Methods

Allocation Concealment: unclear.
Randomisation: randomisation list, no other details reported.
Blinding: unclear.
Power Calculation: sample size based on assumption that dysmenorrhoea would resolve in 50% controls and 80 ‐ 90% PSN group. Number of included patients gives 80% power for a difference of 30% 90% power for a difference of 40%, 0.05 level of significance.
Duration of trial: Recruitment from June 1986 to Jan 1990. Follow up of all women for at least one year.

Participants

Number of women randomised: 78.
Number of women analysed: 71.
Drop‐outs/withdrawals: 7 women did not accept randomisation.
Inclusion criteria: women with endometriosis stage III or IV undergoing conservative surgery, moderate or severe midline or midline and lateral menstrual pelvic pain (dysmenorrhoea).
Diagnosis: gastro, urologic and orthopaedic evaluation to exclude other causes of pelvic pain, endometriosis confirmed at surgery.
Age: Control group mean 31.1, SD 3.6; PSN surgery group mean 32.5, SD 4.2.
Location: Milan, Italy.

Interventions

Treatment: presacral neurectomy with conservative surgery for endometriosis.
Control: conservative surgery for endometriosis.

Outcomes

Dysmenorrhoea, measured by a 0 ‐10 analog scale and by a multidimensional scale which included limitation of working ability, systemic symptoms, and need for analgesics. Data reported as mild, moderate or severe pain prior to surgery and 12 months following surgery.
Adverse effects.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Allocation Concealment: unclear.
Randomisation: unclear, stated as randomised no further details given.
Blinding: unclear.
Power Calculation: none stated.
Duration of trial: Recruited from Jan 1992 to July 1993. Patients followed up for 12 months.

Participants

Number of women randomised: 68.
Number of women analysed: 68.
Drop‐outs/withdrawals: none.
Inclusion criteria: women with primary dysmenorrhoea and/or chronic pelvic pain.
Exclusion criteria: pelvic pathology (lesions).
Diagnosis: at laparoscopy, those without lesions that could be assoc with dysmenorrhoea were randomised.
Age: 18 to 40 years.
Location: Taiwan.

Interventions

Treatment: laparoscopic uterine nerve ablation.
Control: laparoscopic presacral neurectomy.

Outcomes

Pain relief measured on a 5 point scale (0 = no pain to 4 = incapacitating pain unresponsive to potent pain relievers and the inability to function). Pain was measured at baseline, 3 months, 12 months and data was dichotomised into success 100 > 50% pain relief or failure 50 > 0% pain relief.
Adverse effects.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Allocation concealment: stated as maintained securely by storage in sealed, sequentially‐numbered opaque envelopes until the interventions were assigned during the laparoscopic procedure
Randomisation: computer‐generated random number sequences
Blinding: used; participant and investigator blinded throughout the study
Power Calculation: for women with chronic pelvic pain in the absence of endometriosis, in order to have 80% power at the 95% confidence level to detect benefit in 50% of women, assuming 'benefit' in 10% controls, at least 48 participants would be required for analysis following randomisation. For women with endometriosis, in order to have 80% power at 95% confidence level to detect benefit in 90%, assuming benefit in 60% controls undergoing conventional endometriosis surgery, at least 76 participants would be required for analysis following randomisation. Allowing for losses to follow up, it was planned to recruit 50 women with chronic pelvic pain in the absence of endometriosis (achieved) and 80 women with endometriosis (not achieved).
Duration of trial: April 1997 to Dec. 2001.
Follow up: 24 hours, 3 and 12 months.

Participants

Number of women randomised: 123 (108 with dysmenorrhoea)
Number of women analysed: 123
Drop‐outs/withdrawals: 14 were excluded based on laparoscopic findings
Loss to follow up:
24 hours: 1
3 months: 3 (2 LUNA and 0 no LUNA in the population with no endometriosis; 0 LUNA and 1 no LUNA in the endometriosis population).
12 months: 17 (4 LUNA and 2 no LUNA in the population with no endometriosis; 6 LUNA and 5 no LUNA in the endometriosis population)
Inclusion criteria: Women aged 18 to 45 years inclusive; a history of chronic pelvic pain (either dysmenorrhoea, non‐menstrual pelvic pain, defaecatory pain or deep dyspareunia for more than 6 months); no change in medication for the 3 months prior to trial recruitment. Exclusion criteria: previous hysterectomy or pelvic malignancy; previous LUNA; known ovarian cysts; plan for a pregnancy within 12 months; intention to change other medical treatment which could influence pelvic pain scores within 12 months; laparoscopic findings rendering LUNA impossible (for example frozen pelvis with no access to uterosacral ligaments) or the finding of pelvic adhesions which did not appear to be due to endometriosis.
Location: Auckland, New Zealand.

Interventions

2 groups:
Group with endometriosis:
Treatment: LUNA with conservative surgery for endometriosis.
Control: conservative surgery for endometriosis.
Group without endometriosis:
Treatment: LUNA at laparoscopy.
Control: laparoscopy alone.

