them go on [to need repair]. So it may be that there’s a difference in patients feeling that stage 2 prolapse that may be one of the critical issues."

The decision to perform concomitant prolapse repair in women undergoing continence surgery is typically clear-cut if the prolapse is stage 0 or 1 (no) or stage 3 or 4 (yes), according to Dr. Norton. "But it’s more difficult to counsel patients on defects that have some intermediate anatomy or intermediate levels of bother or even no bother."

The total 575 women in TOMUS underwent either a retropubic or transobturator continence procedure. Concomitant vaginal procedures to repair pelvic organ prolapse were allowed at the surgeon’s discretion after discussion with the patient.

The women were assessed at baseline and annually for 5-7 years after surgery with the Urinary Distress Inventory (UDI) and the Pelvic Organ Prolapse Quantification System (POP-Q).

About a quarter of women with stage 2 prolapse had symptoms according to responses on the UDI. As expected, 70% of those who were symptomatic, but only 15% of those who were asymptomatic, had a concomitant repair at the time of their continence surgery.

"These findings are not generalizable to women with higher stages of prolapse since we really only had sufficient power to be looking at stage 2’s," said Dr. Norton. "Also, this was a primary randomized trial of stress incontinence, and patients were not randomized to receive or not receive concomitant prolapse repair, so it really limits our ability to [control for] selection bias or surgeon bias."

Dr. Norton disclosed no relevant financial conflicts of interest.