Evaluation of two vaginal, uterus sparing operations for pelvic organ prolapse: modified Manchester operation (MM) and sacrospinous hysteropexy (SSH), a study protocol for a multicentre randomized non-inferiority trial (the SAM study).

Sascha F M SchultenRosa A EnklaarKirsten B KluiversSanne A L van LeijsenMarijke C Jansen-van der WeideEddy M M AdangJeroen van BavelHeleen van DongenMaaike B E GerritseIris van GestelG G Alec MalmbergRonald J C MouwDeliana A van Rumpt-van de GeestWilbert A SpaansAnnemarie van der SteenJelle StekelenburgE Stella M TiersmaAnneke C Verkleij-HagoortAstrid VollebregtChantal B M WingenMirjam WeemhoffHugo W F van Eijndhoven

Published in: BMC women's health (2019)

Dutch Trial Register (NTR 6978, http://www.trialregister.nl ). Date of registration: 29 January 2018. Prospectively registered.

Keyphrases

phase iii
phase ii
study protocol
clinical trial
double blind
open label
placebo controlled
randomized controlled trial