Outcomes

Changes in non‐menstrual pelvic pain, dysmenorrhoea, deep dyspareunia and dyschezia were assessed primarily by whether there was a decrease in visual analog score for these types of pain of 50% or more from baseline; additionally whether there was a significantly different change in median visual analog score. The numbers requiring further surgery or starting a new medical treatment for pelvic pain and complications were also measured.
Adverse effects: no important intraoperative or postoperative complications occurred (specifically there were no cases of ureteric injury, intraoperative bleeding nor postoperative haematoma formation), other than 2 women who had urinary retention requiring catheterisation within 24 hours of the surgery (both in the endometriosis population not undergoing LUNA).

Notes

137/200 agreed to participate; 14 excluded at laparoscopy; follow up at 12 months: 106/123 (86.2%).

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Allocation concealment: inadequate.
Randomisation: randomised by last digit of medical case number on day of surgery.
Blinding: both participant and clinical psychologist, who recorded outcomes, were blinded.
Power Calculation: none stated.
Duration of trial: 12 mths

Participants

Number of women recruited: 39. 18 were excluded due to pathology (endometriosis, PID).
Number of women randomised: 21.
Number of women analysed: 21.
Drop‐outs/withdrawals: none.
Inclusion criteria: women with severe dysmenorrhoea and no improvement with at least 2 NSAIDs and an oral contraceptive (30 and 50 ug of estrogen only) concurrently.
Exclusion criteria: history of psychotherapy, major abdominal procedures, drug abuse or demonstrable pelvic pathology.
Diagnosis: diagnostic laparoscopy.
Age: 18‐34 yrs.
Location: USA.

Interventions

Treatment: laparoscopic uterine nerve ablation.
Control: diagnostic laparoscopic surgery only.

Outcomes

Pain was measured on a five point scale (0 = no pain to 4 = incapacitating pain unresponsive to potent pain relievers and the inability to function). Pain scores for each patient were reported preoperatively and at 3mths and 12mths.
Adverse effects.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate

Methods

Allocation Concealment: unclear.
Randomisation: computer‐generated randomisation sequence.
Blinding: double; participant and research nurse.
Power Calculation: done; sample for 90% power was 22 women in each group.
Duration of trial: women assessed at 3 and 6 months post operative (recruitment occurred over 33 months Feb.1995 to Nov. 1997).

Participants

Number of women randomised: 51.
Number of women analysed: 46 at 6 months.
Drop‐outs/withdrawals: 5 (1 became pregnant and 4 were lost to follow up). However data points for to 14 women were missing for some analyses.
Inclusion criteria: women with history and physical or laparoscopic examination suggestive of endometriosis who had not received medical treatment for endometriosis within the last 6 months, and had not previously undergone surgical treatment of their disease.
Exclusion criteria: stage IV disease or any other pathology that may have been responsible in whole, or in part for their symptoms.
Diagnosis: at laparoscopy those with stage IV disease or other pathology were excluded.
Age: mean 28 (20 to 41).
Location: Surrey, UK.

Interventions

Treatment: LUNA with laparoscopic treatment of all visible endometriosis.
Control: laparoscopic treatment of all visible endometriosis .

Outcomes

Dysmenorrhoea, measured by linear analogue scale (0 ‐ 10) and pain scoring questionnaire.
Adverse effects.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear

Methods

Allocation concealment: adequate.
Randomisation: centralised randomisation process, with sealed, opaque, sequentially numbered, identical envelopes.
Blinding: single; randomised participants were blinded.
Power Calculation: none stated.
Duration of trial: 6 months post‐operative; however follow‐up continued for a minimum of 42 months.

Participants

Number of women randomised: 8; also 18 women not randomised but followed up.
Number of women analysed: 26.
Drop‐outs/withdrawals: none.
Inclusion criteria: women with moderate to severe dysmenorrhoea scheduled to undergo laparotomy for conservative resection of endometriosis.
Diagnosis: initial detailed history of pain and anatomical diagram for localisation of dysmenorrhoea, endometriosis confirmed at laparotomy.
Age: mean 30 yrs.
Location: USA.

Interventions

Treatment: presacral neurectomy and resection of endometriosis.
Control: resection of endometriosis only.

Outcomes

Relief of pain was reported as the number of women with pain relief in 3 locations.
Adverse effects.

Notes

Data analysed pooled, and split into protocol (randomised) and non‐protocol (non‐randomised) groups. Study stopped by monitoring committee after 26 participants, as it was considered unethical not to provide those with midline dysmenorrhoea the pain relief that PSN exhibited.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Allocation concealment: adequate.
Randomisation: computer‐generated randomisation in single blocks.
Blinding: used; patient and investigator blinded throughout the study.
Power Calculation: sample size based on assumption that dysmenorrhoea would reoccur in 30% of the controls and 10% of the treatment group. 72 patients were needed in each group to demonstrate a difference of 20% between control and treatment groups and to define statistical significance between the groups with an alpha of 0.05 and beta of .20.
Duration of trial: Sept. 1998 to Oct 2001.
Follow up : 6 and 12 months.

Participants

Number of women randomised: 180.
Number of women analysed: 116.
Drop‐outs/withdrawals: 29 pregnant, 14 used oral contraception, 15 lost to follow‐up, 6 miscellaneous reasons.
Inclusion criteria: Aged 18 to 40, undergoing first‐line operative laparoscopy for symptomatic minimal to severe endometriosis who reported pelvic pain of more than 6 months duration.
Exclusion criteria: previous diagnosis of endometriosis, other diseases that might cause pelvic pain, treatment for endometriosis other than nonsteroid anti‐inflammatory drugs up to 6 months before entry in the study, presence of vaginal endometriotic lesions, previous diagnosis of gastrointestinal, urologic and orthopedic diseases in which pain may radiate to the pelvic area, known psychiatric disturbances.
Age: 18‐40. mean for each group not given.
Location: Milan, Italy.

Interventions

Treatment: conservative laparoscopic surgery with the addition of uterosacral ligament resection.
Control: conservative laparoscopic surgery.

Outcomes

Dysmenorrhoea, measured by a 100 mm visual analog scale that ranged from "least possible pain" to "worst possible pain". Frequency was expressed as the number of episodes per each cycle for dysmenorrhoea and chronic pelvic pain.
Hospital anxiety and depression scale, sexual rating scale, SF 36.
Adverse effects: None attributable to pelvic denervation

Notes

Proportion of women satisfied with the treatment were similar.

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Low risk

A ‐ Adequate

Methods

Allocation concealment: inadequate.
Randomisation: Women with even hospital nos.(assigned on the day of surgery) were cases and those with odd hospital nos. were controls.
Blinding: double; patient and clinical psychologist.
Power Calculation: not stated.
Duration of trial: follow up at 1, 3 and 6 months.

Participants

Number of women randomised: 85.
Number of women analysed: 80 at 1, 3 and 6 months.
Drop‐outs/withdrawals:5 (1 in each group had procedure converted to abdominal hysterectomy due to adhesions, 1 became pregnant and 2 were lost to follow‐up).
Inclusion criteria: women with symptoms of uterine myomas, including dysmenorrhoea, menorrhagia, and bulk related symptoms, documented absence from school or work due to dysmenorrhoea and no response to OC or NSAIDS for at least two cycles.
Exclusion criteria: history of psychotherapy, major abdominal surgery or drug abuse.
Diagnosis: ultrasound.
Age: Control group mean 43.1, SD 5.1;
Treatment group mean 44.5, SD 4.4.
Location: Taipei, Taiwan.

Interventions

Treatment: laparoscopic uterine nerve ablation with laparoscopic bipolar coagulation of uterine vessels (LBCUV).
Control: LBCUV.

Outcomes

Dysmenorrhoea, improvement measured by analgesic use, and scale ‐ completely resolved, significantly improved, slightly improved, unchanged or worsened. Pain data was reported the numbers of women slightly, significantly or completely improved.
Adverse effects.

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

High risk

C ‐ Inadequate

Methods

Allocation concealment: unclear.
Randomisation: computer‐generated randomisation in single blocks.
Blinding: double; participant and investigator blinded throughout the study.
Power Calculation: sample size based on assumption that dysmenorrhoea would resolve in 50% controls, 58 women were needed in each group to demonstrate a difference of 25% between control and experimental groups and to define statistical significance between the groups with an alpha of 0.05 and beta of 0.20.
Duration of trial: Sept. 1998 to Oct 2001.
Follow up: 6 and 12 post operative.

Participants

Number of women randomised: 141.
Number of women analysed: 126.
Drop‐outs/withdrawals: 7 due to the presence of other gynecological diseases, 5 because endometriosis was not confirmed, 3 failed to undergo postoperative subjective evaluation of dysmenorrhea.
Inclusion criteria: sexually active women of fertile age with severe dysmenorrhea for more than six months who were unresponsive to medical treatment and had a clinical and/or ultrasonographic diagnosis of endometriosis.
Exclusion criteria: pregnancy, women without midline dysmenorrhoea, breastfeeding, use of an intrauterine device, major medical diseases, psychiatric disorders, neurologic alterations of the lumbar‐sacral tract, previous pelvic surgery, history of severe abdominal or pelvic infection, presence of other gynaecologic diseases, body mass index of >30 kg/m2, history of alcohol or other drug abuse.
Age: control group mean 31.8, SD 4.9; PSN surgery group mean 30.1, SD 3.7
Location: Catanzaro, Rome and Messina, Italy.

Interventions

Treatment: laparoscopic presacral neurectomy with conservative surgery for endometriosis.
Control: conservative surgery for endometriosis.

Outcomes

Dysmenorrhoea, measured by a 100 mm visual analog scale that ranged from "least possible pain" to "worst possible pain". Frequency was expressed as the number of episodes per each cycle for dysmenorrhea and chronic pelvic pain.
Adverse effects: Significant bleeding from middle sacral vein in 1 woman in treatment group, initial urinary retention in 2 women in treatment group; significant increase in operating time in treatment group (P value < 0.05).

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Allocation concealment?

Unclear risk

B ‐ Unclear